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Technological Innovation

229 How the A.R.T. Innovation Revolution will Replace the Current IVF System with Cynthia Hudson

Today’s Advertiser helped make the production and delivery of this episode possible, for free, to you! But the themes expressed by the guests do not necessarily reflect the views of Inside Reproductive Health, nor of the Advertiser. The Advertiser does not have editorial control over the content of this episode, and the guest’s appearance is not an endorsement of the Advertiser. The views and thoughts expressed by the guest are their own and do not mean they are the views and thoughts of their employer.


Are you willing to fight for what’s necessary to lead the fertility innovation revolution, or will you be a replaceable part when the new system emerges?

Cynthia Hudson, veteran embryologist and scientific advisor, gives an earnest look at the current fertility system, the driving forces replacing it, and what that means for today's REIs.

Tune in to hear Ms. Hudson discuss:

  • The verticals creating a new disruptive system replacing the existing one (And the ones we’re missing)

  • New solutions revolutionizing the IVF space (Some you haven’t heard of)

  • REI’s income potential if they lead innovation (And what happens if they don’t)

  • What it actually means to be leading the innovation revolution (Particularly in the IVF lab)

Cynthia Hudson
LinkedIn


Transcript

[00:00:00] Cynthia Hudson: It costs a lot of money to provide these services, and I think if we take the opportunity to kind of re imagine how this infrastructure should and could look like, I think we can dramatically lower the cost of providing these services, and I think we can, Still, you know, listen, everybody wants to make money.

I think there's plenty of money to be made. I think the percentage of the market that is untapped is more than enough to go around, and I think there's a way to do it by lowering the cost of not just artificially lowering cost of providing the service, but actually lowering the cost of providing the services by using some technology and other innovative ways of approaching things.

[00:00:41] Griffin Jones: Something happened in one of the IVF labs of lab director, Dr. Chad Johnson, and he caught it. Listen to this story. Tell me about the story where you realized that two of your embryologists hadn't refilled the tank.

[00:00:54] Dr. Chad Johnson: Yeah, it's actually sort of just a simple anecdote, which has, I guess, bigger consequences.

In one of my labs, The staff got very busy, as they do. These, you know, having done IVF myself, I know what it's like to get busy in a lab. I go on our portal on a regular basis, almost daily really, and I look at, because I'm an off site director, I'm able to go on my PC or my phone and look at that lab's tanks and see how they're doing.

And I noticed that the tank hadn't been filled. It was still well within And, you know, well, it was not even close to being an issue. And I waited till the next day and I noticed that later the day, the next day, they filled the tank and it just changed by one day, the tank count, the fill calendar, the level went back up to normal.

There was no danger in that particular day. So I said to them the next day, I just texted them and said, Hey folks, notice that the tanks didn't get filled yesterday. Great. I'm so glad to see that they're filled today. If the tank had gone to a critical level, it would alarm. Everyone would get texts, phone calls and everything.

You don't want it to get to that level. A tank can have anywhere from 50 to 200 patients in it. I mean, the difference is monumental, which is why when these accidents happen, California, Ohio, and there's been many others, you then end up with multi million dollar lawsuits. And, and that's not even really the point.

The point is that you have lost hopes and dreams. Hundreds of patients. Our goal is to never let that happen.

[00:02:21] Griffin Jones: That's why Boreas Monitoring Solutions was started.

[00:02:25] Dr. Chad Johnson: When people hear the difference between this system and, and several others. They get it, just want to know, you know, that's one of the things where as we do this, we keep adding features to this, like quality control measures and things where people can sign in every day and when they sign in, it automatically clicks a quality control that shows that they physically looked at the tank through the portal.

[00:02:46] Griffin Jones: Visit BoreasMonitoring. com/demo to schedule that time with Dr. Johnson, co founder of Boreas Monitoring Solutions.

[00:02:54] Dr. Chad Johnson: It's a live event, so you can show all the screens that are available, everything from the tank levels to the list of folks who are on call, how do you change the call numbers, the fill chart, the quality control information that's available to you.

Dr. Chad Johnson, I have a PhD and an HCLD in Reproductive Physiology. I'm currently a lab director at Bloom Fertility in Atlanta, Georgia, as well as Virginia Center for Reproductive Medicine in Reston, Virginia.

[00:03:29] Griffin Jones: That's boreasmonitoring. com/demo.

[00:03:33] Announcer: Today's advertiser helped make the production and delivery of this episode possible for free to you, but the themes expressed by the guests do not necessarily reflect the views of Inside Reproductive Health, nor of the advertiser.

The advertiser does not have editorial control over the content of this episode, and the guest's appearance is not an endorsement of the advertiser.

[00:03:57] Griffin Jones: So I recorded this conversation with Cynthia back in November of 23. It's being released now in summer of 24. I thought about having it re recorded, but I would rather just have Cynthia back on because there's too much good content. Thought in this conversation. You should listen to it. We should have Cynthia back on.

Enjoy. My guest today gave me a new way of thinking about not just the innovator's dilemma for the incumbents, but a question I've been teasing a lot with different guests and different topics on the show is what's preventing the new emergent disruptive system from taking over and supplanting the existing one.

That guest is Cynthia Hudson. You might know her because she advises a number of different companies, both incumbents, early startups, and those somewhere in between. She owned a fertility clinic, she owned an IVF lab, she's an embryologist if I didn't say that already. And she makes me think that the reason why we might not have seen a disruptive system supplant the existing one already is because we still need a few more verticals for that system to layer on top of.

She talks about those verticals, these new solutions that she sees as revolutionizing the IVF space, some of which you might have not even heard of, and she talks about a couple verticals that might be missing. It could be the case that those verticals need to be in place before a new system can take over, but it could be the case that we're almost there.

A lot of these solutions are 2, 3, 4 years old. They're rising to some degree of maturity. Maybe we need more of them. Maybe they need to reach a greater degree of maturity. But it seems to me that once those pieces are in place, that's when the old system is seriously threatened. If that investor was right that the REIs Best earning days are behind them if they're not part of the technological revolution, not leading the innovation revolution.

And we can extrapolate that to embryologists and other clinicians and scientists. Then where are you in that revolution? Are you more than a couple years out from retirement? And if you are, are you only going to see your influence and earning potential decrease? Or are you leading this revolution? Are you fighting for these new solutions and improvements?

Because as Cynthia points out, you don't need all of these verticals in place to improve the existing system. There are already immediately obvious efficiencies that are being implemented by the avant garde, but maybe more slowly by others. Cynthia talks about what those solutions are. They reduce administrative burden.

They triage and prepare patients. They add speed and safety to the IVF lab. She names names. I can't fight for any of these solutions because I'm not a clinician, I'm not a scientist. You are. You're the one that can vet them. And if you feel strongly enough about any of them, you're the one that has to fight for them.

Your clinic, your network have to consider the cost benefit. Is their timeline for evaluating cost benefit shorter than yours? And if it is, are you willing to fight for what's necessary to be leading the innovation revolution? Or will you be a replacement part when the new system emerges? Cynthia talks about What it actually means to be leading the innovation revolution, particularly in the IVF lab, what are embryologists going to be doing when they're not technicians?

She talks about the biggest problems that they will be solving. She wishes she had thought of non invasive genetic testing to replace what we're currently doing to biopsy the embryo. because she identified that as one of those critical verticals that's still missing, but we can have her back on for another interview and do a whole topic on that if you like.

In the meantime, enjoy this conversation and let me know, have you tried out any of these solutions? Do you think they're for real or not? And are there others that you think are complete game changers? Send me an email. Enjoy. Ms. Hudson, Cynthia, welcome to the Inside Reproductive Health Podcast.

[00:07:32] Cynthia Hudson: Thanks so much, Griffin.

It's a pleasure to be here.

[00:07:34] Griffin Jones: You are a person that I have known in my periphery for a while. It feels like a couple years that you're someone that I've known as an acquaintance here and there, but I feel like I've gotten to know you more, I don't know, the last six months or the last year. You're someone that I've really enjoyed getting to know.

I perceive you as a popular person. A lot of people know you and seem to like you. And you're also one of those people that seems like, oh, they're really nice. Are they actually that nice? And then as I've gotten to know you more so far, I, I don't know. You could still do a 180, Cynthia. I don't know. You might, you might have a, a, a skeleton in your closet that you're, that you're, you're holding out for a rainy day.

But so far, from what I can tell, it's like, wow. She's, she's really that nice of a person. And and then I've come to realize that part of the reason why many people know you is that you advise a lot of different companies you're involved with. Some. who I would call incumbents some folks that are maybe not incumbents yet, but also probably past the stage of, of what we'd call early startups.

And then it seems like also some early startups. And so, I'm curious as to what it is that you're puzzling together that that's brought you to all these different companies. What are these different needs being filled? What's the ultimate purpose that, that you're puzzling together?

[00:08:54] Cynthia Hudson: Well, that's a loaded question.

And for the record, I, I have a pretty high monthly tab of paying people, you know, to say they're nice. So, you know, thank you to all of those people publicly.

[00:09:03] Griffin Jones: I can't wait to get my, my 5 Starbucks gift card this month.

[00:09:08] Cynthia Hudson: That's exactly right. Yeah, so, you know, great question. I think, you know, I mean, I think one of the things that I've always So, I think that's all I've sort of had in the back of my mind is, you know, how do we, how do we move the needle on expanding access to care?

I think it's I think it's, it's a real, you know, the nicest way to say it is shame that we don't have more people running through our top of the funnel and getting into treatment. You know, infertility has been defined as having the same, you know, catastrophic consequences on, on mental health and, you know, there's PTSD and it's just as traumatic as having a cancer diagnosis and all of these things that, you know, are really The sort of life altering and damaging and changing, and I think that, you know, we have so many cool new things that, you know, are either currently within our grasp or very near to within our grasp that we can kind of deploy and use to bring this type of care to more people.

[00:10:07] Griffin Jones: So, what are those different things, those different, those things that are within our grasp or almost within our grasp, and maybe before we get to what those different solutions might look like, describe those different problems, like when you think of the different companies that you advise on or the different challenges.

that you see to providing this demand. What are they specifically?

[00:10:33] Cynthia Hudson: I mean, I think that, you know, fertility is a fairly young field, relatively speaking and it's not a diagnostic science. So an embryology laboratory is, is a, is a, is not a diagnostic lab, it's more of a therapeutic lab. So, it's an extension of medical treatment and it is not something that you know, some people don't undergo an IVF cycle to get a diagnosis of infertility, right?

So, it's a treatment and because of that treatment modality and because of the lack of, you know, intense standardization, it's a very manual, labor intensive process that takes, you know, Basically takes a village, so you need a physician, you need a nurse, you need a someone to recover you in the operating room, you need a pharmacy to administer meds, you need an embryology laboratory to do an egg collection, an ICSI, you need to do you know, somebody has to do a semen analysis, there's, there's a, there's a whole range of things that come into this therapeutic treatment and Much of that is still fairly, I guess, manual, labor intensive, and so it's expensive.

It's expensive to do, and I think, you know, the opp some of the opportunities that we have in front of us are to, you know, kind of use technology to, you know, To take away some of that administrative burden that we have. So, you know, for instance, we have a, you know, we have electronic medical record systems now.

And some of those electronic medical record systems are more or less easy to enter and extract data from. Some of those systems talk to a pharmacy. Some of them talk to, you know, a testing laboratory. And, you know, how does that data transact and how much, how much duplicate entry do we have to do? I'm working with a company, TMRW Life Sciences, it's not a secret, and what they've done is they've automated some of the process of cryo storage so that we can do a proper specimen management with an immutable audit trail so that the embryologist, who is an embryologist, doesn't have to write down things and remember them and then write them down again and make decisions that We, that don't require the skills of an embryologist.

You know, we have a lot of people in our community, in our world, that don't necessarily know how to get into the front door. And so we have tools like this other company that I, that I advise. It's called Levy Health. And what they've done, they've built an algorithm and they've built a decision support tool to take women who are you know, experiencing some level of difficulty and get them into you know, into a diagnosis a little bit faster.

And whether that diagnosis leads to seeing an endocrinologist for a thyroid disease or whether that just leads to a diagnosis of PCOS and she goes to her OB GYN and, and You know, get some treatment there or whether that leads to an infertility diagnosis and they can go right into, you know, the, the fertility industry.

I think it's, you know, we're using, we're using tools and technology to, to get more people through that sort of funnel. In a more efficient way.

[00:13:40] Griffin Jones: One of the reasons why I wanted to bring you on was to talk about the the path for what it will look like for embryologists in the future when they're not doing some of these things.

But you've laid out a few different solutions and I've asked this question to a couple different people on the show and I've gotten a different range of perspectives, which is, are we able to implement these solutions? into the existing system that we have right now, the existing clinic and lab structure that exists, or does something else have to replace it?

And what analogy I think of is, Cynthia, if I wanted to do this 30 years ago, I would have needed a radio station with a a massive production studio with really

A really expensive engineering system and a X hundred foot tower that could could breach 50, 000 or 100, 000 megawatts on the frequency modulation band, like a ton of infrastructure. And now I have What's essentially a talk show for a fraction of that cost. And so there's no coming back for the radio companies.

They're too committed to that, that, that cost. And it's eventually sinking them and, and they're, they're just not, you know, in that space anymore. They're, They're going on to other areas of telecommunication, and I wonder, in our field, is it going to be something that the existing system can just bring on these solutions as you've described, or is something else going to replace it because there's too much of a sunk infrastructure cost that's unnecessary in the existing system?

[00:15:40] Cynthia Hudson: Yeah, that's a great analogy. I mean, I think, you know, I mean, I think a couple of things. I, I don't think the current infrastructure is going away anytime soon. I mean, think about it, radio stations, you know, in your scenario still exist, right? They still function, they still, you know, they still generate revenue.

They do, you know, so, you know, just in spite of themselves, and in spite of the inefficiency, in spite of the large overhead, and in spite of the cost, they still manage to, to maintain. And so I think that's going to be, I think we're going to see the same thing here. You know, I, I, I believe there's going to be kind of a second, you know, sort of infrastructure design that comes up in parallel at this point.

So the existing in infrastructure will, they will adapt and change slowly, but there's no way to take all of this, raise it down, and then just replace it with something else, right? So, so this is going to continue to iterate and, and, and change and, and this is going to come up sort of in parallel and then, you know, maybe this will eventually die out and maybe this will become sort of like a niche.

You know, for certain markets or for certain, you know, populations, but I, I, I don't believe that the current industry is, is capable or is is equipped to scale in its current form, you know, without some of Some big inherent changes. You're talking about, I mean, think about it. If you have, if you had a, if you, you run a clinic, right?

And so how do you make an appointment? You know, somebody picks up the phone, you've got a website, and you've got a phone number, and then you call, and somebody, you pay someone to sit there and answer the phone to schedule an appointment. You know, if you had technology that could do that for you, and some clinics have done this, right?

So there's, you know, again, you're inching towards change, but You know, it doesn't necessarily negate the need for someone to answer the phone, but that person that answering the phone is then answering sort of real tangible questions where that they don't have to sit and waste their time looking at a calendar when human is capable of doing that themselves.

I mean, I would like to do as much as is humanly possible from my phone without talking to a human. And for the people out there, if you want to leave me a voicemail, it's okay. But I'd prefer you just text me, right? I would prefer that you, you know, just, I'm more of a short, get to the point kind of a person, and if you really need to talk to me and I miss the call, I will call you back.

But I think, you know, is it going to go away? Maybe eventually, but I think it's going to be hard to, to change. You're, you're asking A very successful business to rip up their organizational chart and just throw departments out the door, right? It's just not going to happen. So it's, you know, the ability for these people to shift from this to this is, you know, it's going to go from here to here.

To here, to here, to here. And in the meantime, I think it's, it's almost easier in certain respects to just kind of start brand new. Like, okay, let's take the best of this. Let's take the best of this. Let's, let's use this technology from the get go so that it's baked into our infrastructure. It's baked into our org chart.

It's baked into our, into our you know, to our costs. And it's, it's, this is how we're going to figure out. I mean, it costs a lot of money to provide these services. And I think if we take the opportunity to kind of re imagine how this infrastructure should and could look like, I think we can dramatically lower the cost of providing these services.

And I think we can still have You know, listen, everybody wants to make money. I think there's plenty of money to be made. I think the percentage of the market that is untapped is more than enough to go around, and I think there's a way to do it by lowering the cost of not just artificially lowering cost of providing the service, but actually lowering the cost of providing the services by using some technology and other innovative ways of approaching things.

[00:19:40] Griffin Jones: I think that if you're under, say, age 60, or I guess it depends on how far away you are from retirement, but if you're more than three, five years away from retirement, I think that the only, maybe not the only, but the surest path to success is going to be part of this innovation. I heard someone say recently that that we have reached the apex of how much REIs are going to earn.

Now, this is this person's speculation, but this, I, I thought it was an interesting speculation and, and that they could be right, that the only way that REIs are going to continue to earn more is if they're part of the innovation. Wave, and we might extrapolate that to embryologists and, and other clinicians and scientists as well.

And that if they don't, that if they're part of the current existing system, like radio, they're going to earn less and less and less. And and I think they could be right about that. And I understand your point about Why it's so hard for the existing infrastructure to adapt, partly the reason I understand that is because it's called the innovator's dilemma.

There's a book that Clay Christensen wrote that Dr. Hariton hit me to that, that gives that really explains that. But then why has it been so hard for whatever the new emerging disruptor infrastructure to be to emerge? Like, We haven't seen it yet. And we've seen people try in different ways. We saw a company earlier this year go out of business that had bought clinics and that was their way of trying to get the data to implement the solutions while they introduced new technology on the lab side.

And it didn't happen. I don't know if it wasn't enough money. I don't know if it wasn't execution. But And I'm not picking on those people either. I hope that they return and kick ass somewhere else with the lessons they've learned. But there are others as well that it's like, oh, I thought that was an end to end solution, but they seem to be bleeding money.

And so why is that? Haven't we seen this disruptor, new infrastructure develop?

[00:21:59] Cynthia Hudson: I, I think we're getting close. I mean, I, I think we're on the cusp. I think that it's, it's hard to, it's hard to be an innovator, you know, sometimes. It's hard to do something that goes against, you know, the certain dogma, like this is how we've always done it.

You know, I think that it's, it's a, it's a symptom of, you know, I don't know, it's, it's not necessarily lack of will. It's, it's, it's, it's having the right people in the room and having the right sets of tools and having the right backers at your disposal. I think there's every reason to believe that, you know, there's, there's, there's, there's I don't know, not to say the point solutions, but they're, this, this company solved this problem, and this company solved this problem, and this company solved this problem and it just, it's going to take, you know, a matter of stringing these things together and putting them into an infrastructure that, that make people really want to, you know, I want to go there.

I was talking Rita Bacena, she's a, a scientist and she's, I mean, everybody knows Rita, but we were having a discussion the other day about what barriers, you know, to, to adoption and why people didn't have, why weren't people jumping on, you know, some of these new technologies and new infrastructure.

And, you know, I said, I said, truthfully, I think, I think the innovators and the technology builders and Designers in the space have not done the best job of selling the value proposition or demonstrating the value proposition. And so it's a, it's a, it's a, it's a marriage of blending you know, solid data, real world evidence with cost benefit analysis with communications.

And it's, it's not just one sort of skill set. It's a, it's a skill set that, you know, this person has and this person has and this person has. And I think, you know, what seems patently obvious to you or me, and this is fantastic, why doesn't everybody use it? You know, that, that's just not how businesses work and we've seen businesses fail, you know, because of that.

So, it's. So, you know, we need to do a better job of making sure that our message is being heard and understood and that there is actually real value. And if there isn't, you know, what then is the value? You know, is it that there's no clinical benefit, but there's a workflow benefit? There's value there, right?

So, you know, an example there's a company called DX Now.

So, for either IUI or for IVF or ICSI procedures, and the, the company is DXNOW, and they say, you know, if it, I've always said if it never showed a clinical benefit, which I think it might, but I think if it never showed a clinical benefit, I'm still getting from A to B. Faster, I'm getting there with fewer steps, I have fewer opportunities to make a mistake, because I am a human, and I'm well meaning, but I'm fallible, and I can make a mistake from transferring this specimen from here to there.

To hear, to hear, to hear. I could mislabel something. I could make, you know, we don't want to have, you know, it's, it's a, it's a massive problem to maintain chain of custody. And I think the, the reduced workflow and the reduced number of steps Regardless of a clinical benefit, you know, let's put, let's put them in two buckets, right?

Like, what, what is the value that you're trying to convey to, to the clinicians? And it's, it's a, it's just a matter of, yeah, it's, it's, it's telling, it's telling the story in such a way that communicates what you think and what you believe. And, and you ought to have the data to back it up because if you don't have the data to back it up, whether, again, on an efficiency side or a clinical value side, then you probably should go back to the drawing board.

[00:26:00] Griffin Jones: So you've got these different solutions that are bringing the value on the clinical side or some that, like you said, if they never show a clinical benefit, there's still that value in spades on the efficiency side. Is it that each of these verticals need to develop themselves? Do you think, like, is it, is it, has it been a lack of that there, we're just getting there?

Like when you say You know, we're, we're getting there. Like, is it, is it that now these companies are just about there and there's just about enough of them that are proven enough in these different verticals as opposed to what we might have expected to see is you have somebody that is creating the end to end solution and then they're creating all of the, the verticals.

Well that's obviously, that's going to be really challenging to do. It's going to be really. Cost prohibitive in many ways. But then the existing infrastructure can't adapt these places fast enough, but now are we at a point where there are enough of these solutions, like the one you just described, in different verticals that the layer can come on top of it, and now we have our alternative disruptor infrastructure?

[00:27:23] Cynthia Hudson: Yeah, like I said, I think we're still missing some of those pieces, right? I mean, you know, there's a company, you know, Conceivable wants to automate the entire workflow of the laboratory, right? We don't have that yet, that's a, that's, it's, it's great, it would be amazing, but we don't have that yet, so what do we do now?

Like, what do we do to address all of the humans? that are standing there without the family that they so desperately want. So, how do we get, you know, how do we bridge that gap? Well, you know, I mean, from, you know, from a pure workflow standpoint, there's time lapse incubation, right? So, now this is an incubator where I can put my dish into and I don't have to take that dish out for the next five or so days.

Okay, because it's got a camera on it and I can look at the embryos and I can see if the eggs are fertilized and I can see if they're developing or not. If I don't have a time lapse incubator, now, me as an embryologist, I have to go get my paperwork. I have to sit down at a bench. I have to walk over to the incubator.

I have to grab the right dish. I have to walk all the way back down. to that, I sit down, I put it under the microscope, I make my observations, I write those down because most of us are still not directly entering our observations into an electronic medical record system. It's going on paper and then being transcribed later.

The inefficiency of that and the opportunity for error and transcription errors is, is So, you know, again, that's, that's a whole different sort of bucket to, to challenge, you know, challenge to, to, to, to solve, right? It's a huge bucket of inefficiency. But then when I'm done with my observations, I have to pick up that dish, I have to get up and I have to walk back across the lab and put that into an incubator.

Now, how much time did that take? You know, for me, how much work, how many steps did I have to take? How many opportunities did I have as a human to kind of mess that up versus walk over to that incubator? Press a button, look at it, and see whether or not it's fertilized, and then I can write it down, right?

I can, I can do that. Just, if you just count the number of steps involved, you know, again, there's, if, you know, there's a clinical benefit to, to keeping embryos in an incubator, you know, straight for five days, that's great, but the workflow savings, You know, on the upfront, is, is, is dramatic, and I think it's very real.

Now, is it something that most clinics have adopted? Not so much in this country. It is a cost. It is a, it is an investment but it's a longer term payoff investment. You know, if it's, it's a labor cost savings. For the longer term, so if I as an embryologist, it takes me five minutes to do a fertilization check and I have 20 fertilization checks a day and it takes me 20 seconds to do it in a time lapse incubator, I can count those numbers of minutes and calculate over the year how much of my time of my salary that is going towards doing fertilization checks when I could be doing it in that you know, I could be looking at a time lapse incubator.

I mean, it's just an example, but it's, it's something that. I think we have very kind of tunnel vision sometimes in the clinics and say, well, the humans can do it and that's fine, but they're not actually thinking about the cost and the waste and the opportunity for error that we're introducing by having it be so simple.

100 back and forth.

[00:30:48] Griffin Jones: So there are still pieces missing before the emergent disruptor system can be established. But with the incumbent status quo system, there are existing solutions like what you're just talking about with time lapse incubator, and people aren't there yet. Adopting them. You seem to be very convinced.

You seem to see that there is a clear return on investment. Why aren't more places implementing them? I know we are starting to see more than perhaps we were last year and more than we were two years ago. And so maybe, maybe it's just a case of speed, but yeah. Why isn't that speed faster?

[00:31:32] Cynthia Hudson: I'm not running the clinic.

You know, so, but that's a whole separate story. You know, you know, again, it's, it's a, it's a, it's a change and change is hard, really. I mean, I don't think it's, you know, if, if, So, I don't think anyone could legitimately sit there and argue and say that it isn't a better way to do it, right? So, I think that story is not, that's not the story that needs to be told and sold and convinced, you know, from an infrastructure.

It needs to be a concerted effort on the part of the, the clinic to, to make that investment. You know, we have probably around 50 percent of our, I haven't done the numbers recently, but I would say close to 50 percent of the clinics in this country that are backed by some private equity firm, and those firms are not, I would say the priority is not necessarily massive private infrastructure equipment upgrades, technology upgrades, big, you know, kind of investments in, in efficiencies.

It's, they're certainly looking for efficiencies, but it's not, that's not the kind of efficiency, at least that I've seen so far, that, that they're looking for. You know, there's there's a pretty healthy margin in, I'm running a fertility clinic and that's clearly, it's attractive for a private equity investor, but they're not looking 10 and 20 years out.

You know, they're not looking, you know, longer term. They're, you know, the focus of the PE firm is not necessarily to take the 10, 000 covered lives and, and now You know, increase it to 30, 000 covered lives. You know, we don't see that. We don't see a massive growth in the industry. We see, we don't see them building new clinics.

We don't see a whole lot of new sort of development where, you know, they're buying each other up and not necessarily changing the, the scope and the, you know, the, the numbers of patients, you know, that can go under. And I think until, you know, that's probably, it's just an incremental change, I think at this point.

[00:33:40] Griffin Jones: their timelines on what they need to return to their investors, to their limited partners, because those timelines are shorter, that shrinks the delta between cost and benefit. And so that's why we haven't seen that, perhaps why we haven't seen many of these solutions be implemented faster on those who are in the early stages.

incumbent status quo system. I want to go back to where you said there are still pieces missing. Use the example of the automated IVF lab. There are still pieces missing for this new emergent system to come in and have all of the pieces ready to just have a new system that isn't invested in, in all of the previous no longer relevant infrastructure.

What are those pieces that are still missing? I

[00:34:32] Cynthia Hudson: mean, I think we haven't solved for, we have in a couple of ways, right? You know, one of the things, so to back up a second, the best You know, one of the best tools we have, you know, running an IVF clinic and shortening time to pregnancy is the fact that, you know, a woman normally ovulates one egg per month, right?

And so, the definition for infertility, you know, if you're under 35 is 12 months of trying, assuming you're ovulating normally, assuming you're having regular unprotected intercourse, assuming you're a male partner, assuming you have a male partner, assuming your male partner, you know, has normal semen analysis.

12 times those, those eggs, you know, didn't fertilize or implant or, you know, there's no baby. You know, the beauty of IVF is that we can essentially condense time. We can take those 12 eggs, we can get them all into one shot, and then we can try to see whether or not, you know, there's a baby in there. Okay, and maybe there is and maybe there isn't, but what we can do with IVF and with some of the tools that we've developed is figure out if there is and how do we get to that one faster.

Right? So, you know, we used to culture embryos into day two and day three. Now we can culture embryos to day five. So there are fewer embryos that are capable of developing to that fifth day. We've developed some tools to further screen these embryos. We want to know. You know, what is, which one of those that have, if we have four embryos at the end, it would be irresponsible of us to transfer all four of those embryos back to the woman's uterus.

Now, which one are we going to pick? So, we're going to look at it, we're going to We're going to grade it, we're going to assess how pretty it is, we're maybe going to biopsy it, we're going to take some cells off of that embryo, we're going to freeze that embryo, we're going to take those cells, put them in a tiny little tube, send it off to a lab, and then see if we can figure out if they have the correct number of chromosomes, and how competent are those chromosomes, or not.

Thank you. So, you know, some sorts of assessment. We have now AI tools that can watch the development, you know, of that embryo and say, you should pick this embryo versus this embryo. All of that physical work is being done by someone like myself. Someone has to take that embryo. Somebody has to move it, put it out.

Somebody has to take a biopsy. Somebody has to send it out. Somebody has to label it. Somebody has to freeze it. Like, until we figure out how to get to the right embryo faster. You know, we're, we're still stuck in this. We're doing a bunch of futile transfers that we don't know, you know, that we don't know why, right?

So, we can go through all of this. We can go through all of this work, and we can say, this is the best embryo, and it's got the correct number of chromosomes, and it's beautiful, and you know, the woman's, you know. Uterine lining is perfect and we placed it into the right spot and two weeks later she's not going to be pregnant, you know, we don't have all of those answers so, you know, what we're missing is a whole scientific avenue of development where we can say You know, if the eggs are no good, is there something we can do to make them better, right?

If the sperm is no good, is there something we can do to make them better? Is there a baby in this cohort of embryos? How do we really get to that one or two or three and identify them? How do we get to the point where we understand that we're putting it into the, the most ideal uterine environment? You know, I mean, I think there's so many unknowns that we have here and all of this is, you know, we just, we just don't have all of the tools that we need to make that human get to that family.

Faster, we're still stuck in this, you know, what percentage of infertility, you know, off the top of your head, you know, there are a whole bunch of patients that present at the office, how many of them are going to be called unexplained infertility? Right? You know, there's still so much we don't understand about this process from the biological side, you know, we're stuck in a Well, we'll just keep trying to put them together and figure out which ones, you know, are more or less likely to implant.

We're not really doing anything to improve necessarily those chances. We're, we're getting the correct timing of the transfer. We're trying to pick the best one. We're, you know, we're doing all these things, but we're not necessarily making them better. We're just trying to kind of screen out the things that would just make this the most ideal scenario.

[00:39:07] Griffin Jones: That wasn't what I was expecting you to say with regard to the missing pieces. I was expecting you to say, you know, something along, you know, one of the mechanical solutions for being able to, to, to have a fully automated process. But you're, if, if I'm understanding correctly, one of the barriers to impediments to creating a fully automated system is that it still wouldn't lead to the outcome of of being able to I don't know, of guarantee a live birth, but, or, but, you know, highly accurate.

Or highly accurately predict live birth in a way that you could put a financial model on top of that to where people are paying for successful outcomes. Am I, am I getting that right or am I missing something from what you were saying?

[00:39:57] Cynthia Hudson: No, no, no, you're, you're getting that right. I mean, I think, you know, I mean, sure, you know, would I like to have a system that has, you know, I, you know, me, I, you know, I'm not lazy.

I want to work, you know, smarter and not harder. So, you know, if I could get away with, you know, an annotation of my, my notes, and I could, I could not write anything down and not ever enter anything twice. If I could, if I could build an infrastructure in the laboratory to, you know, You know, to just have a single source of truth and all of my systems talk to each other and, and everything worked, I think, I think we could run a whole bunch more patients through, you know, through this, this ecosystem and, and get them out the door faster.

So, you know, what we're, you know, we're missing pieces of, we're missing pieces of the biology, you know, that, that we don't, so, you know, again, we can do all the treatment cycles that we want. We can use donor egg and we can use donor sperm and we can, you know, we can, you know, we can bring a gestational carrier into the mix and have them carry the embryo versus the, you know, the intended parent.

We can, we can mix and match a whole bunch of these things, but we're not necessarily Really able to treat the underlying or fix the underlying condition. And that, you know, is, is a big sort of hole in the puzzle. Now, from just the existing technology, what we can do and how to get more people in the door and, you know, running them through faster.

I think, I think we have tools, you know, on the table. It's just, you know, again, a matter of stringing them together and deploying them.

[00:41:33] Griffin Jones: So, I'm not a clinician or a scientist, so I might not be able to follow you, and if my eyes start to cross paths, then I will I'll pull us back to something simpler that I can understand, like astrophysics, and we'll But I do want to understand a little bit more of what So, as specific as you can be, what you think is necessary to be developed, so is it diagnostic testing, and if so, what kind?

Is it something that's missing on the medication side, and if so, what's missing? As specific as you can be, what are these missing pieces?

[00:42:18] Cynthia Hudson: Well, I mean, I think we don't, we could do better on the diagnostic side, you know, we, we, if a patient doesn't get pregnant after, you know, several euploid embryo transfers, we don't necessarily have a lot to offer them, you know, we, we, we can't with 100 percent certainty say why, and the only thing that we can do is offer, you know, to replace one of those parts.

You know, you, you know, I mean, an embryology laboratory is, is, in effect, a manufacturing, you know, we don't call it that in this country, but you're taking eggs and you're taking sperm and you're making an embryo, right? And then you have to put that embryo somewhere. So, you can change some of the pieces of the puzzle to see if that makes a difference.

So, we can use, we can swap out the egg, we can swap out the sperm, we can swap out the uterus, you know, we can kind of mix and match with these things, you know. Could we ever really go back to Willow as human and say, well, this is exactly why and, and I, and, and I can fix it. We don't have the, and I can fix it necessarily.

I can treat you differently, you know, to compensate for that, but I'm not actually treating you know, the underlying condition. I think, you know, we have, we could, we've come a long way in you know, the stimulation and, and drugs and, and, you know, managing these ovarian hyperstimulation cycles. You know, now we send very few, if any, people to the hospital for ovarian hyperstimulation.

We figured out how to swap out the agonist, you know, for an antagonist suppression for the pituitary and thereby reducing, You know, eliminating that, that, that great risk of, you know, using these drugs, but why, you know, we haven't yet gotten to the point where, you know, do we need to get the woman's, you know, hormone levels up that high?

Do we need to, you know, Kind of just, just sort of making up and substituting, well, we think this would work, and then this would work. You know, we're, we're not, we're not really at a point where we can say, this is exactly what the issue is, and this is what I'm going to do to fix it, and then you actually don't need IVF in the first place.

You know, but we're not, we're not there. We're tweaking the existing infrastructure you know, but we can't say exactly why it doesn't work. What we can do is just throw things at it to fix it, and every other thing downstream is just trying to optimize that cycle. So, you know, we're trying to pick the best sperm, we're trying to pick the best egg, we're trying to pick the best embryo, we're, you know, we're, we're trying to time the exact, you know, in the uterus, but we're not necessarily.

Solving, you know, maybe some of that inherent problem in the first place. Does that make sense? Am I answering your question?

[00:44:57] Griffin Jones: Yeah, it's, it's a light bulb for me a bit because I've taken you further down this topic than I was originally intending because I've asked it to many different guests and I always feel like, you know, Yeah, but I kind of get it, but I'm kind of missing something.

And I'm seeing more of that there are necessary verticals that need to be established before the overlaying new emergent disruptive system can replace the incumbent one, and we're still missing a couple of what those verticals are. It seems like a lot more of them have matured. more quickly these past couple years, and we're almost there, but there might still be a couple missing pieces.

I'm having a better understanding of what those missing pieces are. And now I want to make sure that we don't end this conversation without me asking you what I originally really wanted to, to, to get out of you, which is what the heck is going to happen with the embryologists? So if we have like you said, you, you have this technology that can get you to A to B faster that can can take fewer stabs, that doesn't need to be doing all of the data entry.

And so, nothing is safe to assume, but it really seems to me that in a decade's time, give or take, that the embryologist isn't really going to be a technician. So when the embryologist is not a technician, what is the embryologist going to do?

[00:46:26] Cynthia Hudson: I think it becomes, you know, more of an more of a a research and an analytical scientist.

I think it becomes the, you know, sort of the puppet master. So there's, you know, there's a machine that, and there's a software system that decides You know, where tissues should go into cryostorage and knows where they are, and there's an automation that takes them in and out of storage, right? You know, there's a, there's a, there's an algorithm that says, you know what, you should transfer the embryo 147 and a half hours, you know, into this human because We, that's the best time, you know, for implantation that matches the embryo and the uterus, you know, the, the embryologist is still going to have to perform that task and do that, but you're now developing the tools to better understand the biology behind the implant.

You know, the mechanism is, you know, we do a lot of, we do a lot of ICSI in this country, Intracytoplasmic Sperm Injection. So, we, we take eggs and we, we clean off all of the cells around them and then we prepare a sperm sample and we take a single sperm and inject it into each egg. That is the skill, you know, of an embryologist.

We, There are teams working on automating that process but you still need someone to do initial, you know, you have to do the egg collection, you have to evaluate them, you have to, you know, kind of put these tools together, and someone has to decide that they need a team, you know, or not in the first place.

You know, I don't, I see the embryologist doing A lot less I guess, for lack of better, walking back and forth. I think, you know, we're going to be able to, you know, stop this, you know, massive, everybody's carrying dish around, and there's 10 people in the room, and everybody's got something, and the jockeying for, for bench space.

I think we're, I think we're going to get to be more of a scientist than, and, and a little bit less on the handling side. Thank you. Tell me more about what that scientific responsibilities will look like. Will people be leading research projects? Will they be do, do, Do you envision embryologists being the ones to, to, to make that call on, on using ICSI as opposed to the clinician?

[00:48:53] Griffin Jones: Do you see there being a need for the number of embryologists that we have now? Like, is there enough of, of that scientific research that if, if in fact, all of this technician work is is replaced, mechanized in the next 10 years or so. Is there enough research to, to work on and what will those, what will that scientific and responsibility workload look like?

[00:49:22] Cynthia Hudson: I think it's going to change, right? I mean, I think, you know, I don't think any embryologist should be scared that they're going to not have a job. I mean, frankly, the industry needs to scale at a pace that, you know, is going to far outstrip the ability for automation to replace it at this point. So, you know, if we're doing what we, you know, what we should do, there should be 10 times more clinics and they should be so there's, you know, I don't think embryologists are going anywhere anytime soon.

I think we could do a lot more research on optimizing the cycles and how these gametes are being handled. You know, what we know is that we take out eggs, we prepare sperm, we put them together, we evaluate embryos, and then we have some disposition. They're, you know, they're transferred into uterus, they're frozen, they're biopsied, they're You know, they're discarded.

But we don't really understand necessarily, I don't believe we've spent enough time optimizing kind of that cycle. So, it's difficult to do research on human embryos, but I think we have a huge opportunity to critically examine the entirety of the ecosystem, right. So, what we're missing here is the big data piece where we can say, okay, there's this human with this condition, with this embryo, with this culture media, with this dish, and really to optimize, we shouldn't, you know, be waiting 20 minutes to do this.

We should be waiting 35 minutes to do this. You know, we should be looking at embryos, you know, at, at this point. I had this conversation the other night, like, who decided that this cadence of picture taking on a time lapse incubator was optimal? Do we need to have a, a, an image taken every five or ten minutes?

Could we get away with an image taken, you know, every ten minutes? I mean, twenty minutes or every hour? You know, would we get the same sort of result out of that? Would we, you know, would we be able to cut down the cost of creating the equipment to, you know, You know, to further, you know, get, you know, kind of get this moving, I think, you know, was the temperature of the hood, you know, was the, the air quality in, in the laboratory, was the, you know, the human that was doing it, you know, what the, was the barometric pressure, you know, affecting any of this?

We don't have Really good visibility into, you know, should we wait 20 minutes or should we wait 45 minutes, you know? Does the temperature variation right now, if I take this dish and walk it across the room, you know, does that slight variation in temperature have an effect? And are we, like, what, I think we have a great opportunity to optimize the current system that we in, that we're in, but we don't, we have, we could do a better job of analyzing, you know, our current workflow.

In the meantime, and I think that would be an amazing area of improvement on the efficiency side because right now we're basically, as I was saying, left with this is the group of eggs, this is the group of sperm, and that's the uterus I have to work with, and I'm either going to get something or I'm not.

You know, and I can try to pick the best one, and I can try to pick the best ones of these. How do I really know that I've picked the best culture media? How do I really know that I've picked the best environment? How do I know that I've optimized the timing? How do I know that I've, you know, done, you know, all I can from a, from an environmental side to ensure that We're, we're making the most of, of, of what we have at this point, so I think embryologists are not going anywhere.

It

[00:53:08] Griffin Jones: clearly gets across to me that there is no shortage of things to work on and that young embryologists today know that this is the right career for them if they're excited about being the person to solve one or more of those problems, and There's so many problems to solve. So, I noticed this a couple of years ago, Cyndia, where I was having embryologists apply to work at my company.

And I was like, you know that there are people that really want your skill set and that want to pay you a lot more than working at, for a media company, right? And one of the things that they kept coming back to is that they, they did not like being in a lab all day.

And so, I think for those that really don't enjoy that maybe don't be looking at jobs at media companies. Be looking at, uh Uh, the work that solves these bigger problems so that you're not the one in the box and that you are, you're, you're solving for these wider scale problems. So, in addition to, to covering that, it seems like the conversation that I, I've kept having about what's missing from this emergent system.

I don't know, sometimes you just need to ask a question similar ways a thousand times and on a thousand one, you get it and I feel like you, you've made a light bulb go off from what might be the last couple steps for this emerging system and how close we might be to it actually disrupting the status quo.

So Let's conclude with maybe one or two of the the, the solutions that you're really excited about that you said that we that, that are either finally here or that are almost on the cusp of what are, what's like one or two things that either you've just implemented or that is just about here that you're really excited about.

[00:55:15] Cynthia Hudson: Well, you know, one of the things that I, you know, again, this is a, this, at the base of, you know, the way I think about things, it's an access to care issue, and one of the things I'm really excited about is is reducing the number of times that the human has to go to the clinic. Right? So, you know, if, I mean, David Sable says this better than anyone, you know, there's time to baby, there's cost to baby, and there's life disruption to baby.

So, if you want to tackle life disruption to baby, you know, we, you know, you do a telehealth visit, right? I think the pandemic kind of shifted a lot of us, you know, into that, you know, Because we were doing remote visits anyway. But how do you then, you know, I think about it as in a distributed care model.

Like, how do you bring the care to the patient and not necessarily the patient, you know, to your office? Because not everybody lives within a reasonable driving distance of a fertility clinic. We have very big deserts, you know, of fertility care. I mean, certainly in parts of the world, but speaking about the United States, there are lots of people that just don't have access to care because they physically can't get there.

So how about we bring care, you know, to you? How about, you know, again, I, I advise a company called Sama Fertility and one of the things that they're trying to do is to have the patient be monitored as much as is humanly possible remotely. So, you know, they'll send a portable ultrasound machine to your house and they will schedule an appointment to be on the phone with you.

With with someone who will guide them through an ultrasound so that that human did not have to get up and drive to the clinic to get that ultrasound, right? You know, they will arrange to have the ultrasound in a, in a local radiology or an OB GYN or something. So, you know, if we think about nothing, it's not inventing anything, it's not necessarily, you know, you're not reinvent, you're reinventing the wheel in the sense of how you manage the operations.

You know, of the, the clinic. You know, you don't have access to care if you don't have a job that allows you to be late. You don't have access to care if you don't have a job that allows you to just take random mornings or afternoons or days off because of retrievals, because of transfers. You know, I mean, a clinic will typically tell you show up at this day and this time and this many times over this many days and if you don't have the job or the life situation that allows you to do that, then you don't have access to care.

This is actually bringing that care So, you know, it's, it's easing that burden. Okay. And so I would, you know, I'm, I'm super excited about, you know, I, Thinking, I always think about this in a hub and spoke model. So there's a, you know, the laboratory is the most expensive, you know, infrastructure part of the ecosystem of a fertility clinic.

But how often do the patients actually have to be there? Right? You know, we can send a kit to your house and you can send in a semen sample and do an analysis, right? You know, I mean, I think we have certainly improvements, but like, we're a really long way to getting, you know, the patient to only show up at the clinic, you know, the woman twice, you know, to get the eggs out and to get the embryo back.

You know, can we figure out a way to treat these people where they live and only have them make those trips for those sort of critical things where you need that expensive? bunch of kit and infrastructure. You know, we're, we're at a place where, you know, again, you say, what are we missing and what are we on the cusp of?

And, you know, I think, I think we're inching along and we're, we're making strides to get more humans, you know, in the door. And I think we're, you know, I mean, I think we're getting there. I think we're, I think we're figuring out. Different ways to bring more people in. I think we're figuring out that, you know, we can't do everything, right?

You know, I talked to Dr. Takor this morning, you know, she's, she started a company called Genome Alley and she's a medical geneticist and she's, she's lovely and, you know, she wants to you know, make sure that patients are being treated for monogenic disease conditions in states in, in, in, in such a way that.

takes some of the burden off of a standard clinic, you know? I mean, I think, you know, we have to We have to figure out how to you know, do what we do best and kind of plug in the things that, that are going to help us, again, get more people in the door and get them to their family faster.

[00:59:46] Griffin Jones: This will be an interesting episode to revisit together, have you back on in like, 3 years and look at the solutions that have been implemented since this conversation.

Something happened in one of the IVF labs of lab director Dr. Chad Johnson and he caught it. Listen to this story. Tell me about a story where you realized that a tubular embryologist hadn't refilled the tank.

[01:00:13] Dr. Chad Johnson: Yeah, it's actually sort of just a simple anecdote, which has, I guess, bigger consequences. In one of my labs, the staff got very busy.

As they do, these, you know, having done IVF myself, I know what it's like to get busy in a lab. I go on our portal on a regular basis, almost daily, really, and I look at, because I'm an off site director, I'm able to go on my PC or my phone and look at that lab's tanks and see how they're doing. And I noticed that the tank hadn't been filled.

It was still well within. And, you know, well, it was not even close to being an issue. And I waited till the next day and I noticed that later the day, the next day, they filled the tank and it just changed by one day, the tank count, the fill calendar, the level went back up to normal. There was no danger in that particular day.

So I said to them the next day, I just texted them and said, Hey folks, notice that the tanks didn't get filled yesterday. Great. I'm so glad to see that they're filled today. If the tank had gone to a critical level, it would alarm. Everyone would get texts, phone calls and everything. You don't want it to get to that level.

A tank can have anywhere from 50 to 200 patients in it. I mean, the difference is monumental, which is why, when these accidents happen California, Ohio, and there's been many others. He's gonna end up with multi million dollar lawsuits, and, and that's not even really the point. The point is that you have lost hopes and dreams of hundreds of patients.

Our goal is to never let that happen.

[01:01:38] Griffin Jones: That's why Boreas Monitoring Solutions was started.

[01:01:41] Dr. Chad Johnson: When people hear the difference between this system and, and several others, they're They get it, just want to know, you know, that's one of the things where as we do this, we keep adding features to this, like quality control measures and things where people can sign in every day.

And when they sign in, it automatically clicks a quality control that shows that they physically looked at the tank through the portal.

[01:02:03] Griffin Jones: Visit BoreasMonitoring. com/demo to schedule that time with Dr. Johnson, co founder of Boreas Monitoring Solutions.

[01:02:12] Dr. Chad Johnson: It's a live event, so you can show all the screens that are available, everything from the, the tank levels to the list of folks on the, who are on call, how do you change the call numbers, the fill chart, the quality control information that's available to you.

Dr. Chad Johnson. I have a PhD and an HCLD in Reproductive Physiology. I'm currently a lab director at Bloom Fertility in Atlanta, Georgia, as well as Virginia Center for Reproductive Medicine in Reston, Virginia.

[01:02:46] Griffin Jones: That's boreasmonitoring. com/demo.

[01:02:50] Announcer: Today's advertiser helped make the production and delivery of this episode possible for free to you, but the themes expressed by the guests do not necessarily reflect the views of Inside Reproductive Health, nor of the advertiser.

The advertiser does not have editorial control over the content of this episode, and the guest's appearance is not an endorsement of the advertiser. Thank you for listening to Inside Reproductive Health.

The views and thoughts expressed by the guest are their own and do not mean they are the views and thoughts of their employer.

222 More Data Than Any Other IVF Lab? CARE Fertility’s Massive 14 Year Build with Prof. Alison Campbell

DISCLAIMER: Today’s Advertiser helped make the production and delivery of this episode possible, for free, to you! But the themes expressed by the guests do not necessarily reflect the views of Inside Reproductive Health, nor of the Advertiser. The Advertiser does not have editorial control over the content of this episode, and the guest’s appearance is not an endorsement of the Advertiser.


What do embryologists do when they own stake in the company?

If you’re Professor Alison Campbell, Chief Scientific Officer and equity owner at Care Fertility, you’d build massive datasets to train a machine learning system to predict live births.

With Alison we dive into:

  • Their proprietary Caremaps-AI system (Saving 10 weeks of Embryologist time per year)

  • Why CARE is building a machine learning system rather than using AI software already on the market

  • How she pitted 10 of her best embryologists against an AI software she was skeptical of (And who won!)

  • The one AI solution she likes for egg freezing (Why CARE Fertility uses that rather than building their own)

Prof. Alison Campbell
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Transcript

[00:00:00] Prof. Alison Campbell: And it's saving loads of time. So now all of that manual annotation is over. I mean, we just get the machine learning model, press a button and in one to two seconds, it's generated all of that data that's previously taken us half an hour or so for a whole embryos course of development from fertilization to, to embryo cryopreservation.

And then it feeds into the same BLAST6, we call it the six, the six model, the statistical model, and we get a score. And that score relates to the chance of a live birth for that particular embryo. We obviously choose the embryo with the highest score. 

[00:00:38] Sponsor: This episode was brought to you by Future Fertility, the leaders in AI powered oocyte quality assessment.

Discover the power of Violet oocyte assessments by Future Fertility. These AI based reports provide personalized egg quality insights to improve treatment planning and counseling for egg freezing patients. Deliver a superior patient experience and improve satisfaction by empowering your patients with an objective, personalized view of their unique chance of success.

Download a sample Violet report plus a roundup of clinical validation research today to learn the difference this tool makes in patient care. Visit futurefertility. com slash irh. That's futurefertility.com/irh.

Announcer: Today's advertiser helped make the production and delivery of this episode possible for free to you. But the themes expressed by the guests do not necessarily reflect the views of Inside Reproductive Health, nor of the advertiser. The advertiser does not have editorial control over the content of this episode, and the guest's appearance is not an endorsement of the advertiser.

[00:02:00] Griffin Jones: What do embryologists do when they own stake in the company? They do cool stuff like amass massive datasets with huge sample sizes and lots of detail to eventually be able to build a machine learning system that predicts live births. You've met Professor Alison Campbell before. She's been on the program before.

She's the chief scientific officer and an equity owner in Care Fertility, the largest fertility network in the UK and Ireland, now with clinics outside those areas. And Alison talks about Care Maps, their system that they started in 2011. When they started with time lapse imaging that is now in its sixth iteration and powered by artificial intelligence to save 10 weeks of embryologist time per annum to improve success rates to be able to predict live birth and why care fertility decided to put in that work to assemble that massive amount of data, make it safe, put it in one place to find a machine learning partner to do that with all on their own instead of choosing one of the AI systems on the market.

Talks about the value of their data set versus that of cares, the expense of those solutions versus what they were able to do. She talks about an AI solution that she does like called Violet, which is made by a company called Future Fertility and what value she saw Violet brought for their egg freezing patients and why they decided to use that solution instead of make their own.

If you're one of these companies selling into fertility networks, you might pay attention to what made Alison and her team agreeable to even do a pilot with Future Fertility. Why would you take the time of 10 of your best embryologists to see how they stack up against a solution that you're skeptical about in the first place?

Better make it easy for them to do that. I asked Alison if CareFertility will begin to sell CareMaps as a solution to other fertility clinics, IVF labs, and networks throughout the world. I asked her if some of the AI companies listening should just try to build that with them instead of what they might be starting to work on now.

Here's what she has to say about that. And once more, enjoy our interview with Professor Alison Campbell. Professor Campbell, Alison, welcome back to the Inside Reproductive Health podcast. 

[00:04:03] Prof. Alison Campbell: Thank you very much, Griffin. It's lovely to be here again. 

[00:04:06] Griffin Jones: It was probably a year and a half ago that I had you on Somewhere Thereabout.

And your episode was popular because you talked about embryologists owning equity and how Important. That is, I have a feeling some of the thread of that topic might reappear in our conversation today, but I wanted to talk to you about a tool that your practice has been using to great embryos and perhaps for other applications using artificial intelligence and perhaps other technologies it's called care maps.

You're the group that you. Work with and for and own part of his care fertility what I didn't realize though Is that it's been around for a little while? so I and I went with a default assumption that maybe it's a couple years old and he started as Artificial intelligence got more into the Zeke Geist in that 2018 2019 Timespan, but I looked and you had one YouTube video from almost 11 years ago now, and so that means you've been using it for at least that long.

So please lay the foundation of what CareMaps is and when it started. 

[00:05:19] Prof. Alison Campbell: Right. Yeah, no, it's a, it's a beautiful story, I think. So it all began around 2011 when the Embryoscope first came to market. And it actually blew my mind, this device that enabled embryologists to to watch the embryo developing in, in real time, really.

So we set upon a great mission to introduce it into our clinics and to collect data from it, to use it to the max. So, and it wasn't easy. It was a very hard sell because of course there wasn't a lot of data around then. So. I had to try and sell the vision to our chief financial officer. We need to buy this kit, and this is why.

And it, it didn't go down well. It, it, they all thought it was just a toy. It was just a nice to have, but it just made complete sense that if we could get more information, from the developing embryo and the time points that it was reaching each of these subsequent cell stages, that there must be some answers within that information that could help us improve outcomes.

So we, we managed to get one free of charge for a fixed period whilst we did a really rushed evaluation just to make sure that it did do what we expected to do in terms of and functionality and imaging. And then we invested in the first one. And we wanted to get some data fast and we wanted to see if we could predict anything fast.

We're quite competitive and we generally want to be first movers in the field at Care Fertility. So we, we decided to annotate really strictly. So that means once we're, whilst we're looking at these time-lapse videos, the embryologist, using the, the viewer using the software that comes with it. Was recording in great detail everything that they saw so every time The cells divided, we introduced user defined variables very early on as well.

So things that didn't come with the software, we thought, well, that might be interesting. Let's also record as a comment, how the polar bodies, the second polar bodies extruded and little details that didn't come as standard. So we had a strict protocol training program and all of the PGT embryos. that were going through our clinic.

It was started in one clinic at this time. We recorded the ploidy when we got the result back. So then we had about a hundred embryos, and this was our very first publication, and we could predict, or we could classify, the risk of each of those embryos. being aneuploid based on the morphokinetic variables.

So quite simply the embryos that were somewhat delayed had a much higher risk of being aneuploid and we published that and it was the frontispiece on reproductive Biomedicine Online, it was really a well received bit of research and that was the first model that we, we developed. That was CareMap. So MAPS standing for Morphokinetic Algorithms to Predict Success.

[00:08:35] Griffin Jones: These algorithms, did they, were they produced by you also? The hardware is the time lapse imaging. And the software you said that you were doing some things like entering for user entered variables. Is that you all building your own software? Did the hardware come with a software? How, how did those algorithms develop?

[00:08:58] Prof. Alison Campbell: Well, the hardware came with software and a viewer and you could enter your own models. within that software. So the first one was quite simplistic. Now we're on our sixth iteration of ChemApps, which is a logistic regression algorithm. So we've had to work with the device manufacturer, Vitralife, to enable us to implement our own algorithm.

So they've been supportive with that. And then more recently we've introduced the AI element. So that sits outside of the equipment, outside of the device. So we've had six versions of ChemApps getting increasingly complex, getting more and more exciting in terms of what they're predicting. So we started initially predicting the aneuploidy.

And then we went on to clinical pregnancy and now our current models are predicting live birth. 

[00:09:53] Griffin Jones: In that video that you had from 11 years ago, it says that it talks about AI was, were you using machine learning at that time or was AI more of a general blanket term compared to what it means today? 

[00:10:09] Prof. Alison Campbell: Well, I, I didn't really know that AI was on the, on our agenda 11 years ago.

I've not seen that video for a while, but that was probably just, just looking to the future and imagining. So we've only been introduced, introduced AI to our care maps in the last couple of years. So that's yeah. And what the element that's. Being with, with it's involved with machine learning is the annotation.

So that's now completely automated. So I can talk much more about that and how it's won multiple awards. It's a quite a great phenomenon. We're very proud of, of the recent innovations that we've done with AI.

[00:10:45] Griffin Jones: I want to ask about that. So in the beginning it was, it was all manual. So you're, you know, you're entering these criteria, but at the end of the day, one individual is grading.

Each embryo just looking at it and then how do you compare so is the it was there anything like side by side like criteria that was just entered in there so that when you're viewing the embryo you're seeing it against your criteria or um, Um, You're just seeing the embryo and then you have to take it somewhere else to evaluate or take that image and information somewhere else to evaluate it.

[00:11:22] Prof. Alison Campbell: Well, initially we do the manual annotation, which is really laborious and we have been doing that for a decade and absolutely no regrets because that's the high quality data, quality assured, manual annotation that we've used to train the machine learning models. So what we do is we sit at the. machine which looked at the device and we'd annotate every stage and then the software that came with the device would calculate the scores based on the model that we'd entered into the device.

So it's, it's, It's only really the annotation element that was really laborious and took a lot of embryology time. The actual application of the simplistic statistical model was relatively easy. 

[00:12:09] Griffin Jones: And so forgive my ignorance, explain to me what annotation refers to it. Is it the, is it's the, the grading of the embryo?

It's the characteristics of the embryo. It's other notes. It's those, that criteria that you set for the, uh, Self-centered variables. What does annotation refer to? 

[00:12:26] Prof. Alison Campbell: So every five or 10 minutes or so, the time-lapse device is taking an image of the embryo through multiple focal planes. And so this goes on continuously.

Right after ixe, you put the embryos or the virtually inseminated cytes into their time-lapse device, and it's collecting these images. So annotation is when the embryologist sits at the screen of viewer. And reviews all of these images. Like a, it's a time lapse movie. I'm using the software that comes with the same device to click to say now it's two cells.

Now it's three cells. Now I've seen the beginnings of compaction and so on. So it's That annotation is the translation by the embryologist of this image information into, into data really. So it's very important that the embryologists are highly skilled and trained at this. And this is one thing that Carefidelity did really well, I think.

We insisted that we trained people very thoroughly, that we quality assured. their annotations. We didn't say, okay, the most junior member of staff can do all of the annotations. And there are arguments for and against, but I think the fact that we, we did it and we stuck with it for a decade, ensuring that everybody was trained and everyone was performing.

Properly as given us this goldmine of data now that's, that's pretty, really valuable. 

[00:13:56] Griffin Jones: I was going to ask about who is doing the annotation. So a junior embryologist could do some annotations, but then what would have a senior embryologist would be doing other annotations or the lab director would have to have the final grade.

Tell me about the delineation of those responsibilities. 

[00:14:14] Prof. Alison Campbell: Well, there was a competency, there was a training program and competency assessment to make sure that whoever it was, it didn't really matter what level they were, it's are they capable, are they competent at looking at these videos. I could train you to do it, I'd say.

It's not, you don't have to be a scientist to do it, you have to be well trained and you have to be meticulous and you have to believe and understand. Why are you doing it? And I think that's so important because if you, you understand the end game, you will do it properly. And then we'll do spot checks to make sure that we agree with those annotations.

If there's something really ambiguous, which happens with the human embryo, sometimes they, they'll go backwards. You'll see four cells and then two frames later, they've reverted to three cells. Anything peculiar, we would call a colleague over and we can say, look, can you sense this? This sends check this for me, and then we'd have a quality assurance scheme that we established ourselves whereby all the embryologists, all the annotators across the network would annotate the same set of embryos, and then we'd look at the intercorrelation coefficients to make sure that they are correct.

close enough, they're not always going to be identical. Sometimes they're a frame early or late. So then we'd look, well, if you are a frame early or late for that particular variable, so for the start of blastulation, let's say, for example, then does that impact the score, the model score, and therefore does that impact the selection, which embryo you would choose based on the model score.

So it was, it was a very thorough and very complex process, but it's, and it's taken a decade to get to where we are. 

[00:16:00] Griffin Jones: Is it now a requirement for every embryologist in your organization, this assessment for competence and annotation? 

[00:16:07] Prof. Alison Campbell: It's always been a requirement at Carefertility, yeah, every embryologist who's annotating needs to be competent to do that, the same way that 

[00:16:15] Griffin Jones: Does every embryologist annotate or is the workflow segmented in such a way that some embryologists are annotating while others, you know, might be freezing, thawing, etc.?

So does every embryologist annotate? 

[00:16:29] Prof. Alison Campbell: Yeah, everyone who's been trained and is competent can annotate. So if they're on the rota for a particular day to do those, the annotations, then they would do the annotations if they're supposed to do vitrification or end collection. So it's, it's done on a rota type basis.

[00:16:44] Griffin Jones: So now you're on the sixth iteration, machine learning has been introduced to, to now be able to do that annotation. Did that, is that new to the sixth iteration? Did that happen? What iteration did that happen? 

[00:16:56] Prof. Alison Campbell: Yeah, it's new to the sixth. So the sixth iteration is the live birth prediction model. It's the most sophisticated model that we've got we've ever had.

It's built on over 6, 000 transferred blastocysts where we know the live birth outcome. And so we realized we are taking so much time to manually annotate all these videos across the network. So. 15 laboratories in the UK, some in Spain and the US that aren't yet fully set up to do this, but at least at the time, what can we do to really save time to improve reproducibility and objectivity because manual annotation is not perfect.

So let's, let's look at this. Let's get the data together, which was no mean feat. Let's find a third party who have experience in machine learning and See what they can do. So we scoped the project. We did the business case and we found a UK company or their international called BJSS and they had no experience in the fertility sector, but they did have experience with.

Machine learning. And I was quite impressed because they'd done some work with, with airports, where they built models to scan suitcases, to identify smuggled animal skulls and things. So I thought, well, it's image analysis. It's very important. And yeah, they were very impressive. So we worked with them very closely for, took about 18 months, I'd say, from them to the release of the minimum viable products.

And it's. It's saving loads of time, so now all of that manual annotation is over. I mean, we just get the machine learning model, press a button, and in one to two seconds it's generated all of that data that's previously taken us half an hour or so. for a whole embryo's course of development from fertilization to to embryo cryopreservation.

And then it feeds into the same BLAST6, we call it the six model, the statistical model, and we get a score. And that score relates to the chance of a live birth for that particular embryo. We obviously choose the embryo with the highest score. 

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[00:21:31] Griffin Jones: This is all embryo grading. There's no oocyte grading happening with CareMaps? 

[00:21:38] Prof. Alison Campbell: No, not with CareMaps. We are interested, um, we've been talking to Uta Fertility, who I know you, you've been speaking to recently. We talked to them about. Trying to do some research together just to see whether Violet, their, or Magenta, their oSight AI tool could add some benefit to care maps.

I'm, I'm a little bit skeptical that it could, but if we could get some marginal gains to improve predictive power, even subtly, then it's worth exploring. 

[00:22:08] Griffin Jones: So would that be for, like, you would be using their oocyte grading in to improve your embryo grading or you would be using it separately to create something for, for oocyte, for oocyte grading?

[00:22:21] Prof. Alison Campbell: Well, they've already got their own tool to assess the oocytes, which we use for fertility preservation purposes. So if we work, if we thought about putting it together with ChemApps, it would be to see whether The assessment of the oocytes from their system could improve the predictive power for embryo selection in our live birth prediction models.

[00:22:48] Griffin Jones: So I want to talk about this, about building an AI solution versus going with one and, uh, future fertility might sponsor this episode. Somebody else might, Burger King theoretically could, yeah, they don't have any control over what you say. So you can, you can say whatever the heck you want, but I, I, I see some people really see the value in certain AI solutions and then other times.

Yeah, I've, you know, I think I heard Santee, Dr. Mune say, you know, try to build one yourself for a lower cost. The costs also range a lot. Some of them seem really expensive. Some of them don't see, seem as expensive, but it sounds like for in the case of, Embryos, you wanted to build your own as opposed to using one of the solutions that are out there with these, these companies trying to get them implemented into clinics.

Why did you decide to go the build your own route? 

[00:23:45] Prof. Alison Campbell: Well, a few reasons for that. We, we tried the systems on the market at the time, a couple of years ago. With AI, we're talking about the AI aspect and it wasn't good enough for us. It didn't It it wasn't comprehensive enough. We can use a an alternative providers Auto annotation tool, but we weren't getting comprehensive auto annotate.

We weren't getting all the data that we needed to feed our models. There were lots of emissions, lots of inaccuracies, lots of, um, sense checking required. So probably a couple of reasons for that, but the main one may have been that it's trained, they're trained on really heterogeneous data from all over the place.

And I have most confidence in our own data. Our own data was massive. Relatively massive. Arguably, probably the highest quality data set for annotated embryos and largest in the world because of the approach that we took. So why would we use somebody else's tool when our data is stronger, bigger, better?

That was at least the mindset at the time. That might be different now, but we've taken the leap and we're not looking back. 

[00:25:05] Griffin Jones: Was that the defining feature of what made those systems on the market not good enough in your view, the, the quality of the dataset? Were there any other reasons? 

[00:25:16] Prof. Alison Campbell: They were expensive.

I think when we first looked at it, and it may, may still be the same, that it doesn't seem to be a really Clear offering in terms of what you get, the pricing model, is it per click per price per click, or is it a flat fee? I think people are just trying to find their way. They don't have lots of publications to justify the quality and the predictive power of their algorithms or their systems.

So it's still relatively new and you have to make a leap of faith if you're going to do it. And so we decided we'll, we'll do that with our own data and take it from there. But I think we've done a good job. We've won. Multiple awards for this solution. We, Amazon web services did a case study on, on it.

We've won a Royal College of Pathologists achievement award, UK IT tech awards. We've just been nominated for another one I heard this morning. So I think, you know, when we're scrutinized by the data scientists and machine learning experts and tech people, they can see that this has been done really well.

[00:26:28] Griffin Jones: Tech bros are scrutinizing you? Yeah. In marketing, we would call them internet Ian's, but that doesn't mean that they don't have a certain expertise. What do they feel that you're, so you've In your view, the established solutions didn't have a high enough quality data set. What do the machine learning geeks critique your solution for?

[00:26:53] Prof. Alison Campbell: Well, they can just see the information that we give them and we're not letting them under the bonnet to just scrutinize it. So they can scrutinize the way we did the build or the way BGSS, our partner did that build, the size of the data. The, the outputs, the predictive power, because we've used this model now respectively for over 2000 transfers.

with the AI element. It's predicting really well, really, really successfully, accurately. And, and the time saving we've quantified, we estimated it beforehand. And now we've quantified it. We've say we're saving 10 working weeks embryology time per year. So that's, that's a great output as well. So there's so many benefits that we've seen from this.

So yeah, patient attraction has been also. A good one, staff retention. We've had embryologists saying, I could not work anywhere else. I could never go back to manual allocation. I could not live without this system and you know, non professional recognition for our work. We've presented it at conferences and we're still writing up.

We've got a lot of information still to share and to publish, but it's, yeah, it's, it's on track. 

[00:28:08] Griffin Jones: You developed this system, you all at CareFertility developed this system because you weren't satisfied with what was on the market and you felt you got a better data set, a bigger data set, better predictive power.

Now that you have something that you feel is better than what was on the market, are you going to take it to market? Are you, should we expect CareFertility to spin off CareMaps and be selling that to the EVRMAs and the EUGENs and the. the, the inceptions, et cetera, of the world? 

[00:28:43] Prof. Alison Campbell: Well, never say never. It's a possibility.

I would say we've got to consider our priorities. And we've, we've got the data. We've got a lot of expertise in time lapse in this type, this area of machine learning, but we don't have a sales force. We've never done regulatory, got regulatory approvals for our, our products. So this is an in house, developed tool.

So we could use it in our clinics, but we couldn't sell it as it stands without certifications, FDA approval, CE marks, and all of those things. So almost certainly if we did that, we would be looking for a partner to help us get there. 

[00:29:25] Griffin Jones: I wonder if any of the current partners who are thinking, man, this is tough.

This is really hard to sell in, into these clinics. Why don't we just do that? Why don't we just try to, to, to take what HairMaps is doing and then make that our product. And we've got the Salesforce and we've got the venture raising infrastructure. And I think that might happen. 

[00:29:47] Prof. Alison Campbell: That could happen. Yep. I think it could happen.

And yeah, open to conversations. And let's say we, we don't have a Salesforce, but actually. You can probably tell, you know, I'm so passionate about it, it's, I probably, some of our team members would be the best people to sell it if it's, uh, if we were to take it to market because we, we've lived and breathed it for 10 years and we trust it.

[00:30:09] Griffin Jones: I'm sure. 

[00:30:10] Prof. Alison Campbell: And so, it. 

[00:30:13] Griffin Jones: And so maybe future fertility can help with the, with the embryo grading, but, but you're, you're a bit skeptical of that, but they are helping you with oocyte grading for egg freezing. Why go with them in that situation, as opposed to then trying to develop your own oocyte solution. So the embryo grading systems on the market weren't sufficient.

And, but, and so you built your own. didn't go that route for egg freezing. Why not? 

[00:30:46] Prof. Alison Campbell: Well, yeah, we considered it, of course, and, and it may still happen that we, we do our own thing, but we focused on one, one thing at a time and we focused on the embryo selection. We, Caught Future Fertility's Violet through its paces early on, because I was really sceptical.

A static image of an egg to predict outcomes, but saying that, we, we assessed it, got 10 of our expert embryologists to compete against Violet, and it beat us. So yeah, we, it could, it could assess and predict better than we could. Not at a very high rate, because there are so many other variables. Sperms takes a huge part to play in it and lots of other factors, but at least for patients who, who want a bit more information and they say, well, how are my eggs?

Without Violet, we'd give them our best judgment, but it wasn't particularly accurate. And with Violet, they get more information, they get images of their eggs. And so it was a nice to have. So, yeah, I, and generally I'm skeptical of static image assessment because human, human embryo development is a very dynamic process and yeah, there's so many things that can impact it.

So yeah, we just got to focus on what we have the most faith in, I think at any one time and put our efforts into that. 

[00:32:12] Griffin Jones: You were skeptical of the static images, and then you put it against your team of 10 embryologists, and it won, but to do that pilot test, you must, they must have communicated some sort of value to you, or if they didn't, you You just perceived the need, you know, it's tight grading to be that great.

I remember last time we spoke, I asked you how many of these different companies pitch you over the course of the year. And I think it is probably a couple dozen that you said. And then I asked how many in a year do you do any, even like a pilot? Program with, and you said, you know, maybe three, I think it's something along those lines.

So you were talking about one out of every 10 or, or, or something like that, that you're actually piloting. What was it about that pilot that you said, this is worth the time of 10 of my embryologists to, to put them against. 

[00:33:09] Prof. Alison Campbell: Well, it was a relatively easy thing to do. It was a quick pilot. It was on a, an app.

And so we could do it quite quickly, gather information fast. There were nice people. There were also passionate. Dan Neo, particularly when he first knocked on the door, very passionate about his product, made sense for them to have looked into that element. And I wondered why so few people had ever really tried to come up with a tool to.

assess the quality of an oocyte. But yeah, they were there right at the start and simple and effective. It's not going to change the world. It's not highly predictive, but it's better than we can do. So I think that's a positive for patients. 

[00:33:53] Griffin Jones: Do you think that's the future of AI companies in the fertility space, like more segmentation?

Or do you think so that they can find a place where they really can be valuable one and then to make easier pilots? Or do you think that somebody has to win this battle to become the AI solution for, for all, you know, embryo and, you know, site machine learning? I should say all embryo and gamete machine learning.

[00:34:25] Prof. Alison Campbell: Yeah, I think it'll, um, it'll be quite a slow journey. There's a lot of competition, a lot of people trying to get a piece of the pie at the moment. Um, but eventually, I think there'll be just a couple of High quality solutions, which incorporates gametes and embryo assessment. I don't think it's really going to be, we're going to see hundreds of different options.

I think eventually the cream will rise to the top. There'll be collaborations, partnerships, merging of solutions. Cause what we want in the clinic is, is simplicity. We don't want to be moving between systems and causing confusion. We need integration of, of good systems and simple, simple tools. 

[00:35:10] Griffin Jones: Are other networks doing this to your knowledge, developing their own embryo grading, machine learning?

[00:35:18] Prof. Alison Campbell: Not to my knowledge. I don't think at the scale that CareFertility have been moving and developing this, this CareMaps AI, I don't think I, I haven't seen that or heard of that. Now I've spoken to some big group scientific leaders who've said it's so difficult to get the together. So I think, I know it was a huge undertaking for us to get all of that data off all of those servers into one safe place.

And so we were fortunate to have the expertise or have the partnerships to enable us to do that. So that was the first step. And I think that some of the big groups might, will be struggling with that. And also if they didn't embark on the journey like Fertility did, annotating rigorously and religiously, comprehensively.

Then they won't have that data set, but you can accumulate it very quickly. Some of the networks now are enormous, and if they just decided to change tack and do exactly what we've done, it wouldn't take 10 years to do it. 

[00:36:25] Griffin Jones: It's difficult to get the data together. You talked about it was possible for you because you had partners, but they could go out and get the data.

Adequate partners to help them with that. What made it possible for you all to bring that data together? 

[00:36:42] Prof. Alison Campbell: Well, teamwork and shared vision, I'd say it's, uh, but it's 

[00:36:47] Griffin Jones: gotta be something in the shared vision because if they wanted to, they could, they could align the teamwork to it. So there was something about your shared vision that prioritized it in a way that maybe others haven't.

What do you, what was that? Why was this a priority? 

[00:37:01] Prof. Alison Campbell: Well, because we'd already got Care Maps, so we already, we were getting great outcomes for our patients, we were generating revenue, we, we loved the technology, we were getting publications from it, so it was part of our DNA, so it was the next step, really, to bring machine learning into that, to save time, we, we were never going to say goodbye to, to Care Maps, we wanted to keep developing it, we'd done that six times over over the last six years, 10 years.

So it seemed to be the next step. And it's quite possible now, you asked the question, that These guys tapping on our shoulders saying, well, look at our solution. Look at our solution that they catalyzed our actions because we we'd been talking about it. But once we realized that other people are starting to bring tools to the market that can automatically annotate and predict outcomes, we should, we should be.

Lead in the way. We should be doing that. Let's, let's get on with it because time moves quickly and We have the potential to to make all those benefits that I described and particularly saving time for our embryologists It was a huge driver. 

[00:38:11] Griffin Jones: Again, my ignorance are other labs not annotating to this degree of detail?

[00:38:16] Prof. Alison Campbell: I don't believe so. No, they're not. I think we were annotating every single embryo for a very long time and And Some of the clinics will have not annotated at all, or else they'll just annotate the blastocysts, or just the euploids. So, if you do that, you, you're restricting your dataset because you're only annotating the good quality ones.

You've not annotated the ones that have arrested the patients. On the third day at five cells, for example, or degenerated at the more realist stage, we annotated everything. So the data that trained us, we've used the manual annotation data that we've trained the machine learning models is, is really comprehensive.

[00:39:04] Griffin Jones: Did that set out, was the vision for that originally to eventually compile a massive data set? Was that the, the main or only driving reason, or were there other reasons for that level of detail in your annotation? 

[00:39:22] Prof. Alison Campbell: Yeah, no, that was the main reason is because we want to the data and in the data will be the answers.

So unless we collect the data really thoroughly and comprehensively, we're not going to get all the answers that we want to find. 

[00:39:36] Griffin Jones: And so now you're at a point where you're predicting live birth rates. Tell me more about that. 

[00:39:42] Prof. Alison Campbell: Well, when I'm describing it to patients, I'll say, well, we've Transferred embryos in good faith.

We transferred blastocysts in good faith and we've put the ones that have resulted in a baby in one bucket and the data from the ones that haven't, they've been transferred in another. And we've analyzed to see the differences in their morphogenetic values, in their developmental timings and morphological scores to see what the differences are.

And then we've built these predictive models. So we, when we do apply our models, to predict live birth, we get a score and the score one will mean that embryo, it's made of blastocysts because these models are applied to all of the blastocysts, the live birth chance is about five percent, so really low chances.

of live birth, even though we, we can see a blastocyst, which is sometimes seemingly beautiful. And then it just goes up to a score of 10 and the chance of live birth is over 50 percent with that embryo. So of course we choose the highest score and we've used the So we've retrospectively validated these models and now we've prospectively validated the models and they work exactly as predicted.

So we achieve the birth rates or the clinical pregnancy rates just as we predicted because it's, it's so accurate. And when you look at morphology alone, which is the alternative, really a standard practice, you have trophectoderm quality and inner cell mass quality, and you have a stage of expansion. And those variables are nowhere near as predictive of life birth.

They, it's just over flipping a coin. It's not, it's not good enough. And it upset, it upset me a lot over the years working with standard practice that one embryologist would choose one blastocyst from a cohort and another embryologist will choose another. Now with CareMaps, we will choose the same one and we'll choose the best one.

[00:41:45] Griffin Jones: With this level of detail and all of the data that you've assembled, would that even be technically possible without time lapse imaging? 

[00:41:56] Prof. Alison Campbell: No, it wouldn't be possible. 

[00:41:58] Griffin Jones: And so it was 2011 where you first started using time lapse imaging. I would say in the U. S. Probably fewer than 20 percent of clinics are using time lapse imaging in their labs right now.

Maybe it's around there. It sounded like you had to make that case in the beginning, but I want to ask what, what percentage of embryos are PGTA tested in the UK about? 

[00:42:31] Prof. Alison Campbell: It's much lower than the U S I believe it's probably closer to 20%. Whereas in the U S it's It's, it's more than 50%. 

[00:42:38] Griffin Jones: Yeah. I think it might be 60, something like that.

And so are, are these two things either or in many people's view that we either do time lapse or we do PGTA? Is there a reason why it's not both? 

[00:42:53] Prof. Alison Campbell: Well, yeah, I'd say in most people's view, they think right. And embryo selection, is it PGT or is it time lapse? If we're talking about modern or more sophisticated.

embryo selection, but actually there are synergies. between them. And we've shown from our own data that you're, you've got a patient with multiple euploid embryos, then you can apply care maps to distinguish between those euploid embryos. And of course we want the best embryo transferred. So if we've got that technology, then, then we should be using it.

[00:43:27] Griffin Jones: So you had to make the case though for the, for the time lapse imaging back some 12, 13 years ago. And This might tie back into the first conversation we have about embryologists owning equity in the clinic and the network, because I think you said something to the effect of that. They thought it was just kind of a nice toy and you had to convince them of a greater business value.

And I think When I just kind of ask around, I've started every embryologist that comes on the show. I asked them, do you think time lapse imaging is a nice to have or a must have? And it seems like everyone is saying they think it's a must have. And yet we have so many networks that don't have time lapse imaging.

So you had to convince them of that. Of that value. And you also had to have seen the value yourself because you own equity in the company. What was that business case that you had to make to your colleagues and, and to your self and that you feel maybe isn't being made strongly enough? 

[00:44:35] Prof. Alison Campbell: Well, you know, it's a long time ago, but the business case related to it being a differentiator and having the potential to improve outcomes.

So it wasn't um, a rock solid because we didn't know if it would definitely improve outcomes. We didn't know how much, how much it was going to cost us as a whole network if we were going to end up rolling it out across all of the clinics and we hadn't really been certain about what we would charge patients for it and if that was appropriate or not.

So there were lots of discussions. We did invest in it because the hardware is very expensive. We did start to charge patients. Once we'd got confidence in it, we had, we didn't charge for six months while we collected the initial data and we built our preliminary models. So once we had demonstrated that it was going to help us with outcomes and it could predict, predict Ploidy at that stage.

Or risk classify and the patient feedback was really positive. And one of the questions that we asked the patients was how, how, what, what, uh, did you like about the time lapse? What did what, how could you relate to it? What did you feel about it? And the patient feedback was mostly we, it really aided our understanding as to what went on in the laboratory.

And we also asked them, do you think the price. Is appropriate. And the vast majority said yes. So that was really, that was really promising and that helped us invest in further devices and keep rolling it forward and then invest in the statistical analysis and then more recently in the, in the machine learning.

[00:46:20] Griffin Jones: So it was more of a longterm play though, if you're thinking about differentiation that way, because I think if, if you're not looking on a. Five, 10, 12 plus year horizon. Maybe it's more expensive. If you're, if you're looking on a three year horizon, then it's pretty big expense to have for all of those IVF labs, isn't it?

[00:46:43] Prof. Alison Campbell: It's a huge expense, but the return on investment. Didn't take much, it wasn't too long before it came, came back because if you're charging 500 pounds per cycle and the device was 60, 70, 000 pounds at that time and you're getting good uptake and because it's a patient choice, it's an add on. It, it wasn't too difficult to get the money back in order to then buy the next device and so it just kept rolling and so it's been a great success financially, success rate wise.

Staff wise, time savings, efficiencies, and R and D wise. 

[00:47:22] Griffin Jones: It seems to me that in order to meaningfully improve success rates, and in order to have differentiation, people have to have the data. They have to have the data for everything. And so that refers to the tools in the lab that allow you to capture embryo and gamete data refers to, uh, software that allows you to capture clinical data and.

Other inputs and outputs. I don't think people will be able to differentiate without it. We talked about the market possibilities of CareMaps. Maybe somebody listening will say, Hey, why don't we throw in the towel on what we're doing and try to build CareMaps out into a, a side company that could sell into.

Other networks. We talked about the possibility of some of those companies merging as competition thins out and someone emerging as the ultimate AI solution for the IVF lab from a technical perspective, what's on the horizon for care maps. This is how I want to conclude our conversation today. What would we expect from iteration seven?

[00:48:33] Prof. Alison Campbell: Right. Iteration seven would ideally. be device agnostic. It will be cloud based. It will not be tied to one particular time lapse device. It would be accessible to this maybe version. This is the future. This is the dream. It would be nice if we could get it certified and enable other people outside our network to use it and to see, feel the benefits of it.

And for those patients of those. competitor clinics to also feel about the benefits of it. So we'll see. 

[00:49:11] Griffin Jones: When do you work on the next iteration? Does it like, does that work immediately begin as once you've completed an iteration or is you, you work on an iteration for once an iteration is implemented, you wait a little while to see what the needs are.

How does that work? 

[00:49:28] Prof. Alison Campbell: Yeah, we wait a little while. We usually Keep one version going for 18 months, two years before we see like how big is the data set now? Are there any, where, where, where's the area we could tweak and improve? So yeah, it's, we'll be coming up for those port processes soon, but version six is, is working phenomenally well.

[00:49:50] Griffin Jones: And how often do priorities shift in what you expect the next iteration is going to need versus what you end up actually doing? So in other words, going into iteration five, you implement. the fifth iteration and you're thinking this is probably what we're going to need for the sixth iteration. How much does your expectation, your assumption match up with what you end up actually needing for that next iteration?

[00:50:18] Prof. Alison Campbell: That's a really good question. We, I'm not sure so much thought goes into it as you might imagine. Really, it's because the data set is growing. We've got the ultimate, in my opinion, the ultimate outcome measure, which is live birth. So previously we were just reaching for the better outcome measure. So it took time for us to feel confident we've got enough data now to predict live birth because you have to wait, obviously, quite some months to get the live birth data after you've done the annotation, after you've collected the embryo data.

So we'd started with ploidy prediction and we'd moved to clinical pregnancy prediction. And then we got there with the live birth prediction because we had the data, we had the numbers. So I believe we've got it. Got that in terms of outcome measure. It is the best. And people do argue that it might not be this.

There are other variables. Pregnancies can be lost, needs to be a euploid. So we'll see that that mindset could change, but I don't think it will. So going forward, what we're going to be looking to do is to save more time, make the model, uh, better. faster and better and bigger and more accurate, but always I think looking for the, for the live birth is the outcome measure.

So it'll come now, the improvements will be more for user friend, more user friendliness. It's more time savings, and I think now with predictive power. 

[00:51:46] Griffin Jones: I look forward to having you back in another year or two to see the progress that you're making with CareMaps, with the other technologies that you're paying attention to.

This has been yet another fun conversation that I think our audience, especially our lab audience, is going to like to hear. Quite a bit, but I think also the executive leadership is going to appreciate your take two with differentiation and new market opportunities. Professor Alison Campbell, chief scientific officer of care fertility.

Thank you very much for coming back on the program. Thank you very much. 

[00:52:18] Sponsor: This episode was brought to you by future fertility, the leaders in AI powered Oocyte quality assessment. Discover the power of violet Oocyte assessments by future fertility. These AI based reports provide personalized egg quality insights to improve treatment planning and counseling for egg freezing patients.

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Visit futurefertility.com/irh that's futurefertility.com/irh

Announcer: Today's advertiser helped make the production and delivery of this episode possible for free to you. But the themes expressed by the guests do not necessarily reflect the views of Inside Reproductive Health nor of the advertiser. The advertiser does not have editorial control over the content of this episode and the guest's appearance is not an endorsement of the advertiser. Thank you for listening to Inside Reproductive Health.

218 "The Clinic Operating System We've All Been Wanting" with Dr. Mark Amols and Elizabeth Lee

DISCLAIMER: Today’s episode is paid content from our feature sponsor, who helps Inside Reproductive Health to deliver information for free, to you! Here, the Advertiser has editorial control. Feature sponsorship is not an endorsement, and does not necessarily reflect the views of Inside Reproductive Health.


Ever wondered how much your fertility clinic could achieve with just a 5% increase in efficiency?

In this week's episode of Inside Reproductive Health, we explore this question with returning guest Dr. Mark Amols, Medical Director of New Direction Fertility Center, and Elizabeth Lee, VP of Wellnest Fertility.

Join us as we dive into:

  • The impact of your EMR on your clinic's performance

  • Where a 5% efficiency boost can generate 25% overall clinical improvements

  • How enhanced efficiency can unlock patient access to care

  • A brief demo of Embie, spotlighting its clinic-streamlining features


Dr. Mark Amols
LinkedIn

Elizabeth Lee
LinkedIn

Embie Clinic
LinkedIn
Instagram

Transcript

[00:00:00] Dr. Mark Amols: I think one of the reasons that everyone needs to demo this, regardless if you're looking for an EMR or not, it's going to open your eyes to realize that there's more to the EMR than what you've been looking at. You've always looked at the EMR as a system that just tells you the information that you want, but this system actually works with you.

It's a marriage where you're not working against each other, but you're working with each other. 

[00:00:20] Elizabeth Lee: This is really the clinic operating system that we've all been wanting, but never could find. Think about how, if we started to think about clinic operations like this, in this type of succinct, smooth way, think about how many more patients we could help.

[00:00:37] Sponsor: This episode was made possible by our feature sponsor, Embie Clinic. Is your EMR holding you back? Is an Excel sheet your one true source of data? Are you wasting your time with disconnected point solutions? Embie Clinic's unified solution for the clinic and patient provides a single source of truth. Our suite of tools helps you flex and scale your fertility practice from clinical care to the lab, administration, and beyond.

From onboarding to baby in arms, Enby makes sure your patients are informed, Educated and supported every step of the way. Say goodbye to the old and welcome a new standard of care with Embie Clinic. Visit embieclinic.com/irh now to book a demo and take the first step to modernizing your clinic. That's embieclinic.com/irh.

Announcer: Today's episode is paid content from our future sponsor, who helps inside Reproductive Health to deliver information for free to you. Here the advertiser has editorial control. Feature sponsorship is not an endorsement and does not necessarily reflect the views of Inside Reproductive Health.

[00:01:57] Griffin Jones: Could it be that this is the Chosen One? Is this the promise that has been foretold? The Slayer of EMR? The Trident of Triumph? That allows you to finally start getting some meaningful clinical efficiency and stop doing all that junk you hate? I have no idea. I'm not a clinician, remember? That's why you have to check out for yourself and why I brought on two clinicians.

It's worth it. Elizabeth Lee, who's been a fertility clinic nurse for many years and is now the VP of operations at a new fertility clinic network called Wellnest Fertility. And Dr. Mark Amels, who's been on the program a few times now, despite the annoying technical difficulties I've thrown at him more than once.

Thanks Mark. Before we even talk about EMRs, we talk about how a 5 percent efficiency in one area of your clinic can lead to a 25 percent efficiency or greater and have impacts. in every area of the clinic and the lives of the people touched by the clinic. Yes, including patients. Yes, including providers.

Yes, including staff. If you've already decided that you're only going to listen to half or a third of this episode and all you care about is what is this revolutionary EMR slayer, skip to the last third. I think this conversation about compounding efficiency is really valuable because whether it's this solution or another, this is what we've been asking for.

It's the direction that we have to go in. I did a teensy tiny baby demo with Elizabeth in that part of the episode. I can appreciate you're probably going to want something longer form. We're putting those links in with the show notes with this episode, in the places where this episode comes out. Click on that, schedule your demo with Embie, and let me know.

Because I'm not a clinician. Are Elizabeth and Dr. Amos just sugar high on pixie sticks? Or is this the technology that you have been clamoring for years? Your input really matters to me. Please. Let me know what you decide ms. Lee Elizabeth. Welcome to the inside reproductive health podcast Dr. Amos mark.

Welcome back to this darn podcast 

[00:04:01] Elizabeth Lee: Yes, thanks for having us really excited to be here 

[00:04:04] Griffin Jones: There's a particular angle that I want to get in today because of a previous episode that I had recorded where I had a number of REIs from many different parts of the world email me after that episode and I want to get into what that was about.

I first want to broached this concept of thinking about how marginal efficiencies can have a compounding impact and maybe like the efficiencies themselves aren't marginal, but I'm talking like if you make your clinic 5 percent more efficient, if you make it 10 percent more efficient, that There is a compounding benefit to that.

And, and so Mark, you are someone that I think lives it's, this is now your probably third or fourth time on the program. It's at least your third. The first time I had you on was during COVID. It was a live episode. We had over, We had maxed out the zoom limit for the people that could attend. And I was like, people are going to have to do things this way.

I thought that it was going to have to be, I thought it was going to be sooner because I didn't know how many trillions were going to get pumped into the economy. That bought people some time to not be crazy efficient. But now as I, but now where I see things are going, it's okay. The way that Dr. Amos and a handful of others are approaching this.

That's. Just the way it's going to have to be to expand access to care. So what about this idea that increasing efficiency by 5 percent or 10 percent or something, what you might consider small can have a much larger impact.

[00:05:45] Dr. Mark Amols: Yeah, I mean, absolutely. That's how I run my whole business is efficiency, getting rid of the bottlenecks.

I think one of the interesting things about this show is when it comes to this product MD, that is really the center of your entire. Practice, right? So everything goes through it. So when you talk about bottlenecks, even a 5 percent increase in efficiency, if it's at the EMR might actually lead to a 25 percent efficiency because now different departments can talk to each other faster, different things are happening versus like you're saying, if only a 5 percent or 10 percent efficiency occurs on one area, let's say at nursing.

That only helps at that nursing portion. So there's different things that have downstream effects that also make the full clinic more efficient. And so this is what's unique about this system, which I'm excited about. And we've been working with now for a period of time, is its efficiency for the whole clinic, not just one area.

And so most of my focus has always been on individual areas, how to make nursing more efficient, how to make room and patients more efficient, all those little things. I look at everything in time. So as the old adage goes, time is money, I look at everything as time. And so that is one of the efficiencies is time, because the one thing we all don't have is, is more time.

And so we're all working on the same rules there. And so the ones that can find a way to improve the time efficiencies are the ones who are going to come out ahead. 

[00:07:06] Elizabeth Lee: Yeah, it doesn't count. It doesn't take that long to count to a hundred. It really doesn't. And so I want to even posit that 1 percent efficiency gains over time are the reason why people like Mark are able to run his practice the way, uh, that they are.

Mark and I actually know each other really well, and I helped him build a, Getting things really going in terms of being very high volume. And what he and I found was that same thing. It was these little areas that really added up quickly, just the costs. And one of the ways Mark's able to offer the costs he is because he really cares about looking at each line item and saying, okay, these consumables are too expensive.

We don't need to be spending this much money on syringes or something. So I think 1% Little 1 percent gains are all that's needed. And I think people think about it in much bigger chunks and that makes it harder to swallow. 

[00:07:59] Griffin Jones: Why don't we talk a little bit about what it is that you do in helping other clinics?

And I understand you're the VP of ops for a brand new clinic network. And I want to talk a little bit about that because before. We started recording and you said that you and I had met. I didn't remember. And I'm, and I thought I would have, it seems like I would have remembered that because I know who you are.

Like I've heard your name in a lot of different places and people are like, Oh, you got to talk to Elizabeth Lee. Elizabeth Lee is over here doing this. And so I've, I've. I've seen some of the activity that you've had in a lot of different places, and more than one person, it's probably three or four, have directed my attention to you.

What is it that you're up to? 

[00:08:44] Elizabeth Lee: Yeah, thank you for that. That's having started as a little baby IVF nurse with Mark many years ago. It's very humbling that anybody would mention my name. I spent the last year or so really doing consulting and trying to bring this topic that we're talking about, this idea of minimal efficiency gains to create big change.

But working with some big clinic groups, some donor banks, just some different groups that were really looking to make that type of shift. In their thinking to realize some of their goals. And I really spent the last, like I said, year or so working with CEOs really trying to help to shift that mindset and to help see on the ground level or the direct level.

Patient to staff communication level where some of the improvements could be made. That's not an easy thing, right? To say, Oh, you need to make improvements here. No one wants to necessarily hear that. And it's certainly not an easy thing to tell people, but when, you know, this, some of the biggest successes I've saw from organizations was, were ones who said, Bring it on.

How can we change? How can we shift our mindset? But since then, I got offered the opportunity kind of a lifetime, which was to start a clinic from de novo, from scratch entirely. And so that is with wellness fertility, which you're right is a new network of clinics. And we're really looking to bring care to places that there is none.

So Griffin, you talk a lot about it. Mark talks a lot about it. We all three talk a lot about access to care, which I think has become a little bit of a buzzword. Something that I'm looking to tackle with my newest venture at Wellness Fertility is actually looking at how do we really do that? And part of the way we are doing that is we brought on a consultant from Johns Hopkins who actually wrote his PhD on how to improve access to care.

across the U. S. Like he and his wife went through fertility treatment, and he just so happened to be very passionate about this topic. And so he actually helped us do some really deep dive analyses to figure out where to put these clinics, right? Where are these white spaces where there are population densities sufficient enough to support a clinic, but there isn't a clinic there.

And then how do we show up Yeah. To serve communities like that. So that's really what I'm up to now. I thought I was going to just continue talking and geeking out about operational efficiency for the rest of my life. When someone says, Hey, you want to start a brand new clinic? It's hard to say no. 

[00:11:15] Griffin Jones: Yeah.

It turns out if you have good enough ideas and you can communicate them to people specifically enough, somebody is going to say, I want you to do that for us, and you decided to say, yes, Mark. Before you said that. In some areas, a 5 percent efficiency might just be a 5 percent efficiency, but in others, a 5 percent efficiency might actually lead to a 25 percent efficiency.

You mentioned the EMR as an example of that. One, why is that principle the case that a 5 percent efficiency can lead to a 25 percent efficiency? And then why is the area of EMR a good example? 

[00:11:56] Dr. Mark Amols: Cool. Yeah. So like anything, there's a central part, right? So let's think of like a computer, you have a CPU, right?

You can make, you can add on better parts of your computer. And the end of the day, if your CPU is slow, the computer is going to be slow, right? Everything has to go through that portion. And so my example would be like, if I went in and improve, let's say making calendars for a nurse, I might improve that 5%, right?

But it doesn't make me any faster. It doesn't make my front desk any faster. But if I upgrade my CPU. So now the central portion, which everything goes through, improves even just by 5 percent there. It could make the entire clinic increase in productivity because each department now improves. And that was my point.

I think we're a really good example of a clinic that will benefit a lot from a better EMR. I like my EMR. I don't want anyone to think I don't like my EMR. My EMR is not made for IVF. And so one of the issues that we deal with my EMR is that there's a lot of fragmentation. So like anyone who's in the EMR that wasn't made for IVF, there are workarounds you have to make them.

The workarounds usually add time. They usually create a second or third step. And so to become more efficient, you have to get rid of those steps. And one of the things that an EMR would allow me to do if I have one that was made for IVF. is we could skip those steps, get more efficient. And obviously I'll let me talk for themselves.

But one of the things we've been looking at is, and I'm sure if you ask anyone, no one's going to say there's the perfect EMR because just as it exists, because no EMR is made for just one clinics made for a bunch of clinics. But of all the EMRs I've looked at, most of them have one thing that's Not the focus, and that is efficiencies.

That's the one thing you don't see in most EMRs. It's more about documentation, which is important, all the important things you have to have, prescriptions, billing, all that, but they really don't focus on efficiencies. And that's why EMR we've used for a long time is it has been very efficient in certain areas, but it's definitely not efficient in others.

And that's why we're looking at this, and that's why I look at that as the CPU. I look at it as, everything has to go through the EMR, and if that's efficient, it makes everyone else efficient. Does it 

[00:14:09] Griffin Jones: have to be that way? Is the reason why EMRs don't focus on efficiency, it has to do with something that the other outcomes for which they're responsible precludes them from being efficient?

Or is it simply that they have other priorities and efficiency isn't at the top of the list? 

[00:14:29] Elizabeth Lee: Yeah, I don't mind taking that. I think, as Mark said, like his EMR, for example, wasn't made for IV, other EMRs aren't made for a specific clinic, right? And so what happens is, I think, I don't think that any of the EMRs don't necessarily think that efficiency is important, but clinics are having to back their process up.

Into the way the E. M. R. runs. For example, you might have something we're really looking to focus on. It must is trying to tee up our patients so that when they get to the R. E. I. They have all their diagnostic testing done right now. The E. M. R. S. Don't really entirely support that diagnostic front end. Why?

Because not a lot of places do it. I don't know. But at the end of the day, I think what we do have in common is that all E. M. R. S. Serve patients, Right? As different as our clinics can be, we all do the same thing, and that's serve patients in some way. I think that might be what makes Embie special, or have that spark that has caught both of Mark's and I, and my eye, is that it was actually created by a patient.

And it shows, it really does, does show in the flow, in a lot of the headaches that patients experience are, those things are gone. So if there's smooth communication with the clinic, there's ease of scheduling, there's ease of data portability, ease to see your data. You don't have to call the clinic and ask them to release your follicle count to your portal.

It's really a seamless two way communication so that the patient can actually be the center of the care team. I don't know if that answers your question, Griffin, but I think, I don't think it's a matter of not wanting to necessarily focus on efficiency as much as it is that a lot of the EMRs are just really set in the way that they work.

And you can either fit into it or you can do something different. I actually think a little bit different view.

[00:16:24] Dr. Mark Amols: I do think that they are set in their ways. I do think that one of the things MD has in any EMR coming in today is they now have the foresight of what's coming up, right? The one thing we all know is.

There's just not enough positions out there, right? And everyone's looking at different ways to fix that. Some of us look at efficiencies. Other of us look at, we'll just pull in more money and take another doctor. But at the end of the day, there's only so many doctors, so much time. I think Griffin, when you look at what an EMR is, you're right.

There's like a basic portion of EMR that says, okay, I have to be able to do this. I have to be able to do this. What the original EMRs came in with was looking at how do we make things fit better for IBM? For example, is, oh, we can make the partners match up. You can't do that. Most EMRs. So people, oh, that's great.

But again, that's not a very efficient feature. Sure. It helps a little bit. Right. But it doesn't really make you more efficient. It's just, okay, now I don't have to put in there a little note that the husband is this. EMRs used to be able to now track certain lab things that you would have in a lab. But again, doesn't make it efficient.

And when the EMR gets a bunch of people, at the end of the day, this is, these are all businesses. I think the thing we always forget about is everyone's trying to make money, right? We all, we're all just trying to make money. And so when these EMRs get enough customers, they're like, why do we need to make it more efficient?

Everyone's using the program. It's doing the job they need. That it's like a card. It's from A to B. But no one knows that there's more efficiencies there. For example, like a Tesla now, you don't have to drive it anymore, right? It just takes you there. So it's efficient. You didn't even know you needed, but you're like, I really liked this.

Now I can just pop in the location. It takes me there. I think MB is very fortunate. They're coming in at a time when there is this change in our field and this change of meeting efficiencies. And one of the things that, you know, that Elizabeth has, because most of them talk about the selfless and said it, she's extremely smart person.

So just so you know, when I met Elizabeth. I met her and she was, I think you were only a nurse in IVF for what, three months I think it was? I think it was only three months with the clinic you were at. I met her and she had more knowledge and more understanding of fertility in three months than nurses I worked with for, been in a year or two.

And when we met, one of the things that, Really, I got about Elizabeth. We both got each other. We realized that we had to be efficient to make this process work. I told her what the goal of my clinic was, what I wanted to do and the obstacles we're against. And we were coming up with many things. And I'll give you an example of efficiencies that you don't think of.

So back before there was programs like Clara, OMD, all these different kind of text to patient message things. When we first saw it, we were just like anybody else going, Oh, it's extra costs and help us. But then we started thinking about it and we thought about how long do we have to stay on the phone every time we talk to a patient because there's no such thing as a five minute phone call.

Every patient, Oh, it's five minutes. It's 20 minutes. And when Lisbeth and I talked about it, I said, Lisbeth, how long are you on the phone for? I'm on 15, 20 minutes, even for a simple question. And I'm like, wow, if we think about it, we look at the cost and we figured it out, we would save not just a ton of money, but efficiencies.

And so before we had this system, Liz would be there maybe till 5pm or something. We got this message system, and all of a sudden now, Liz would leave at like 3pm because the work was done. We were able to answer 50 patients in an hour. And so the point is, like I said, not everyone realizes, There's a benefit.

Just like we didn't that day. I didn't know there was a benefit, but I'm always looking for it. And that's where I think Envy is so fortunate. And like most companies, they're coming in at the right time. They're coming in at a time when we now are becoming like the primary care, where we have to see more patients in a short amount of time.

And it's the only, not everyone at CCRM can charge a million dollars for a cycle and get away with it. Most of us aren't going to be able to do that. And we're gonna have to do volume. That's how most are going to have to do, especially if it becomes a mandate, when you look at like a Boston IBM, right, they have efficiencies.

And so they're coming in at the right time when efficiencies 

[00:20:26] Elizabeth Lee: are needed. There's really something there that we don't think about our staff burnout levels and what contribution that. Our tech stack or lack thereof is making to those burnout levels. And actually some of the efficiency gains we've talked about earlier, where 1 percent actually may have more of a compounded effect, that's where I think this is because the EMR is every interaction you're having with a patient must be.

Put in the EMR. And so if we're able to create the efficiency gains in that Avenue, then I think our staff become less burned out. They become more engaged. Then they have more to give the patient. Yeah. 

[00:21:08] Griffin Jones: I don't think you can totally bucket efficiency just as this metric for productivity or profitability.

And, but I, and I encourage people to think about it, that your, your Team or your perspective team simply will not use the old fashioned tools over some time because it's asking too much of them. It'd be like asking a landscaper to do an entire football field with just it. a set of shears, right? It's like, we have giant industrial size lawnmowers for a reason.

And once you have them, there isn't any going back to saying, Oh, just use these shears. And, uh, it'll take you about four months, but, uh, have fun with that. It's the same for operations in the clinic too. How did Embie come about though? Which of you two discovered it first?

[00:22:08] Elizabeth Lee: I did actually, I was working with a client while I was doing some consulting work and.

They were getting a presentation over lunch of this new EMR and I was like, okay, blah, blah, blah. And then as soon as I saw it, I was captivated. I was like, wait, what is this and how do I get it? And then very shortly thereafter, I'm texting Mark going, have you seen this thing called Embie? You need to see this new direction.

This would make every impact on new direction. So then that he started to become excited about it at that time. at that juncture. 

[00:22:41] Griffin Jones: Why did you get excited about it first though? 

[00:22:45] Elizabeth Lee: Me, because I could see the drastic difference in, in efficiency, starting with just right upon login, being able to see this sort of bird's eye view of the, the clinical picture.

So Mark will probably start nodding his head here when a patient calls. He and I actually have really good memories as memories go, we remember some strange things, right? But not everybody is that way. And I'm a real believer that systems and processes drive behaviors, right? Things aren't going to happen by accident.

I need to be able to see at a quick glance what the picture is that I'm looking at, who the patient is, who their partner is, what sperm, eggs, uterus, tubes look like. And Embie immediately showed me that in one glance. I didn't even have to try. To find it. And then just as I started to go through it, it just, I could feel the intuitiveness of it.

And at the time when I first saw it, I didn't realize, I didn't know that it was made by essentially from a patient who had gone through eight cycles of IVF and ultimately found success in the cycle where she demanded, not demanded, that's probably too strong of a word, but she insisted on triggering at a different timeframe.

Then her doctor was indicating and why, because she had her own data set from all of her cycles and did some predictive modeling, right? Patients like Mark and I are, and we can remember things patients don't have all don't have that capability, but it just was very clear to me quickly. Not only does it have a beautiful aesthetic, but it's just so intuitive in terms of how to navigate.

And it finally, I found something that could templatize. The things that became very routine, but where mistakes become a big deal, for example, prescriptions. If I order something incorrectly for a patient, everybody's going to be okay. Everybody's going to be safe, but that patient might have spent an extra thousand dollars on a medication that she can't return.

And so Embie also really does a lot of that systematizing. Right? So if systems and processes drive behaviors, then we can build those systems in and Embie really seemed to me to be the first product that I've ever been exposed to that did that, that started to bake some systems into how the clinic should flow.

[00:25:12] Griffin Jones: Will you show me some of this? I want to do a little mini demo because after the previous episode that Embie did sponsor, but it was not a feature sponsor episode. So what that means to the audience is that this, for example, is a feature sponsor episode. If I say Embie’s meh. Embie can ask me to cut that out because it's a feature sponsored episode.

And we tell you the audience that in the disclaimer brought to you by sponsorships do not work that way. They are, we try to match advertisers with relevant topics, but they have no editorial control over the episode. So someone can say something's mass. Um, somebody could refer a competitor, even though that particular advertiser is advertising in that episode.

And after that episode where. And we just had the little mention and an ad in it, there were a number of people that scheduled demos with Embie. And then they emailed me telling me, this thing is awesome. I heard about it on your podcast. And then I booked a demo with them and I'm blown away. And so that kind of gave me the idea for wanting to see some of this today.

And, and I like the idea of having Mark on, because I was saying prior to our conversation that. Dr. Amos is the guy that will try everything and be impressed by not that much of it, is the impression that I have of him. And so, the fact that you're into this makes it intriguing. 

[00:26:45] Elizabeth Lee: That was one reason why I attacked him, because I was like, you know what, he'll bring me down from the clouds.

This is too good to be true. It can't. And so that was really one reason that I wanted to loop the bend, besides just seeing the benefits of his practice, was knowing that he really does have that sense of filtering things out. And I knew he would bring my head back down from the clouds if, if I was over seeing more in it than was actually there.

[00:27:08] Griffin Jones: Will you show me a little bit? 

[00:27:09] Elizabeth Lee: Yeah. Yeah. I would love to. Let's see here. This is your general patient chart. And this is what I was alluding to a moment ago about having all of the relevant data right in front of you. I need to know who this patient is partnered with, right? Cause that makes all the difference.

And then there's just a few key pieces of data that I need to see in order to form the clinical picture. Because Mark, Mark will nod. When you pick up the phone, you have such a brief amount of time to put that picture together before you start losing trust. Because the patient does expect you to remember everything.

And again, Mark and I are like, okay, luckily we remember things pretty well, but not everybody does. And you want to be able to convey trust to your patient that you understand what's going on with his or her picture. And this was really what struck me initially was having this high level overview, but then having the ability to dive under the hood where needed and have all that relevant data.

And Right at my fingertips, but that was a patient chart specifically. This is the clinic dashboard that sort of that practice management hub where. You can also get a bird's eye view of what your day looks like. Oh, I didn't know we had a monitoring today. Who is that? Oh, shoot. Who's the, let's say there's a transfer there and you didn't realize.

There's a lot of reasons that having these, these types of C's are really helpful and then it's just, it's really pretty and that helps, it helps. It's very easy to navigate. If I want to go dive into this patient, I can just double click her. There I go into her chart. If I want to hop on a telehealth with her, I can right there.

Click a telehealth button. I'm not looking for a zoom link. I can immediately. Present the option to just hop on a telehealth. Maybe there's something so you can see within here. I'm not sure if it's ultra mirroring it, but that ability to just right in the moment, hop on a telehealth with a patient. See here, sorry, zoom was covering the ability to exit out.

[00:29:12] Griffin Jones: Sorry, Elizabeth, I want to ask Mark, because I've never worked in a clinic before, right? Explain to me like what Elizabeth has shown us so far. What is the impact that it's having these different features? What is the benefit that it's having on the way your clinic operates? 

[00:29:34] Dr. Mark Amols: Yeah. And I think this is important to understand what area you're looking at.

So for what she was specifically talking about, and this is where I think it's huge is when a patient calls in. And you have to answer a question, even if it's not calling, let's say even just a situation where they send a message through the message system. In most EMRs, you have to go looking through the chart for things.

So maybe you don't see a cycle they did. And so you're talking to the patient and you say, Oh yeah, when you did this, they go, I didn't do that. You're like, Oh, you're right. I'm sorry. And then it makes me sit there and go, what else? 

[00:30:03] Elizabeth Lee: That moment in that moment, you lost a nugget of trust, right? 

[00:30:08] Dr. Mark Amols: Exactly. It's that meme where it says at that moment, you realize you effed up.

That's that moment where you realize. Crap. I just said something wrong. 

[00:30:17] Elizabeth Lee: And that's a lot of stress to put on your staff, right? 

[00:30:20] Griffin Jones: So that brings it up as soon as the person calls or leaves a message. Yes. All their information is right. I just, okay. So now I'm making the connection of what you're talking about, Elizabeth.

If I had the, it's almost like a CRM function, a customer relationship management function. If I had that, I wish that I had that for every time, you know, somebody, Texts or calls me, it's like, Oh gosh, what was the thing that we were talking about? Where's their information? 

[00:30:48] Elizabeth Lee: And I like to think about Embie.

What I think is so beneficial about it is it's really a suite of tools. So instead of having this CRM over here, and this is our telehealth platform, and this is our RCM tool, it's really aggregated all under the same roof because all of those platforms need to share the same data, but typically they don't do a very good job integrating with one another.

And so this is really pulling it, just allowing you to have really. One source of truth, one single source of truth without having to manually redo data. I know for me, one of the big bottlenecks that I saw in clinics was lots of spreadsheets, right? And why? Because it's, as Mark said earlier, it's, I think, I don't think you said a band aid, but it's a workaround, it's a workaround, right?

And Envy really took all of those workarounds and put them into, we don't need a workaround anymore, here's how you'll access that. So here's that overview that I was showing you. One of the things that Mark and I think is really cool about Envy is its ability to visually show data. In a way that really is syntonic with the way we think about it.

So we think about cohorts of follicles and we think about actually the stem sheet will be a little bit better. Um, we think of cohorts of follicles and we think about, um, those developing over time with, in relation to lab levels and just different assessment values. But usually those pieces of data are all in separate places.

Where Embie just brings it all together so that you can see at one glance, once again, this patient started stimulation here. She had her egg collection here. This is how many embryos we reach or eggs we retrieved. Here's how many were fertilized. Of those that fertilized, here was their ongoing culture development.

Uh, here's what was frozen on day five. It's just really this intuitive view of, Oh, what was her estrogen that day? I can hover right over and say, that was her estrogen that day. I don't have to go somewhere else. And look for it. So this was another area that really sold me on the efficiency piece because typically your staff are really left to put all these pieces together and this just puts it all together the right information for the right people in a way that's understandable and in a way that it clicks.

Do you want to say more about what you like about this piece, Mark? Because I know you really like the SIM sheet. 

[00:33:24] Dr. Mark Amols: So I want to make a couple points because I think Griffin was So I want to go stay here, but I want to talk about the last page was, so I was saying how the nurse could look at that page and now they don't have to say something dumb.

They take a look at everything. But as a physician, when you are going through a chart and trying to make a decision, having all that together in one page, your decision making changes. So if I'm thinking something, I look at the anterofocal count and I go, wow, that's a low focal count. I'm really worried about her.

But then I can see the AMH on the same page that says, Oh, our AMH is three. That might change my, my view now that may change what I may do. And so that's having all that in one place makes me more efficient and more accurate. But I want to show you one of the things I just, I was going to tell you, if you asked me, like one of my top things I think so great about this place is the intuitiveness of that.

So when I was at Mayo Clinic, we had a system very similar to this where it had dots and the dots were just a way you could watch everything grow. What's intuitive about that is we're not very good with numbers. Meaning like when someone hears, Oh, 22, 18, 16, 14, in our mind, we hear a cohort. But when we see it, it's so simple.

You look at this page, you go, there's the cohort, there's two that are hired. But they show you the intuitiveness of this program. I don't know if you even know this, but what do you notice about the colors? The purple represent the left ovary, and it's on the left. The blue represent the right ovary, and it's on the right.

They even positioned it anatomically correct. So when you look at it, you have to sit there and go, wait, is that the left or the right? Are those both of them? I You get to make that decision, right? That intuitive, that putting that thought into this is what makes it so great. And every step of the way, that's just how it is.

I love, like I said, to me, that little detail makes it so easy that I don't have to sit there and ask, well, which one's left, which one's right? I know I looked at the screen once on the left and left ones on the right are the right. Those are the type of things that, like I said, speed up the process. 

[00:35:13] Griffin Jones: Yeah, I wanted to ask you about how it normally looks.

And by normally, I mean in most EMRs. Yeah, not like this. Usually it's a number. 

[00:35:23] Elizabeth Lee: Yeah, it's usually a number in a cell, as Mark said. So you'll have the follicular size in a millimeter, and it's just in a cell. And you're usually having to look to see is that left? Is it right? Is it even different? So it's certainly not is not given in the, in a picture that actually just intuitively you can look at and go, okay, I have a really good sense of what happened in this cycle.

Can I show you something else that I think is really cool? It's. Something that the physician has done speaking with the patient, they're going to enter a plan. And that was something that Mark and I, we struggle with sometimes because there was no really great area to communicate a plan within the EMRs.

As the nurse, as the patient calls and reports their cycle day one, that's a, cascade that gets everything flowing. But in, at that moment, at cycle day one on the phone, I can't go find all of the relevant information that I need in a typical system without saying to the patient, let me call you back.

What's really neat about Embie is the physician can enter the plan. And then when the patient calls, I can click one button. That says activate cycle and then right within here I can begin making any adjustments that are needed. Maybe I've heard from Dr. Amels since the patient was seen that maybe they actually need PGTM.

They need something more than we thought or maybe, maybe she's actually going to be using some donor eggs. So there's the ability to craft or to, to fine tune. But then once we save the cycle, now this is another brilliant piece. The system knows. That we do monitorings on specific days relative to the start of the cycle.

And so all of this is baked in to where I can click one button again, systems processes, now I don't have to remember how does Dr. Amos like to do it? Does he like to see them on day five or day six? And then even within here. Being able to make adjustments to the lab orders for that day. Maybe we wouldn't draw a specific lab that day or something like that.

But these are the types of intuitive features that I know really were exciting to me because it was the ability to not have to think through all of this, but have a system in place where I can just let that cascade roll out. 

[00:37:45] Griffin Jones: And so how does this part normally look like? Is there, normally 

[00:37:50] Elizabeth Lee: there isn't, normally this doesn't really exist.

So what you would do is you would build a calendar for the patient somehow. Some people do it in Excel. Some of the EMRs have that ability, but you're going to build a calendar and try to put all of the relevant information that the patient's going to need. And then you have to transmit that calendar to her somehow.

But all of this that you see us doing is all being sent to her app right now. Okay. So this patient can right now see, Oh, my cycle's active. Here's my doses. Here's what I'm doing in the traditional EMR. Now, after the calendar's done, now I have to give the calendar to somebody to schedule all the appointments.

That's super inefficient, right? Who do I hand it to? And what were they doing when I walked up to them? So in the traditional EMR, there really aren't tools like this that allow you to, in a templatized fashion, repeat things based on protocols. Would you agree with that, Mark? 

[00:38:43] Dr. Mark Amols: Yeah, when I first saw this, I thought, did they steal this from our clinic?

Because basically what we do at our clinic is, Elizabeth and I came up with the idea to make all the calendars ahead of time. So when someone's going through IVF, we just pull out the calendar that they're going to be doing. We know the days where I see them, they walk up to the front, they make all the appointments.

And again, it's, it's efficient, but this is more efficient. And the thing that came from a, from a standpoint of, uh, someone who's inputting data, One of the nice things about that too was, I don't know if you noticed that Griffin, you can adjust things even on that page before you hit send. A lot of the programs I've seen, it's pre made and that's how it gets sent out, but there you can actually, even before you hit submit, you can change every little part to it that you want.

Delete things, add things, which now makes it a simple click and you're going. And again, it's just so many steps to remove. 

[00:39:31] Elizabeth Lee: There's just a lot of feeding the staff, the next step, right? Cause like how easy would it be to forget a step to forget to order the meds? This is prompting us. To actually go in and sign the various orders.

Let's say the patient wanted to she was going to go do outside monitoring somewhere These are all of her lab forms that I that are just auto populated The data is transferred over and now one click and this order is gone. I didn't have to write anything I didn't have to pull any data from anywhere else.

So it's really that Continually prompting you. Okay, what to do next and then bringing that information to the patient. Something else that I think was I really liked about this and I would encourage people go to the app store and download the patient app because I really don't think we can overstate That a patient created this and that it really speaks to the needs of patients.

So the educational needs, the mental health and emotional needs of patients. Go look in the app and you'll see that's a little bit of where the secret sauce on the patient side comes, but being able to integrate it across is. To me is a really brilliant piece. I

[00:40:44] Griffin Jones: want to, I want to jump on that for a second, because I've thought there have been apps in the past and maybe, and I think that there's still are that do add a lot of value to the patient in terms of information, in terms of even helping to a certain degree as concierges, but there's always been something missing.

And we've seen app after app come in and either have to change business model. Or they burn through tens of millions of dollars and without ever, like really finding what the business model is. And I've constantly asked, what is it like, how, what needs to happen in order to make this work? And it could be the case that the limit to those apps is that they just never connected to the other side.

Like never really fully integrated with the clinic that there was. It's okay. We can give you this information. And we can. Monitor stuff about your menstrual cycle and maybe even some of your treatment. But then there is a wall once, uh, once we're interacting with the clinic and we have to try and leap over the wall.

This to me seems to be two different sides to the same coin. 

[00:41:54] Elizabeth Lee: You bring about a great point. And it's just, I think It comes down to where is the value ad? And it also depends on what your clinic needs are too. Right? As Mark was saying, we haven't mentioned this, but this tool specifically, something else I thought was really brilliant was the customizability of it.

So the ability, like maybe Mark always likes to see, I don't know, a certain value, and it's not naturally displayed in the app. It's very easy to, to see. To pull that beta in and to customize it for how he works. So, so not only is it just very intuitive and efficient on its own, out of the box. But then you're able to further create refinements to, to make sure it runs the way that, that your practice runs.

We haven't shown this site at all yet, Griffin, but we, and Embie thinks this is really cool. I think this is really cool. Mark and I talked about. Implementing Clara, that use of the bi directional communication tool with the patient, but this bakes it directly into the EMR and it provides that remember that 30, 000 foot overview of contacts.

that matters when I reply to a patient, right? Oh, that's right. No, they're not using a surrogate or, oh, that's right. She's on her 21st cycle or something like that. On our side, on the clinic side, we can see it all aggregated in one thread. So we can see who sent it. And then each of the patient's responses on the patient side, however, they see it as individual conversations.

So they have that ability to send to financial team or send to maybe send Dr. Ams a question. So this is really, I think, quite brilliant in terms of, 

[00:43:37] Griffin Jones: so in a normal pa, in the typical patient portal, how would that look? Would it just be just that? 

[00:43:43] Elizabeth Lee: Usually it's message gets some individual. Yeah, it's usually like an individual message itself.

So if I want to go back and look and see, I may have to click in and out of 20, 30 messages to get the whole thread where I can just scroll up, go, got it. All right. I know what's been said off I go. And yeah, in a traditional EMR, you'd be opening up each individual message from all the different teams.

[00:44:10] Griffin Jones: This is almost like a group. 

[00:44:12] Elizabeth Lee: Yeah, yeah. It's like a WhatsApp group thread. Yeah. So on our side, I can easily say, see, Oh, fantastic. Finance has touched face. The admin has touched face. The counselor has touched face. I can see all of that. And the system allows for tasks to be fired based on the cycle that patient's doing.

So we know every patient is a financial consultant. Every patient needs to sign consent forms, every patient needs to do on and on. And this allows you, when we activate that cycle, it cascades all the tasks out to the right departments to say, okay, we know now she needs a financial consult. We know now she needs these things.

And that too is. I have never seen that in the EMR space. That's always what we're seeing here or what I have traditionally seen people build workarounds for. 

[00:45:06] Griffin Jones: I feel like for so long we've been saying, man, somebody ought to build this. Like somebody ought to I'm not gonna, I'm not a builder. And I think I've known Ravid and Josh for probably a year or so now.

And I don't think that I've fully appreciated what they've done until now. 

[00:45:28] Elizabeth Lee: Griffin. I don't know if you know this, but obviously it was started as a patient app and really looked, they wanted to join forces with the various EMRs and offer this, their platform as an overlay for the patient portal. Right.

Let us give your patients this really intuitive, pretty experience, but none of the EMRs wanted to play ball. And so they looked at each other and said, okay, let's just make it ourselves. And that's exactly what they did. And it's to look at this and to know that this was built less than a year ago and to see the progress with which new changes are coming about.

Something we haven't gotten a chance to mention yet, Griffin, is the AI component. It's not live yet, but it's still in, in, we're still working on it. It actually helped, we created an abstract to submit to Esri to show the data, the accuracy of the data from AI is there. So I'll give you an example. In Embie, we're going to have the ability to click a button and have AI generate the progress note for the day.

[00:46:30] Griffin Jones: You know, who's going to love that mark beyond your team, not having to look at your digital chicken scratch anymore, but your, your family is going to love it. My wife's a physician and she's not in, she's not an RAI, she's not in women's health, but she, it sucks. Like when she's on service week and she has to.

Come back and do notes. And she's just, should I stay at the office and do notes? Should I come back and put the baby down and then do notes? And that's how it would be a lot nicer if that could just go away. And I've been trying to tell her that it will go away someday. And finally, somebody is at least doing it.

[00:47:08] Elizabeth Lee: Well, now she should, now she should just become do be a fertility doctor and she's got a platform. 

[00:47:13] Dr. Mark Amols: I didn't know a step further. And again, this is where I go back to that point. We all think around us. We don't think about everyone else. I'll go a step further. It's not even just about my time. Now, notes are going to be more thorough, right?

I mean, when I read a note and I'm dictating it, I'm not putting every single thing that half the time patients get Dr. Emeril talked about this. I'm like, well, we don't see the note. Cause I can't put out. I got to get home and see my family now. Not only do I save time, but now a complete note is there.

Every little detail is there. And. What AI is going to allow us to do, and which is one of the reasons I'm, be honest, I'm mostly sold on them is because they want to add AI. Is it's going to make things just more efficient, but also it's going to be more thorough. And so I think it's not just about the physician saving time, it's the better quality of notes, the better documentation, the speed of it.

Now more time for the patient, right? So now it's not even just about me. Now I can spend a full hour talking to the patient versus having to spend 30 minutes and the other 30 minutes having to chart. You brought up a point earlier about. Programs. And this is taking everything in. There's a program. I'm not trying to diss on it.

It's a program. I think it was called Sal. I saw it at ASTM one year. I remember what I saw. I was like, wow, this is really pretty. And the reason it came around wasn't because no one could do it. It's because it comes back to that principle again, as an EMR. You have to make decisions. Am I going to make this?

Am I going to make this? People are already using our product. Right? Why do I need to make this? So South came in and said, listen, I'm going to solve a problem. I'm going to give this beautiful, interactive tool between the patient and the clinic. But the problem was, it's a workaround. You're still not going to the EMR.

So what's great about Embie is, they're taking all those things like you said about why don't they put this in a thing and they're putting it into a program, but they're always looking to go ahead. And I do. I think it's perfect. I'm not going to lie and say there's nothing that can't be perfect. But what's interesting is when I talk to them about things and they hear about the efficiencies, they make the changes or they at least think about them.

[00:49:17] Griffin Jones: I want to ask about that because we have, and maybe Dustin will make me cut this part out, but we have seen EMRs in the past come in and to your point, Mark, maybe be more in the time of this digital revolution, starting off with cloud based, starting off with a lot of the digital technology that we have now.

And you've even seen some clinics adopt them, but then some other clinics try to adopt them. And it's just, this doesn't work. There's way too many. Bugs and glitches, and they had to even go back. Imagine how much it sucks to switch in EMR and then having to go back. Yeah. So, so what are the glitches here?

What's the, what are the things that. Aren't ready for primetime. 

[00:50:06] Elizabeth Lee: Yeah. I think that the AI component is really still very much in production. It's not, I wouldn't say today, if somebody were to pick up and be up as their clinic tool, do not expect that's going to be available today. It's something very much still being massaged.

[00:50:20] Griffin Jones: But that's an add on that's being incorporated. What about the core functionality of this? 

[00:50:25] Elizabeth Lee: Is what the biggest opening for opportunity is really to pull their reporting capabilities together. Cause they're all there. But it's just, I think, about finding what are the reporting tools that are going to be really important and then extracting those out.

So I think that's the, in my mind, where I see the biggest area of opportunity is that the ability is there, the framework is there for all of the reporting, which is amazing. But I want to dig a little deeper on how am I going to get the exact reporting that I need to do my best work. 

[00:50:59] Dr. Mark Amols: There, there's a couple of things that when you're looking to look at EMR, right?

You mentioned about adding a product, right? So if you look like Windows, for Windows to be able to keep where it is now, they had to scrap everything and start from scratch. And you're right. A lot of these EMRs might not be able to do this stuff. The way things were written, the way it's coded may not be allow it to.

So this is actually coded in a way that is very HTML5, that's what I'm looking for. It's able to be adaptable a little bit better than some of the EMRs. But. Where the question you were asking is, I think we're the biggest drawback to going to the Amari is the amount of work that's going to it. And I know one of the things they're working on is ways that be almost a turnkey approach where you hit a button and it pulls all your data and goes into it.

And, and that's really the biggest. drawback of going to another EMR is, okay, these are great functions, but are those functions worth the headache of going into a new system? 

[00:51:53] Elizabeth Lee: And I think this is where I like to equate it to a marriage, Mark, right? You've got to be certain, for you, this is such a vital part of your business, that you really need to be certain.

And it is very much like a marriage, and the longer that you are with it, a certain EMR. The scarier it is to think about making the jump and is the data portability there? I think that's what you were speaking to, Mark, is how do I get, how do I not interrupt my clinic operations? And that's actually something I think is quite brilliant about Envy.

And it is, it's just very simple. It integrates with either your Google Calendar, your Outlook. So it's very simple in terms of getting implement, getting implementation up and running. There's not a lot of back end. I think the biggest thing is like customization, right? Where Ravid sits down and she says, okay, give me all of your form.

Give me all of your workflows. Show me all, show me at all. Right. And then she helps to create those little tweaks. 

[00:52:47] Dr. Mark Amols: And it's not AI, right? One thing is you're talking about, everyone can put AI in it, but how you do it matters, right? Just because something has AI doesn't mean it's going to be useful for you.

There is the potential here when you have a company that's really willing to integrate it to make efficiencies, that again, it's not going to be the same as someone saying, Oh yeah, you can get an AI to dictate your notes for you. Like I said, they're looking at it from a different perspective. Which is what makes me excited about them 

[00:53:14] Griffin Jones: to your marriage analogy Elizabeth prior to a marriage You typically go on a few dates a first date might be a demo Do you know the demo that I know reviewed does demos for perspective clinics that do you also do them for?

Perspective clinics, or am I just getting a special treatment right now? 

[00:53:29] Elizabeth Lee: You're just getting, it's you Griffin. But Tiffin, you really, what you have seen is just very much a scratching of the surface. And I do want to make that clear. This is not a full demo. There's so much more to see. And Mervy does an amazing job at walking you through really line by line, the magic of it.

Yeah. You're getting, you're getting me, but Mervy really is happy to give those, those demos. And then the second, third, fourth date is something like what you see here. And that's a sandbox. So Mark's had the ability, as have I, to really dig under the hood and play with it and look at, okay, for my patient flow, how will this work?

How will that work? Seeing what it looks like on the patient's side, right? So we can actually, through the sandbox experience, link, A patient to say Dr. Emil's phone. So he can actually see what the patient is seeing. I think that's really valuable because especially if you, part of your business model is an amazing patient experience.

I think that those kind of the information gleaned from those second and third dates as it were, it's really valuable for them for the overall 

[00:54:30] Griffin Jones: decision. So I'd like to conclude then is why someone should spend the time to do this demo, to go through this demo and probably tying back into the, where the conversation started in the first place of how some efficiencies in particular areas can lead to much greater improvements in many other areas.

And the whole time that you each have been talking about, I'm thinking of. We have to do this as a field, whether it's this particular solution, whether it's other particular types of tech solutions, we have to, there's no other way where there's no other way to get Gen Z's and millennials to, to get even the productivity that earlier generations of docs had been doing much more.

All of the rest of the patient population that needs to be served without these kind of improvements. And, and I'm thinking like, there's just, this has to happen. It's got to happen yesterday. But so I, but I'll let each of you decide of, of what people should be considering about what they test and why this makes sense to think about.

[00:55:42] Dr. Mark Amols: Yeah, I can go first and then Elizabeth and really summarize everything. But I think one of the reasons everyone should do this demo is to realize what they don't have. I think it's going to open their eyes, whether they decide to go with this product or not, it will open their eyes to realize, wow, I didn't realize how much I'm leaving behind of efficiencies, of benefits, just to name a few programs that this would get rid of.

Things like Clara, EngageMD, Salve, All those different things easily gone. Potentially billing. Potentially using AIs right now for dictation. It even gets rid of nurses in some ways. I hate to say that, but I may not need four nurses. Now I may only need three because I don't need someone to double check everything because the system's already double checking it.

So, I think one of the reasons that everyone needs a demo desk, regardless EMR or not. It's going to open your eyes to realize that there's more to DMR than what you've been looking at. You've always looked at DMR as a system that just tells you the information that you want. But this system actually works with you.

It's a marriage where you're not working against each other, but you're working with each other. And the part that we really have not delved into, and I think you just hit on Griffin, is the patient side. We're in a different world now. The old days of sitting down with a patient for an hour or calling them up and set up an appointment, those are gone.

Very few people want to do that anymore. Most people want to point, click, have an appointment, get their information via email. Text versus getting it through the phone. And so, you're right, these changes have to be made. But the problem is, no one realizes what they're missing because they've only seen it through one view.

And that's the view of the old antiquated EMRs. And I don't know if NV is going to be the best forever. There may be something else that comes ahead. But one thing I can tell you right now is, They are definitely far ahead of the other EMRs I've seen, and I work with what I think is one of the more efficient EMRs, and I'm even seeing it have progress over what we're doing.

[00:57:37] Elizabeth Lee: Yeah, for me, Griffin, I think why everyone should go book a demo is because this is really the clinic operating system that we've all been wanting, but never could find. And I think that it is this suite of tools that now finally brings the all of your clinic operations under one tool again, like that single source of truth.

And I think we talked a little bit about it earlier about Access to care being a really important sort of North Star for Mark and I both, I know, Griffin, you talk about access to care a lot, but think about how if we started to think about clinic operations like this and this type of succinct, smooth way.

Think about how many more patients we could help. Right. Think about all of the wasted time, like the massive efficiency tax of just clicking from program to program, just even reorienting yourself. There's a lot of studies that show that is, is very counterproductive. So having that single source of truth, I think allows because we can start to get rid of a lot of that.

That's yeah, that efficiency tax from our current systems. I think 

[00:58:48] Griffin Jones: the financiers would definitely like that topic, Elizabeth, as well as the patient advocates and yeah, and oh, I would love to have you back on in the future for another episode. I also think this is a segue for a topic that I want to have Dr.

Amos back on for which is talking about that top of license. being applied to every different role in the clinic, not just the REI. This has been a pleasure having this conversation with you. Thank you both for coming on the Inside Reproductive Health podcast. Thanks. Thank you. 

[00:59:20] Sponsor: This episode was made possible by our feature sponsor Embie clinic.

Is your EMR holding you back? Is an Excel sheet your one true source of data? Are you wasting your time with disconnected point solutions? Embie Clinic's unified solution for the clinic and patient provides a single source of truth. Our suite of tools helps you flex and scale your fertility practice from clinical care to the lab, administration, and beyond.

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Announcer: Today's episode is paid content from our feature sponsor who helps Inside Reproductive Health to deliver information for free to you. Here, the advertiser has editorial control. Feature sponsorship is not an endorsement and does not necessarily reflect the views of Inside Reproductive Health.

211 AIVF's Tech-Driven Mission to Personalized Care, Efficacy, and Efficiency with Daniella Gilboa

DISCLAIMER: Today’s episode is paid content from our feature sponsor, who helps Inside Reproductive Health to deliver information for free, to you! Here, the Advertiser has editorial control. Feature sponsorship is not an endorsement, and does not necessarily reflect the views of Inside Reproductive Health.


In the realm of fertility, many claim to prioritize personalized care. But how often is this a reality versus following predefined profiles?

Daniella Gilboa, Co-Founder and CEO of AIVF, shares her thoughts and leverages her experience as a seasoned clinical embryologist to shine a light on where fertility can improve patient care and how AIVF is stepping up to the challenge.

With Ms. Gilboa we discuss:

  • Her definition of personalized care (Contrasting with what is being done today)

  • The micro & macro of what’s happening in the IVF field

  • New technologies improving efficacy & efficiency (And where the two come together)

  • AIVF’s innovations allowing embryologists to do more cycles more effectively (And its impact on the embryo) 

  • How this same technology can provide non-invasive genetic screening.


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Transcript

[00:00:00] Daniella Gilboa: So we've been hearing about personalized medicine for some time now. And it's it became like a, slogan, like we do personalized medicine, but what's the essence and where does it meet us? the, IVF ecosystem, do we really. give personalized medicine? So the answer is no, not yet.

then IVF clinics, that's as they work now, as we work now, there's no personalized medicine. There's we understand like profiles of patients and this is what we could treat like profiles of patients. 

[00:00:34] Sponsor: This episode was made possible by our feature sponsor, AIVF, the pioneering force behind the revolutionary EMA platform.

AIVF is at the vanguard of transforming reproductive medicine through cutting edge AI technology. The EMA platform sets new standards in precision IVF care. Learn how EMA can grow your fertility's efficiencies by going to aivf.co/precalc. That's aivf.co/precalc.

Announcer: Today's episode is paid content from our feature sponsor, who helps Inside Reproductive Health to deliver information for free to you.

Here, the advertiser has editorial control. Feature sponsorship is not an endorsement and does not necessarily reflect the views of Inside Reproductive Health.

[00:01:30] Griffin Jones: Personalized care. Nearly every fertility provider of a fertility practice says they want to provide personalized care to their patients. But are we delivering truly personalized, individualized care, or are we following profiles to deliver care? If we're being honest, I think we all know the answer to that.

Now imagine if one of your most talented embryologists noticed that. And after 15 years of experience in the IVF lab, got the backing and started a company to solve for exactly that. That actually happened. That's the story of my guest today, Daniella Gilboa. She's the CEO and co founder of AIVF. She was a clinical embryologist for 15 years.

She has a master's in biostatistics and epidemiology. And through this background, we look at the macro and the micro of what's happening in the IVF field in the soaring demand, but also from her experience as an embryologist, the insights for the limit of supply. Listen to Daniella's definition of personalized care and contrast that with what's being done today.

Then listen to how new technology is improving efficacy and efficiency and where the two come together. Are we really going to be the most effective in clinical success rates? Are we really going to be the safest in operating an IVF lab? If half of the workload that embryologists are doing can be offloaded today, what would you do if you had twice the number of embryologists?

Daniella explains how her technology allows embryologists to do more cycles more effectively. How does this technology provide non invasive genetic screening? What's the impact that will have on the embryo, on the field? And then toward the end, listen to Daniella double down on what so many embryologists have said recently, where she says time lapse incubation is a way of life.

As you listen to her explanation, I think, are we ever really going to be able to scale fertility care if we're manually collecting data points and manually entering them into various disconnected channels? If you're interested in AAIVF, they have an efficiency calculator on their website. It will be linked where this episode is distributed.

I recommend you go to the AAIVF website and use that calculator. But if you also just want to get in touch with Daniella, feel free to ping me for an intro. I hope you enjoy this conversation as much as I did. Ms. Gilboa, Daniella, welcome to the Inside Reproductive Health podcast. 

[00:03:33] Daniella Gilboa: Thank you for having me. 

[00:03:35] Griffin Jones: I have been interested in following the efficiency improvements in the lab, the efficacy improvements in the lab.

I'm also really interested in the AI revolution and you're at the seat of where all of those things come together, because I really do believe that AI is going to conquer every segment of our, world for in different purposes and every place in the marketplace and our field is no exception, but I guess even before we get to some of the technologies.

Your background, you're coming into this not first as a tech entrepreneur. To me, it sounds like tech entrepreneur came later, but you have what? Some 15 plus years in the IVF lab as an embryologist. Tell us about that. Tell us about the challenges that you were seeing that then brought you to the areas of interest that you're in now.

[00:04:35] Daniella Gilboa: Yeah. So first of all, I wanted to thank you for this amazing opportunity. My passion is really to talk about IVF and AIVF. So thank you for that. And yes, I'm a passionate clinical. I actually have two hats, clinical embryologist and a biostatistician. So I look at IVF, sorry, I look at IVF from the very, from let's say bottom up from the, from the clinical work and embryology and facing patients.

And also let's say from the top down as in looking at the data and trying to understand like different trends and correlations. so this gives me, I think, a holistic view of IVF from the inside and out and inside again. So I'm a passionate embryologist. I live and breathe embryos. I'm a big believer in time lapse.

I think time lapse, the introduction of time lapse into the IVF. Labs was something that empowered embryologists. It gave us real true knowledge of, embryo, sorry, embryo development and evaluating embryos. I think it became, it, brought us embryologists to do more of a data driven decision guesstimation.

So I'm a big believer in time lapse, and I've been working with time lapse for many years. It was introduced to the market, I think in 2012. So yeah, so it really, and time lapse for me was really the first step of AIVF because what time lapse did mostly is introduce data to clinics. Time lapse allows the clinics to actually generate data, and once you generate data, you're not only relying on embryologists copying, the patient's folders into Excel.

Once you generate data, you have the power and the knowledge and you have real value. So I think this is, this was the first step that the industry of IVF and the IVF professionals became to realize. That they have something here that could, I, think us as an interest, industry realized that we have something that could really take us forward and really move the needle.

And so this is where, IVF was, born due to the realization that A, we now have data we can work on. So we could transfer IVF from a very clinical biology into tech. Enabled ecosystem. so this was, the, understanding that labs have are able to generate data. And the other reason of course, is what I've been experiencing as an embryologist in terms of how, you work as an embryologist and the workflow and the success rates and the interactions with the physicians and interactions with, patients and with, my peers, with.

other embryologists and maybe can we really take this very complicated and sophisticated setup and do it maybe different to help more and more patients realize the dream of having a baby. So this was like a very vague kind of concept. back in around 1960, 1917. And I'll just add, this is where I started thinking about maybe doing something else than a clinical embryologist.

And I started my PhD thesis. It was in the field of biostatistics and IVF. And so the, company was born from, my years as a PhD student. 

[00:08:48] Griffin Jones: with a background in embryology and biostatistics, it seems to me like you'd have a pretty unique point of view on both the macro and the micro and how they come together.

So tell us about the, macro that you were seeing and the micro that you were seeing and Where they come together, how that's affecting personalized patient care or a lack thereof. 

[00:09:18] Daniella Gilboa: So, we've been hearing about personalized medicine for some time now and it's it became like a slogan, like we do personalized medicine, but what's the essence and where does it meet us?

the, IVF ecosystem. Do we really give. personalized medicine? So the answer is no, not yet. then IVF clinics as, they work now, as we work now, there's no personalized medicine. There's we understand like profiles of patients and this is what we could treat, like profiles of patients.

So we talk about different age groups, for example. So we talk about the 34, the 34 year old patient or the young patients or the, advanced age patients, but it's not, There's nothing personalized here. So it's, profiling. going down to the, if, I analyze the industry as an industry or, IVF from the bottom up and top down, so I think we realized two major trends and this is very interesting and so let's start with 40, 000 Viva.

48, 000 feet above ground and understand like the macro. So what happens macro and, this is interesting is a trend, I think a decade now of IVF becoming not just under medical indications, but rather something that we might choose to do. Like we want to plan our fertility journey. So like 40, 000 feet above ground, we see two major trends.

This one is IVF is now not only under medical indication, but rather something that we might choose to do. Like we want to plan our fertility journey, we want to understand more and maybe even control it. So this is a way for us, so IVF is a way for us to do it. First, I think it's, a decade now, I think 2013, we can freeze our eggs.

We want to delay childbirth. IVF is a way to do preventive medicine through PGT. New families, surrogacy, all this drive IVF to be social IVF, not under medical indications. So more and more people are seeing IVF or, are looking to do IVF, not because they have any medical indications, because they actually choose to do IVF.

So this is an important and interesting trend, and we see it more and more, and there's even a very interesting, paper that was published, I think, in Nature, trying to predict the effect of IVF by the end of the century. And, the numbers are about 3. 4, 3. 5 or 4 percent of global population would be IVF.

So this is big numbers. This is enormous. This is amazing, unbelievable. So this is the demand. Demand is IVF is growing enormously and it's not going to stop. And then there's the supply. The supply, the clinics are limited because we do mostly things, it's an art. We always say the art of ART, so it's, an art.

It's subjective human analysis, and it's really based on, on. the, group of embryologists and, everything in IVF is expertise. So it's not just OBGYNs, it's IVF experts and it's not nurses, it's IVF nurses and it's not biologists, it's embryologists. So it's another layer of expertise.

And so the fact that we have scarcity of IVF specialists and scarcity of embryologists, and, the way. we communicate and we do IVF by hand. So this makes the supply side to be limited, so unable to scale, not able to scale. And then the demand is huge. So demand versus supply, huge demand versus limited supply.

The only way for us to ever bridge that gap is by technology. And so this is where IVF comes in and we say, we come from the supply side, deep within the supply side. We understand the supply, we understand the state of mind, we come from within and we know what it means to do IVF and good IVF. And we know what, it means to have a group of embryologists that are, the end of the day doing the magic.

So we are here to create this technology, this magic that will help the clinics scale. the clinic's scale, more demand, or patients are able to realize the dream of having a baby. at the end of the day, this is the way to really move the needle and help more and more people. 

[00:14:30] Griffin Jones: On the macro, you have the giant global demand, the increasing global demand, not just from what's currently come from a medical diagnosis from infertility, but those that are doing their family planning in many different ways, whether they're same sex or single women or delaying childbearing, or perhaps more so in the future, those that are, that want to prevent genetic diseases.

And then there will perhaps be more implications in the future after that. And then on the micro side, you're seeing where, why the supply is falling short of the demand because you're working in the IVF lab, and the only way that the supply will be able to meet that demand is through a technological revolution through major technological advancement.

We're not there yet. And it sounds from talking to a lot of people, it sounds like we're, far and we're close. Like we're both far and close at the same time. You, which one do you think? Do you think we're further or closer? 

[00:15:30] Daniella Gilboa: No, I think we're there and I think that technology is there and I could only speak about the IVF, but I think that technology is there and I think that there's excitement now, and we see it, in the industry and people are willing to try and understand that this is part of, the evolution. It's not a revolution, it's an evolution. And so I think, it's there and it's, and I'm very optimistic.

I think we're now in a very exciting Time where we actually see the industry that we so much care for and you know the science IVF science Really changing and evolving into the next generation and you know We are there to lead it and it's very exciting and in fact I see the industry, of new technologies that is now forming.

And it's an industry and it's actually an industry. It's not just a bunch of companies. It's not just groups of, university groups in universities. It's an actual industry and we see it forming. And, we've, we even have a conference every two years of the, IVF. So, the, technology industry of IVF.

So I think, we're forming groups and working groups and think tanks and we work together as an industry and we sit in conferences, the, domination of the very dominant pharma. That is a bit, slowing down, and we see the rise of the, our industry, and it's very exciting.

It's exciting for all of us. It's us, exciting for the, for the physicians, and embryologists, and nurses, and patients, and, all the stakeholders in, in the IVF ecosystem, because at the end of the day, this is a real revolution, a revolution in evolution of, a new industry. 

[00:17:32] Griffin Jones: So by being so close, that the technology has finally seemed to arrive and now it's not, I'm starting to see people implement it at rates faster and higher than they were even just two years ago.

You mentioned that we're not there yet with regard, meaning, meaning what the average patient is experiencing right now is not personalized medicine yet. what exactly needs to happen in order. for that patient to receive true personalized medicine, not just profiles. 

[00:18:05] Daniella Gilboa: Yeah, so that's a good point.

So just to clarify, clinics who are not using any new technology, the very old fashioned clinics or the conventional way of doing IVF, this is not personalized medicine. This is profiling. I think with the arrival and the introduction of these new technologies, we, are going to be able to provide personalized medicine as in I'm Daniella Gilboa.

this is my medical history, my age, this is where I come from. How will this affect my chances of conceiving? When is it going to happen? How long? Will it take me how much? Will I have, to, how much time do I have to commit to doing that? Do I have to stop working? Can I change my job while I'm doing IVF?

Can I maybe pursue doing my PhD when I'm, while I'm doing IVF? All of these questions, how, how much it will cost me, all of these, this is personalized medicine. So what exactly like the, what medication? Will, is the best for me, what protocol will be the best for me to produce, six, eight, ten mature eggs.

It's like, all of these, this is personalized medicine, and if I'm diabetic, how will this affect my chances of conceiving? If I had, if I have, I don't know. Some, disease in the background. How will this affect? Can I conceive? Maybe I should do, surrogacy. All of these, this is personalized medicine, but we don't have any personalized medicine in IVF today as it is today.

So it's not just the efficiency of the clinic and the lab. But it's always, it's also providing real, real precise medicine and all of this can only be, can only happen if we introduce technology and, AI driven decisions and data driven decisions and, that we get used to working with.

data and really monitoring different KPIs and understanding what KPIs are and what KPIs we want to, monitor and who's going to monitor that. Maybe, I'm a simple embryologist, instead of just doing the wet embryology and the wet work and ICSI and IVF and thawing and freezing, part of my routine task would be, checking the different KPIs and, analyzing the data.

This is another layer. That IVF labs needs to be doing on a daily basis, not just when they want to publish something, but on a daily basis as in part of really understanding how good you are is looking at the data and looking at the data. You have to have data. When do you have data? When you work with data, you need an EMR that's connected to a time lapse, and that's gen, actual generation of data that you could, work and analyze, and it, needs to be part of your thinking, part of the method, part of who you are as an embryologist.

[00:21:12] Griffin Jones: It's messed up, isn't it? How this level of personalization is in areas of sales and marketing, but not in areas of healthcare yet. Like on Amazon, Amazon isn't targeting people that, watch golf and therefore might like bourbon. They're targeting people who bought a very specific type of bourbon and then can send them, ads for.

Particular types of whiskey glasses. And you bought this and oh, you bought this bourbon at this frequency for the last two years, and therefore you probably want this next bottle coming to your house on March 24th. we've got this in areas of sales and marketing, but we're, pretty behind on it in many areas of healthcare, including fertility.

It's a way of life for you as you're describing it, this bringing technology to. the fertility field to provide personalized care in this way. Tell me specifically, what is, what's AIVF doing? Wow. 

[00:22:12] Daniella Gilboa: Okay. So thank you for asking. So we are, a great company. And the reason I say it is it's not just a company that's developing AI or, or like a product, it's a company that lives and breathes.

Breathe is embryos and IVF and the patient journey, because we have here a bunch of people, from different domains, all of them looking at embryology and asking, how can we make it better? How can we really make an effect on the patient and on the physician? The embryologist. So what I love about IVF is that we have mathematicians and physicists and product people, and engineers and marketers and sales and legal and finance.

All of them are looking at I-V-I-V-F and the IVF journey from different aspects. So this is great because as an embryologist, my interaction was only with. Fellow embryologists and physicians, but now we all, we've, we, I think we opened up the IVF ecosystems to so many other domains that is just really exciting.

So this is, so IVF or AIVF is, deep in the sense of that we do technology and we do science and we even do basic science and, and we really create. The next generation of, IVF clinics. And so now I'll dive into IVFs, AIVF. So we're, I said before, we come from the deep within the supply side, the clinics, and we're developing the operating system of a clinic.

What we want, what we provide now to the market is a one single system that everyone. So we take, we're integrated in the IVF lab, and this is where the magic happens, the IVF lab. And we connect the IVF lab to the physician, one hand, and to the patient, on the other hand. So it create, it becomes like a transparent lab.

so any data that the physician needs In order for them to deliver the news to the patient or to, make decisions, clinical decisions, they have on the palm of their hand any, needs or information that the patient needs. They don't have to rely on the nurse, or the administrator, or the physician.

They have, they sit. Decision making will always be with, the, physician, and with The, embryologist or the lab, but it's like empowering all different stakeholders to access the data and to see, to understand and access the data. So it's like a transparent lab and again, the lab is really the essence because this is where the magic happens.

So it's the connector. And so we are the operating system and how we do that. We're connected to all different systems you normally have in a clinic. Like it could be a freezing system. It could be an EMR, of course, the incubator, whether it's time lapse or non time lapse, and we collect all the data and this is where we come in.

So for different decision points that you have throughout. The process. We have our own very deep AI algorithms to help you make better decisions. It'll never be an AI that makes decisions without the expert, but it's part of your methodology. It's another layer of information that helps you assess and understand and and evaluate whatever you need to evaluate.

Whether you're an embryologist or. a physician. And about the AI, I'll talk more in a moment because it's, very interesting. And apart from that, there's a very deep engineering and product that needs to be facing different stakeholders and needs to be interacting well and needs to be very easy and friendly and empowering.

So it's, it's, there's expertise there. But at the end of the day, the way we envision IVF is that you log in the morning, you open the lab, you open the clinic, you log in into IVF, and everything is there. Everything. We bring so much, value to clinics that we work with, it's in terms of the AI, in terms of more and more modules, that it's just become something that you cannot do, you cannot live without.

And this is something that we hear from many clinics we work with and, for me, this is what takes us, what makes us wake up in the morning and, A good IVF clinic and happy physicians and embryologists and a good IVF clinics means many more pregnancies. 

[00:27:35] Griffin Jones: You've got a lot more on the horizon it sounds like in terms of increasing the number of solutions that, that clinicians, the lab directors can't live without and right now using AIVF to make decisions that they aren't making on their own, that they're using technology to make much more.

informed decisions. What are the operational efficiencies that you're helping with? 

[00:28:01] Daniella Gilboa: So the two KPIs that we collect and we monitor, as AIVF are efficiency and efficacy. Efficacy is success rates. And I truly believe that AI, any AI solution could do a better job than myself as an embryologist without any other tool.

looking at embryos and evaluating embryos and predicting which embryo is bound to be a healthy baby, which embryo should I transfer, freeze, when to transfer, how many to transfer. This needs to be I need an aid here, and any, it's, by the way, humans can never predict, we can only identify. We're not good predictors, we don't know how to predict.

So this is where, this is really the next gen, and having such systems help us with understanding. What are the chances of each and every, embryo to become a baby? and the prediction of the genetic makeup of the chromosome. By the way, this is interesting. I'll talk about that in a minute.

It's our genetic tool. So efficacy is really success rates and increasing success rates. And yes, we can do it because once you work with AI and AI helps you make decisions, you will see it in the success rates. It's that simple. and, the other metrics is, efficiency and efficiency is how well we work in an IVF lab and how we can take the group of embryologists and get them do more cycles.

So this is having them focused on the wet clinical biology and all the, about 50 or 60 percent of the IVF workflow, workload is due to reporting and documenting and QA, QC risk analysis, safety analysis. There's much work here. All of this could be automated. I don't need as an embryologist to do, to, to do reports.

You could have AI do the report for you, and frankly, it will, do a better report than I can do. so all of this is efficiency. This means that we can really save time. We could really reduce the workload. We could really get the group of embryologists do more cycles. See more cycles because 50 or 60 percent of their load could be offloaded 

[00:30:51] Griffin Jones: 60 percent 

[00:30:52] Daniella Gilboa: but something like that 50 or 60 percent, you know as you know from clinic as a whole is We do a lot of reporting and documenting and, speaking to physicians and delivering news to the physicians and on the phone and making, trying to make decisions with the physicians and consulting and all of this could be aided and offloaded from us.

So you know. As an embryologist, and I consider myself a very good embryologist, I'm gonna do the one, the, the tasks that are not yet, could not yet be automated, like ICSI, or thawing, and then, the actual biology, which we all love. And part of the, training, and part of the day to day tasks that I love, like embryo evaluation, which takes a lot of time, and if you do it correctly, it takes a lot of time.

This needs to be aided by AI. And so the way we would do embryo evaluation from now on is a bit different. It's less, looking at the different biological features and trying to realize whether it's, exactly right or it's, working with the data and understanding the data. So it's a bit different, but I think it empowers us as embryologists and as physicians to work with data and understand the data and leverage the data.

[00:32:28] Griffin Jones: I'm glad you brought up physicians because one of the implications of technology that technology should have is it should allow physicians to practice more personalized care. I think some physicians are worried about some sort of vending machine type of future where it's only robots delivering care and I don't think that's the case.

I've always said that human beings should be Must be doing that which human beings should be doing, and human beings must not be doing that, which human beings should not be doing that. We should be using this technology to deliver more personalized care. So how does this allow doctors to practice more personalized care, to give more individual attention to their patients?

[00:33:13] Daniella Gilboa: imagine you have everything out there for you and not really, not, not needing to look for the data. So you, open the, computer, you open your iPhone and you have, meet, this is Daniella, you see the picture, you see all the different information, medical information, medical history, everything is out there for you.

You don't have to look for anything and this is not even talking about AI, it's just really, accessing. the data. And so this is one thing. And the other thing, of course, is this is personalized medicine. It's like not profiling, but understanding who sits in front of you and being able to provide the best IVF care that is specific for this patient.

And this is part of the macro and micro that we talked to before is like someone who's, I don't know, it's like diabetic. We don't know now if it really affect. the, the treatment and the, chances. We don't know, you don't know what type of medication you should consider if she has some kind of, medical background.

This is one specific example, but all of this We'll help, we'll guide you, or we'll help you, much better doctor, if you are able to provide personalized medicine, and really know your patient from the inside and out. Not just a profiling of, okay, you're 35, and you've been getting this and that. So let's see, the way we do now IVF is, okay, let's see how you react, and let's see how many eggs you'll have, and let's see, the fertilizations rate, and let's talk to more and see, what we get from the lab, and let's decide.

Just before the, transfer, how many embryos, whether it's one, maybe two, we don't know how many will, grow to be a blastocyst. So let's wait and see how many will be able to really freeze. And we'll, we'll be in touch. You're always, it's like a, it's an ongoing thing. So it could be better.

It could be different. 

[00:35:32] Griffin Jones: When you talk about being able to, offload half of the embryologist's workload, I want people to think about that another way, which is, what could you do if you had twice the embryologists? And people often think of it in those terms. We gotta get more embryologists, we gotta try to recruit more, we have to try and take the other embryologists from the Other labs in town, we have to figure out some way of training junior embryologists up and many of those solutions need to happen, but also what we have to do is take away some of the things that the embryologists are doing right now because it, we The recruitment problem is not going to solve itself.

It's going to be around for a little while. And even if you can figure out the recruitment challenge to a degree, as the demand continues to increase, you're always going to have that same problem. And then add to that, Daniella, when I'm talking to younger embryologists, like people and by younger, I just mean like under 40.

And many of them want to get out. of the lab because, not because they don't like the science. They just, they don't want to do these rote tasks. They don't want to do all this manual stuff. They don't want to sit in a little box where they're just like, punching in numbers into spreadsheets and.

So talk to us a little bit more on that. 

[00:36:58] Daniella Gilboa: Okay. So imagine a different world where you would have embryologist experts in different things. So you will, have like more of a data embryologist, someone who's working on the data and, getting trends from the data. You would have more of a basic science, so you could actually see if you have, if you have enough embryologists, you could do basic science.

This is really interesting. You could do what I call computational embryology, and, this is a new, field. that is now emerging through the, by, because of the fact that we have data and actual new technologies. So this is computational embryology. I'll give you an example. Again, another way of doing research in the lab and really understanding embryonic development.

So It's part of empowering the, the embryologist. It's not just routine tasks. And I'll give you an example because you have AI that identifies different features in the embryo and features that cannot be seen by the human eye. then now you have a sack of new features that you haven't, you, never realized and are, were identified by.

machine learning. How does this affect embryonic development? It's a new way of doing research, and it's part data, and it's part basic science, but it's very interesting. It's computational embryology. It's like you have biostatisticians, which are, the intersection of statistics and medicine. Now we have computational embryology, which is the intersection of, embryonic development or embryologist with embryology with computer science.

So it's a new field that is emerging, and it's not only going, it's not the new, it's not the, only one that's going to be emerging, it's, one of, out of many, I, think. So, you've got research, you've got data, you've got the ones that are, really clinical embryologists doing the day to day, the ICSI, you've got the ones.

Doing more maybe patient facing and more consultation. And so you could have different layers. If you have enough embryologists, you could, you could have different layers. And you have this IVF system or, a new system that really manages everything in the lab and collects all the, data and all the information into one single point where, one single dashboard.

This is huge. This is really unbelievable. And then you have different tools, like prioritizing. What task am I doing first? I come in the morning. Which of the embryos I have to look first? Which one is, emergency? What's, like, All of this is through, a new type of solution. It was never handled before in a, in a conventional lab.

what if there is an emergency? Something is happening in one of the incubators. I will have no idea. But now I can't. So it's part of safety, and it's part of efficacy, and it's part of efficiency, and empowering the patients. And I think all of us caregivers, through working with AI, our jobs or our positions are going to be slightly changed.

And we just need to accept it. And I think it's, very exciting for me. It's very exciting. So one more thing about efficiency and, why AIVF is really, affecting the IVF in terms of scalability is that imagine you have the best embryologist in the world In each and every clinic, you don't have to actually look for, these, for that embryologist.

It's there. This is seeing IVF is the best expert in the world. It could be the best physician, IVF expert. It could be the best embryologist, but it's there. And it does exactly this, it does, efficiency and efficacy. So I think it really, changes. The way we do IVF, this is clinic patient as patient wise and this we see, we've been collecting data for some time now and we see that it really affects time to pregnancy.

[00:41:31] Griffin Jones: you're sharing different aspects of efficiency, but I, and efficacy, but I'm seeing how they bridge together that you have to have the embryologist doing that which the embryologist should be doing, or otherwise there's too many distractions and too much wasted work. And that can lead to safety issues.

And we've seen safety issues of. A lot of different kinds happened in the IVF lab the past some years. They're all bad. They're all, really bad for that particular lab, that particular clinic. They're bad for that person's career. They're bad for the patient because dreams are shattered.

They're bad for our field because of the public relations that happens from it. There's things going on right now with lawsuits happening. And, and we have embryologists doing. manual work that could be automated. if we have them unaided where technology could be aiding them, then I think we would expect to see more incidents where there could be less.

[00:42:36] Daniella Gilboa: Definitely. Definitely. And I think the way it will affect our lives is. Something that we measure and we monitor as we speak, and it's seeing a chat GPT for the last, I don't know, a year or so, and seeing the responses and the interactions of people with this tool, and each one of, us work with it differently, so I think we're, this is something that we will see in IVF clinics as we go along, and some clinics would see it more as a, most of my embryologists are junior, now I have a very, senior best embryologist in the world here, I'm more relying on this.

so I don't care about the reporting and documenting. I just need that all of the, decision making would be made by AIVF, of course with the embryologists, but something that they would be more relying on. such systems. And some other clinics would say, great, this is a great tool for, for AI and for embryo evaluation.

But the other modules are something that are much more needed in this specific environment and in this specific lab. So I think it's just, it's different for, different settings. And it's very interesting to see the, different effect. For me, I think everything is important, but for me seeing embryologist interacting with the AI, it's really like iterations, like asking questions.

And as an embryologist, working with something like that and having such another layer of information that helps me make better decisions, real decisions, like which embryo has the most chances of becoming a baby and which embryo is. genetically normal or abnormal, even without subjecting it to biopsy.

I now have a tool that predicts ploidy status. This is huge. This is a game changer. And I just need to realize, and it is an embryologist, that all of this data empowers me and makes me I'm a much better embryologist, a much better caregiver, and, the system as a system would do much better IVF care.

I truly believe in it, and I see, now clinics are much more interested and excited, and I think they understand the value. 

[00:45:21] Griffin Jones: Is this what you're talking about, being able to see the aneuploidy of a, of an embryo? Is this moving towards non invasive genetic testing? 

[00:45:32] Daniella Gilboa: Yeah. And again, it's a screening tool.

It's not a diagnostic tool. It's not PGT. It will never be PGT because it's not a diagnostic tool, but as a screening tool, yes, it's, exactly this. And it gives us a prediction. And a very good indication of, okay, we have a bunch of embryos here. Should we subject to biopsy? Should we not? We can consult the patient, maybe the patient would say, this is And now for me, I have two, good looking embryos, they seem to be normal, let's transfer one, freeze the second, I don't need to do PGT, I don't want to do PGT, I'm afraid of the biopsy, or I only have one embryo.

And I'm 42 years old. I do not want it, never ever biopsied. So up until now, people really didn't have a choice because part of the game and part of the, state of mind is not only is it a good looking embryo, but is it normal, abnormal, is it healthy? And so I think now, so for, before AIVF, the only way to answer such a question is to do biopsy.

most. Really, most cycles are PGT, but now we have another layer. And this not, another layer, this layer is very interesting. It's another way for the physician and patient really consult and discuss and the end, of the day, everyone wants the best for the patient and they want her to succeed.

We want her to succeed. So it's just another tool for us to discuss how can we create this, how can we get this cycle to, to be the best for you. 

[00:47:21] Griffin Jones: Tell me more about the impact that's going to have on the field, because I recently recorded an interview and that one might actually air after yours, but I was asking the person, what do you see as the, this is the biggest need, that'll come down in the future and yeah, after, the interview, she said, Oh, it was, non invasive genetic testing.

That's what we need. So what is, what impact do you see this non invasive genetic screening having on the field? 

[00:47:49] Daniella Gilboa: I think it's a game changer. I think it's exactly like the NIPT. What NIPT did to, pregnant women, and, it's being able to access screening tests and understand, by the way, it's really understanding the, what you're going through.

And PGT is really sophisticated and complicated, and it's, it's massive. Like you you free, you, go home as a patient. First of all, you do, A fresh cycle and you go home, without a transfer, right? And then you ship it out to genetic test, genetic lab, sorry, you do the biopsy, you ship it out, you freeze the embryos.

As a patient, I really wait for the result to come in and understand whether this cycle is worth something because it's. Are my embryos are normal or not? I don't know, and the embryos are frozen and then I have to come back again and throw the embryos and throw the only one that is normal. So this is the patient side.

Science side, this PGT is controversial because of the, fact that it has, we see a high rate of false positive, which is, it's there, it's there. So I'm not talking about the fact that the biopsy is a biopsy needs to be done by the best embryologist in the world. And if you, a clinic do not have the best embryologist in the world to do a biopsy, it's really, it might harm the embryo, right?

And the biopsy is a biopsy harms the embryos. This was something that was proven and even, published here and there, but it harms the embryos. It alters. The, timing of the development, there is, an effect, okay? And then, and the, hustle of everything, so you, need to have embryologists doing the ICSI, you need to have embryologists doing the biopsy, and you have to have a double witness everywhere, it's like a hustle, the, we all work for this hustle, and, but it's a diagnostic test, right?

it's a diagnostic test, but, and that's okay, that's great. So we're going to have PGT, always. But then, it's another layer in between that might, some of the patients would say, I want the screening tool. And, yes, I want to verify or validate that the embryos that were screened as normal are in fact normal.

Let's also do a biopsy on these embryos. That's great. Some patients would say, this is enough for me. Some patients would say, I don't want the screening tool, I just want the PGT. That's great. But I think the more tools we have and the more options we have, it empowers us to really give best IVF care. And now we have it.

And it's a game changer. I'm excited to see it. I'm excited to see it in work. we've been testing it. A lot before launching it and we're still always, collecting data and always, running studies in the publishing results and it, doing very good science and doing very good study designs is part of this ecosystem because It is science, so we always have to speak this language, but we actually see it happening and it's, very exciting and it's, here.

[00:51:28] Griffin Jones: At the beginning of the conversation you were talking about being a big believer in time lapse and I keep hearing that from people and so I started asking every embryologist, every lab person that comes on the show, I ask them, is time lapse a nice to have or a must to have? And everyone has been saying, I think it's a must to have.

And I've never worked in. an IVF lab. I don't have an embryology degree, so I need you to educate me a little bit. But the first time I asked you that question, is time lapse a nice to have or a must have? You said time lapse isn't just a must have. it's a way of life. What did you, mean by that?

And what helped me as somebody who's never stepped, or of course I've stepped foot in a few IVF labs, who's never worked a day in an IVF lab to understand why it's a way of life. 

[00:52:16] Daniella Gilboa: Okay, before that, I want to tell you a story, I'll call it a story. So I think in the first days of, time lapse, so people, the, first response was, let's see if it's a better incubator than the conventional incubators.

So every, everyone like ran studies on the time lapse incubator, versus. It's the conventional incubator and it's like the same, like you don't see more or less, like you don't see more pregnancies in time lapse versus a conventional incubator. So like the, so, everyone were, was very frustrated with, okay, so why do we need to spend so much money on time lapse?

It's a gimmick. the, IVF center where I worked, huge IVF center in Israel. So they were saying like, it's a gimmick and we don't need time lapse. And it's not, and this is not the question. And I was like, really, I was angry, so much angry. And I said, it's not the right question. You're not studying.

The right question. it's not an incubator versus an incubator. Timelapse allows you to generate data. This is it. Okay. it's a, it's an incubator. It's closed system, which is of course better than any open system, but it's a closed system that has a camera built inside that captures images of the embryo.

Every 10 15 minutes, something like that, and so you end up after 5 6 days, you end up with hundreds of images that are translated, this is time lapse, okay, translated into a short video of the developing embryo. So do not tell me that you could do better evaluation based on one single image every day you have 3 4 points, rather than hundreds of points.

This is data driven decision making. And this was the early days of data driven decision making in IVF. This is one thing. The other thing, it generates data. Real data, okay? It's not me, copying to an Excel sheet, row after row. It's, automatic generation of data. Once you have data, and now, you, we can connect everything and we could connect the patient's history to the embryos and to the child that is born.

This is like longitudinal database, which is huge in terms of the value and the understanding of IVF and your IVF center. And all this could be done if you generate data. And data generation is not me copying things to an Excel sheet. this was like the early days. And now, it's a way of life.

Because, again, this is, this decision making could, should be made by looking at data and understanding what I do good and what I do wrong. And by the way, when we train algorithms to understand embryonic development and we see that an AI or, an algorithm that was trained on one single image cannot extract enough data rather than, the entire development from day zero to day five or six.

So I really don't understand, I don't understand clinics who are saying no to time lapse, I admit. 

[00:56:05] Griffin Jones: I think you may have summed up the crux of the technological revolution. IVF is that we'll never scale this if we're manually entering data into spreadsheets in order to scale, you have to have data and you have to have mechanisms for According and producing that data, then you've walked us through a lot in what's happening in the AI revolution in the IVF lab today, we talked about personalized care and what it actually means to deliver personalized care versus what's currently being done, talked about how that can be used to give doctors more time to practice personalized care and have a better experience for the patients you talked about specific operational efficiencies.

in the IVF lab and talked about the impact of non invasive genetic screening here, now, and perhaps more on the horizon. You talked to us about why time lapsing is a way of life, how it unleashes, and what you're doing unleashes the power of time lapse incubators. How would you like to conclude about the problems that AIVF is solving?

[00:57:13] Daniella Gilboa: That's a good question. let me finish by some optimistic, Looks or, or just the optimism of this industry. I think we're now in a time where things are happening and it's, a, it's an, we're going through an amazing process of technology coming into our lives and we have to find in within ourselves, as clinicians and as, embryologists, as.

As, IVF centers, we have to understand that this is the time for us now to really engage ourselves with these new technologies and to understand that's more and more to come. And we, if we choose not to engage ourselves with technological innovations, then we'll lose at the end.

We'll just stay behind. And the, the. these innovations are happening in a very fast pace. It's just going so fast. And what's now, beginning of 2024, it will be completely different. In six months and in a year time, it is what it is. It's not going to take forever. It's not going to take five years.

Like in five years, it's like my mentor in the PhD, she said to me, she said, you're going to have an amazing PhD, but in five years you'll end up with a very nice publication. And someone else. We'll actually create it and put it in IVF labs. So what I think you should do is you should found a start, you should go and do a startup.

This is what she told me and, yes, it's so right because it's just going so fast. So I think we're now in a point in time that we see these changes happening and it's just exciting and it's great and we have to do it. So join us. Everyone, join us in the science, in the technology, in the quest of what's next for IVF and how we can help more patients realize the dream of having a baby and help us really bring this evolution slash revolution to life.

[00:59:46] Griffin Jones: I hope they do and thank you for sharing this vision of the future of a more effective and more efficient form of delivering IVF and fertility care to patients that need it in a personalized way that aren't getting it in that way today. Thank you for sharing that vision with us. Thank you for taking the time to come on the Inside Reproductive Health podcast.

[01:00:10] Daniella Gilboa: Thank you so much, Griffin. It's just a pleasure. 

[01:00:14] Sponsor: This episode was made possible by our feature sponsor, AIVF, the pioneering force behind the revolutionary EMA platform. AIVF is at the vanguard of transforming reproductive medicine through cutting edge AI technology. The EMA platform sets new standards in precision IVF care.

Learn how EMA can grow your fertility's efficiencies by going to aivf.co/precalc. That's aivf.co/precalc

Announcer: Today's episode is paid content from our feature sponsor, who helps Inside Reproductive Health to deliver information for free to you. Here the advertiser has editorial control. Feature sponsorship is not an endorsement and does not necessarily reflect the views of Inside Reproductive Health.

Thank you for listening to Inside Reproductive Health.

209 Privademics and the Future of REI Research with Dr. Kate Devine

DISCLAIMER: Today’s Advertiser helped make the production and delivery of this episode possible, for free, to you! But the themes expressed by the guests do not necessarily reflect the views of Inside Reproductive Health, nor of the Advertiser. The Advertiser does not have editorial control over the content of this episode, and the guest’s appearance is not an endorsement of the Advertiser.


Has research output in REI atrophied?

Dr. Kate Devine, Medical Director and Chief Research Officer at US Fertility, guides us through the current state of supply and demand for fertility services, and how Privademics could build the infrastructure to meet the growing demand for ART.

Dr. Devine shares her thoughts on:

  • Why, in her view, research in REI has atrophied

  • Her robust definition of a Privademic Practice (and their advantages)  

  • How Privademics can adopt new technologies faster (with a higher standard of quality control)

  • The specific research she believes is needed to improve innovation

  • Current technologies she’s paying attention to

  • Academic programs (will and should they be Privademic programs)


Dr. Kate Devine
US Fertility
US Fertility LinkedIn
US Fertility Instagram

Transcript

[00:00:00] Dr. Kate Devine: I would argue that our field actually faces a little bit of risk as more and more graduating fellows go into private practice, that if we don't encourage them to continue to contribute academically or private emically, as the case may be our research output will atrophy. And I think that even Is happening a little bit.

[00:00:21] Sponsor: This episode was brought to you by AIVF, the innovators behind the EMA™ platform. The EMA™ platform is designed to empower fertility clinics with cutting edge AI technology, enhancing the precision and success of treatments. It's not just a tool, it's a game changer in reproductive medicine. Learn how EMA™ can grow your fertility's efficiencies by going to aivf.co/precalc. That's aivf.co/precalc

Announcer: Today's advertiser helped make the production and delivery of this episode possible for free to you. But the themes expressed by the guests do not necessarily reflect the views of Inside Reproductive Health, nor of the advertiser. The advertiser does not have editorial control over the content of this episode, and the guest's appearance is not an endorsement of the advertiser.

[00:01:19] Griffin Jones: Research output in the field of REI has atrophied. That's according to today's guest and her colleagues. We examined some problems taking place in the fertility field. The demand for ART services greatly outweighs the supply. We need to adopt technology that makes the clinic and lab safer, faster, more efficient.

We need to do that yesterday in order to start making a dent in the supply and demand issue. But clinicians and scientists need to be able to prove that those solutions are in fact safe and effective. And this is where Privatemics might come into play. Dr. Kate Devine is medical director and chief research officer at U.S. Fertility. She's an OBGYN clinical professor at George Washington University. She's the associate program director for REI, for the fellowship program, that is. and age. She's the chair of the SREI research committee. She's the chair of the SART QA committee, and she's on the editorial board for fertility and sterility.

She practices for Shady Grove in the D. C. area. And so I get Dr. Devine's thoughts on why research output and REI has atrophied in her view, what specific research needs to be done. done to improve ingenuity and innovation. How PrivateMX addresses the supply and demand issue by training more REIs, APPs, and OBGYNs.

Dr. Devine shares her thoughts on if all academic programs will and should be PrivateMX programs. And she talks about some massive advantages that PrivateMX programs have. She talks about the powerful research database that U. S. Fertility has. doing approximately 20 percent of the IVF cycles in the country and the collaboration that they have between research and fellowship programs being affiliated with five of them across the network.

Dr. Devine talks about how private emics can evaluate and adopt new technology faster and to a higher standard of quality control, and she talks about some technology she's paying attention to. We start with her definition of private emic practice, which is more robust than mine. Enjoy this interview with Dr.

Kate Devine. Dr. Devine, Kate, welcome to the Inside Reproductive Health podcast. 

[00:03:15] Dr. Kate Devine: Thanks so much, Griffin. I'm thrilled to be here. 

[00:03:17] Griffin Jones: It's been a little while since I've talked about the privademic model. We've introduced it on the show, but I don't know if we've ever done a podcast. episode dedicated to going through the privedemic model, to going through the future of what it looks like.

As I was preparing for the interview, I started to think, is this what academic medicine is going to become universally? Will all academic medicine be privedemic? And so I'll, I guess I'll start with what I think my definition of Prividemic REI medicine is, and you'll correct me, and and maybe give us a more comprehensive definition, but I think of prividemic medicine as an academic or health system REI division that has partnered often in equity partnership, but maybe not always with a privately owned fertility center network that maybe private equity back that maybe venture back that maybe just regular independently owned network if there still are some of those left, but I think of the R. E. I. Division from a R. E. University health system that is partly owned and if not partly owned, partly operated and operated in conjunction with a privately owned network. How close am I to the correct definition? 

[00:04:56] Dr. Kate Devine: I think that's pretty accurate. I would be even more expansive than that in my definition.

I'd also quibble a little bit with the Equity portion being part of the definition. I would say that's pretty uncommon actually for the university based REI practice to be owners in The practice that is private practice that's participating and certainly vice versa It can happen, but I would say that's not really part of the definition.

Everything else is spot on. I'd say that essentially, we are in a position where a lot of the volume in terms of the practice of fertility medicine has shifted out of The university setting and fellows need experience and fellowships need funding. And so from the fellowship training portion of this and even residency training portion of this, universities have a need.

And private practices have the ability to fill that need. Particularly if they are practicing evidence-based medicine and have academically interested. REIs. The other piece of this, though, is I would expand private emics even beyond those practices that are necessarily affiliated with the fellowship or university.

I think of it as basically wanting to keep moving the ball forward. academically, intellectually, and in terms of the knowledge base of our field, whether or not you are at an academic institution. So wanting to practice evidence based medicine and do research. So contribute to academia, whether you're there or not.

[00:06:39] Griffin Jones: What does that contribution look like though? Because then can't anybody that just submits an abstract each year say I'm doing Privatemic medicine. I'm advancing research. What, how would you qualify those contributions? 

[00:06:54] Dr. Kate Devine: 100%. And I think that's fine. There's no limitation to the number of card carrying Privatemics there can be out there.

And I would argue that our field actually faces a little bit of risk as more and more graduating fellows go into private practice. That if we don't encourage them to continue to contribute academically or private emically as the case may be our research output will atrophy. And I think that even Is happening a little bit.

And certainly our ability to train enough high quality REs will will atrophy if we don't have private practicing REIs contributing to education. And if somebody hangs a shingle, which you know as well as I do is a little bit. Harder and harder to do all the time in this field. And decides that they wanna do research, God bless 'em.

And of course, there's a peer review process to make sure that the research is legitimate, a legitimate contribution. And then hopefully that doc decides over time that they do wanna affiliate with the university and train up and coming OBGYNs and Reis as well.

[00:08:01] Griffin Jones: You said that the research output might already be atrophying a bit.

What specifically makes you say that? 

[00:08:10] Dr. Kate Devine: They'll remain nameless but even speaking with some of my colleagues who work hard to You know make sure that our output as an, as a field in terms of our main fertility journals stays strong and again, contributes to advancing patient care and our technology and our abilities have told me that they think that the quantity and quality, more so quality of the submissions is 

[00:08:39] Griffin Jones: I'm a lay person, I have no clinical or scientific background, so when the quality is going down, does that mean the robustness of what they're attempting to study, or does it mean that some basic tenets of research are not being followed?

[00:08:58] Dr. Kate Devine: I think both things. I think just the ingenuity the innovation in terms of just being bravely going out there and trying to answer the unanswered questions. There's maybe a little bit less of that going on as fewer and fewer REs see research as part of their vocation. So I would say in terms of how novel the body of research that we're producing that is.

Seems to be less. You'll, I'm sure you heard or have heard at some national meetings, people saying, Oh, it's all the same stuff. I, not learning anything. And part of that is we're approaching an asymptote as a field that we've gotten very good at this, right? But I think part of it is that while we are increasing in being entrepreneurial as fellowship graduates, that comes to some extent at the expense of fellows.

Yeah. wanting to do research. And, it's not a coincidence. They also are having lower and lower requirements for research as part of their fellowship training. Why is that? I think it's multifactorial. Part of it is The demand of the fellows saying that if they're not going to do research for their whole lives Why would they need to do 18 out of 36 months of their fellowship doing research?

part of it is Diminution in the number of an hour is available from university based faculty to mentor fellows in research but you know most immediately it's A bog and acgme who make the rules in terms of what's required to cipher boards Have reduced the requirement. I think they feel that they are being pragmatic and answering a need that's Based largely on also increasing Number of things to learn over the course of a fellowship and cutting back, therefore, on the number of months spent on research.

[00:10:54] Griffin Jones: This is happening at the same time as people are debating should the REI fellowship be three years at all? Should it only be two years, and then if it is only two years, What gets cut? What? What is condensed into those two years? How much does this need for research play into that debate?

Where do you stand on that side of the question? 

[00:11:18] Dr. Kate Devine: I actually am of the mind that I think there should be a two year option. I do think More important than making sure that every single fellow comes out being an academic and a researcher is that we meet the demand of the population and we are not meeting it now and we sure as heck are not going to be meeting it as the demand continues to rise as has been predicted.

It's a very controversial topic, we just published this white paper in fertility and sterility just in advance of asrm We had about 27 reis or 27 authors including reis As well as app's Who really hotly debated this and there has been a expert panel that met that was convened by ASRM that came to the conclusion that it should be two years.

Our group by and large and. In garnering support from the various stakeholders, ABOG, ACGME and most importantly, SREI, ASRM, and SART ultimately decided that to recommend two years was too likely to just result in a diminution of the funding that's available that chairs of OBGYN programs would not allocate the saved monies from the program.

Going down by a year to additional spots That was what we heard from most rei program directors. And so basically it would just be less training but not necessarily more fellows I do think in programs where The feedback is they could get More fellows by offering a two year option That should be piloted.

That's my personal opinion. And I do think that if it enables us to train more fellows and I think it can be structured such that it could that should be an option. There are going to be those fellows that are extremely talented and driven towards research. And there could be three or programs for them, or they can apply for postgraduate K level funding with directed training.

So that We are focusing the resources on the most talented and ambitious people who want to conduct high quality research. 

[00:13:40] Griffin Jones: In your view, would that option be based on program? Would every program have a two year option, or would some programs be two years and some programs be three? 

[00:13:52] Dr. Kate Devine: I think it's, it would work best as the latter.

GYN oncology has done this for years now, where some programs are three years and some years our programs are four years. And so based on interest level fellows will opt in or out of a three year program, and the third year could be. focused on different things for different programs. Everyone has to meet a certain baseline level of knowledge base and curriculum, but then some programs would have an extra year that was focused on reproductive surgery.

Some programs would have an extra year that was focused on, obtaining an HCLD and learning more in the embryology laboratory. Some programs would have an extra year that was focused on research, whether that be clinical research or bench science. 

[00:14:37] Griffin Jones: Tell us more about this paper. I've seen it circulated on LinkedIn.

You said you, there's 27 authors on the paper, even before we get to some more of the findings. What did the paper set out to do? 

[00:14:50] Dr. Kate Devine: So the paper set out to define the scope of the problem in terms of the supply demand. Issue that we're facing as a field, both now and in the foreseeable future, and also to start to identify some potential solutions and then really largely to and live in this conversation because we're way late to trying to address this as a field as we both know industry is actively working on trying to solve this problem already in a way that will be as profitable as possible for them as REIs, we want to do it in a way that is as safe as possible for The population and so that's what we set out to do and it took us a year to publish what ultimately at the end frankly isn't An ironclad plan by any stretch of the imagination but essentially what it concludes is that we need to train more fellows.

We need to make appropriate use of other professionals in this field, especially nurse practitioners and physician assistants. And ASRM is hosting a meeting in a few weeks actually convening experts to try to figure out what's the best way to train and certify these professionals.

And then also we need to make responsible use of the available technology to make the process more efficient. 

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[00:17:40] Griffin Jones: So how would you say that you defined the scope of the property? You talked a little bit about it. Likely involves training and certifying APPs, there's technology involved, but in terms of the words that you ended up all coming to, and when you think back to the paper now, how do you define the scope of the problem of supply and demand as it is now?

[00:18:02] Dr. Kate Devine: So Right now, 40 years into the history of ART Even a little bit more than that we've got 10 million kids that have been born from ART And if you think about the world population and the number of births per year, which is somewhere around 150 million, and the fact that the incidence of infertility is around 9%, And then there's lots of other indications for ART other than infertility.

We really, in theory, and this is a pretty conservative estimate, should be able to help 20 million children be born per year. Of course, we're talking globally and not all of these, the infrastructure is in place to make that happen any time in the, future. But if we really wanted to help everyone that needs our help I think that is the magnitude by which we're underserving the demand.

[00:19:05] Griffin Jones: I suspect that there's a role that private emic plays. And getting us to a point where we can meet that demand globally and the reason I'm pulling at that thread is not just because I want to weave the two topics together, but I actually I perceive them to be related partly because of the tension that you described of you've got the industry side that wants to go full tilter is incentivized to go At full speed.

And then perhaps you have an academic system that it has atrophied on its research capability. And perhaps the bridge between those lies somewhere in private demics. Where do you see privademics in this greater struggle, if for lack of a better word, to expand the supply to meet the demand for infertility services.

[00:20:05] Dr. Kate Devine: Yeah. I think it's in 0. 3 training more fellows is the responsibility of every REI. It's actually, otherwise we're going to put ourselves out of a job if we don't. To also be part of the conversation as to how do we most responsibly use and work with our colleagues that are advanced practice, practitioners, providers and then also to be extremely open minded and curious about the technologies that are available while also being incredibly rigorous about validating those technologies prior to implementing them.

And to the first point about training more fellows, people in strictly academic settings think of this and they like, start to have palpitations because they say oh, every RE in New York City is gonna just Open up a fellowship and Start training a fellow that they that just plan to hire they're not going to give them really high quality training and the field that we love is going to lose a knowledge of endocrine and genetics and everything else that is and I agree intrinsic to The richness of our knowledge and our ability to manage complex cases That in fact cannot happen.

And so many changes in our system would have to happen. There are so many checks and balances to prevent that. So first of all, you have to be affiliated with an ob gyn department as a residency to be able to train a fellow so you can't just like You know say i'll train you'll be certified and then by the way You also have to work for me afterwards or something like that.

I would hope that our ethical standards would Discourage that anyway, but there are other things to discourage it, too and in fact despite the increasing demand You know there have been Fewer the number of fellowship slots has not increased in recent years The number of new slots has basically evened out with the number of closing and it's incredibly challenging to get approved To open a new fellowship slot.

One of the recommendations of the paper is actually for programs Who are experienced in expanding a fellowship or opening a fellowship to help mentor and be a resource to programs that want to add slots Because there have been a number of applications that have been denied in recent years probably just due to an experience in the process and knowing how to apply for lack of a more complicated explanation.

So yeah, so at the end of the day, I too want fellows to have a, an extremely rigorous training and to have a rich knowledge to be able to. And I don't, I actually don't think that some of the requirements, including to be affiliated with an REI or an REI fellowship and to be affiliated with a residency should change.

[00:23:18] Griffin Jones: What role does Privademic have in training? OBGYNs outside of an REI fellowship, if any. So this is another debate that's going on concurrently, is how much should generalist OBGYNs be trained to do without having to be fellowship trained in REI. And still seems like a pretty contentious topic. I think that it's shifting it seems to be.

In the last few years but I was at an event at ASRM where there was a British REI that was perplexed that generalist OBGYNs aren't trained to do things like retrievals and even transfers and and this individual said, where I come from, if you can deliver a baby, you can suck an egg and and there was a number of In attendance that agreed with that statement.

There were there are still some that do not agree with that statement. But I'm curious without getting so much into that debate because it's its own topic. What role does private Demick play in training? 

[00:24:24] Dr. Kate Devine: Yeah, my opinion is that the fellowships train OBGYN residents to know what they need to know about fertility medicine to be able to practice general OBGYN and hopefully to induce some of them to pursue a fellowship.

I am of the mind that. I think that generalist OBGYNs, should collaborate closely with REIs. I think that they are can safely do ovulation induction. I think that they can be a huge resource, especially our minimally invasive gynecologic surgeon. Colleagues and doing some of the cases that you know, REIs that are involved very deeply in endocrine or an ART maybe don't have the time or haven't maintained their skills to be able to perform.

I do think that it's a challenging question because We don't want to define being an rei as the ability to do an egg retrieval or an embryo transfer because that's not it That's a fair. Those are both fairly simple technical skills but they are not all created equal and Again, the management of complex cases is something that's well outside the scope of somebody who hasn't done a an rei Fellowship, which at this point is still three Full additional years of training.

[00:25:47] Griffin Jones: So that, that question ties into what is the future of the REI? What is the future role and responsibilities of the REI if more people are being trained to do retrievals and transfers don't comprise what a REI is or does, and ostensibly with a I. You'll have a much greater case load and R.

A. I. Is over more cases, and maybe it goes back to what you, you mentioned earlier in the interview of wanting more ingenuity and innovation from the research. So let's talk a little bit about that. What is ingenuity and innovation in the research look like and how does it develop the REI's role?

[00:26:37] Dr. Kate Devine: Yeah it's a great question. It's a great question. So there are lots of different fronts where I would where I think we hopefully will see innovation where I would like to see innovation I think towards that goal that we've also been talking about which is to Help the 20 million babies that would be wanted Be born, every year and so I agree with you in the setting of Ai and automation I think that in future decades the rei will likely be Overseeing apps who are appropriately trained and certified Managing a much larger caseload per rei And I think that and hope that more and more graduating fellows will take on a privedemic stance and see it as their responsibility to help train the next generation of REIs and also to do research.

There's plenty of scientists and entrepreneurs out there that are developing technology that hold great promise. For better or worse, given the regulatory environment in our country, the actual responsibility of validating those technologies falls on REIs, and that's not something that's likely to be done in a university based setting.

That is likely something that will be done in a privademic setting, if at all, and it's our responsibility not to just implement without validating. And so I think REIs and privademic settings. In coming years, in addition to managing more cases and overseeing, their team in managing more cases should also be actively involved in doing studies, appropriately designed studies, to validate technology before they're implemented 

[00:28:35] Griffin Jones: I want to explore more about what validation of technologies looks like, but staying on the research that you'd like to see.

If you had your druthers, what would privedemic REIs be researching more of if we were to say in two years, you know what, it's no longer the case that research is atrophying an REI. It's no longer the case that we're not seeing as much ingenuity and innovation in the research as we'd like. We're seeing plenty of it, and here's what's happened.

If you had your druthers, what would that research be specifically? 

[00:29:14] Dr. Kate Devine: I think there, there's a couple of different realms that it could that are my favorites, I guess I should say. Was talking about validation and, there are plenty of folks out there that are working on laboratory automation.

And I think that laboratory automation and the implementation of AI together have the potential to help us get to where we want to be in terms of serving the number of people, but it's super scary to, to, To let the machine, do IVF for us, right? And so one really important, and again, this is not ingenuity so much as being extremely conservative, right?

And cautious is to make sure that whatever it is that we are allowing to create embryos and manage our laboratories has been tested against the current standard of care as being just as safe. Effective in achieving success for our patients and also of great importance is, of course, safety.

So I hope that's something, and that's something that Privademics is ideally placed to be able to do. Other areas that I think are, hold massive promise but are extremely challenging to do research in academic settings in the United States because of the Dickey Wicker Amendment and because, no NIH funding can be used to do any research involving human embryos is, Again, the potential of genetics to cure and prevent disease.

And the applications of that are massive and varied but our field is ideally placed to be able to help to support and participate in that research, and again, even the smartest scientists in university based settings need foundation funding to be able to do it so I hope that's something that You know great scientists housed in universities and private practices will partner together to, to work on in the coming decade.

[00:31:17] Griffin Jones: Do you work on multiple research projects at once? Do you do like the paper that you just finished, do you do one of those and then do you take a breather and start the next or do you work on multiple projects concurrently? What is your privademic practice look like? 

[00:31:32] Dr. Kate Devine: Busy. We have currently five REI fellowships that we're affiliated with at U. S. Fertility. And all of those fellows, as we discussed, has research as a requirement as part of their fellowship. And yeah, no, I'm doing. A dozen projects at once all with lots of help we have two phds in epidemiology a number of physician scientists at u. s fertility that are Really committed to research and education I'm working currently on industry sponsored trials NIH funded trials, the NAPRO study is focused on maternal fetal health following frozen embryo transfer.

Given how many kids are going to be born from frozen embryo transfers in the coming decade, I think that's one way that we absolutely must contribute is to make sure we're doing it in the safest way possible. And then, we have, with the help of AI and improved data analytics, really, in my opinion, the most powerful research database out there because we have so much granular information, much more so than, some of the databases that are amazing that they've collected in Europe over the years, or even that SART has collected.

Very involved in SART and SART research, but there's just, you're limited by the quality of the data entry and the number of fields. And so we have a database that has enabled us to answer. Really almost any question that somebody has about what if you change this or if you do this in ART how will it affect the outcome and there are myriad outcomes that can be evaluated And so it's a huge resource for our trainees and thankfully and we hope to get better and better over time, but we hope that it is also benefiting our patients because we're able to figure out the best way to do stuff.

[00:33:31] Griffin Jones: And so you yourself are working with all five of these programs. You don't work with, let's say, just Jones over here for this Shady Grove Fellowship partnership. You're saying you at a network level are working with all five, five of the academic programs? 

[00:33:50] Dr. Kate Devine: I'm a associate program director for the NIH fellowship.

So I work most closely with that fellowship. And each fellowship program has its own academic infrastructure So it would be incredibly irresponsible for one person to be overseeing five different fellowships. That's not the case But my responsibility and really joy is to oversee the interaction between those fellowships And US Fertility so to help them with their u. s. Fertility based research projects as well as to help with their clinical rotations that occur at U. S. Fertility which are largely apprenticeships as is the tradition of training and academic medicine. And yeah, we actually started a new rotation, research rotation, which we've all been super excited about.

We've done it twice now, where all of the fellows from all of the various five fellowship programs come for one month and. They have the opportunity to come in person or attend virtually most do come in person to rockville And they have are paired one to one with a research mentor And they have a project defined in advance of coming to the rotation They have a data set a statistical analysis plan and over the course of that one month the four or five fellows that are there help troubleshoot each other's manuscripts with the help of their dedicated statistician and mentor.

It's been incredibly fun. They have structured didactics and they really learn soup to nuts, how to.

[00:35:30] Griffin Jones: So this is an interesting way of thinking about the future of private epidemic that I hadn't really thought about. I always thought about it one to one, Mount Sinai, RMA of New York NIH, Shady Grove, USC, HRC, always just thought about it one to one. But when you're talking about the network level.

You're introducing a couple more dynamics, one of which is the pure volume that you have to be able to study. You have a lot more data to be able to study because there's a lot more cycles happening over that many places, with that many labs, with that many docs. But the second is that a network can be affiliated with multiple university system, multiple fellowship programs in multiple areas, and and there's a way to bring those in the fellows and the researchers and the scientists from those institutions together.

[00:36:27] Dr. Kate Devine: Absolutely. Yeah. And honestly, it's a way for the fellows to network across a much broader swatch of the field with, as a national network, they meet, other trainees from all over the country were pretty dogged about making sure that they're paired with a research mentor that is outside their home institution.

So they get to know that person well and expand their professional network. Yeah. And yes, the big data is a massive asset that this provides, with somewhere around 20 percent of the cycles in the country, but with, every access nearly every data point that one might need for research it's extremely powerful.

[00:37:11] Griffin Jones: Do you think that for these reasons and the other ones that we discussed, that all academic medicine will have to be privademic in the coming years? That all of the hospital system and university system RAI divisions will be have to affiliate be affiliated with networks or at the very least large practices for these reasons.

[00:37:35] Dr. Kate Devine: I don't think And I sure hope not, honestly. I gave a talk recently at the fellow symposium in Park City. About private ems. And I said this and I really mean it, that if a fellow is graduating and just wants to be a basic scientist or do translational research please do it

We need those people who are really doing the basic work. That is the seed that inspires everything that downstream. And I think that's really hard to do in a private practice. Now, might there be a day where. Private practice is actually funding that research And that academic programs come to rely almost entirely on the big networks to train the upcoming reis maybe But I don't think so there is there are still things that can only be done in a university.

The converse is definitely also true, but I really think we need both things. 

[00:38:38] Griffin Jones: So let's talk about the evaluation of technology as part of the crux of private and academic and. What can be solved for uniquely with private demic because you mentioned that if just at the academic level, a lot of this technology isn't going to be implemented, but you also need the research to evaluate it.

So talk to us about a couple of technologies that you're paying it to. You mentioned I lab automation, but talk to us about a couple of technologies that you're paying attention to. And what is the appropriate level of adoption. Okay. It's being adopted somewhere at the clinic level. While it's still being researched.

[00:39:24] Dr. Kate Devine: Yeah. A hundred percent. I don't think that anything should be adopted at the clinic level commercially and sold to patients until it has been proven to be effective and safe full stop. Our patients are desperate and they are They will do anything we say if they think it's going to help them have a baby.

And, we all took an oath to first do no harm. It's my opinion that if we are charging patients and exposing them to anything invasive or even any lag in initiating what is standard proven treatment, we are doing harm if we don't have really compelling reason to believe that it works.

And so I think that we should absolutely be participating in studies to do those things. And, we just published earlier this year a trial on ERA, which we all had great hope for that Was in JAMA, I think just because of this phenomenon, not because it's like such a groundbreaking thing to publish a negative study but essentially because it is really important that we don't implement add ons before we know that they work.

And so we are working with a number of AI companies and participating in their studies to validate. We are also working on with a couple of different sperm selection. Companies to validate those technologies, which I think hold great promise if they were to be helpful but until those things come to bear and I sure hope they do of course Anything that we can do to help us raise that asymptote that we've approached in terms of success rates be massive It also goes to our overall goal of helping people have more babies and being more efficient, right?

So if we have to do fewer cycles and fewer transfers, that's efficiency and that's helping the population. So You know, I think that we have to bear in mind in the meantime that people get desperate after one unsuccessful transfer. That doesn't mean that you start throwing the kitchen sink at the problem.

We know that after three optimized transfers, based on Pertea's data, we get up to 95 percent chance of a baby. And so we really need to take the time to counsel patients that these things are not validated and to say, Keep calm and do another transfer until we know for sure that these things work.

[00:41:50] Griffin Jones: What about partial implementations or maybe partial utilization? I think of if many of these solutions, maybe they're still working towards FDA approval, or they're still working on they're still working on Their studies, but they have a workflow component that that they solve for, that they can streamline things and require fewer man hours.

And and so how do you think about that when the clinical benefit may maybe yet to be proven but in the meantime there's a clear workflow benefit. How do you think about those types of solutions? 

[00:42:29] Dr. Kate Devine: Yeah. The devil's in the details for sure. We could talk through specific examples, but at the end of the day, if it's no harm and it's improving workflow.

So one good example of this is quick warming, right? I don't know if you've heard anything about this, but used to take hours to warm an embryo for frozen embryo transfer. And now many labs and we're about to publish these data presented them at ASRM, yeah. We're doing it in minutes.

And there's enough data to show that there's minimal harm that I think that is completely reasonable to implement. And some things very much fall on the side of QA, right? And so if you are able to do appropriate QA in your lab, and every lab should Do this independently on these technologies, even if there's published data that show it to work in one center, you have to show it in yours to not everything needs a randomized controlled trial.

And yes, things that improve workflow and there's no biologically plausible reason why you think it would cause harm and you have enough data in your own center to show that it hasn't. I think that's totally appropriate. 

[00:43:38] Griffin Jones: How about networks and centers paying to be involved in certain trials, or if there's some of these companies might be ready for prime time, some of them might not be, but at a market level, I, me just standing back and not having a clinical, Dog in the fight.

I can't. I can't evaluate these products based on scientific or clinical quality, but I can see there is a market issue where they're not getting the adoption because they're, they are they're not advancing, with their findings because they're not getting the adoption necessary.

And the centers want to see maybe more Proof from studies. How do you view if they've got low cost? If they have a low cost barrier to entry, and it looks like they've got something promising that centers paying these places that are still doing studies. These companies that are still doing studies.

[00:44:39] Dr. Kate Devine: Yeah, I haven't seen that particular model. I guess you're saying there is commercial update before the study's done or before approval comes through or maybe they're using it off label or something like that. Yeah, I think you got to be pretty convinced by those data before you would ever have your patient buy it, or even if you're buying it and it's a a cost that's passed along to them really the way that, that it should happen, and I think it mostly is that at a minimum, these Companies that are bringing these add ons to market that again, I hope that they all work together and create the miracle.

Solution to help us administer patient care more successfully but they should Be offering it for free under a research protocol Until the data are robust if they are Great by all means they you know clinical adoption is appropriate but that really the And this is a whole other conversation, but they can't afford to pay the centers because they're startups But they really should be paying The centers to do the research, right?

That's the way it works with more established companies like pharma, et cetera. 

[00:45:51] Griffin Jones: I think it's a part of the challenge. And I think we'll see the rise of who's going to be the company's standing, but I think one of the challenges that they're facing is is that what their investors are looking for is, are people willing to pay for this?

But there's a huge upfront. Cost to be able to create something that clinicians are willing to pay for the reasons that you're talking about. And we've explored a lot with regard to privademic medicine. Will it will it make academic medicine obsolete? How is it involved in evaluating new technologies?

What is the specific research that you'd like to see to, that would? show more ingenuity and more innovation and stop the atrophy of research in REI. What is Private M. E. C. 's role in training APPs, OBGYNs, and REI fellows? We've covered a lot of ground. Kate, how would you like to conclude on the topic of private M. E. C. medicine? 

[00:46:52] Dr. Kate Devine: I'd say that we need to Better serve the population of americans and people globally who need fertility services We are not training enough reis the Industry side and the academic side are both going to be instrumental in solving this problem together and we need to collaborate We should do so in a way that maintains a high Quality of research output and we need to bear in mind always that as industry is involved and should be and must be we need to validate any newcomer to patient clinical care to make sure that we are first doing no harm.

[00:47:39] Griffin Jones: Dr. Kate Devine, thank you very much for coming on the Inside Reproductive Health podcast. 

[00:47:44] Dr. Kate Devine: Thanks very much, Griffin. 

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208 Dr. John Schnorr's Advice for Bootstrapping Your Fertility Company

DISCLAIMER: Today’s Advertiser helped make the production and delivery of this episode possible, for free, to you! But the themes expressed by the guests do not necessarily reflect the views of Inside Reproductive Health, nor of the Advertiser. The Advertiser does not have editorial control over the content of this episode, and the guest’s appearance is not an endorsement of the Advertiser.


We bring back fertility entrepreneur Dr. John Schnorr to share his experience and advice for building companies in the fertility sector without investor money.

Tune in as Dr. Schnorr talks about:

  • Some great examples of how he’s proven concept (both functionality & market value)

  • The conditions for bootstrapping without a proven concept

  • How Cycle Clarity gave equity to early employees (and how you might be able to do the same)

The pros & cons of hiring top-down in the accountability chart (And bottom-up)


Dr. John Schnorr
LinkedIn

Cycle Clarity
LinkedIn
Facebook
www.cycleclarity.com
www.cycleclarityconnections.com

Transcript

[00:00:00] Dr. John Schnorr: I would say that importantly, I think you need to really be a master of that domain and know what the market is you're trying to hit and understand the details of that market. I had an advantage there. I think that you should set a financial limit on what you need to have happen before you put in your next hundred, $200,000. Like, you know, I need proof of concept and I need this to do X, Y, and Z. And if we don't get to that, I'm going to rethink whether or not I'm going to put in the next 200, 000 again, using examples. And so I think always stepping back, seeing where you are, figuring out what that financial commitment is, what our progress has been.

[00:00:38] Sponsor: This episode was brought to you by Mind360, a leading fertility mental health platform. How long does it take your clinic to get patients through their third party psycho psychological evaluation? Find out how your clinic compares with Mind360's free report at mind360.us/reducedwaittime. That's mind360.us/reducedwaittime.

Announcer: Today's advertiser helped make the production and delivery of this episode possible for free to you. But the themes expressed by the guests do not necessarily reflect the views of Inside Reproductive Health nor of the advertiser. The advertiser does not have editorial control over the content of this episode and the guest's appearance is not an endorsement of the advertiser.

[00:01:23] Griffin Jones: He's back and we're talking about bootstraps. first conversation with Dr. John Schnorr was a popular one. We talked about the IntegraMed autopsy where Dr. Schnorr's group had been a part of the IntegraMed network and he talked about the collapse of that, what his entrepreneurial rebirth was like, and this is a sequel to that conversation.

And we talk about bootstrapping. Bootstrapping a company in the fertility sector. There's been a lot of companies in the fertility sector that have raised lots of money and some of them have done well, but others have really struggled to be able to prove what their business model even is, and some of them have gone bust.

We talk about what it's like to build companies in the fertility sector without investor money. What are the conditions for when you should bootstrap? When the total addressable market is smaller, when the concept isn't proven, when the money that you need to raise is less than what you could do by putting in a couple years of sweat equity or self funding.

Dr. Schnorr gives some really good examples. about how he's proven concept, not just the concept of functionality, but the concept that this is something that people in the marketplace are willing to part ways with their dollars for. It gives a really good example about why he had to shorten the length of his product's performance by six or eight X, even after it was a four or five X improvement of the status quo.

It wasn't good enough for 50 percent of the marketplace. He talks about why. He also gives a really good example of fertility clinic workflow. It seems like something small, but is embedded into the structure of how fertility clinics operate and makes it really difficult to adapt to change. It isn't just as simple as people don't want to change.

And I think that example that he gave illustrates it as best as any I've ever heard. John lays out how cycle clarity gave equity to their early employees and how you might be able to do that as a bootstrap company. He and I debate the pros and cons of hiring from the top of the accountability chart versus from the bottom of the accountability chart, having more smaller seats versus having more senior people doing more things.

And we each give our tips for how to solve the chicken and egg issue that comes with entrepreneurship and especially bootstrapping. I give my tips for constraints around pre selling. as a means of self funding and ask Dr. Schnorr for his thoughts on the topic too. You might have to bootstrap now in the fertility field.

The era of free money might be over. Oh well, partner. Might be a tough go for a couple years, but you'll end up owning a lot more of your company, which we hope is a really successful one. Enjoy this conversation with Dr. John Schnorr. Dr. Schnorr, John, welcome back to the Inside Reproductive Health podcast.

[00:03:56] Dr. John Schnorr: I'm so grateful to be here. Thank you for inviting me. 

[00:03:59] Griffin Jones: It's like a sequel to your first conversation because the first interview was an, it was an REI's entrepreneurial rebirth, and we're going to talk about more about what that venture has been like. And we're talking about bootstrapping. Will this be, will this sequel be as good as the original?

Will this be the Godfather 2 to the, to the Godfather part one? 

[00:04:18] Dr. John Schnorr: I guess all of the audience will know, and maybe they can tell us in a couple of weeks. 

[00:04:22] Griffin Jones: We'll try our best not to let them down. So it's specifically, I want to talk about bootstrapping companies. That's what you've done to this point. So your, your, your business as a clinic, coastal fertility in the Carolinas.

We talked a little bit about last time we talked about your relationship with IntegraMed. And that's not the business that I'm talking about this time, more your new venture cycle clarity. We're not talking necessarily about the features and benefits of cycle clarity today, but you up to this point, as far as I know, have bootstrapped it is, is that right?

Have you taken out any investor money up to this point? 

[00:04:56] Dr. John Schnorr: I have not. No, we did get a grant from the state, a very small amount of money just to encourage people to start businesses in the area. But it was a very small grant that helped us early on with kind of our kind of proof of concept, but a very, very small amount of money.

[00:05:11] Griffin Jones: Well, the reason why I think we should be talking about this now is because I think more people are going to have to bootstrap in the coming years for a decade or so. We saw a lot of VC money flying around because if you can borrow money, it's one or 2 percent rates and those limited partners want a much bigger rate than what they're getting in the stock market.

You're going to see. More money in venture capital. But if interest rates are 7 percent or, or whatever, and you have some of that money drying up, then you're likely going to see less venture capital money. And I've had some other, I had Dr. Santiago Mune on the show who runs a, uh, Basically a venture firm for fertility startups, and he said it's dry out there.

So I think people are going to have to do bootstrap down whether they like it or not. Why did you decide to do that though? Because you still probably could have gotten in on that era of free money. You chose not to. Why? 

[00:06:10] Dr. John Schnorr: Yeah, it's a great question. We started CycleClarity in 2019. At that time, it was a dream that had some patent protection that we were able to acquire or to develop.

And at that time, we needed a proof of concept and needed to move forward. I think there was an ability to get some seed round funding at that time. We did some preliminary talking with different seed round investors, and I think there was a lot of interest. But what was clear to me is, is that It was going to be a relatively limited amount of money that typically I think a seed rounds three, 400, 500, 000 for a seed round.

And it was going to be smaller than we probably really needed to do to get the job done. But number two, there was going to be a lot more time and effort into finding the right seed round investor, uh, doing the due diligence, doing all that work. And I honestly, A, had the ability to self fund and seed round myself, basically is what we're talking about.

And I could save time doing it, meaning I could spend time on the product and the team and the platform and the development, whether than the time to go out and court money and kind of get some investors to kind of go along with it. So I had enough belief in what we were doing. I had enough belief in my ability to know the market, which I think is really key.

I think if you don't know the market and the needs and the challenges and demands, you can end up with a product that misses the market. And I think that would be a big painful lesson to learn as a seed investor. And I think trying to bootstrap it myself, knowing what we had, knowing the team we had, developing, increasing confidence in the technology over time gave me the, the ability to move forward with confidence as our own investor.

[00:07:53] Griffin Jones: Do you think that if you had not owned a fertility practice for a couple of decades, been an REI for a couple of decades that you ever could have bootstrapped the company that you're starting now? 

[00:08:04] Dr. John Schnorr: I think financially, yes, but I think you just wouldn't really have true insight is to the demands on a reproductive endocrinologist day to day in his or her lives to know really what the limitations are, what the problems are.

What problems need to be solved and it's just not my viewpoint on the problems, but you get a connection of three, 400 other reproductive endocrinology, as you know, well, and get converse with them and share problems and understand how they're solving them. And I think it gave me the confidence that this was a good place to invest some of our resources.

[00:08:41] Griffin Jones: So there's a little bit of a lesson there of aligning with one's core competency in order to be able to bootstrap it is not necessary there because there's a million problems out there in the marketplace, and many of them will probably be lucrative. But there's something to be said. That allows you to bootstrap for going to, uh, to build something that you know.

Do you think that you could have even started PsychoClarity if you had not been an REI and not owned a practice? Even if, if it weren't bootstrapping, if you had somebody else's money, could you have done it? 

[00:09:17] Dr. John Schnorr: Wouldn't be real easy and it would be much more expensive because we used our own patients for the ultrasound images that got de identified that then got used for the training.

So we had our own data and images that we could work with, but actually very important. as the platform developed, I could use it in the office with the patients and understanding is it developing in a positive direction? Is this something that actually is going to be beneficial to, to clinicians and patients at the end of the day?

which gives you increasing conviction throughout the journey that this is a positive experience, this is going to become something. You could see its strengths and you could see its weaknesses and you could see it develop from month to month and year to year. And something that's been quite interesting is I like to journal what I've been doing just to remember what we were doing a year ago and two years ago and three years ago.

And to go back and look at where we were a year ago It shows how amazingly we've grown over the last year and over two years and over three years, literally three years ago, we didn't know if this was going to work at all. And if artificial intelligence was ever going to be able to see a follicle in the ovary.

Now we've gotten to the point that not only we can see the follicles, the ovary, we can do it with 94 percent accuracy and we can do it in less than 30 seconds. It used to take us five minutes to get a result process. Now we're doing it in about 30 seconds. And it's amazing to see that evolution with time.

What do you journal about? You know, everything. About meetings, like you have a big, important meeting, you know, that talks about an IT challenge and that kind of stuff. I put in kind of notes about who I met with, what the challenge was, how we're going to try to solve that, you know, what platform we're going to use to do that, what we think the cost is going to be to do that.

And it's, it's good to be able to go back to that. So when you get into that same conversation about, for example, how do we track follicles within the ovary, that's one of our challenges is. the same follicle will be in 10 different frames of an ovary. How do we track that same follicle through the ovary?

And it's a fairly complicated algorithm that looks to see how much overlapping there is from image to image and what the size is and what the degree of confidence is and, and all that little minutiae matters. And You know, at some level I'm functioning as the CEO and the CEO needs to be able to understand all aspects of your organization and help prioritize resources and troubleshoot problems.

And you need to have a real granular understanding as to how your organization works, what your strengths are, what your weaknesses are, what your problems are and how you're going to solve those. And journaling to me, is a tool for that where I can go back to that conversation, you know, six months ago and with really granular clarity, know what was said, who said it, how we're going to fix it and reflect back on that conversation.

So you're ready as you develop forward with tracking or whatever the issues are you're working on. 

[00:12:16] Griffin Jones: So you journal based on when there's an event that or an event or something that goes off in your head that merits journaling as opposed to like a calendar frequency, like on the first of the month or the first of the quarter calendars, 

[00:12:30] Dr. John Schnorr: I journal, I personally journal sentinel events like if something big's going on and we had a big meeting, I'm going I'll put notes about that meeting so I can reflect back on it.

And you know, it's, it's good for that minutia, but it's also good to look back at the progress of your company over time and to realize last Thanksgiving, for example, we were still solving these problems that you now look at and you say, God, that would, that seemed like that was a year or two, three years ago.

We're well past that. We're moving on to what the next star. And, you know, I think what we're learning over time is that the problems get smaller. You know, earlier on, there can be a lot of big problems that would derail you completely. And this will never work like the ultrasound machine, not being able to transmit the images efficiently, or maybe just one manufacturer being able to do it.

But the other manufacturer is not. And as you get. further down the road and eventually put more and more resources into it and understand in the clinic, this does work and this does work accurately. And it's a benefit to the patients and it's a benefit to the physicians and it's a benefit to the embryology lab.

You start to get increasingly conviction that this is meeting the market demands, that this is a product that fits the market well, and kind of gets you further down the road where you can actually then start. working with it in physician clinics, getting their feedback, making changes. And over time, we're finding that the feature changes that are requested from the clinics are smaller and smaller as we meet more and more of the demands.

And There's a lot of really great ideas out there that initially were revolutionary. And now the ideas that kind of come in to our platform are smaller little tweaks, which are very positive, but not as heavy of a list, don't require as much engineering and really actually enhance the output of the platform at the end.

[00:14:20] Griffin Jones: That's probably a way of thinking about proof of concept that makes it more tangible that I hadn't really thought about that. The part of proving concept is that the problems get smaller and smaller. That's probably a good sign. I want to come back to the topic of proving concept. But first, what, in your view, are the conditions for when someone should bootstrap?

If these things are true, that means that the company should probably more likely bootstrap. 

[00:14:49] Dr. John Schnorr: Well, I think a, I think you should have, of course, the financial resources that you can bootstrap comfortably. I wouldn't underestimate the resources needed that it's probably going to be twice as much money as you thought it was going to be at a bootstrap.

I know you're shaking your head. You've been there yourself. You understand that. So I think you need to prepare for the long run. I think along the way you need to understand, you know, is this product truly something that's going to meet the market? Meaning if I were developing something in gastroenterology and I'm a reproductive endocrinologist, I wouldn't have near the confidence to invest my own resources in it if I wasn't able to monitor the output and outcome and how it's developing over time.

So I think that would be good. And I would say, do you have the time to do it? Because, you know, I'm a full time reproductive endocrinologist. I don't mind working hard, which is why I'm kind of working cycle clarity after hours. And, and, you know, I would tell you, I probably put in six hours a week doing cycle clarity.

I think my wife would tell you it's really 12 hours. That's probably true. I mean, the time commitment's gigantic, but I think that eases off a little bit over time as you've solved more and more problems over time and you start gaining some clinical efficiencies, but also get a good team around you that can support you.

And I think that's really the key to success and bootstrapping is having a good team around you. 

[00:16:08] Griffin Jones: My brother and I used to backpack across the world when we were in our 20s and my brother always said, lay out all your clothes before you pack it, lay out everything you're going to bring on your bed, and then bring half the clothes and twice the money.

And, and so it's a, you know, Like half of the, it's probably half of the business plan and twice the money of, of what you're, of what you're going to need. Um, so there's a couple things that I, that I, I think you're pointing out that I, I've been writing down. Um, I think it's important to, uh, I think it's important to bootstrap.

If you really don't have the concept proven yet, um, I, we, we see so many. companies that have gotten a lot of money, tens of millions of dollars, sometimes even more. And they don't have a solid proof of concept of what it is that they're selling yet. And I know that there's a lot of technology companies that it would be really hard if not impossible to bootstrap because of the development costs that go into it.

So I understand not everybody can bootstrap, but I do think there is something to be said for that. I still would want to. Have more of a proof of concept of like knowing exactly what it is. I'm going to sell before I raise 25, 50, 75 million. So I, I think that's a piece of it. I also think if the total addressable market isn't that big, that you should probably bootstrap because you might not, you might not end up with the next Uber Airbnb, but you could still have a pretty decent.

Small size business. And I sent you, and do you remember the article I sent you like a month ago about it was, it was from this newsletter that I subscribed to called got acquired. And they told the story of some business that I wrote down the numbers that I could remember, but it was like a 2 million revenue business.

That had about 400 K in EBITDA and the person wanted to sell, but they had raised 2. 5 mil and, and so anything that they would have raised and anything that they would have sold it for would have gone to that, to the investors. And that's. When you think about it, that's a pretty lousy deal for both the investors and the entrepreneur, because the investors that day, that after the, the, the time value of money lost over that time period, even if they break, even they've lost money and the invest or the extreme of the entrepreneur has toiled for those years and has nothing to show for it.

But. If they didn't take that to begin with, if they could have made up for that 2. 5 million by sweat equity and slower and small pace and pre sale deliver, pre sale deliver, then that's a six and a half EBITDA and you're making 400k profit a year. Like that's a good small business for a lot of people.

So for you, when, when you think about cycle clarity, like. You don't have to give us exact figures, but how big of a venture do you want this? Or how, how small of a venture are you okay with it being? 

[00:19:09] Dr. John Schnorr: Yeah, I think it's a great question. And I think more than anything is, is I just want to see it through the journey.

So of course I want it to be a 5 billion company. I mean, everybody wants it to be a 5 million company, but. I, you know, I think it's going to be what it's going to be. We're, we're trying to make the best product we can for the market and then figure out, you know, how it enhances efficiency in the market and what it's worth is in the market.

So I think we'll know that as we get further down the road and your points, a good one is that a significant amount of equity is given up to seed round and a round and B round and. You know, we have had some of those discussions and realize what those numbers look like. And I'm doing my best to give that equity back to the employees themselves so that it encouraged them at a cycle clarity level to work a little bit harder.

And the further I can get us down the road with internal funding, the better we can be when we do want to get some, say a B round funding or even C round funding, depending on how we're going. But, you know, we've got a product now that I think has. product market fit. I think we have happy customers who were doing well.

We're learning from it. And the question becomes, you know, if we were to get a lot of funding, what would we do with that now? And would that really spin us out in a positive direction? And we're continuing to have those discussions to figure out what the next step is. 

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[00:21:55] Griffin Jones: Maybe this is in line with what you said. You had the ability to self fund, but I think even for those people that don't have the ability to self fund, maybe it's, maybe it's a couple of years of doing something else as opposed to having the money right off the bat to self fund.

But do you think that there's a, there's an amount that's too small to raise? Like, I think two and a half million dollars is probably. And anything below that is probably just not even worth raising. I know that's that's probably an arbitrary call. Probably depends on the type of business and and all that type of thing.

But it's like, man, I wouldn't want to give away any piece of my business like for two and a half million dollars, I guess. And, you know. I don't know do you think can you put better rules around it than I can 

[00:22:41] Dr. John Schnorr: yeah I mean I think I think it depends on how much money you're going to need to get a product to market you know I mean I think if you can get a product to market with three hundred thousand dollars you should probably do it on your own to your point if you're a big database company and you're going to compete with Oracle and you're going to need a lot of money to do it.

30 million to get to market. You better go ahead and get some, some venture capital and seed Monday to help get you through that. But you know what we had done along the way is just kind of figured out what our number was and ended up, it ended up being twice that, which I guess it always is. But you know, we kept seeing progress through it and it kept developing in a positive direction.

It kept being usable and you know, I didn't want to fool myself. So I wasn't trying to make these decisions about usability myself and We did beta testing with Michael Levy, who was incredibly helpful. I'm really impressed with Michael and his vision and his ability to see technology. And we worked with other doctors within the community who used it and loved it.

And so that just further emboldened me that this was headed in the right direction and we should continue to. Invest in it and move forward and invest in our team. I think you're never better than the team around you. We got an amazing group of engineers that have been great. Medical device specialists to go out and innovate, chief operating officer, who's amazing, a team around us that just gets better day by day by day.

And I love seeing that happen. 

[00:24:02] Griffin Jones: Tell me a bit about the rules that you've learned for proving concept. You talked about it first. It started off as a problem that you wanted to solve for yourself as a provider. Then you approached other providers that, you know, like Dr. Levy, tell us about how you prove the concept.

[00:24:18] Dr. John Schnorr: Yeah, so I started with just an idea. I think it was Philadelphia at the ASRM. I met with Michael Levy and I said, Hey, Michael, I got this idea that I think we can see follicles with AI. And, you know, I think it'll improve pregnancy rates. That's really what I said to Michael is we can better, more accurately do that.

And this was lunchtime. And Michael said, you know, John, I agree. You might be able to do that. He goes, but the value really is the clinical efficiency, right? to him, the value was not that we were necessarily going to improve pregnancy rates, but that we could do it quicker and more efficiently. And that's, of course, somebody who runs the largest fertility company in the United States and, and knew the value of clinical efficiencies.

And so we focused on that. That was the first thought we then needed to figure out who was going to help us. Kind of see this follicle with AI and even more importantly, who's going to track the follicle through all the images. And by serendipity and luck, we ended up with an AI company that specialized in tracking a football with AI go across the goal line so that they could predict when a score happened or not.

So they could track something over a video series. they looked at what we had and said, yeah, that should be able to work. And so with a relatively small amount of money, we were able to take about 300 images and which is a small number and train them. And they were able to show with some crude output that they could track this follicle across it.

That then started with COVID. COVID happened around then. And so we were all kind of locked in our homes, which is a great time for us to be. Annotating thousands and thousands of images and follicles and using kind of images that came from coastal fertility that we completely de identified and then we would show all the follicles and develop it.

That was probably a nine month journey of kind of annotating every follicle. I felt it needed to be done the right way so I as the physician viewed every follicle that was called a follicle and approved it and that resulted in what we called proof of concept is that we could with accuracy of greater than 90 percent figure out where the follicle was and how it was growing and so that showed that we could do it.

Now the next challenge was getting the data off of an ultrasound machine and securely transmitted to the fertility center and the data analysis center where we could see these images and provide them back. There was a whole separate team that helped us do that, and that was our third kind of piece to the platform we needed to make things work.

[00:26:51] Griffin Jones: How much familiarity did you have in the A. I. Space before you started working on the concept? Did you know those sports guys at all or so? Okay, so you had the fertility space pretty well covered in terms of knowledge and connections. Then you had to develop those knowledge and connections in the A. I. space. What was that like? 

[00:27:13] Dr. John Schnorr: That was a challenge because it's a whole different language with a whole different set of people. And so I think we got lucky with one of the first people we started working with that they had the competency to do what we needed to do. I had a conviction that if you can see a breast cancer with AI on a mammogram, that you can see a follicle on an ultrasound, to me they're much easier to see.

And so I had a conviction that this was something that would work out. And we had many, many meetings with people international who were eight hours apart time zone wise where, you know, I'd be trying to grab an empty conference room at the ASRM to do a video meeting with our group who's doing our AI training and understanding.

And it was interesting and fun. And then in the middle of COVID, literally I was on video calls with a group in China who were in the middle of COVID, you know, where COVID all started to the best of our knowledge. And. Talking with them in the middle of COVID about annotations and ultrasound machines.

And it's really interesting how the whole world becomes so small when you're able to telecommute and discuss all these things and collaborate together. So it really took a lot of people from all over the world to help get us to where we are. 

[00:28:22] Griffin Jones: So that's how you prove the concept in terms of functionally.

It could work. How did you prove, or maybe still are proving how it, it it is valued in the marketplace that people are willing to part way, part ways with money for it. 

[00:28:39] Dr. John Schnorr: And that's its own challenge, right? I mean, you're, you're smart to bring that up because you can create your own technology that works just great at coastal Fertility.

But not everybody's coastal fertility. That's probably good that not everybody's coastal fertility. Everybody does things a different way. And, you know, I think everybody wants to innovate. Like if you sat in a room with a hundred physicians, he said, who wants to innovate? I think all 100 would raise their hand.

But what we find is everybody wants to innovate, but nobody wants to change. Like if I said to you this is going to really make things better and you're going to have a better outcome because, you know, maybe MAs can do the scan and not the ultrasonography would be more accurate, but you're going to have to do the ultrasound first and draw the blood second on a patient.

That's just an example. You don't have to do that. But if I said, You're going to have to do the ultrasound first and draw the button second blood second, but they're used to drawing the blood first. That's a gigantic change for a clinic, particularly if you're a high volume clinic. And you might say, well, why is that a big deal?

Well, probably because the room for phlebotomy is right next to the reception area. And the ultrasound machines are on the other side of phlebotomy. So now you got to walk patients through phlebotomy to ultrasound, to ultrasound, and then bring them back. You know, all of a sudden this becomes a bigger problem than you would think it was.

And so we had to learn very quickly that every practice is different. Every practice sees and does things differently. And we need to be flexible on the cycle clarity end so that we can address all those things. And so one example is it used to take us three to four minutes to process an image. And while it sounded crazy, I went back to team.

I said, guys, we got to do this in less than a minute. We got to drive this number down and leave it to our great engineering team. We literally are processing images now in 30 seconds, meaning that you can be doing the ultrasound, push the first save button. And by the time you're done, the first image is already done.

And by the time you hang up the probe and help the patient up From laying down, the second image is done and you can show them all the results that revolutionized what we did, because no longer do you have to draw blood first or draw blood second, you can draw blood anytime you want. You're going to get results back instantly and be able to make instant decisions.

And so that was forced on us by the market who just did things in different ways, and we need to accommodate for that. And so that has been a change and that's something we've had to work on. 

[00:31:00] Griffin Jones: Why was that in, why was three to four minutes insufficient in the market size? Why, why, you know, because you would think, oh, if it normally takes 15, 20 plus minutes, three to four minutes, that's a four to five X improvement.

Great question. Uh, but why was, why was that not sufficient? 

[00:31:17] Dr. John Schnorr: Great question. At Coastal Fertility, we draw the patient's blood. We do their ultrasound, an ultrasonographer does their ultrasound, we then review the results about four hours later, we look at the ultrasound, we compare it to the blood work, we make a decision, and a nurse calls the patient back with the decision.

At least 50 percent of all clinics, the doctor is doing the ultrasound. They want to make a decision in front of the patient that might be a preliminary decision so that when the patient leaves they already know what they're doing so they don't need a call back. And so therefore if you're going to be efficient you need to do the scan, you need instant results so that you can show it to the patient and say we're going to do the same medicine and come back in two days.

But you couldn't do that if you had to wait three and a half minutes for the ultrasound. You already wanted to be in the next room and starting on the next patient and that really disrupted flow. 

[00:32:11] Griffin Jones: I love this. This is where companies are actually made in terms of proving their concept because everything is great.

Theoretically, right? We could come up with all sorts of businesses that sound great on paper. It's actually finding out when you're trying to get people to pay money, what the challenges are. And that isn't something that I would have expected either. And you weren't even expecting it as it didn't sound like, Oh, 50%.

And and they need to be able to do it because they that's what's important to them. What's important to them is being able to give the decision to their patient right there. And so that was an assumption that you had that that you had. Oh crap. Like we have to figure out a way to provide exactly right.

And I think your example of The the phlebotomy is like, Oh, why is it so important that they draw blood first or second? Well, because the, the, you know, the phlebotomy room is right next door. That's a really good example because there are so many good solutions that are having a hard time being adopted in our field and to say, Oh, Well, they, they can't just change.

It's like, well, it is kind of like they're there. You really have to understand it because there are reasons why they do things. And even if there are better ways of doing things, it's, it's hard to change. And it's not just because they're comfortable necessarily. It's because they, there are, there is an institutional momentum to do certain things in the structure and changing those structures is a lot different than just Changing one thing in a, in an order of operations on paper.

[00:33:45] Dr. John Schnorr: And to their credit, they've been doing it for 30 years. So to me, to ask them to do something different than they've been doing for 30 years to save them a couple of minutes on an ultrasound, but then hire a nurse to call people back in the afternoon that they're not used to, that's an instant fail, right?

I mean, that was going to go nowhere fast. So. our platform, our technology needed to accommodate for that. And, you know, never in my dreams would I think that I can really ask our team to get processing down from five minutes to 30 seconds, but they have been able to do that. And I think that's part through computing getting faster and platforms getting better.

And we've done more annotations and other things that have allowed this technology to get better. And to me, that's just one amazing example of going back to my journal, what's changed over the last year or two years, but also. A way to look forward at the future and think, well, if we can do that in one year, where are we going to be in the next two years with how the platform changes and how things improve?

[00:34:40] Griffin Jones: Do you feel like, because that you're bootstrapping, you are able to do this at a pace that allows you to actually figure it out? Like that's one of the, I would add that to the reasons where people might want to bootstrap is I like being able to go at. My pace that and I know there are certain things, certain like business fundamentals that I really want to master.

That wouldn't make sense to an investor. They would just figure it out, move on to the next thing where I'm trying to master it at a cellular level, like really trying to master how you delegate to outcome and manage senior leaders over other leaders. And I think that a lot of Venture capitalists would say too late.

You should have got an MBA for that. Hire an MBA to figure it out and just move on. Whereas like, I, it's like, I really, really want to, like, I really want to fix this, how, how much of bootstrapping. Has allowed you to go at this pace to figure out these challenges. 

[00:35:41] Dr. John Schnorr: I think a lot. I think a lot because we can make our own decisions.

We no longer need to go to our investor and say, Hey, we're thinking about doing this or investing in this or doing that. We can literally sit together as a team on a on Friday at 2 p. m. and identify a problem. prioritize that problem to the top and be starting on it Monday morning and done with it by Wednesday or Thursday of the same week.

We can just instantly pivot. Uh, and one way we're doing this. Another example of what we're doing is I'd had a doctor not too long ago who lives three and a half hours away from coastal fertility and she used to live in Charleston. She moved three and a half hours away. She said, John, I would love to refer patients to you.

Um, but you're three and a half hours away. I can't. figure that out. I can't make that work. And I said, I have the magic. Why don't we go ahead and install cycle clarity at your center? Your ultrasonographer can do the ultrasound. That image will instantly show up in our platform. I can see the image from top to bottom.

I can see every follicle and I can make decisions with every follicle while the patient is still three and a half hours away. And that formed what we call cycle clarity connections, the ability to connect patients at a distance to the fertility practice with technology that occurs instantly with the same accuracy as if the ultrasound was done in your own clinic.

And so we actually thought of that idea on a Friday and by three days later, the following Monday, We're halfway down the road in getting that developed. We already had the core technology. We just needed to add a couple of pieces to it. And so that is a new product line for us that was really thought about just over the weekend.

Does it commit capital to do that? Yes. We'll have some capital commitments to do that. Did I have to go to any investors to get approval and to meet on it and talk with the board? No, we just did it because it seemed like it fit the market. It was a need. We're probably now 3 to 4 months into that cycle clarity connections, and it's been a revolution for care of patients at coastal fertility.

There are a distance. And we're going to soon roll that out nationally and even internationally to help patients at a distance go to their center of choice, whether it's a lower cost center or a higher pregnancy rate center or a more compassionate center, then go wherever they want now. 

[00:37:58] Griffin Jones: Where have you had a board of investors?

They might've said, well, John, we think that's kind of a distraction. Forget about that for now. Whereas you're able to, you're able to make that decision as a, as a bootstrapper. 

[00:38:08] Dr. John Schnorr: Instead of them saying, Hey, we committed X number of dollars to you. You've used them up, you know, move on. We're not doing that or.

We don't have the time for that. You can see it as the end user, the physician, that this is really something that needs to happen. We had most of the technology here. Now let's just prioritize that above everything else we're doing and get that role in and then circle back on the other things we've been working on in a month or two, and I love the ability to do that.

And it really empowers the team that you're working with. to feel like they're a committed part of the process that's influential on the outcome to really make things better at the end. So not only do they have equity in the business, but they have significant say and sway in the business. And that's important to me.

[00:38:52] Griffin Jones: So this is the long drawn out battle to prove concept that I think is missing from a lot of companies that raise money really fast that they they get the money and then they're trying to prove the concept. And I think I think if you can, it is worth it. To spend that long, arduous battle, figuring out the concept and then you go get the money.

And I think the examples that you've given are are really good one. We both know Julius Varzoni, I think. And I think you've checked out his new venture, Mind360. I'm not just saying that because he's advertised on the program before. I'm saying it because I've, I've gotten to watch him on the entrepreneurial side.

And I think They're doing it the right way off of making sure that they've got something that's really valuable and we can take this off of your plate for the mental health professionals. We can integrate. We can do it a lot faster and we can ensure the quality. And I think That's a concept where, as you know, if he had investors at that time, I'm not saying it's wrong to ever get investors, but if he had them in that time, they may have said, no, move on from that, move on to the next thing without ever really mastering what, what they're doing.

[00:40:10] Dr. John Schnorr: We're one of Julius's customers. We love Mind360. They've done a great job. 

[00:40:14] Griffin Jones: I think there's another group, Cicero Diagnostics. I don't know them that well, and I don't, so I don't want to speak on them, but I, there is something that I could tell. is true for them that I don't think would be true if they were a VC back group, which is they, their testing is for a very, it's for a very particular niche where they, they think the scientific evidence really bears out that for this niche, this is truly valuable.

And I think that if they had more. Like investor money behind them, they would be pressured to try to expand what that niches and say, Oh, you should use the test for this. And you should use the test for that. Even if the scientific evidence doesn't bear it out. And so I think there's in addition to the proving the concept on me on the marketplace side that it allows you to find the niche that is actually Okay.

Going to benefit from from that solution, as opposed to having to expand it to be some kind of unicorn. Do you see that when you see other do you see like when you see some of the new solutions coming out? It's like, well, yeah, this would be useful for like this particular use case, but not for everything that they're trying to sell it for.

Do you ever see that? 

[00:41:26] Dr. John Schnorr: Yeah, I think my team hears that a lot. I think they hear my input on other products that are coming to market and what I feel might be hitting it solidly and what might be missing it by a mile and a half. And so, you know, and maybe that's just one person's viewpoint, you know, maybe I'm just one reproductive endocrinologist, but, you know, I've talked to enough doctors and seen enough clinics function that you kind of know when something solves a problem or when it's a.

Uh, near miss or far miss. And so you do see some of that. 

[00:41:54] Griffin Jones: Talk to me about your team struggles. So you mentioned, you mentioned your team a couple of times and, and how you've, how you've built that. Well, struggles, wins, lessons, the lessons you learned along the way. How did you structure your team? Would you have done anything differently in hindsight?

Would you have done more of things in, in, in hindsight? Talk to us about your team. 

[00:42:12] Dr. John Schnorr: Yeah, well, the team started with a close friend, a former next door neighbor who had a lot of expertise in software as a service and and kind of doing the engineering of that. And he quickly became our CTO to kind of pull all this together.

You know, with his help, we got a very senior engineer. Who's actually doing a lot of our engineering and we've been lucky to have him around. And so, you know, my thought is, is that I always wanted everybody to be fairly paid. Uh, so we wanted salary to be at market rates. I wasn't trying to low ball anybody on salary.

We tried to do salary adjustments along the way as the market demanded salary adjustments, but importantly wanted equity. I wanted people to be incentivized and the outcome of this. And so we use equity for this. And I think that's really helped us out a lot. I think we've been very fortunate with Paul.

Who's our CTO and Jack, a senior engineer. We have a data scientist named Seth who helps us with all of our data analysis. Who's been amazing. Caroline is our lead integration specialist who's been amazing. And then Chad, our chief operating officer. So I think we've gotten really lucky with who we've hired and they came from extensive interviews and making sure we were aligned over time.

And if things kind of got out of alignment, we're pretty candid and open about how we want things to change and why we want them to change and people got on board. Fortunately, we haven't really had any turnover and I think there are our greatest strengths by far. We meet monthly with big reviews. We meet weekly twice a week to go over minutia.

And I think everybody knows kind of what's going on at a macro level and what the problems are and how we're solving them. So I think keeping the team small, keeping it tight, keeping a team who's willing to. work outside their field. Like it's a common thing where we're going to want to do videos and, you know, who on the team knows how to do video editing?

None of us, right? None of us were really good at it. Okay. Well, who wants to learn it and master it moving forward? So we didn't go out and hire expensive video people. We did it ourselves internally. There's software that allows you to do that. And Cut and edit clip and probably all the things you know better than I will ever know, Griffin.

But, you know, we had team members who just volunteered to go out and pursue that and to learn that. And I think that really helped them out. We have engineers who, you know, have really learned how to do training with AI that they never knew how to do before, and it's broadened their horizon and helped them out a lot in their knowledge base, and they enjoy being a critical part of our successful platform.

[00:44:48] Griffin Jones: I think you got a little bit of lucky too. And I'm not, I'm not saying a lot of it. I think you did. And I'm not, and I'm not saying that you didn't do the right things with, with giving equity and the right things with, with how you figured out market rate and salary. But you know, I've gotten to know Chad and Caroline pretty well, you know, the last year or so.

And they're, they're There's not it's not so easy to find young people that can be put into roles like that that are it's like you're getting the people on their way up and you know, they're not always that easy to find. And when you can, they don't always necessarily want to work for a small company or or if they do want to work for a startup, they want to work.

They want to work for the one that's getting headlines for raising Yeah. 10 million in, in tech crunch and all that sort of thing. And so, so I think you, you've done well with that. And what I've noticed about each of them is that they're, I think they're both kind of old souls. And I think that might have to like, you have to be forward thinking to work in any kind of startup that by definition you have to, but I think for bootstrap, you have to have a little bit of an old soul.

Do you think that's the case? 

[00:45:53] Dr. John Schnorr: Sure. I agree. And that the people who are okay, not spending a billion dollars on little things here and there, and to be resourceful and to be proud that they've been resourceful, you know, to really take pride in the fact they did this for a thousand dollars instead of 10, 000, you know, those are things that I think really matter.

And so they. They've been great to do it and I think they enjoy it. A lot of them have worked in large corporations before and I think they run from that. I mean, I think all those endless meetings they had in these large corporations where no decisions were made after a four hour meeting. I mean, literally we'll have a 35 minute meeting and make pivotal decisions and then move forward and start implementing those the next day.

And that's just really rewarding and something I love about a small business in the startup. 

[00:46:36] Griffin Jones: Yeah, I think that that industriousness that you're talking about is necessary and bootstrap and, and I worry about that being kind of like pushed out of the culture a little bit that if we, if we lose too much of that, being proud that I did something for a thousand dollars that we could have spent 30 grand on willing to just kind of eat crow for, uh, for a longer period of time than you would like, not forever.

I don't want anybody to eat crow forever, but, yeah. But to be able to endure for a little while, if we don't do that, if we, if we only, if, if, if all of the fringe benefits become table stakes, like we, we, we all got to have the company car. We all have to have the ping pong table in the giant office. We all have to have, you know, Amy Schumer come to our, our annual retreat.

Then, well, then you're only going to have a small. handful of very financially embedded companies that can even afford that. And you look at who actually, who is doing a lot of bootstrapping in this country right now. It's the immigrants think about immigrants that come to this country that have no money to sell fund and they work 90 hours a week and they grind and they grind and they grind and they reinvest that in their business.

And all of a sudden this, this immigrant that came here with nothing 10 years later owns. 13 Baskin Robbins and 12, 12 Dunkin Donuts. I think, I think it's missing. And from a big part of the culture, I think you've found a couple of people and that's amazing. How did you decide to do, do you have a thought before I move on to my equity question?

[00:48:13] Dr. John Schnorr: Yeah. Let me give you a classic example. Caroline, our lead integration specialist said, I would love when I go to a center. I would love to have a phantom with me to train them. So I don't have to have a patient to train them. A phantom is, you know, a device that represents what a patient would look like with an ultrasound.

So you put your ultrasound probe in and do the scan. And I said, that is a great idea, Caroline. I said, you think that's important? She goes, I think it's critical. I said, OK, well, let's buy a phantom. Well, you can't find an ovarian phantom for less than 15, 000. Literally 15, 000. So Chad, who's got a degree in biomagical engineering, who's our chief operating officer, he goes.

You know what? I think I can help you make a phantom. So we bought ballistics gel, which you would use to shoot a gun into to stop a bullet, right? It's real dense gel, which phantoms are made from. He melts it down in his oven. He takes condoms and puts water in condoms and wraps it up. Melts it into the gel, puts it into a jar, and creates a phantom that looks identical to an ovary.

And that cost us 75 and it's perfect, and it's small enough to fly around with it gets through TSA without any problems whatsoever. And wherever we go, we got a phantom. So we have probably 7 or 8 different phantoms. Now they have all been named. They all have different architectural and feature characteristics of it.

Our favorite phantom is CC moon, a CC for cycle clarity. And so it's just fun and it's team building. It's inspiring. And it's just one of many things we've done to innovate, to become who we are. 

[00:49:48] Griffin Jones: That, that is amazing. And, and it's only like the fourth coolest Chad Clark story I've ever heard. Yeah. You guys.

Right. He's got a bunch. So I've, I've been interested in giving team members equity and thinking about that. I don't feel like I really understand the structure that I would use to do that. We, at one point tried to launch profit sharing and, and I still want to redo that, but. It was, it was more involved in, in terms of, of how you're able to do that.

And, and I realized that the team, it was not immediately obvious to them, like the incentives for doing so. And so I realized like, okay, I need some more training on this. How did you do that? How did you, how did you give equity to folks? 

[00:50:31] Dr. John Schnorr: Yeah, so, so by far this is probably my weakest area is corporate governance and all that kind of stuff.

But we do of course have a corporate attorney. We've done it mostly through stock warrants, which basically mean we promise to give you stock if you sign this when you want to do it. So they don't have ownership right this second, but they have Uh, you know, a guarantee that they'll get it once they sign it, which gives them tax benefits that they don't own it.

Now we don't, um, share profits with them cause we're not profitable. Hopefully one day we will be profitable and we actually do it in a way that I think people need to be part of the corporation to exercise that warrant. So, you know, if you got a stock warrant, you can exercise it whenever you want and we'll give you X number of shares.

for nominal dollar, like 10 or something, basically give you it, but you need to be working at the company at the time. Meaning, you know, if you choose to be an employee now and to work now and to work for stock warrants, but then you decide you're going to chase another dream in three years and not be part of us at the end of it.

then the stock needs to come back into the corporation so it can be redeployed to other employees who are now working with the company at the time. So we've chosen to use stock warrants. I'm sure there are many different ways of doing that, but it seemed like a tax advantage way for the employee to use it.

It seems like a non dilutional way that if we diluted shares over time, but you have a warrant. You wouldn't be diluted out. So that protects them in that way. And they get to exercise that at the end of the journey. If there were to be a transaction, if they wanted to, 

[00:52:03] Griffin Jones: That is a good lesson for those considering giving equity to their team members.

Was there, are there any hard lessons that you've learned about? With your team, giving them things that are outside their scope. Like, you know, you've got your COO helping with, it's not the mannequin. What is it avatar? What's it called? 

[00:52:22] Dr. John Schnorr: It's called a phantom phantom, or, you know, you've got people doing video editing.

[00:52:27] Griffin Jones: So I, a mistake that I made in an earlier generation of my business, John was that I gave too much to certain people at certain times. And I, I, I, it made it. Difficult for me to hold them accountable to an outcome because I had stacked other outcomes that were outside of their seat on their plate, and then I couldn't just walk away from that outcome because they weren't accountable for that one outcome because they were distracted with other things that I had assigned to them.

And so in this generation of the business. I've been hiring from the bottom of the accountability chart going up and I will get more independent contractors and part timers and I'll have them in smaller seats, but I've got different people in smaller seats and then I can walk away because I can divide it down to an outcome for which they can be responsible.

And so instead of like hiring a full timer that maybe I'm giving them like four or five, you know, main core outcomes, it's like you hire part timer two outcomes or something like that. Sometimes only one. And and then, you know, as is. Is the company grows? I've been adding more full time people to manage those folks once they have a team of those folks.

I seem to like it better that way because of the mistake that I made. Have you ever? Have you? Have you run into that challenge at all where it's like when you have a small core team that you're loading too much up on them? 

[00:53:42] Dr. John Schnorr: Yeah, I do think that, you know, we need to be understanding people's demands and their bandwidth and those types of things.

I think we've been lucky to get consultants who will train us and teach us so that they can learn from the expert that allows, for example, Caroline and Chad to become expert themselves because they're learning from the experts and to practice that discipline internally. So they become our guides and kind of mentors these consultants.

And I think that's worked out very well for us. 

[00:54:09] Griffin Jones: It's a good idea. What other tips would you have for people that are that are trying to solve this chicken and the egg when it comes to bootstrapping. So I have come to understand entrepreneurship is the art of solving the chicken and egg problem. I said in passing to David Sable one time in a conversation where I said, Well, yeah, but how do you do that?

That's chicken and the egg. And he just looked at me and said, Griffin, the entrepreneur's job is to solve The chicken and the egg. And then I thought, Oh yeah, that's all it is. That is exactly what the entrepreneur's job, what comes for it? Well, we can't, we can't make the product if we don't have the money.

We can't make the money. We don't have the product. We can't hire the people if we have et cetera, et cetera. It's, it's about trying to, to, to balance that. And I. The ideal of having capital investment come in is that we can circumvent some of that chicken and the egg because they just give us a chicken.

I don't think it actually works out for that for the conversation that we've talked about that many times, but what tips would you give to people trying to bootstrap to overcome this chicken and the egg paradox? 

[00:55:11] Dr. John Schnorr: Yeah, I would say that importantly, I think you need to really be a master of that domain and know what the market is you're trying to hit and understand the details of that market.

I had an advantage there. I think that you should set a financial limit on what you need to have happen before you put in your next a hundred, $200,000. Like, you know, I need proof of concept and I need this to do X, Y, and z. And if we don't get to that, I'm going to rethink whether or not I'm going to put in the next 200, 000 again using examples.

And so, I think always stepping back, seeing where you are, figuring out what that financial commitment is, what our progress has been. Again, I'm big on journaling. I think being able to look back and see where you've been. Forget where you've been and how big of problems you had three or four years ago compared to the problems you have now.

I get tremendous reassurance out of seeing that and then really listening to the team around you. And then, you know, I'm a physician who has my own opinion, but do other physicians have the same opinion? I do meeting with people like Michael Levy and other experts in the field and making sure I'm not too far off base, incredibly reassuring.

So I would say. Really get to know your market, get a product out to market in a beta form, look to see what's hitting, what's missing. Don't be afraid to go back to the drawing board, make quick decisions along the way to readdress the market as we have with, for example, ultrasound processing timing so people can make decisions in front of the patient.

[00:56:46] Griffin Jones: Yeah, I might go a little bit beyond that of you saying getting to know the market, which is what you did, which is work in the market. And I think that it's part of, you know, I, uh, it took me a while to build fertility bridge to, The goal that I had for it probably took like seven years in something I wanted to do three, the version of inside reproductive health that I'm building is going faster because I had that experience with fertility bridge.

I would, I would recommend that people work in the field that they go work for someone. I think that there's a lot of contemporary advice that says, You're not a true entrepreneur if you ever work for somebody else. I think B. S. Like maybe if you're Mark, if you're Mark Zuckerberg, sure. Like go and go and go and do the thing.

But for most people, especially if you're going to end up being a small business owner, a 10, 15, 20 million business, which by the way, is being a one percenter, you know, it's being. It's still a really, really good life, then you can learn a lot by going to work for somebody and maybe go work in one vertical and then another.

So if you wanted to work in the R. E. I. Space and the tech space, go work for R. E. I. Company for three years, then go work for a tech company for three years and In meanwhile, network with everybody you possibly can because you're going to need those early customers fast and you're going to need to hire people that can deliver really fast and not have to figure, figure that stuff out later.

Is there anything about that you've learned about pre selling or, or selling, you know, On one hand, you don't want to sell so early that you can't deliver something. Um, on the other hand, if you waited for the perfect solution, like the absolute theoretical perfect solution, you would never actually get it because you need to sell in order to figure out what it is.

So have you learned some lessons around rules for pre selling? 

[00:58:44] Dr. John Schnorr: We've learned a lot of lessons and I think the sales cycle is longer than I would think and again my own Personality is I'll look at something I'll decide if I want or not and move on and implement it move on and act quickly But now all organizations can do that.

So you might be bringing a software solution that improves clinical efficiency And in some organizations, there's going to be one or two people who are going to make that decision. You're going to move on to the next week and everything's going to be fine. There are other organizations. You need to get through three or four committees to make sure it gets approved along the way to make sure that it is okay.

And security is okay. And then some centers want to measure every follicle for three months to make sure it's accurate. And others are going to say, well, you know, if the FDA approved it, then I'm good with it too. Let's move on. And so I think everybody's different and you need to understand. A, what the center's challenge is.

Why are we here? What are you trying to address? B, talk about what our technology can do and figure out how we can implement it the best. And I think you need a physician champion. And I think for us, you need an administrative champion too, who's going to try to encourage people to invest time into it.

Technologies like ours, you start by losing you time. You, you lose time to learn this technology and implement it. By two months in, you might break even, you really don't start seeing the benefits until four to five months down the road and you got to prepare the client for that journey. 

[01:00:08] Griffin Jones: John, this has been a blast.

I've had a great time going through this with you because I think your company is doing it right. I think you're doing it right as a bootstrapper. I'd like to see a few more companies do it. Other companies like the ones we talked about, I think are. doing it well. And of course, there's more, but I, I think it's a solution that is not for everyone or a pathway that isn't for everyone, but should probably be considered by more than it is now.

And so how would you like to conclude, you know, maybe you will raise money someday if the time is right, but you haven't up to this point. So how would you like to conclude with how you think about bootstrapping in this space? 

[01:00:46] Dr. John Schnorr: I would just like to conclude and say that I think entrepreneurship is for the brave.

That it, you know, you got to have bold ideas. You got to have convictions. You got to be willing to put resources behind it. Sometimes less, sometimes more depending on how you end up funding yourself. But I think that entrepreneurship creates great ideas that make the world a better place. And I'd like to encourage people to pursue their dreams, to think about.

what problems are that they can help solve and help solve those. And the more of that you could do with your own funds, the more equity you'll have at the end for having a big investor kind of help get you to that, you know, international, you know, deployment or wherever you're headed next. 

[01:01:26] Griffin Jones: Dr. John Schnorr, it has been a pleasure.

I look forward to having you back on for a third time. Thanks so much for coming back on the Inside Reproductive Health podcast. 

[01:01:36] Dr. John Schnorr: Thank you so much, Griffin. 

[01:01:38] Sponsor: This episode was brought to you by Mind360, a leading fertility mental health platform. How long does it take your clinic to get patients through their third party cycle psychological evaluation?

Find out how your clinic compares with Mind360's free report at mind360.us/reducedwaittime. That's mind360.us/reducedwaittime

Announcer: Today's advertiser helped make the production and delivery of this episode possible for free to you. But the themes expressed by the guests do not necessarily reflect the views of Inside Reproductive Health nor of the advertiser.

The advertiser does not have editorial control over the content of this episode and the guest's appearance is not an endorsement of the advertiser. Thank you for listening to Inside Reproductive Health.

203 7 Categories of AI Investment in Fertility, and the Barriers to Their Adoption with Abigail Sirus and Dr. David Sable

DISCLAIMER: Today’s Advertiser helped make the production and delivery of this episode possible, for free, to you! But the themes expressed by the guests do not necessarily reflect the views of Inside Reproductive Health, nor of the Advertiser. The Advertiser does not have editorial control over the content of this episode, and the guest’s appearance is not an endorsement of the Advertiser.

Quality Disclaimer:
Despite our best efforts, technical issues can occasionally arise.  Please excuse the audio in the following episode as it doesn’t reflect our usual quality standard.


The innovative potential of AI is an increasingly common topic in IVF and beyond. But on this week’s episode of Inside Reproductive Health we bring back Dr. David Sable and Abigail Sirus to ask a different question.

What’s preventing AI from completely taking over the fertility space?

Dr. Sable and Ms. Sirus discuss the seven big areas of AI investment in IVF and the obstacles standing in the way of full fledge adoption.

Tune in to hear:

  • The 7 categories of AI Investment (And their criteria)

  • Their visual for how they categorize AI in the fertility field (Corresponding to their seven categories)

  • Current developments in AI across the IVF space (Including the sticking points)

  • What’s preventing the inflection point of AI completely sweeping fertility treatment (And making their four principles the standard)


Abigail Sirus
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David Sable
LinkedIn
Twitter

Transcript

[00:00:00] Dr. David Sable:
But the big part of that is doing the work is merging the software with the hardware so that you're getting reliable data so that the information they give you is based on the hardware and software shaking hands. in a, um, in a valid way and not giving you, it's not like, it's not like with chat GPT when you ask it a question and it makes mistakes and it makes things up.

The data we're getting now is not made up. It's really truly reflective of what the hardware is finding. Taking the next steps of plugging that into real decision making is going to be difficult. 

[00:00:38] Sponsor:
This episode was brought to you by LEVY Health. Seeing more patients for a first consultation may actually decrease IVF revenue by 30 to 40 percent.

To see why, download the numbers for free at levy.health/conversion. That's levy.health/conversion. Today's advertiser helped make the production and delivery of this episode possible for free to you. But the themes expressed by the guests do not necessarily reflect the views of Inside Reproductive Health, nor of the advertiser.

The advertiser does not have editorial control over the content of this episode, and the guest's appearance is not an endorsement of the advertiser.

Despite our best efforts, technical issues can occasionally arise. Please excuse the audio in the following episode as it doesn't reflect our usual quality standard.

[00:01:34] Griffin Jones:
Why? Why? Why? If any of you are gracious enough to think that I'm good at my job as an interviewer, it's simply because I'm a child that wants to know more specifics.

I want to know why, and I'm not satisfied with the answer of fertility clinic workflows are just too complicated. Why is this tipping point that almost all of us can see we're so close to having a I move over this inflection point and totally dominate how fertility treatment is delivered? Why are we still not at that inflection point?

When we're so close, what's holding us back? So I bring back two very popular guests. They're Dr. David Sable, who you know very well, a former practicing REI turned investor, and his colleague Abigail Sirus, a venture capitalist who worked with IBM for a number of years. Last time Abigail and David were both on the show, they went into their four guiding principles for democratizing IVF.

That's have a la carte options for IVF services, go around incumbents if you can to incentivize them. Set the standard of today's highest pregnancy rates as the absolute basement for outcomes for the future and pay for outcomes, not cycles. In today's conversation, I asked David and Abigail, what's preventing the inflection point from AI completely sweeping fertility treatment and making these four principles the standard of the day.

David and Abigail have . visual of how they categorize artificial intelligence in the fertility space, corresponds into seven general categories, and we go into each of those categories. David and Abigail share some developments of what's happening in each of them, and they detail the sticking points for each.

That's oocyte assessment, embryo assessment, sperm selection, hormonal stimulation, non invasive PGT. clinic decision support and workflow. And in their other category, which may overlap with obstetrics and other areas of healthcare, you're talking about follicles, preterm birth, reproductive immunology, and ovulation.

If you're having trouble picturing this visual, we'll link to it in the show notes and follow along as I try to get the specifics of why we're so close to AI domination, each of these areas and what specifically is standing in the way of each. Enjoy this conversation with two of your favorite recurring cast members here on the Inside Reproductive Health Show, Dr. David Sable and Abigail Sirus. Ms., Sirus, Abigail, Dr. Sable, David, welcome back to both of you on to the Inside Reproductive Health podcast. 

Always a pleasure, Griffin. 

You're both troopers. You're both gonna have to go to the chiropractor after this episode because like our last episode, your backs are gonna break from carrying that episode.

Last time, it was after Thanksgiving and I... It was the first thing on the Monday morning after Thanksgiving. And I know business owners are supposed to say, I love Mondays. I love mornings. I don't, I don't love Mondays or mornings. And I really, really love Thanksgiving. I remember being in a funk and you both carried that interview.

Now you're going to carry it more today because not only did I ask to talk about a visual concept on a show where the audience is 90, 95 percent audio only, I also. Send one image where I sent you one image and said let's talk about this and then was thinking of going in a different direction so you have so many different visuals for investment areas of the IVF space so I will have you back on for yet another episode to talk about the.

Other map that you've used to, to wireframe the, the, the whole IVF process. But today let's zoom into AI and the visual that we're talking about today, Abigail and David, is this going to be something that we can either share or that we'll be able to direct people to, to your website or previous article that they can reference themselves?

[00:05:28] Abigail Sirus:
Yeah, so I think that we we've published it on David's blog, David's medium site, so it's what you're not seeing to everyone who's on on audio only is it's basically just a chart of the different areas of innovation and AI in the IVF industry, so we're Talking about things like an oocyte assessment, embryo assessment, sperm selection as well.

So just the different versions, uh, different flavors of companies we're seeing innovate in AI and IVF.

[00:05:58] Griffin Jones:
In this realm of AI, you break it into oocyte assessment, embryo assessment, sperm selection, hormonal stimulation management, non invasive PGT, clinical decision support and workflow. And then you've got an other box.

And then in that other box, you've got follicle preterm birth. REI and ovulation. So, or excuse me, that's not, that isn't REI, that's reproductive immunology. That's, that's in your other box. Why did some things make it, uh, it, why did the things that are in your map make it to the central part that it is?

And others, Not appear here. 

[00:06:37] Abigail Sirus:
Yeah. So the way we think about it, Griffin, we're venture capital investors and fertility is, is really looking at the market as a whole. So we map out a universe of all the companies. Find IVF and right now that number is around 280 and what you're looking at is our map of AI Subsection of that larger one, which is specifically the 20 plus companies It seems that the number is is growing more and more with every week that passes That are specifically focused on AI or are using AI as part of their processes and the way we map it out We're just looking at two buckets The first is companies that are looking to optimize IVF, the procedure itself, using AI.

And so that might be via oocyte selection tools, embryo grading tools, or things like, um, hormonal stimulation tools. And then the second bucket are the companies that are kind of adjacent to IVF itself, that are looking at the processes and procedures around delivering. IVF care and using AI to optimize those.

So we're talking there about, for example, an AI enabled chatbot that can help answer patient questions perhaps more quickly. Or, um, there are a number of companies that are focused on kind of the iOS for fertility or the operating system across a clinic or clinic network and using AI, AI to optimize things from billing to staffing, etc.

[00:08:03] Griffin Jones:
As the players become more fluid on either side, as there's more vertical integration, do you see the map changing? And that one bucket is the company's optimizing IVF itself, and there's others working on processing procedures. But as these players Start to overlap with each other and with what they provide.

Will we see this change over time? Or do you see these two buckets as a long term way of looking at this? 

[00:08:30] Abigail Sirus:
I think it will change over time as we're early stage investors. So startups can, can. Pivot from time to time. But really, we're seeing a mixture of startups that are going after either point solution.

So we're really focused on making the best AI enabled salute or embryo assessment or those that are taking a more comprehensive approach. So might be doing The solution I just mentioned, while also looking across the clinic at ways to opt. So it really varies across the ecosystem in terms of whether people are focused on point or comprehensive solutions, but I think it's only going to continue to evolve.

It feels like there's been this kind of tidal wave of interest in AI ever since. Chat, GPT came to the fore and had, I think it was a hundred million users in the first few months, which far passes any product launch. But in reality, a lot of these companies that that we're mentioning in IVF have been working on it for a number of years, but it still feels early days.

[00:09:27] Griffin Jones:
The visual that you have is broken into these categories, and then as the offshoot, there's a, a blurred out section. Are you mapping companies that are in each of these different areas are working on each of these different areas? Right now? I know because you all are in venture capital, there's regulation about you not being able to talk about specific.

Companies. And so is that what's blurred out? Are you tracking who's doing who's involved in each of these sections? 

[00:09:57] Abigail Sirus:
Exactly. So you can imagine that even behind this, I'm a data and spreadsheet person. So we have kind of our database that, that in those blurred section takes all of the 20 plus companies, which are what's represented as kind of the options that you were mentioning.

And we analyze them each across a number of dimensions. So one of them is. What I mentioned before, whether it's a point solution or whether it's comprehensive, another would be with something like A. I. Data is so critical to how we evaluate these. So it's understanding what are the data sources that each of these startups are using?

Are they proprietary? Is that data source going to grow? And we've been talking a lot, at least in the ecosystem about quantity of data. But from our perspective, it's really about quality. So it's about the signal that the data is releasing because IVF is is still growing. And in many ways, when you compare it to healthcare in general, it's a niche industry, even though we believe it's going to grow exponentially over the next coming years.

And so a lot of the companies that we talked to are using similar data sets. So what we try to understand is how are they differentiated because when you're building an AI algorithm and you're using all the same inputs, we're, we're curious to see how it shakes out in the coming years among these companies of how the outputs are really different and how that makes an impact on patient care.

[00:11:15] Griffin Jones:
How is it shaking out right now? Are you seeing meaningful differences? Are they all coming to the same conclusions and starting to build very similar solutions? Or are they coming up with radically different solutions using very similar data sets? 

[00:11:33] Abigail Sirus:
I'd say it's still too early to tell in terms of which, which are going to be the winners of the pack and so on.

What we are seeing is kind of a convalescence or convergence around the same use cases, which are kind of laid out on that diagram that you mentioned before, embryo grading and selection. Hormone stimulation using AI, but what we are noticing as well is what's what's potentially differentiate companies or what clinics are they partnering with and going beyond that software or an AI powered algorithm is only as powerful as it can be actually applied in the clinic.

So what we're also looking for are companies that are focused on integrating their solution with Hardware and kind of bridging the gap between the digital and the physical worlds, because what we've seen is that companies who come into the space and might be really excited about this small part of the universe that they're innovating on, if you don't think more broadly about how it would actually be Impacting an REI's daily workflow or an embryologists and how you can make that part of their experience in a seamless way, solutions can have a hard, hard time taking off and being adopted when we're not thinking not only about the product itself, which is driven by AI or powered by AI, but also how it will be distributed and be made part of the IDF ecosystem as it is today, or the IDF ecosystem as it will be defined over the coming years.


[00:12:52] Griffin Jones:
Because hardware integration is so important, are you seeing multiple, in this blurred out section, are there multiple players that are appearing in different, in the different core categories, these eight boxes, as you have them laid out, or do you try to, do you try to identify which of the eight boxes they are most Best describes them and keep them in that singular category.

[00:13:19] Abigail Sirus:
It's a great question. And it's one that, that David and I talk about a lot because we like to be precise, although with things changing as quickly as they are, it's hard to do. So it really depends on the company and what we've learned and kind of. How far along they are. So yes, there are some companies that are tackling several of these areas that might be going after both oocyte selection and sperm selection.

And so they would be listed in that blurred out area that you mentioned before in both sections. But for others who might be in the early days of exploring one use case, but farther along, much farther along a different one, it would only list them in one section.

[00:13:55] Griffin Jones:
You mentioned that they use similar data sets very often.

Is that equally true if they're in very different categories? Meaning you might expect the folks that are working on O site assessment that they are using similar data sources, but are. Does it matter, are the people that are working on PGT, non invasive PGT, or the people that are working on clinic workflow, and the people that are working on sperm selection, is there still great overlap in data sources for them?

How much did data sources vary depending on if they're in entirely different categories? 

[00:14:35] Abigail Sirus:
I think it's, Definitely different. If you're focused on oocyte selection, you're not going to be looking at the sperm data, unless maybe that's going to be part of an algorithm and your future roadmap. So in that case, what I would be talking about is, so in oocyte selection specifically, I'm looking at the map on my computer now, but that's not blurred out.

We have five plus companies just focused on oocyte selection. So they would be like using the same or similar data sources. 

[00:15:03] Dr. David Sable:
One of the problems, Griffin, that we do see is that you see a difference in data sets, not so much the data being collected to make the decisions, but in some of the categorizations.

Something as simple as a diagnosis. One clinic's unexplained infertility will be another's ovulatory dysfunction. Depending on what the algorithms pull out, the connections they make, you hear that one of the great The beauty of AI is that these are unbiased mechanism agnostic algorithms. So if we use these things kind of differently from one clinic to the next, or maybe one operator within a clinic to the next operator, that's going to sort of infect the data.

And we're going to see these kind of artifactual differences. And since an IVF, we're limited by the fact that the data sets are pretty small, relatively. These are not big. When you talk about big data, when we're only doing a few million cycles worldwide every year and capturing only a tiny percentage of those into these data sets, we're handicapped from the start.

You start throwing some, I don't want to call it sloppy data, data collection, but let's just say inconsistent data collection. On top of it, and that makes our job that much more difficult, and it makes the algorithms have to work harder to avoid presenting things to us that are not really real. 

[00:16:37] Griffin Jones:
Is this part of your advisory role for your portfolio companies?

Do you advise on the data sources that people are using? Oh, we, we've seen this before. We know that the data that you're showing us here is inconsistent and you might consider this other source.

[00:16:56] Dr. David Sable:
I think the, I think the data people, the data scientists know that going in, and they're, unfortunately, they're limited by who's going to, who's going to work with them, who's going to send their data to them.

Let's say, as you can imagine, and rationally, rightfully so, clinics are very protective of their data. So it's a, it's a bit of a trench warfare, trying to accrue enough things to feed into the systems to start building the training sets and building the algorithms themselves. 

[00:17:27] Griffin Jones:
What would allow for more data sources to become available?

So if there's, if, if there's. So a lot of redundancy and overlap in different companies using similar data sets, what would allow for more data sets and more data sources to become available? 

[00:17:48] Abigail Sirus: I think even before tackling that question, there's a level of kind of data uniformity or unification. So in a previous life, I was, uh, focused very much on data, uh, while I was working at IBM.

And we would build out a, you know, garbage, garbage out. And what we've heard in the industry is sometimes even using a popular EMR system for one clinic, they might use a specific data field or mapping that's, that's different than another clinic. And so there's this high level of customization across the industry today.

In terms of how they're just thinking about how they talk about data, and that's going to create challenges of bringing the disparate sources together in a way that makes sense and unifying them so that you could even be run an AI algorithm on top of them. 

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[00:20:05] Griffin Jones:
I wanna ask, uh, you, you can't talk about particular players, but I do wanna go through each of these categories and give the audience an update on, on what's going on in development.

And I understand that in some things you're gonna be limited and I'll try to press. for specifics where I can, but tell us what's happening in the development in an O site assessment right now. What's going on with that grading and with regard to AI. 

[00:20:32] Dr. David Sable:
In a large sense, the big challenge is demonstrating the value proposition.

The, uh, we, we know that the use of. Uh, advanced imaging systems and vast data handling can give us legitimate, uh, insights into which oocytes are more likely to turn into good blastocysts and good pregnancies. Uh, they can rationally rank the embryos as to which should go back First. Problem is how, when, you know, you and I and and Abigail have talked before about our criteria of dollars to baby time to baby and life disruption to baby.

And if we can do it little bit better by offering a point solution to put back an embryo in February instead of, instead of in March, so the pregnancy occurs quicker, how much is that worth in the grand scheme of things? By itself and how much better are we doing some of the business plans that we've got early in the AI journey were beautifully engineered solutions to answer a question and absolutely terrible business plans with the expectation that the price points that you could achieve.

Sometimes per cycle, sometimes hundreds of dollars per embryo assessed. We're just completely unrealistic in terms of getting the patient to where she wants to be. And we kind of, you know, then you may ask about advising the companies. Well, you sort of start advising them and say, Listen, you got to go back and put this into the grand scheme of What the patients themselves in the clinics are trying to solve for.

So we haven't really seen data telling us how much better we can do on specific, specific items. Embryo assessment, the same embryos are going to be sitting in the lab anyway. So it's a matter of when an embryo goes back versus other embryos that might not turn into a pregnant. Oocyte assessment is a wonderful, uh, science project.

I think it's, it's fabulous knowing which oocytes to use. But frankly, what we do now is we let nature tell us which oocytes to use because Some of them will fertilize, some of them won't. Some of the ones that fertilize will develop well, some of them won't. And then we've got other means of assessing the subsequent embryos.

So, up front, Determining which oocytes to use really is valuable, I guess, only if you have very, very limited numbers of sperm to use and you're triaging those sperm. Our work in AI for sperm selection is brilliant work being done right now. But it may be work that's being done looking at the wrong things.

For ever since we put sperm under a microscope. Hundreds of years ago, we've used this, the number of sperm, the way the sperm look, and the way they swim, as surrogate reasons for choosing one sperm versus another to, to fertilize the eggs. When we do, certainly when we're doing ICSI, in old fashioned IVF, we just kind of squirt the sperm into the dish.

Nature does that choice. Now, we don't know yet Whether the computers have been smart enough to find new things to look at versus what we look at. Because the important things are really the quality of the DNA and whether the DNA is normal within the sperm and the sperm's ability to kind of direct early regulation of first early cell division.

We have no way of measuring that. So while we have trained the algorithms and in some cases the algorithm and hardware combined to do things in a more systematic fashion. And some of the things that we as human beings just don't have the capacity to do, like we can look into a dish under a microscope of sperm and how many sperm can we track versus a brilliantly designed surveillance system with computers that can track all the sperm and then choose them based on certain criteria.

The algorithms haven't been trained back on the pregnancies yet that result from those tests because there just haven't been enough experiments done. Again, getting back to the limited amount of data that we have. So it's a very incremental process by which we can put in the, put the playbook into the various steps and try to extricate better chance of having a baby.

Now the stuff that we can judge earlier are some of the efficiency steps. We do something quicker. Can we do it? More error free. Can we free up people so to let machines do work that people do that takes longer or it's subject to fatigue? Or frankly, we just can't do as well as a well trained machine.

And those are things we're getting data back on. Now, I don't think we're in a position yet where we can judge company A does it better than company B, because these are all iterative processes and AI and IVF is such a new thing that it's exciting to watch things get better with the expectation that we're going to get some real, real decision making quality data. We're just not there yet. 

[00:26:20] Griffin Jones:
The answer to the question of what's going on in these two categories, is the answer not enough? 

[00:26:24] Dr. David Sable:
Well, they're, they're, they're in spring training. 

[00:26:27] Griffin Jones:
Is that gonna be the, is that gonna be the answer for each of the categories? So before I go through each of the categories and, and just find out that everybody's in, in spring training, maybe instead of going through each category one by one, where would you say of, of these eight categories, oside assessment, embryo assessment, sperm selection, or hormonal stimulation, non-invasive, PGT.

clinical support and workflow, and then other, where would you see, where would you say we are, who's beyond spring training, or which of these categories is seeing players that are beyond spring training? 

[00:27:03] Dr. David Sable:
Well, certainly clinical support and workflow. That's pretty straightforward. In embryo assessment, there is data showing there's validity to the ranking systems.

Again, we're challenged in proving that we have a viable value proposition, but certainly the rankings, some very good publications on the ability to rank embryos in ways that improve the efficiency of selection there. OSI selection, sperm selection, we have, a big part of that is, Doing the work is merging the software with the hardware so that you're getting reliable data so that the information they give you is based on the hardware and the software are shaking hands.

in a, uh, in a valid way and not giving you, it's not like, it's not like with chat GPT when you ask it a question and it makes mistakes and it makes things up. You know, the data we're getting now is not made up. It's really truly reflective of what the hardware is finding. Taking the next steps of plugging that into real decision making is going to be difficult.

The clinical data support, having the algorithms choose. What stimulation should be done having them make the decisions along the way for how the stimulation should be should be run That needs a lot more cycles to chew on and to have those cycles and have them collect connected to the outcomes So and there we're going to stratify the value in two ways The first will be that when it shows that we can relieve doctors from having to look at dozens or hundreds of data points per day for each cycle they're monitoring, and the computer can do it for 98 percent of them, just kicking the outliers out, we'll know that before we learn that the computers make better decisions than the doctors did.

So this can be a two step process there. So it's, yeah, I think that given that AI infertility was pretty much non existent, just a few years ago. We've made some terrific progress, but it's kind of like, like in biotech, what we say, we're still preclinical. We've got, we've identified molecules that can make a difference in the body.

Now we've got to stick them in the body and see what happens. 

[00:29:20] Griffin Jones:
You mentioned that some of that is down the road. What's happening? What are these players that are in the support, the clinical support and workflow category right now doing that's being implemented right now that maybe wasn't even happening a year or so ago?

[00:29:36] Dr. David Sable:
There's, there's two areas. One is they've got to plug them into, into existing clinics and have them adopt them into their workflow. The other end of it, some of these companies are actually starting their own clinics. And they're running clinic prototype clinics with the AI systems in from the start as foundational elements.

And it's going to be really interesting to see in those two settings, what kind of difference we make in just the efficiency in which we can run an IVF program and those efficiencies will flow to both the clinic operators themselves later. do what they do cheaper, and hopefully to the patients themselves at a lower cost point, and in down the road, a faster time to getting pregnant.

[00:30:28] Griffin Jones:
Those that aren't starting their own prototype clinics and those that are still selling into clinics and being implemented by clinics, are you seeing a different rate in, uh, adoption than was happening a year or two ago? Have we passed a threshold where. They are starting to be implemented, or is that still the beginning of a mountain yet to be climbed where most clinics are not implementing these solutions?

[00:30:58] Abigail Sirus:
Yeah, and so when I used to do software development, we would describe it in three phases. There's proof of concept, when you're just getting started, testing things out. The next is pilot, when you're maybe working with a couple clinics or a few clinics or a handful at a time. Having them initially adopt the software, testing it out with them with maybe some real data, some simulated.

And then the third stage is production, when you're fully live, maybe across a handful, a number of clinics or clinic chain. And so I think for clinical decision support and workflow, we're seeing a mixture between still in proof of concepts phase, but also some that are doing pilots with clinics, with some live and simulated data.

I wouldn't say that any. Solutions that I've come across are quite production scale yet. It's still early days there, but I will say that what has been interesting for me to see is the difference. It's the difference in how incumbents, so existing clinics are integrating AI solutions and the new startups that are coming to the fore with kind of AI as part of their, their backbone or, um, their core foundation.

It's, it's kind of like with other platform shifts we've seen with. The Internet coming to the fore, for example, there was this general assumption that a lot of the advertising companies that already existed would just simply port everything that they already did onto the Internet or the World Wide Web and would continue to maintain their market leadership.

And then there were these new upstarts like Google's and others of the world at that time who were originally written off who came to the fore with the being on the Internet, and ended up being able to kind of come after the advertising industry and really flip it on its head. So, we're still in the early days of understanding how the adoption is going to be spread.

And these, these clinics are powerhouses for a reason. They are innovative and thinking towards the future. And they also control... pretty much all of the data that upstarts would need in order to have meaningful algorithms that actually make a difference in patient care. So it's going to be something that we're monitoring closely.

[00:33:08] Griffin Jones:
So a lot of the programs in the, the players in the clinic decision support and workflow category are still in pilot. Mode. What are they working on specifically? Is this that is using smart technology so that when supplies are low, they're automatically reordered. Is it that when a certain prognosis is given that, or a certain diagnosis or prognosis, it automatically schedules tasks, tell us about what specifically is happening.

[00:33:37] Dr. David Sable:
Yeah, it really depends on clinic to clinic. And one of the things we can't ignore too, is there's still the incredible amount of consolidation going on with larger and larger networks being formed and there they've got to homogenize their processes before they can, they can, before they can even think about adding something new in terms of the technology and what they're doing on the ground.

A lot of it depends on. what specific problem they're solving. Some of this, like doing order procurement or deciding which test to order relative to a single diagnosis, these are not exactly sophisticated decision, decision treats. Some of the things that we've been presented with are, yeah, I used to say it's kind of like making the Instructions, instructions to the babysitter.

It's like the baby wakes up and cries. If it's this time, you do one thing. It's not a heck of a lot of choices, not a lot of decision points. And applying, quote unquote, AI to it is, you know, kind of glorifying a little. And really, the benefits that we're going to see are in the much more complex decision making, where you just have a tremendous amount of data that's all being aggregated that needs to be looked at.

We've been making connections that we haven't been able to make yet. We've got 40 years of great human artificial intelligence based on the work that the embryologists and scientists have been doing in the lab before. They're just iterating and iterating and iterating slowly because that's what humans do.

If we're adding this extra layer on top of it, the greatest amount of benefit we're going to get are the toughest things to instill. And realistically, the more complex Problem you go after the more constituents you have to. Get behind it. When you run the lab, you've got to get the doctors behind, you've got to get the embryologists.

The scientific director needs to get each embryologist to sign off on it because, you know, you get one person in your workflow who wants to slow walk the implementation of a new system. And as, and where are we going to get the best information? We're going to get them from the largest clinics that do the same things, but they're also the ones that are consolidating most.

So it's a, you asked a perfectly good question. And here I am doing my best to dodge the answer because the reality of the IVF industry right now makes it a lot, it makes it kind of tough to get to that so what kind of thing where we say, oh yeah, we absolutely need this and we can define precisely what the benefit is.

So we know how much we should be paying for it. Once we get to there, we're going to see really rapid adoption. Now, you see the, a lot of the entrepreneurs, the founders will come to us and say they'll approach a clinic. The clinic will say, all right, well, you got to make it effortless to do it. We don't want to pay for it.

And we're going to give you nothing for what you're going to do. The, the founders themselves want to go to the clinics and say, all right, we're going to do this for you. Here's what we want to charge you for, and we want access to all of your data, so we can advance what we're going to do moving down the line.

Those are not easy negotiations to have. So in some cases, they're really left at the, all right, so let's make a little micro step along the way. But that microstep is not particularly clinically meaningful because they're being asked to optimize something that's easy to optimize. Frankly, this could have been done by systems that don't have the AI name on them, but are really just some combination of arithmetic or math or basic computing.

So it's a kind of a multi tiered answer, uh, a long winded non answer to your very good question. 

[00:37:40] Griffin Jones:
Well, let's maybe get answers in a different category because even a general answer would be more than I've covered on the show before. I never have really delved into the category of hormonal stimulation management and the solutions that are coming in that category.

This is the fourth category that you have in your visual and so is Am I understanding it correctly by thinking of it, this is how AI is going to impact pharma and dosage and, and, and med protocols that talk to us about this category. 

[00:38:17] Dr. David Sable:
Let's, let's go to the do it yourself IVF cycle and let's, let's fast forward to when every, every one of these systems works perfectly.

So there the patient. Does her own diagnostics because there's a list online of all the things you can order from Amazon You need a lot of testing done very easily If you need some type of invasive test it can be done the way a colonoscopy is done You just make an appointment in a place that does it you never get to know the doctor gets it's done So you line up all your basic testing?

You have, you've disaggregated stimulation from the big box, big tent IVF program, and there are OBGYNs that do it, or maybe freestanding IVF stimulators that do it, run by whatever combination of medical professionals. They take the information that you've put together from your checklist of pre IVF testing.

It gets fed into the computer. The computer says, all right, here's the optimal. stimulation regimen. Frankly, there's not that many regimens. We, again, we have a version of that written out on a yellow legal pad as instructions to the babysitter now. So that stimulation starts, the patient gets her medication from lots of different ways of sending medication to someone.

And she's monitored the monitoring. We hope to move to the home. Urine testing instead of blood testing, ultrasound only when it's needed. We do over, over scan people now and maybe we'll invent a really good cost effective home ultrasound, kind of like putting a pro, you know, patient. Places the probe herself saves hours of going to the clinic each time data that's collected the hormonal levels Whether it's from urine or saliva or whatever and the images from the probe go to the cloud the cloud sends them to a Processing system that in a big data AI way Uses those inputs to make the decision as to what the medication should be changed to or kept the same and when the next monitoring should be.

Now, on the ground, having done thousands and thousands of IVF cycles over the years, personally, and as a field, we've done millions of them, we know that most of these decisions are pretty routine, so that the computer will do maybe 98 percent of them, and kick out the 1 or 2 percent that are outliers, and that will go to the reproductive endocrinologist, who may be in a consulting role.

We've talked to you, I don't... Griffin, we talked earlier about moving the reproductive endocrinologists from doing a couple hundred cycles a year to overseeing thousands of cycles a year. This will be part of that. So that the AI system has chosen the stimulation, the AI system does the monitoring, and in conjunction with the overseeing RE, decides when the trigger for retrieval should be.

At that point, the AI system can take a break for a couple days. We go to retrieval. The oocytes are retrieved. The AI system is part of the microscopy. It talks to the microscope, sees the eggs as they come out. If there's a need to rank the eggs to be fertilized, because there's very, very few sperm, Or, if we get smarter about oocyte culture, and maybe different eggs need to be treated differently depending on things that the AI system may be able to see that we can't, the AI system will kick in there, and now the AI system is working in concert with the embryologists.

So it helps us choose the eggs to fertilize if there's minimal sperm, or stratifies the type of handling of the oocytes themselves. And then the fertilization will occur. This is where, hopefully, we'll be in a system where the AI system is really good at choosing the sperm that should be, maybe based on some type of marker that it sees that we as humans can't, that correlates really, really well with the genetics of the sperm.

Something we can't tell now, like we look at a sperm, the way it swims, the way it looks now, many sperm. It's like trying to figure out what's in the trunk of the car by looking at the license plate. So here we've got the AI system can look inside the trunk of the sperm and know what's inside. So it tells us which sperm to use and, and for which eggs then mechanically.

Let's say we're doing ICSI, there is an optimal angle that the needle should be at. There's an optimal speed that the needle should go through the zone of pellucida. There's an interplay between the elasticity of the shell of the egg. And the speed button, the speed and the sharpness of the angle needle itself.

This is a Toyota assembly line type optimization. May make a big difference or may not make any difference at all, but as AI gets smarter and smarter and smarter and smarter, it's going to turn ICSI from a procedure that maybe hurts a certain percentage of the eggs, maybe doesn't hurt to one that doesn't hurt any of them.

Then we go to the development of the embryos and the culturing. Right now, it's sort of a one size fits all type thing, where the embryos are treated all alike. They may be all in their own little wells with a probe inside, monitors the vital signs of the embryo. How much fuel is this embryo eating?

What's the pace by which the cells divide? Maybe we should hit the gas a little bit or hit the brake a little bit on the specific embryos themselves. And then ultimately we'll reach a time when we need to do the choosing. So there's tons of things that a really great hardware software hybrid that measures everything in ways that we as humans can't.

And over time, if we implement systems that are efficient enough and, very important, it's cheap enough to gather these data, then it's going to start telling us things that we had no idea we were doing wrong. All of which, hopefully, will result in being able to do the procedure cheaper and better, getting better yields at every step, higher fertilization percentages, higher number of blasts, higher numbers of percentage that develop well because we change what we do during culturing, and better decisions.

So that'll result in higher pregnancy rates and cheaper implementation of the cycle itself. A real virtuous process. Problem is, there's so many things that we could work to optimize, that it's just to figure out which ones make a difference first. So what we've been doing is we've been choosing the stuff that's easiest to do.

Like, okay, we got 12 embryos in the dish. Let's train the system on the embryos and start matching up which ones get pregnant based on what they look. And so the solutions that are being find now may not be the ones that important, but there's the ones that in this early stage, I hesitate to say this embryonic stage of AI infertility.

It's sort of that really, really early auto assembly line in the 1920s. Let's say, okay, there are some things that we can just do easily. It may not make our outcome that much better, but let's just start checking them off. So, uh, that's, that's sort of where, where we are in terms of the, you know, what's being looked at now and where it can go.

[00:46:24] Griffin Jones:
How do these changes, particularly those in hormonal stimulation management, impact the pharmaceutical, the, the pharmaceutical manufacturers, the, the Drug volumes other than just ordering more of them because it ostensibly if you have a I doing the monitoring and they are doing 98 percent of what the area I used to and they can scale that volume that there be an increase in the use of pharmaceuticals, but are there other input?

Other implications that these changes will have on the pharmaceutical side? 

[00:47:02] Dr. David Sable:
Well, AI and drug development is a huge thing now. And we're trying to figure out what these same huge data crunchers, these mechanistic huge data crunchers, can tell drug developers about how molecules should be different. There may be a modification to the drug itself, or the drug's delivery itself.

Or, something that it picks up in the dynamics of when a dose changes, that can take that information, take it back to the drug developers, and they could do something different to their drugs to make them more effective. Or it may turn out that a combination of hormones that's been used rarely makes a big difference and We can package the drugs in a way that takes advantage of that.

So it's certainly, you're right, the most likely is great, cheaper, easier IVF, more drugs. Terrific for the pharmaceutical industry. But in so far as they're always looking for better versions of what they do or novel versions. All these data that we collect may make connections that just never occurred to us or never dawned on us.

We'll go back not to the way the cycle is managed, but to the way the drugs themselves are designed or manufactured, which would be enormous for the pharmaceutical companies. 

[00:48:26] Griffin Jones:
Are there specific features that we might expect to see because it like other than press release around Esri time that we're not that close to oral FSH, is there features that we should expect to see?

We have a An article that will probably come out before well before this episode airs just about some things happening in the pipeline, but what's of note Abigail? 

[00:48:52] Abigail Sirus:
Yeah, but maybe before we get to that topic, I just wanted to mention that there are there's a couple companies that are focused on the hormone stimulation and one.

Release paper last year that showed that they could potentially decrease the amount of drugs that were needed for a cycle. So you could maybe decrease the cost. And we know the average IVF cycle is expensive and out of reach for, for most patients today. So being able to decrease that cost could be a part of it.

And then it would be that kind of cost decrease, which would be obviously less sales or fewer sales for the Pharmaco, would hopefully be offset by more cycles being able to be done over time as the industry expands. 

[00:49:30] Griffin Jones:
Are we starting to see any features that might be, that we might see in drug development in the next year or so, or are any of them close enough to call?

[00:49:41] Abigail Sirus:
No. No. I think there are some exciting developments happening in drug development and IVF in general, but I haven't come across data to suggest that they were driven by any kind of age. 


[00:49:56] Griffin Jones:

Yeah. Okay. So let's, well, let's get into PGT because I have been in this field as a non clinician for nine years. And as a non clinician, it seems to me like the debate is still the same, Dr.

Gleicher's camp talking about PGT being overused and then other. Other folks saying that we might not be using PGT enough. Are we, is AI being used to break this stalemate yet? And if not, will and how it'd be. 

[00:50:33] Dr. David Sable:
Two areas. One is. You're right. AI at PGT has done too much and it's done not enough because we really haven't figured out who we should be doing it for.

That is a great AI challenge and we need a ton of data for the AI to tell us, to answer that question for us. So that's going to be, that is an ongoing issue. The other is making PGT better and the obvious thing there is using a mass data Processing AI system to help us figure out just to what extent we can do non invasive genetic assessment and other means of embryo assessment.

There are other things we can do without biopsy. It's, it's, it's got some encouraging data sets, but they're way too small to be anywhere near conclusive. AI should be able to answer both of those questions once the once enough data has been fed in. And once the AI here, really, particularly in non-invasive assessment, it's gotta be able to look at things that we don't.

So here we're doing a lot of mixing and matching of the data handling capabilities with things like new visualization tech. All these systems were based on light microscopy. And some rudimentary staining. And now they're based on more sequencing technology. So which also has its limitations. So we've got sequencing and we've got visual visualization of embryo characteristics.

So we let the AI systems digest all of that and tell them to tell us the stuff that we've missed. We've been probably been pretty good. about optimizing within the context of the limitations of the systems we have now. Then the AI systems are And you didn't notice the connection between this and that.

And if we start throwing all that stuff in, that's where the AI system is smarter than we are. And it's going to turn around and say, Okay, you can get all the information you want, the problems that you want to solve in terms of detecting implantability, ability to turn into a good, a good term pregnancy and genetics and disease prevention in ways that we're just not smart enough to do yet.

So the AI can do all that, but again, you're going to hate me for saying this, but we're way too early. 

[00:53:01] Griffin Jones:
For it to be clinically meaningful. I'm trying to salvage this with some, somebody that's, that's kicking butt. If I can, if I can think of an area where it might be happening in, in your other categories of your seven categories in other, you've got follicle, preterm birth, reproductive immunology, ovulation.

And is, is part of the reason that this is an other category is because that's where you have a lot of overlap. So in this category, you've got overlap with obstetrics and, and genetics and, and, and broader areas of women's health. And, and so are there things that are happening in this other category developments that are happening fast that we might expect to.

Be adopted in the fertility field fast because they are mature. They're in other areas and now they're starting to to take. on like wildfire in the fertility field. Is that happening at all in this other category? If not, tell me the damn reason why. And if, and if it is who, what's happening?

[00:54:02] Abigail Sirus:
Let me give you, first of all, it's, it's unfortunate about that.

Not that exciting. This other category in terms of why. And broken out separately. It's just that in this area, there are, um, typically just one or two companies working on each of these segments. So that's why I just kind of grouped them together just because they're not necessarily haven't reached the point where they need to be broken out on their own, like embryo assessment, which has the most.

On that topic. So that's not an exciting answer. However, what I will say is that there is a company working on, they're adding AI to a, that they're using a software system to look at follicle development, which is already being deployed in clinics. So I would actually put them at kind of a mature pilot stage.

So that is exciting. And they are, they are maybe farther along than I am. Uh, majority of other names on this, on this image specifically. So hopefully that's, that satiates you, Griffin, and we salvage it a little bit there. 

[00:54:58] Griffin Jones:

What are they doing? 

[00:55:01] Abigail Sirus:
They have a software solution that you could use while you're looking at follicles, obviously.

And they are using AI on top of it to help identify development and to make the process faster and more efficient along the way. 

[00:55:16] Dr. David Sable:
Griffin, for the part two of your question, the why has been so few things that reached the kind of clinical so what stage and in the other areas, women's health is really difficult that way, both fertility and women's health in general.

It goes back to the information we use medically. It used to be all pattern recognition, analog, it's like it's syndromes and yeah, diseases were defined globally or by organ. Now we're at a molecular and cellular level. The more molecular and cellular you are, the more usable data you can, you can plug into systems that will look at them digitally because the data is much more homogeneous.

Women's health is back with psychiatry and neurology in areas that are really difficult. to get reproducible quantitative data. You can't just stick a probe into the uterus during early pregnancy. And figure out what's going on and measure lots of stuff. And that filters all through women's health. Even the diagnoses we have.

A lot of them have the word syndrome attached to them. Syndrome is almost like the Latin word for we have no idea what's really going on. Just a bunch of observations and we make logical things that we try to do. But we really don't know. So, that shows up in a lot of the stuff that we try to develop.

Like, and we've talked earlier about in IVF, there's only so many things we know how to measure. There's a few hormone levels, there's a number of eggs, number of sperm, percent fertilization, percent to blast, genetics of the embryo, and whether you get pregnant or not. Now, when you try to engineer the system, and you try to intervene at different points along the way, whether it's selecting an embryo, whether it's...

The angle by which your ixy needle enters the egg, which eggs that you choose to fertilize and when, the change that you make on the sixth day of stimulation, you try to figure out what difference does that make in getting pregnant down the line, each of these things gets drowned by what we call confounders.

All these other things that are happening in an uncontrolled way along the cycle and it makes observing, making meaningful observations very, very difficult. And the data scientists tell me, it's like, yeah, you just need a data set big enough. to plot all that noise. Problem is in IVF, the data set is maximally, if we had every cycle in the world being analyzed maximally, still only 3 million, which isn't a lot.

If it's something in pregnancy, and you're trying to figure out, well, what should we be doing in that 11th week of pregnancy to avoid the chances you're going to have hypertensive disease in pregnancy in the third trimester, you're going to deliver early or something of that sort. Well, you've got... 130 million pregnancies worldwide, but you've got nine months of observations to lose the validity of that one intervention.

And women's health is just, it's one of the reasons, in addition to women being kind of discriminated against and women not being put into clinical trials, it's one of the reasons that the amount of investment into women's health. has been relatively low because it's damn hard to do. So when you asked before, say, well, why, why haven't we gotten there?

It's, I have no doubt we will get there and we need. Technology to take us that next, next mile on the backs of all the really great human artificial intelligence that we put together. But that's why in 2023, when I first saw my first AI company in IVF in 2018, we're still in that kind of early, it's like, it's like when the genome was elucidated around the turn of the century and three or four years later.

Who cares? Like what's come out of it? Well, now it's incredible what's come out of it, but we're in that kind of foundation building stage, like spring training, if you will, where we haven't gotten to the so what test and maybe two years from now, five years from now, seven years from now, it's going to be dizzying, all the benefits we're getting from all this, it's kind of frustrating and I can see from your point of view, you want some headline stuff for us, we want to be able to give it to you, but it's kind of all, it's all inside baseball.

[00:59:45] Griffin Jones:
But it still is a fitting sequel, even though I prepared for the wrong sequel to our previous conversation. It still is a successful sequel because the last time when we were discussing the four guiding principles for democratizing IVF, I wanted to know why, what, what's blocking us from this inflection point that we're Almost at you mentioned you started investing in AI in this space in 2018 2023 and the next two to seven years are going to be dizzying, similar to how no one had heard of chat GPT.

And then that became dizzying all overnight is barely hyperbole in terms of its. Release and recognition to the public. And I, I, I can see that we are so close to that point. I needed to go in specifically into each of these categories and find out what's preventing us from being that at that inflection point that we're almost certainly going to be at very soon.

And we did that today in detail. And I want to give each of you the opportunity to conclude of what we might expect to see as we march toward this inflection point in the next year or so.

[01:00:54] Abigail Sirus:
I think that it feels public sentiment talking about AI is at a fever pitch. It's almost a subsection of every news site you look at now, but we are still only in the early days.

And I know that that's frustrating, but for me personally, thinking about the future of IVF enabled by AI, We have one in six people are struggling with infertility. Only 2 percent of that population is actually getting the care they need. We have a massive... Massive match between supply and demand. And it's only going to be technology like AI and bringing those into the clinic, optimizing existing processes, making it more efficient that we can close to serving the number of patients who are struggling with this.

And so I'm really excited to see more of these, these proof of concepts emerge as pilots and these pilots start to gain traction. And we start to see results that are actually making an impact, whether it's on the time to baby, the cost to baby. or on cycle outcomes as well. So still early days, but definitely lots to be excited.

[01:02:00] Dr. David Sable:
Griffin, what I'm most excited about is AI is going to catalyze the trying of new delivery methods, cutting up the cycle and disaggregating the cycle away from the big box, enormous lab, trying to find ways to pull in that 90 percent of people that aren't even in the arena yet that want to be, whether it's by Cost efficiencies or just setting up prototype programs that treat people for much less expensively and discover things that result in operational efficiencies.

I think it's going to be a little ways until we start seeing specific techniques that result in. higher pregnancy rates, only because pregnancy rate, by the time you get to the pregnancy rate, again, the data of teasing out the influence of one thing. But I think that it's going to show up first in the ability to deliver IVF cycles of one type or another to a lot more people than we do now.

And I think that's in a way that just as exciting as getting higher pregnancy rates, which will virtuously happen faster. The more people we get into these systems. So, I think let's look for operational efficiencies, let's look for people opening clinics, whether it's people outside the field or whether it's the big networks saying, look, there's other ways to do this and there's lots more people we can help.

Let's start going after that as well. I think it's a great facilitator for lots of areas of one degree of separation, uh, from the pure tech part innovation. 

[01:03:39] Griffin Jones:
Abigail Sirus and David Sable, you're like the Star Wars or the Marvel franchises to my sequels in that we'll just keep making them forever and people will keep eating it up.

I look forward to having you both back on. 

[01:03:51] Dr. David Sable:
Looking forward to coming back. Thank you. 

[01:03:54] Sponsor:
This episode was brought to you by LEVY Health. Seeing more patients for a first consultation may actually decrease IVF revenue by 30 to 40%. To see why download the numbers for free at levy.health/conversion. That's levy.health/conversion

Announcer:
Today's advertiser helped make the production and delivery of this episode possible for free to you, but the themes expressed by the guests do not necessarily reflect the views of inside reproductive health, nor of the advertiser. The advertiser does not have editorial control over the content of this episode and the guest's appearance is not an endorsement of the advertiser.

Thank you for listening to Inside Reproductive Health.

200 The New Standard of Care for PGT-A and Preventing Catastrophic Gamete Swaps Featuring Dr. Peter Klatsky and Chelsea Leonard

DISCLAIMER: Today’s episode is paid content from our feature sponsor, who helps Inside Reproductive Health to deliver information for free, to you! Here, the Advertiser has editorial control. Feature sponsorship is not an endorsement, and does not necessarily reflect the views of Inside Reproductive Health.

Dr. Klatsky’s opinions are his own. He receives an honorarium from CooperSurgical for his time and expertise.


I always recommend parental DNA checking. Parental QC provides important protection for everyone, both patients and clinicians” – Dr. Peter Klatsky

Dr. Peter Klatsky, Co-Founder of Spring Fertility, provides harrowing examples of catastrophic close calls with gamete swaps, prevented only with the help of the latest advanced technology in PGT-A. Dr. Klatsky is joined by Chelsea Leonard, Clinical Science Specialist at CooperSurgical®, as she walks us through the current and future developments of PGT and its place in helping to maximize patient success while minimizing risk of irreversible harm.

Ms. Leonard and Dr. Klatsky dive into:

  • Developments in PGT-A testing that are critical to help avoid gamete swap

  • Real life examples of where and how PGT discovered DNA mismatches (Helping reduce legal and ethical liabilities)

  • The technology behind a new test called PGT-Complete (And its impact on the origin of aneuploidy)

  • AI’s place in PGT Testing (The new possibilities in scaling and learning)

Why tests like CooperSurgical’s PGT-Complete℠ Tests are necessary to help avoid gamete swapping catastrophes (And how they might protect those providing fertility treatment)


CooperSurgical
Dr. Peter Klatsky’s
LinkedIn
Chelsea Leonard’s
LinkedIn

Transcript

Dr. Peter Klatsky: [00:00:00]
100 percent of your patients, 100 percent of, I'll speak in the first person, 100 percent of my patients, whether they articulate it or not, have in the back of their head the day of their egg retrieval, don't mix up my eggs. I'm giving you my eggs, I'm giving you my sperm. How do I know that those are going to meet?

And it's a massive degree of trust that your patients send you and place in you. 

Sponsor:
This episode was made possible by our feature sponsor, CooperSurgical®. Download CooperSurgical’s brand new PGT-A Clinician's Reference Tool, an indispensable guide for clinicians like you to unlock the full potential of genomic treatment, by clicking the button below.

Announcer:
Today's episode is paid content from our feature sponsor, who helps Inside Reproductive Health to deliver information for free to you. Here, the advertiser has editorial control. Feature sponsorship is not an endorsement and does not necessarily reflect the views of Inside Reproductive Health. 

Dr. Klatsky 's opinions are his own. He receives an honorarium from CooperSurgical® for his time and expertise.

Griffin Jones:
You've got to hear this story because I think people are going to be talking about this at ASRM and other conferences. The whole time he's mentioning this example, I'm thinking it's a hypothetical. Come to find out, this was an incident that actually happened at gamete swap. But they caught it and that's at the root of my conversation today with Dr. Peter Klatsky, who, you know, as the co-founder of Spring Fertility, fast growing bi coastal group in New York and the Bay Area growing beyond. And Chelsea Leonard, she's a Clinical Science Specialist, a genetic counselor at CooperSurgical®, and she has some really keen insights. On the development of PGT-A developments that have implications that are critical for preventing some of the potential catastrophes like the one Dr. Klatsky talks about. We talk about because I was curious, why is PGT one of those things that you all really seem to care who you partner with for that other categories? You'll pick any random vendor, but it seems to be very important to you who you choose for PGT. So I want to know why that's the case.

Dr. Klatsky shares his view. We didn't cover an inflection point that happened around 2018 with PGT, particularly at Cooper. I asked Chelsea to reveal some of that. You can't get enough AI content, it seems, but we've never talked about how AI can be used for PGT, specifically PGT-A tests. Chelsea talks about the scale and the learning that the AI technology has that simply wasn't possible before.

And I asked her to let us under the hood a little bit about what's happening at Cooper. She talks about that technology and specifically the technology behind a test called PGT-Complete℠. That test, PGT-Complete℠, ends up becoming central in the conversation because we talk about how it impacts the origin of aneuploidy, how it changes the philosophy about discarding or keeping abnormally fertilized oocytes. [00:03:00] 

And we talk about how this test raises the standard of care and has almost an incalculable benefit to the clinic and to the business because of its critical use for parental quality control. That has to do with the story that Dr. Klatsky tells. Have you ever heard of someone deliberately bringing someone else's sperm to the fertility clinic?

I hadn't I thought Peter was talking about something hypothetical. But keep on listening in the conversation and you'll find this was something that actually happened at Spring Fertility that would have been awful for them and awful for everybody involved, but they caught it. And they talk about how tests like PGT-Complete℠ are necessary for having that level of quality assurance, ensuring parental quality control, preventing gamete swap catastrophes.

And yes, they are catastrophes and how they critically raise the standard of care and protect you as someone who provides fertility treatments or who pays for those who provide fertility treatment. You can look for Dr. Klatsky and Chelsea and certainly the rest of the Cooper team at their booth at ASRM. [00:04:00] 

Tell them they did a great job putting up with this host and they can tell you more about it and you can get more information by visiting Coopersurgical.com, by clicking on the page that's associated with this podcast episode that will take you right there. Enjoy this conversation with Dr. Peter Klatsky and Chelsea Leonard.

Ms. Leonard, Chelsea, welcome to the Inside Reproductive Health podcast. Dr. Klatsky, Peter, welcome back to the Inside Reproductive Health podcast. 


Chelsea Leonard:
Hi there. 

Dr. Peter Klatsky:
Thanks Griffin. It's a pleasure to be here. 

Griffin Jones:
I'm in a fun spot where I get to talk to a scientist and geneticist and an REI physician about PGT and I want to talk about what Cooper's got going on. I have a premise to start with Peter, which is as I talk to docs, I'm just always curious about why do they buy things? Why do they choose certain things? Why do they hire people? Why do they partner with certain people? And there are certain categories of goods and services that they really care about who they partner with and then other categories that they don't.

Sometimes it's like, that's just a commodity. We can use any vendor for that and then there are things that they really care about who they partner with and PGT-A is almost always one of those things that they really care about who they partner with for PGT-A. 

So the first question is, Is that correct? Is PGT-A in that camp of who they really care they partner with?

And if it is correct, why is that the case? 

Dr. Peter Klatsky:
Absolutely. It is one of the most important decisions we make in a lab, that also where we get media and what reagents we use. We, patients trust in us and we take that trust and that confidence very seriously. If we are going to send four cells, a sample of four cells, five cells out for analysis, that's on us later on.

If we are trying, if we get inaccurate results, if we get a high no call rate or if we are potentially throwing and discarding good embryos, potentially viable embryos, all of that will hit our patients, lower their success rates, and in turn, lower their confidence in us. So similarly, the ability to accurately call diagnosed embryos will make us appear better to our patients and ultimately deliver better results. So once we send that sample out, we are really relying on our partners to deliver accurate and complete results. 

Griffin Jones:
What makes a good partner then? Like, why does it matter who you choose? I get the gravity of PGT-A, but what's the difference in the type of people that could provide what makes someone really good at that. You feel trusting them with that. 

Dr. Peter Klatsky:
Well, I, first of all, I love that you said partner, right? Because whoever you're working with, with PGT, they have to be a trusted partner. It's not a vendor relationship because it's not a commodity. So a good partner is somebody who's going to, with regard to PGT, is get us the most accurate results first. [00:07:00]

And that means the lowest false positive rate. A low no call rate, but who's going to have a really high level of professional confidence and professional professionalism and accuracy and who's going to be your partner if something happens and I don't know any PGT companies that haven't experienced a case or cases where there's a high no call rate.

Or something happens in the amplification and we expect our partners to continue to be our partners and not try to throw the clinic under the bus. Oh, something happened in the lab versus something happened in the center. We want to investigate it. We want to explore it together and when you have a high priority situation like that, you really want their attention.

And occasionally there's cases where you need a result quicker or there's some specific peculiarities about it and you want a partner who's going to listen to your clinic's needs. And who's going to be responsive to those, both on individual case and as you grow together, I would also say that the field is so rapidly advancing. 

The technology that we're using today for PGT-A is not the same technology. It's not the same platform that we were using four years ago. And frankly, I would bet that within 12 to 18 months, the entire field is using a different platform, a whole different template procedure to analyze embryos. So, also in choosing that partner, you want to choose a long term partner who's going to have the resources to be at the bleeding edge of the field, but not advance that technology, not advance that science until it's been adequately tested, validated, so that your patients are getting accurate results. 

Griffin Jones:

I want to talk about that progress that's happened in the last four years. So it's not even the same platform that was used four or five years ago. Chelsea, our audience probably has a general idea of the history of PGT, you know, at a high level, but to what Peter's talking about.

The dramatic changes that have happened in the last four or five years. What are those and what's been happening at Cooper during that time? 

Chelsea Leonard:
Yeah, so I think it's always really incredible when we reflect on that history. Like you said, Griffin, even in the last couple of years, Cooper came out with what we call  PGTai®. 

AI standing for, of course, artificial intelligence and its first iteration in 2018, where we moved away from what we would consider totally subjective interpretation, where you have a human technician looking at a next generation sequencing profile, all of the blips along every chromosome, making decisions.

 [00:10:00] Is this noise? Is this aneuploidy? Somewhere in between mosaicism, what am I looking at? So removing that potential for error with that subjective component and really making calls based on big data with all of the embryos, thousands at this point where we have made a classification, seen an outcome and fed that back into the algorithm.

And as Dr. Klatsky said, really important that we have confidence in our calls and we're doing that based on big data. 

Griffin Jones: Tell us more about how the AI works. There's been a lot of hot topics on our show in the field recently. The episode that I did with Dr. Gada and Manish Chadwa about chat GPT was like a really popular episode.

And we talked about the different applications that AI might have a virtual Dr. Klatsky in a couple of years that people are seeing on there, but we didn't really talk about how AI specifically applied to PGT. So tell us about how AI is specifically being applied to PGT. [00:11:00] 

Chelsea Leonard:
Yeah, so I know that AI is a really hot topic and not all forms of AI, even in the context of PGT, are equal, right?

But I like to think about it when I'm explaining PGTai on an individual basis with clinicians is that human technician that would be making a call on an NGS profile, may have years of experience, be highly qualified and trained, but that person doesn't ever get to know the outcome of an embryo they classified, right?

They don't know what happened. Did that embryo implant then miscarry? Did it result in a healthy live birth? The difference with AI is we have a classification, an outcome, and all of that data can then be fed back into how we decide on and classify embryos with with future patients. It's not continuous learning, so we don't let it run wild, but it's important that that data is being fed back into how we make those future decisions and how the platform continues to improve.[00:12:00] 

Griffin Jones:
This might be elementary for a lot of the audience, but then how are human clinicians getting, how are they advancing their knowledge of what worked? Are they basically having to look at retrospective data in cohorts afterwards? And how does this compare to what the AI is doing? 

Chelsea Leonard:
Yeah. Are you talking about the subjective interpretation approach?

Griffin Jones:
So if the human clinician doesn't actually get to know, like, the, what happened afterwards, then how are they learning about what's working? Are they just looking at retrospective data in cohorts after where the machine is learning about specific cases and what happened in specific cases? 

Chelsea Leonard:
Yeah. So I, of course, Cooper doesn't use that approach at this point, but I would imagine to your, to your point, you know, there, I'm sure there are training sets and comparison between technicians to make sure they would make the same call on the same sample, but that's not big data, right. And we can't learn from nearly as many embryos nearly as quickly when we compare against AI. [00:13:00]

Griffin Jones:
So you've got big data happening for, at a scale that isn't been the case for when we were calling it PGD and PGS years ago. How did this start to unfold in 2018, 2019? What did that timeline look like at your company?

Chelsea Leonard:
Yeah, so I think one of the things that many of the listeners may recall if, if they were in the field in the last five, six years is Cooper Genomics formed from several legacy genomics companies and at that time, when all of those laboratories were coming together and standardizing protocols amongst themselves, it was realized that technicians at each laboratory, whether within a single location or across, were sometimes making different calls on, on the same or similar samples, right, using different approaches and so it was realized at that stage, as the labs were coming together, that this subjective interpretation component was really a problem because again, we want to have confidence in the call we're making for embryos. [00:14:00] 

So at that point, Cooper decided to invest in this AI approach that we've continued to iterate on and lots more to share about that in the coming discussion. 

Griffin Jones:
And Peter, can you tell us about like what's happening with case studies during this time that you talked about the emphasis of you have to be able to innovate but only after there's a substantial amount of evidence to support it.

Can you tell us about the case studies of what's gone on in the last few years? 

Dr. Peter Klatsky:
Yeah, or not case studies, but clinical trials really, where they compare the outcomes and the calls and how often are they different and how would they be different? And you know, so anytime you're applying AI, I think best practice is to do so with clinical oversight, human oversight, for a long time, and I believe Cooper did that for several thousand cases prior to writing it. [00:15:00] 

So what if, you know, I, I'm a quote, believer slash somebody who fears the implications of AI long term. So there are benefits, there are social challenges with it that are going to be dramatic, but I think whenever you're introducing new technology, you need to validate it, and you need to validate it.

Not, you know, in a small case series with a hundred people, but rather, you know, series of thousands and thousands of hundreds. 

Chelsea Leonard:
And Dr. Klatsky, I think that's such an important point because the validation as, as we've talked about so far, this is based on actual. embryos, embryos that have resulted in an outcome that's been tracked rather than cell lines, for example, which might not be the best representation of, of what we're doing with PGT.[00:16:00]

So real embryos, real outcomes. 

Griffin Jones:
Peter, can you give me an idea of like what the significance of the scale is introducing this new technology, because it seemed to me like PGT has always been a powerful tool. I'm a complete lay person, not a clinician. I'm not a scientist. And it seems like whenever you have a powerful tool, it's going to be more important in certain cases than in others.

And the more data you have, the more scale you have, the better you're going to have for fine tuning exactly which implications and which uses maximize them. So, can you give me an idea of, of how much of scale is a game changer with having the technology of AI behind it? 

Dr. Peter Klatsky:
I'm not the best person to speak to that.

I think somebody at Cooper or one of the other genetics companies are, cause they know how much time it takes for somebody to look at the data point, the key point for the audience to recognize is when you're currently testing an embryo, you're getting read lengths of one of those chromosomes that you're testing that are only about 70 base pairs long and, you know, 75 to 150 base pairs.[00:17:00]

That's the current generation of, if you're, if you're doing it through sequencing, if you are, you know, and then you get a area that may be five to 10, 000 base pairs with no reads. And, and now you've got a chromosome that's a hundred million bases long, right? So you can get enough, and I always talk about it as Shazam for embryos, like you get enough, you know, snips of that song, you know, okay, that song is present, and here's the number of times that's present.

And so when people are looking at it, they're looking at how many hits are in chromosome seven, how many hits are in chromosome eight, how many hits are in chromosome nine. And they're using that to judge how many copies of that DNA, and if there's twice as many hits on chromosome seven as there are on chromosome eight.

And then chromosome seven and chromosome eight have the same length. Then someone's going to interpret, well, chromosome seven, there must be twice as many copies of that chromosome than there are of chromosome eight. And that's how this is done. And sometimes when you look at the reports and you know, in those heat maps, it's super clear and a monkey could do this.[00:18:00] 

And then sometimes, it’s ambiguous, so the AI probably gives that human interpreter more confidence, um, potentially, you know, does it help in the workflow? Um, as increasing numbers of people are using AI should, and you know, and where I think it probably helps is on those edge cases where, where they're developing confidence intervals and where they are constantly learning.

But as far as like, does it improve flow? Does it improve ability to scale? That's a question I'd leave to the Cooper, Natera, genomics, you know, all the other, you know, to the companies that are delivering this service. 

Griffin Jones:
Chelsea, can you expand on that a little bit? 

Chelsea Leonard:
Yeah, I think a little just to say it, it does, right, but I think At least in my clinical conversations with providers, we really focus on not so much how it improves the workflow in a practical sense on our side, but what it means in terms of confidence for those cases that Dr.

Klatsky mentioned, right? If, if we have a noisy sample that we're not over calling that as aneuploidy, if we're seeing blips across multiple chromosomes, but that sample may in fact be noisy and is either euploider or no result as an example. So in those cases, it's critical for us. [00:19:00]

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Griffin Jones:
Tell us about how this impacts parental quality controls from the business development seat that I sit in the public relations seat that I sit in whenever I see a case of someone got the wrong embryo or or something happened, not having necessarily to do with genetics testing, but just any case like that, I, you know, anything happening with down the road in chain of custody, I think, wow, that's, that's a big area for concern. [00:22:00]

So are there implications here for improving parental QC? 

Chelsea Leonard:
Yeah, so from our end, one of the things that we've been excited about what we've sort of built on in the last year or so is our newer test PGT-Complete℠ that is built off of PGTai. So our, our standard PGT-A test, but with the addition of parental buccal swabs. And in those buccal or cheek swabs, we're looking at SNPs, single nucleotide polymorphisms and comparing those genetic markers from the egg and sperm provider to what we're seeing in the embryo and with that, we're able to do a couple things. One of those is parental QC. Helps us confirm that we have a match between the egg and sperm provider and the embryo sample that was submitted to us.[00:23:00] 

The other components that I'll share very briefly that I'm sure we'll get into later are what we call genetic PN check where we can confirm at a genetic level that normal fertilization has happened. That we have not only two copies of every chromosome, a euploid sample, but that one copy came from each side, the egg and sperm, and also origin of aneuploidy.

We know that that information is important to patients and to providers as they make future treatment decisions. 

Griffin Jones:
Peter, how important is that as a clinician to and how different is that from what previous technology it offered? 

Dr. Peter Klatsky:
Anytime you can make a technology safer, I think we should. Anytime you can provide reassurance to a patient, I think we should. And, you know, in parental QC or parental DNA matching and confirmation PGT a hundred percent of your patients, a hundred percent, I'll speak in the first person, a hundred percent of my patients, whether they articulated or not, have in the back of their head the day of their egg retrieval, don't mix up my eggs. I'm giving you my eggs, I'm giving you my sperm, how do I know that those are going to meet?[00:24:00]

And it's a massive degree of trust. That your patient sends you and, and placing you and, and as the provider, I am not present when the sperm and egg are being fertilized and we are not present at every step in this, in this equation. We make sure at Spring, we 100 percent of the time, we have two people signing off on every transition of every gamete.

[00:25:00] That's what I tell everybody. And, and we never sacrifice on that and no matter what somebody is doing, you have to stop, get a second eyeball. Right? And without that, you can't be sure. Your patient has to trust you on that, and they do, and, you know, having that other layer of backup of saying, hey, by the way, we took a cheek swab before this, we, we have a copy of your DNA, and, and just when we ran that, that, that embryo result, oh, we have a little check mark, yep, it was your DNA.

That reassurance to your patient. It is well worth the extra time in this whole process where we're making people go through multiple blood tests, right, to see how your estradiol is changing, how, you know, is your progesterone fluctuating, go through multiple ultrasound things to get that, you know, reassurance on egg quality.

Why wouldn't we just make sure that that embryo corresponds to the embryo that was tested? 

Griffin Jones:
I had heard of a gamete swap case recently. I wasn't familiar with that case study. Are you familiar with that, Peter? [00:26:00] 

Dr. Peter Klatsky: 
No, I'm not. Well, no, I, so one, you know, there are these crazy stories that you hear about on the Today Show, Good Morning America, that are devastating for families and then, you know, you hear about cases in the back, you know, round of people who, at age three, their child, they're devastated by the fact that their child develops leukemia. And they're trying to see if they can give a bone marrow transplant to their kids. In this one case, you know, high profile lawsuit where the parents then found out while their child's going through chemotherapy that not only was the, the father not an HLA match, but, but it wasn't his sperm.

I can't even fathom what that must be like for that family and for that clinic. And, you know, fortunately, every case I've ever heard of that happening, there were not two people witnessing every transfer of every gamete. So I want to, so I always want to reassure patients that to date, at least to my knowledge, there's never been a gamete mix up with double identification at each step.[00:27:00] 

Every single one of those cases that I'm aware of, one embryologist working that day. You know, and, and, and didn't have double sign offs. So, to my colleagues and peers out there, like just let's make sure we all take that really seriously to sign offs, two names, two eyeballs every time and not signing it, but really looking at it.

Our lab director enforces that in our lab takes that very seriously. The other part about this is one that one has trouble contemplating when you have high profile cases like that. That are going on Good Morning America, Today Show, and there's lawsuits that one can't even begin to contemplate what the settlement amount is.

[00:28:00] One could also contemplate that somebody, a bad actor or somebody for other reasons, might decide to misrepresent fraudulently a relationship and have somebody else provide sperm in place of their, their partner. So, so the way this could work out is that if I were a three parties, right. And, and there's my intimate partner who I want to have a child with, but maybe for other reasons, I married somebody else, whether they have to do with whatever reason, right. And so you have a legal arrangement with a marriage with one person. And, and maybe the, the intimacy has changed. And there's a third party who's really the, the, the long term life partner for, for that patient. Um, now that person could go into a fertility clinic, um, take Shady Grove, right?

They're a very big clinic with deep pockets and, and, and they could. present themselves as two people, man and a woman, who want to have a baby together and they end up doing IVF and they want to do PGT and they go through the process and the day of the egg retrieval, the husband brings in the other intimate, the true intimate partner's sperm source, right? [00:29:00] 

And, you know, sperm production remains a private act without two people identifying the actual sperm production. And it's not that hard to, you know, bring in a cup with somebody else's sperm. And then that sperm is handed off to the embryologist who confirms the identity of the person who came out of the sperm production room, but it may not be his sperm.

And if you do at home sperm production, then it's just, you're trusting the husband is handing off his sperm. And you would never know about that, right? The only way you can know about that before transferring embryos, so let's play this out, if you didn't do parental source DNA, you'd then transfer an embryo, lose somebody else's DNA, and then that family, six months later, says we have a baby and we did a 23andMe cheek swab, and it says my husband is not the genetic parent of this baby, but we went to your fertility clinic. [00:30:00] 

Jaw drop, right? You're in a really a world of hurt. And if you don't genetically type everybody and make sure that that embryo's coming from the sperm and, and egg. And in that case, that fertility clinic might have done everything right.

And…You know, yet, what would be your, your next steps, right? I, I would want to QA everything, make sure that everybody signed off, that we, and you'd look at chain of custody with a sperm and you'd see there were no errors on your side. And yet you're looking at a baby and his ostensible two parents and there's not a genetic ID.

So, so just, there's like a pause thing. Okay, now what's your next step? Right? And, and, and your next step is, well, how, if this baby's not using this husband's sperm, who gave us the sperm, where could an error have gone off? And so, in that moment [00:31:00]

Griffin Jones:
Okay, Peter, now that you've scared the crap out of everybody, I actually, I actually do think this is worth digging into, because these are, these incidents do happen from time to time and they can be career ending. They can be reputation tarnishing. They can be, they're beyond traumatic for the families that are involved. So I do think that this is a point that is worth digging into more. And I also think that things that start off as new features or new tools, sometimes quickly become the standard they're established.

I feel like it could be something like five or 10 years from now, we're saying like, oh, remember back when Cooper started doing this? Remember back when they were calling it PGT-Complete and now it's like, and, and so it's like, it, it's something thar you know, is, is starting now. That might become the standard of care in short order. [00:32:00]

Chelsea, can you talk a bit more about how it works at, at a technical level to prevent the types of situations that Peter's talking about? 

Chelsea Leonard:
Yeah, absolutely. I think. Really, really what we're talking about here is with those parental buccal or cheek swabs that are collected before or at the time of the egg retrieval, you know, when we can and get patient and partner to provide an easy sample, we are using the SNP or single nucleotide polymorphism data from.

And it becomes very apparent when you're looking at all of those genetic markers for those three parties, if there is a match or a non match. I think it's also important for listeners to understand that a non match could occur for a variety of reasons. For example, contamination, maternal cell contamination is another thing that we think about in these examples where we're seeing only SNP representation from the maternal side.[00:33:00]

In the sample, and that's another situation where we could end up with a false result for an embryo, even if we've done everything right in the laboratory, because we'd be picking up euploid or normal female just from the maternal cells and underneath the surface, that embryo could be male, could be abnormal.

We could have any number of scenarios. And if we didn't have those parental swabs, then we may not know that until after a transfer. So lots of different things that we can detect in addition to gamete switches.

Griffin Jones:
I want to talk a bit about aneuploidy as well. It's something that I have very little understanding of. It's something that I hear you all talking about all the time. And it's. And so I hear about it being associated with maternal factors, but I also hear that that's not always the case. It sounds like this test is able to determine where aneuploidies come from. Can you each talk more about that? [00:34:00] 

Chelsea Leonard:
Yeah, I think I can jump in and just start that conversation by saying, you know, we, we often think of aneuploidy primarily in that maternal context.

Right. We know that aneuploidy rates increased with maternal age and that most of the aneuploidy and most cycles is maternally derived. Right. So for an example, if there's an extra copy of a chromosome in an embryo, most of the time that may have come from the maternal side, but not 100 percent of the time.

[00:35:00] We know that about 90 percent of whole chromosome aneuploidy is maternally derived. On average, but about 70 percent of segmental aneuploidy, where just a part of a chromosome is impacted is paternally derived based on recent studies. So we've all had those cases where we get a PGT report back for a patient and there's aneuploidy across embryos and it's unexpected based on maternal age. Something's not really making sense. I think we're realizing more and more that at least in some of those cases, it's the sperm that's creating that result. 

Dr. Peter Klatsky:
And if it's the sperm, is it accurate? 

Griffin Jones:
Tell me about that, Peter. 

Dr. Peter Klatsky:
Chelsea made a really good point. When you look at the studies on just mono, uh, monochromosome aneuploidy, so single whole chromosome aneuploidy, you will see most studies looking at that. We'll find rates that I think Chelsea now correct me if I'm wrong, but around seven to 8 percent paternal whole chromosome derived aneuploidies, uh, and maybe depending on the platform, it may be higher, but, but, but I've seen data as much as 6 percent whole chromosome.[00:36:00] 

So then just talk about your, your, the test PGT. It's not perfect. It may, it has false positives. Does not matter whose platform you're using. Every patient should recognize that there is, there are mitotic errors and mitotic errors are going to happen and that's going to lead to the ability to sample an embryo and and have discordant trophectoderm and inner cell mass.

So, so if you recognize that this is a good test but a good test means there's a four to five percent false positive ratio. Every single one of my patients getting this test knows that. Every single one of my patients says no matter what platform I'm using we are going to throw away We are going to discard some potentially good embryos.

[00:37:00] And that's a cost of the test. It's a cost of the improved accuracy, the lower number of embryos to transfer. And that's a limitation. It's not a platform limitation. It's a biologic limitation. Unless you believe there's no mitotic errors, which I don't think anybody believes. And so a mitotic error, Griffin, is as the embryo is growing, cells divide and have errors.

Right. And so you can be sampling up so that, so then the embryo is a true mosaic and the area outside is going to become the placenta may have errors. You biopsy that, that embryo is called abnormal. And then the inner cell mass, if you were to re biopsy, destroy the embryo, you'd find more normal. And in the studies looking at that range from about 3.5 to 5%, and that's what I, what I tell patients. Now, there's a really nice non selection study where they transferred 104 abnormal embryos and not one live birth. So that's reassuring. But if they'd transferred a thousand embryos, I would bet you'd find about 20 live births. So about 2%. That's my guess based on my understanding of the false positive rate.

So now say you're 44 and you've been at IVF for six attempts and you've been fortunate enough since you were 43 and 44 and been able to make a lot of embryos. And in one of those embryos, you find out that the only chromosomal abnormality was parental, paternal DNA. Is it possible that that's your false positive? [00:38:00]

Well, if you look at sperm DNA studies... Right. Looking at individual sperm from sperm donors, what they find is about 98, 99 percent of individual sperm are, are you not, you put it, but haploid and have one copy of each chromosome present. So they have 23 chromosomes, each one copy of each chromosome in 98 to 99 percent of sperm.

And there's a nice study out of China looking over 20, I think it was like over 20,000 sperm samples and so that's a pretty low error rate, one to 2%. And now if you're looking at clinical studies saying, Hey, we're seeing 6% whole chromosome abnormalities that only come from the sperm, but we know that most sperm, maybe it's 2%. [00:39:00] 

And if you were to find that difference, what, 4% is the difference? Isn't that the false positive rate in the test itself? So, so could we take a patient well counseled, maybe under a research protocol to say, if you have a whole chromosome abnormality, nobody's doing this yet, by the way, this is like, like just forward looking for that rare patient who, who's so hard and only has one, and it's one of like 20 chromosomes.

And if you don't think this exists, like it's personal to me because like I know a patient's name who's like this and we got tons of embryos and we couldn't get a euploid embryo. There's one aneuploid embryo that only had parental, paternal only error and I'm looking at the studies showing that, well, paternal only aneuploidy of embryos about 6% sperm DNA about one to 2%. And then most of those other studies are showing that four to 5% false positive rate. 

[00:40:00] So does that mean that for that embryo, there's a two-thirds chance that, that that was actually one of the false positives. And if it was a two-thirds chance, we're looking, you know, so there's a 66% chance that this is actually a euploid embryo and that's a mitotic error.

And if you were to sample the inner cell mass, and, and if you knew that, then you could transfer that embryo. You wouldn't give her a 65% live birth rate, but you might give her a 35% live birth rate. with their own DNA. So I'm getting a little bit into the weeds here, but like these are ways in the future with further studies.

I've always wanted to do that study looking at well counseled patients with a paternal only whole chromosome aneuploidy. Obviously not chromosome 13, not chromosome 18, 21, but something that's not compatible with life and transfer them. And, and you might find similar to the segmental aneuploid studies.

[00:41:00] Julia Kim did a great study during her fellowship looking at segmental aneuploidies and not finding a difference in, in outcome when you transfer those. So, you know, as we refine our thinking about how to use this technology, you know, we talk a lot about the platform, but I'd almost argue that as important as choosing a platform is understanding the underlying science and the limitations across all platforms.

Griffin Jones:
Are these the same as AFOs, Peter, because I hear, I hear abnormally fertilized oocytes, but is this the same thing that you're talking about? 

Dr. Peter Klatsky:
It is a bit different. So this is more of, as an embryo is dividing, say it's going from four to eight cells, does one of those four cells have an error in that mitotic error?

And then is there, you know, and so now you've got two out of six cells that are abnormal, but they keep dividing and and some people would argue that well those abnormal cells won't divide as well And so it's lower chances But we know that there is not a hundred percent concordance between the trophectoderm which we biopsy and the inner cell mass Anybody who says differently has not read a scientific paper on this, right?And so it doesn't mean you throw the baby out with the bathwater, right? [00:42:00] 

Like, it doesn't mean you say, you say, okay, the test is no good, right? There, you know, the folks who are anti PGT, it's inaccurate, it's got false positives. I say, yeah, you're right. And I still do it over 95 percent of my cases. I counsel the patient, here's the limitation, but the ultimate benefits of the test, lower miscarriage rate, higher single embryo transfer, you know, we do a hundred percent single embryo transfers when you have a euploid embryo, but I don't kid myself that there's not an error rate.

So, so I talk too much. Sorry, Griffin. Back to your question of like, how does identifying the parental source of the aneuploidy make a difference. One, it provides a reassurance to the patient that their DNA were used, in fact. Two, it addresses the issue that Chelsea mentioned that maybe it didn't fertilize and maybe you've got two copies of maternal only DNA that you wouldn't otherwise know and then, or maternal cell contamination. [00:43:00]

And then three, if there's a really smart fellow with a great REI division director and program that wants to do this study and, and, and we'll collaborate with you at Spring Fertility because, because, you know, we all want to participate in those studies too.

I would love to understand when you have paternal only errors. If there's viability to those embryos, if that's a marker of a possible false positive and mitotic error. And if that were true, then you, that could be a way to pick up about half of those mitotic errors. 

Griffin Jones:
So AFO is being something different than it's a, it's a different category.

Chelsea, can you talk a bit about, have you seen changes in philosophy in terms of whether you discard those evos, whether you keep them, what's, what's happening in that landscape? 

Chelsea Leonard:
Yeah, I would love to, before I just have one additional thought to, to tack on to what Dr. Klotsky was describing with origin of aneuploidy.[00:44:00] 

Which is when I go into clinics and talk with providers about that feature of the testing, you know, oftentimes the provider will share. There's that case that they recall where a patient had persistently high aneuploidy in their embryos across cycles, and that patient was transitioned over to egg donor.

And in that cycle, after utilizing an egg donor, there was still unfortunately a high rate of aneuploidy. And at that point, the provider considered maybe it was. the sperm that was contributing in that particular case. And typically providers can think of a case, maybe a handful of cases where that was the situation where we realized after shifting to egg donor that it may have been the sperm that was contributing.

[00:45:00] And so I think for that reason also origin of aneuploidy information, especially before we consider transitioning a patient over to a gamete donor, making sure that we're going in the right direction. And sometimes it could be the sperm. But the area of, of AFOs or abnormally fertilized oocytes, I think is really exciting and love chatting with colleagues in the laboratory about this because there's that step that occurs after the egg and sperm meet.

I love that phrase that Dr. Klatsky used where we want to make sure that fertilization has occurred, right? So the embryologist is looking under the microscope for, uh, the pronuclei in the Petri dish to make sure that we are seeing what would represent a copy of chromosomes from both sides, the egg and the sperm fertilization has taken place and we have an embryo starting to develop.

[00:46:00] We know though that that's not a perfect science and there are laboratories that may look under the microscope at a single time point to try to visualize those pronuclei. Maybe they're faint, they're stacked, it's hard to see quite what we're looking at. And that call that the embryology just makes, for example, this embryo has one pronucleus or has two pronuclei.

Oftentimes that's then a decision made on whether to discard that sample or attempt to keep growing it out to the blasts stage. What we have found is that there are laboratories that are shifting their protocols on that slightly, where they will hold on to what we would call those abnormally fertilized oocytes, try to continue to grow them out to that blastocyst stage and biopsy them for testing.

And from the studies that have come out to date, there are what I would consider a meaningful, significant amount of those AFOs that continue to develop. And when we biopsy them, They turn out to be euploid and not just euploid, meaning two copies of every chromosome, but with proper representation from both sides, egg and sperm.

[00:47:00] The implication of that is that this is an embryo that may have been discarded based on that visual check that can now be considered for transfer. And that's so important for patients, especially those that have few options in the process. 

Griffin Jones:
Peter, in your view, is this going to become part of the standard of care?

Because I just go back to the what used to be nice to haves become must haves, what used to be a feature or tool or, or then becomes part of, you couldn't imagine practicing medicine without it. And I think I'm paraphrasing one of David Sable's quotes, but he says that today's ceiling has to be tomorrow's floor.

In other words, if, as we expand access to care, we can't lower the quality as the quality raises, that needs to become the, the minimum in order to provide the scale, we have to be able to, to have more control over outcomes. And so these technologies are part of it. So is, is, is this task something that you see going to become a part of the standard of care? [00:48:00] 

Dr. Peter Klatsky:
Yeah, I mean, first of all, I love everything David Sable says. So, today's ceiling, tomorrow's floor, like... I like that. Yeah, you know, for me, you know, in our lab, we don't tend to discard, you know, if there's a 1PN for exactly the reason that Chelsea mentioned.

So, so that part may add value and it may add value again to the fact that, you know, to avoid, um, you know, uniparental and so to me that, yeah, I don't know whether the PN check is the way really solves for that, but it, but it certainly would solve for the rare cases of uniparental disomy. And again, once you get it into your clinical flow, it doesn't slow things down much, and it just adds more reassurance.

[00:49:00] And so finding ways to do this in a way that is not necessarily increasing cost to the patient, but providing that reassurance and safety, like I said before, I think it should become the standard of care. I think it protects. Patience is, it protects, it protects the clinic, and it just, you know, the safer we can make our technology, the better it is for everybody involved. Physicians, embryologists, and above all patients. 

Griffin Jones:
Let's talk a little bit about that in terms of the benefit to the clinic as a business. That is, after all, why the heck people listen to this show or pay any attention to whatever content I put out.

They're not coming to me for the latest scientific developments. The reason why this platform reaches a few thousand of you. 

Dr. Peter Klatsky:
You have some good stuff, man. You have some good stuff.

Griffin Jones:
Peter, I'm not saying this to be modest every time I say it on the show I was a D student in high school. I barely got through high school biology.

 [00:50:00] What I understand is what's, what's important to end users. What I understand is how markets function and how things that that maybe were once novel become part of the standard of care. That's part of how innovation happens. I also understand how competitive forces come together. And I try to bring all these perspectives together so that people can listen to them.

And they listen because there's so many people that are either, maybe they're young docs and they are starting a trajectory of where they're going to be a senior partner at a big group. Maybe they're going to come join you. Maybe they're going to go start their own group. We have more embryologists and lab directors, lab directors starting to take business interest.

[00:51:00] We've got a lot of CEOs that listen to this show and CFOs and COOs who are parts of these big MSOs and it used to be just us people that are listening and now it's people from India, it's people from China, people from Australia, it's, it all of these business folks that are listening. And so I, I look at a test like this and I, and I see like, okay, I can, I can see that this clinical benefit and I can see at a public relations marketing level, how necessary these controls are to have in terms of the scale and opportunity. I see how important the AI implications are. I'd like to hear from you. What are the business benefits that you see from a test like this? 

Dr. Peter Klatsky:
Anything that makes, first of all, you've got a great audience of amazing people listening and biologists, clinicians, any of them who want to have the most rewarding career possible, who are interested in going to the Bay Area or New York please reach out to Spring Fertility. 

[00:52:00] So I, I, sorry, Griffin, I can't help, but for our, our actual practice, anything that makes this process safer, anything that makes this process one where I can have more confidence that when I transfer an embryo, I am going to, you know, have the highest success rates possible and avoid a catastrophic event.

In our field, we've seen catastrophic events. We've seen, you know, child fertility in Los Angeles does not exist anymore. We've seen cryo tank failures. Those are catastrophic events that I cannot fathom. And my heart goes out to the patients. My heart also goes out to the doctors who are in that situation, who probably didn't have anything to do with it.

But we'll be held to account. So what, what I know is that this, you know, this is a tool that can make a double check and everybody who's been in an IVF lab who knows the, the, the behind the scenes knows that there's redundancy and there's not redundancy twofold there's usually in triplicate. 

[00:53:00] So our nitrogen gas, right? We have three tanks and two rows. So when this tank ends, we go to the second row and in fact, in most of our gas tanks, we have three rows of multiple tanks so that we will never run out of gas. We will never run out of CO2 and duplicate isn't enough. Almost every IVF center in the world has three levels of redundancy.

So this is just another level of redundancy to reassure your patient and so if you want to be totally business, attempt about it. We've never had an embryo mix up at Spring, but we did once have somebody take somebody else's sperm, and we only caught that because we were checking parental source and to this day, I don't think that they were bad actors.

[00:54:00] I think there may have been other cultural factors, other, other issues going on, but I couldn't figure out, you know, at first it sounds funny, right? When somebody, when you hear about, like, essentially a married couple that separated, yeah and they're no longer living together. And the husband brings in the new partner's sperm.

And for the first four minutes, when you discover that people are like wow, relationships are complicated and interesting. Right. But then when you say, well, why? And you think, hearken back to that Good Morning America episode with it, with the, with the gamete mix up and you think about the liability there that shook me and everybody who had visibility into that because you couldn't help but wonder, are we being set up?

So yes, if you're, if you're managing a practice that in you are the CEO and you are the Director of Operations. I can't fathom why you wouldn't want to have that double check. Because that is so easy to do. 

Griffin Jones:
I think of, of, if you're the CFO of a group or the CEO or whatever, and that catastrophic event does happen. It's one thing if the technology doesn't exist. You can say, well, these are the measures that were currently in place. But if you didn't have it and like two or three other networks do and use it and, and people can point it, courts can point to that. Patients can point to that. The media can point to that. 

To me, that seems like doomsday. I want, I want to focus more on the positive of the, the, of the test, but part of what the positive is, is avoiding that potential absolute negative cat. [00:55:00] 

Dr. Peter Klatsky:
That's right. And I want to be fair, you know, Cooper is not the only company that offers that and and so but but I would make sure whatever whoever your PGT partner is that they are providing that. 

Griffin Jones:
I want to talk to you about your selection process for a partner because I know how, oh, what's the polite word of saying idiosyncratic you and Nam Tran are with you QA at, at Spring and like, it's so embedded into how you, you've built your, your practice group. You have QA measures that I hadn't even heard about before. We talked about that in the first episode that you came on and I know everyone listening is, is really important. QA is really important to them. I just feel like you take it to another level.[00:56:00] 

And so it's like one of those scenarios where it's like, what if they're good enough for him. That means, that means there's something there. What was it about, and I, and I also presume that you have worked with other partners in the past. What was it about Cooper that made you say this is the partner for me?

Dr. Peter Klatsky:
I want to be cautious because there are a lot of great colleagues in this space and there are a lot of great PGT labs. And so I want to speak more in general, generalities because you know, one, you want to have like we started off at the beginning, you want to have a, I want to have that one, a high degree of confidence in the accuracy of the calls.[00:57:00] 

Two, I want to have a low, no call rate. My current no call rate is under 1% in New York with Cooper. I have worked with other companies. I know I had a positive experience with Natera as well and so I want to know the professionalism of the people. I want to believe in their accuracy. And then I want to know my limitations in Griffin.

I am not the smartest person at Spring Fertility. I want so I, when I need that scientific, we're going to go to Nam Tran. Who is our Chief Medical and Scientific Officer working with our, our head of all of our IVF labs, Sergio, and, and get insight from them. But it's also important that your physicians who work in your practice have autonomy and, and physicians may have preferences as well. [00:58:00]

So when physicians are working at Spring, we, we put it up to our whole group. We look at the data. We have every group come in and, and give a presentation. After that presentation, we talk about it. We, we try to limit. The number of PGT partners to two per each lab, just because it makes it easier for your lab.

It's hard if you're going to have 10 different providers using 10 different labs. That's hard. So, so you want positions to have autonomy and to be respected and have their reasons, but you want to have an open dialogue. And I'm lucky enough to have, you know, people smarter than myself guiding me and then we constantly review the literature.

We constantly review the outcomes. And so when we choose a partner, we want to make sure that there's a quick turnaround time that they are responsive to the clinic, that if we need something in a hurry for a particular case or particular reason that they're able to do that, if we need, uh, an exceptional case that we need to do that, but as a general rule, I don't want to work also with a PGT provider who can't source the DNA, can't provide parental source DNA.[00:59:00] 

And, and, um, my experience with Cooper working in New York has been wonderful. I don't want to be, you know, a commercial and I have a lot of wonderful colleagues who work for other organizations, you know, outside of Cooper. And so I don't, but, but I think you want to have an honest conversation. You want to know that you're in this together.

And if something happens, you know, that you're going to get a phone call and you're going to be able to work through it quickly and come to a resolution about things. Because there will always be cases, no matter who your provider is, where you'll have like suddenly a high no call rate. For one case, right?

And, and you want to be able to delve into that and in a non confrontational, but, but information finding way solution. 

Griffin Jones:
I want to conclude with a couple of different ways. First, what are the takeaways that, that people should walk away with about this test specifically thinking of PGT-Complete℠, knowing that we have the scientists listening. [01:00:00] 

We get the lab and embryology folks. We've got the docs listening. We have the business folks. that are like me that don't have clinical backgrounds. Chelsea, maybe you start. What should they walk away with?

Chelsea Leonard:
Yeah, I think from my perspective, a buccal cheek swab takes 20-30 seconds. It can be done from home or from the office at the center itself and really enables us to produce the most informed and confident results, right?

[01:01:00] When we get that PGT report back for the embryo reassurance protection and the potential to, in some cases, rescue embryos that may have been discarded or make the correct treatment decision going forward. For example, choosing, choosing the appropriate gamete toner. So, it's an easy thing, a cheek swab, and it leads to our ability to offer improved outcomes to patients, and, and we all know that there are cases where this could have been useful if, if it had been around at the time, and now it is, and it's available.

Griffin Jones:
Peter? 

Dr. Peter Klatsky:
Yeah, I think that's, I think you said it well. I've given a variety of reasons. I think that one case in particular probably is going to stand out for a lot of people in this audience. And, you know, again, there, you also want to track your outcomes, right? So you also want to track what is my, uh, single euploid embryo by birth rate.

[01:02:00]And, you know, if there's deviations in that, if you feel like you're not getting the outcome that you should be, that's, that's what I do. But, but, but, Griffin, I think the ceiling should be the floor and when you have something that makes a technology safer and provides reassurance for patients, again, 100 percent of your patients are afraid of this, whether they tell you or not 100 percent of your patients.  

Griffin Jones:
So let's use the things that give them less to worry about. I want to as you about where people can learn more about PGT-Complete℠. We're going to link to information about PGT-Complete℠. It will go out in the email that delivers this podcast. For those that subscribe, it will also be on the podcast page. We'll also include it in the show notes. Tell us, where can people learn more about PGT-Complete℠? 

Chelsea Leonard:
Yeah, of course, there's lots of great information about PGT-Complete℠ on our website, so CooperSurgical’s website, including white paper, you know, further description of the features, some case examples. We'll be chatting about it extensively, I'm sure, at ASRM, as well as hopefully some upcoming discussions about real case studies with what we've observed with Complete in the last year or so, since it came out.

Griffin Jones:
So that’s the timing. Some people are going to listen to this episode, maybe three or six months after it comes out, but a lot of people are going to be listening to this episode right as it comes out, which is right about ASRM time. Some of you are probably on the plane right now, headed to New Orleans, listening to this episode.[01:03:00] 

And if that's the case, Cooper's I imagine is going to have a big booth and big presence as always. And you're going to have a lot of your scientific people there. A lot of your sales people there. I invite you to go to their booth, talk to them about it. Tell them about this conversation. Peter, will you be at ASRM?

Dr. Peter Klatsky:
I will be, and anybody who's interested in having an amazing career in New York or Bay Area, we're hiring there. We're interviewing people. We're a great group of folks. We deliver the best science and look forward to meeting my peers there too. 

Griffin Jones:
When you bump into Dr. Klatsky or Chelsea, tell them that you heard them on the show and tell them thanks for putting up with the host. [01:04:00]

Dr. Peter Klatsky:
Are you going to be there Griffin? Are you going this year? 

Griffin Jones:
I wouldn't miss it. Yeah, I will be there. 

Dr. Peter Klatsky:
Will you bring your baby? 

Griffin Jones:
I will go sans baby. But, uh, I've thought about future appearances with the baby in some matching suit that I wear that fits my Conor McGregor suit MO. So not 2023, but, uh, we might see it in 2024 that all right, Cooper Marketing team, there's, there's something that we could do for our 2024 initiatives, but brand, brand new baby.

Two, two months old. Yeah, it'll be two months old by the time this episode airs. 

Dr. Peter Klatsky:
Awesome. Congratulations. 

Griffin Jones:
Well, thank, thank, thank you. And thank you both so much for coming on and advancing the conversation. 

Chelsea Leonard:
Thanks so much. 

Dr. Peter Klatsky:
Thank you.

Sponsor:
This episode was made possible by our feature sponsor, CooperSurgical®. Download CooperSurgical’s brand new PGT-A Clinician's Reference Tool, an indispensable guide for clinicians like you to unlock the full potential of genomic treatment, by clicking the button below.

Announcer:
Today’s episode is paid content from our feature sponsor, who helps Inside Reproductive Health to deliver information for free, to you! Here, the Advertiser has editorial control. Feature sponsorship is not an endorsement, and does not necessarily reflect the views of Inside Reproductive Health. 

Dr. Klatsky 's opinions are his own. He receives an honorarium from CooperSurgical® for his time and expertise.

Thank you for listening to Inside Reproductive Health.

 
 

194 Digitalizing, not digitizing, fertility treatment end-to-end featuring Dr. Cristina Hickman

DISCLAIMER: Today’s Advertiser helped make the production and delivery of this episode possible, for free, to you! But the themes expressed by the guests do not necessarily reflect the views of Inside Reproductive Health, nor of the Advertiser. The Advertiser does not have editorial control over the content of this episode, and the guest’s appearance is not an endorsement of the Advertiser.


Embie has calculated 23 metrics for REI and clinic benchmarks for converting IVF Patients and we are making them available to you.

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  • Conversion Rate from Referral to REI Consult 

  • Avg REI Appt Time for NP/ 1st Consult, Incl Prep and Notes

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  • Total Appointment Time Per Year, Per REI

  • IVF Cycle Cancellation Rate

See the numbers for these metrics and 18 others to see how your clinic compares.


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Transcript

Dr. Cristina Hickman  00:00

If you want to think about the presence in the presence is the data is being captured automatically. So I'm using an electronic witnessing system, which is capturing the time that I started at the end of the procedure just by performing the procedure. So the doctor comes into his collection, he taps in his his cards onto the pump, the pump automatically knows that this particular doctor likes this particular brand of needle and preferably a single lumen needle, it automatically changes the pressure to match that single lumen needle. And now documents every time this doctor is pressing on the pedal to pump is documenting every tube that's being filled, and so on. This is now live recording of the data. It's not something that he did when he left it's recording as it's happening. So as a consequence of this, we can get live KPIs live and continuous KPIs.

Sponsor  00:53

This episode was brought to you by Embie. To see where your time is going visit embieclinic.com/report. That's embieclinic.com/report. Today's advertiser helped make the production and delivery of this episode possible for free to you. But the themes expressed by the guests do not necessarily reflect the views of Inside Reproductive Health, nor of the advertiser, the advertiser does not have editorial control over the content of this episode. And the guests appearance is not an endorsement of the advertiser.

Griffin Jones  01:31

250 fertility clinics. How many clinics have you visited? That's how many today's guest has visited. Dr. Christina Hickman is an embryologist by trade. She has her PhD in embryology. She's the co founder and co owner of a clinic in central London called Aria, Aria? I don't know how to pronounce it. I didn't ask her how to pronounce it because she's involved in so many different companies and has been in the last several years, some that she's founded. Somewhere, she's served as Chief Scientific Officer or Chief Clinical Officer and somewhere she may serve as an advisor. And I like that background for really thinking about what the digitalization of fertility treatment looks like. Dr. Hickman makes the distinction between digitalization and digitization and a lot of you better listen closely because you're going to think your digitalizing but you're really just digitizing. So pay attention. She talks about the difference in digitalization versus digitization and everything from consents to prescription ordering and beyond including smart lab equipment, smart clinical equipment. I pressed her on, well, who's going to be the hub for all this because everybody wants to be the hub. Dr. Hickman proposes an alternative to the hub. She says there doesn't have to be a hub. Take a listen to that argument. Tell me if you think it holds water. I ask her why come we don't talk about blockchain no mo. Is it still a thing? Dr. Hickman talks about the route that the field took instead of blockchain and why she paints a picture of how the physical environment of the clinic and lab can merge with the digital environment so that it's one environment I liken it to a not Oscar worthy but better than airplane worthy movie from like 10 years ago that you can add to your watch list. You're welcome. Dr. Hickman paints a different picture than only vertical integration where one or three companies own everything, and she sees how community of different companies in different verticals can successfully integrate in an ecosystem and she shares some players that she thinks are doing really well in this area. Enjoy this conversation with Dr. Christina Hickman. Dr. Hickman. Christina, welcome to the Inside Reproductive Health podcast.

Dr. Cristina Hickman  03:29

Thank you very much for the invite. It's a pleasure to be here.

Griffin Jones  03:32

You were recommended to me by a few people, some which was the team at Embie but then some others. Everyone described you as forward thinking. So I thought that was interesting. I went to your LinkedIn profile. And then I saw a lot of X date to present, X date to present, X date to present. You got a lot going on right now. Tell us what are you up to?

Dr. Cristina Hickman  03:56

Yeah, so I'm a clinical embryologist. I've been a clinical embryologist for 20 years. And you know, as a lab manager, I have experienced myself as well as through my team, a lot of the challenges associated with providing care to patients. So I stepped out of the lab manager for brief periods where I traveled the world and visited 250 clinics around the world. And I did that through consultancy, supported by industry. So this allowed me to get a completely different perspective of how reproductive care is offered outside of the UK. So I got some insights into the US into Asia into you know, China and Japan as well as Australia and South America. And it was very interesting to see that the challenges that I was experiencing in my clinics in the UK, were very similar to the challenges in all the corners of the world. So from that point, I ended up joining some venture capital back to startups. This was my like tomorrow or fertility opportunity And each of these, we're trying to solve a part of the fertility journey. Together these, each of these companies kind of when you bring them together, you can now have the entire journey of the patient being able to be resolved. So the challenges we were experiencing were too big for a single company to resolve them. And this is why I'm involved with so many different companies, because each of them are the number one provider that supports that particular solution to a problem that I was experiencing for caring for my patients.

Griffin Jones  05:33

You mentioned that the challenges were surprisingly similar from what you were familiar with in the UK, when you would go to East Asia, Latin America, the United States, Australia, all corners of the globe. What were those challenges specifically?

Dr. Cristina Hickman  05:48

So for instance, doing consents of patients, right? So we historically we would do it with paper. So in the UK, we have a lot of consents that we have to go through which are regulatory required, we also have our own clinic consents to get through, and, you know, going, they're very complicated for the patients. So there have been digital solutions that have come into the market, you know, trying to provide you with PDFs, that our have made our life a lot easier. But the problem is that these consent platforms, although they are maybe integrated with your EMR as any deposits that PDF into your EMR, it's still like a separate digital solution to the rest of your digital ecosystem in your in your clinic. So one of the things that we've been working on is how can we get away from PDFs, you know, so PDFs is what we call digitization. But what we want to do is move towards digitalization, you know, those two extra letters, the A and the L provide a whole different leap into into efficiencies in the clinic, but also a different experience to the patients. So no longer do we have to deal with the patient having to complete the same consent three or four times, because he got one box incorrect. And therefore they have to do the whole form again. So we don't have to do, those inconveniences are automatically eliminated. And further to that, by taking away the PDF, you now you get a phone friendly version, because our patients are on their phones and not on a computer, they're on a phone. So now we can make it easier for them to to understand what it is there consenting for through convenience. And thirdly, because we're not in a PDF that's siloed. On the side, all this information now becomes business intelligence, because it's interconnected in the rest of your ecosystem, each individual fields that the patient has completed is part of the information that helps us better understand this patient. Now you take that just from consensus, or you evolve it now to every step of the process, every ultrasound scan you perform on the patient, you have that information directly from the source, every every time that a patient has an embryo on the embryos cultured in a time lapse incubator, that information, all of that is capturing that data automatically. And moreover, none of this is being captured by our staff spending time inputting information into the system. It's information that comes from the source of the information without administration. So the administrative tasks are completely removed. That's one of many examples, you know, that we could go through but every step of the journey that a patient is going through, there's a pain point for the patient and a pain point for the staff that's trying to support the health care of that patient.

Griffin Jones  08:34

So major difference between the two letters between digitalization in digitization, digitization, does that still include a DocuSign is just digitization because you're simply taking your existing consent, you have it in Docusign. And then staying on the example of consent at a platform level or at a software back end level. What does digitalization of that same consent look like? If it's not a PDF? That's being stored in a DocuSign signed via something like a DocuSign? What would the digitalization of that same consent look like?

Dr. Cristina Hickman  09:12

Let's say you're trying to fill in your your PDF form through your phone, you're gonna have to zoom in with your finger and you drag left and right you know, just to read the full sentence. But here everything is portrayed in fitting your your your your phone view, you're you're easily able to move from one page to the other, and your your your signatures and consents are connected with what you're permitted to do. You can enter if so, for instance, in the UK, historically, you couldn't put more than 10 years, you know, for for your consent period, or maybe your consent periods that you're putting for the storage of your embryos or eggs and storage is not aligned with your partners. Or you know, some clinics like to align it with with with their with their own conditions within their clinic. So all these things, you can provide a tool that educates the patient as they're going through, but not necessarily by them watching a video in advance, receiving the in the informational videos at the time they need it. But let's say this is not a visual patient, this patient doesn't like to learn through videos, because videos is not for everyone and she prefers to read, you can now choose the different forums of learning or educating yourself about the various decisions that you have to do throughout your treatment. And it's not just consents, you know, you can use this for instance, for embryo development. So you're able to see your embryo developing live as it's happening inside the time lapse incubator inside the clinic. So the patient is sitting at home. And they have that transparency of care to be able to see what the embryologist sees as well.

Griffin Jones  10:51

So Can these still exist as separate platforms? Is that even the right way to think of it in this move towards digitalization as opposed to digitization? I can't be the engage in engaged MD does it have to be an over encompassing EMR? It's you know, it's it's the it has to be the EMR in every function of the clinic and lab.

Dr. Cristina Hickman  11:14

So the challenge that we have with EMRs is that there's multiple reasons where I opted for building an EMR free clinic. So I need more for one thing is designed for a somewhere for you to put your information in there. Okay, so I've performed the procedure. And then I go in there, and I type in that I've started a procedure 8:00am, I finished at 8:30. And Christina did it together with Griffin who did the egg collection. Okay, so we, we've I spent, I did the procedure, and then I went out there and I documented that procedure. That's what an EMR is kind of designed for. And if I want to know about my KPIs, I will once a month, I will extract all the data, assuming that is an EMR that allows you to extract data, because not all of them do. I'll extract all the data, create my graphs, and then present this in a KPI meeting. Okay, so this is the old fashioned way of performing your, you're doing things from the past, okay? Now, if you want to think about the presence in the presence is the data is being captured automatically. So I'm using an electronic witnessing system, which is capturing the time that I started at the end of the procedure just by performing the procedure. So the doctor comes into his collection, he taps in his his cards onto the pump, the pump automatically knows that this particular doctor likes this particular brand of needle and preferably a single lumen needle, it automatically changes the pressure to match that single lumen needle. And now documents every time this doctor is pressing on the pedal to pump is documenting every tube that's being filled, and so on. The doctor just comes in performs the procedure and leaves only needs to document if there's anything out of the ordinary that that takes place. Otherwise, the documentation was just from him tapping his card onto the electronic witnessing system that includes the pump. So this is now live recording of the data. It's not something that he did when he left, it's recording as it's happening. So as a consequence of this, we can get live KPIs, live and continuous KPIs. So the moment that I put an embryo in a time lapse incubator, the AI comes in and automatically tells you when that egg has fertilized when it's degenerated when it's formed the blastocyst when it formed, the good quality blastocysts what was the pace of development, what was the score it was given. And all of these are automatic and continuous KPIs that allow us to monitor how our lab is performing a so we're now moving like beyond digitalization, where we're going now kind of towards a future where we're not just getting the data present. But we're getting the data for the future, we're getting it to predict and prevent what might happen next. So that we can take action before any non conformities have a chance to directly impact your success rates.

Griffin Jones  14:11

So are all of these different areas, whether it's the smart reporting from the electronic witnessing system, or the equipment ordering, or the informed consent, or all of these different tables within one master platform or these different platforms that somehow have to be integrated together?

Dr. Cristina Hickman  14:32

So a lot of when you're talking with the different companies, you know that the hardest thing to get this done is not the technological aspect, the technological aspect of integrating the different platforms is very easy. The issue is every company wants to be the hub or the central, you know, and and getting the negotiation of who's going to be the brain of the system is what makes it really hard to get the companies to collaborate with each other. Unfortunately, we are in a field which is run by humans. Humans are thinking on what's in it for me, right? If I want to collaborate with you, I want to get us to a point where we're thinking as a field, what's in it for the patients, if we really want to practice patient centered care, we need to be strategizing what's best for the patient, across companies, across clinics, and working in a in a way that creates this community of digital experiences that feels like a single one. And this is what we are creating. So the the two companies that that we built, one is called Avenues, which is clinic in the UK. And the other one is called Ovum Care, which is a new German entity, which is going to be opening the first clinic in Portugal later this year. These are now two companies that are coming together, to create together with Embie, and with many other digital suppliers, this, this neutral experience, where as a community, we can bring the digital tools together synergize without a single entity, a single hub, you know, nobody is the brain of the system. We're just interconnecting all of the solutions, so that they all get the best out for the patients to experience the best possible care. So it's a different form of thinking rather than going in what's in it for me, we're thinking that's now wipe out the all the options strategize with all these chess pieces we have available. How do we get it? What's best for the patient?

Griffin Jones  16:27

Am I understanding correctly, that there's an alternative to the hub? Because when you say everybody wants to be the hub, they sure do. And so to their venture capitalists and their private equity partners, and there's a whole lot of money at stake in in them being the hub. And many people do have the patient's interests at heart, but they're not going to say to their competitor or their potential competitors, as their vertical start to overlap. Oh, no, we all want the patient to be number one here. So why don't you go ahead and be the it's not a Canadian standoff with after you, you go ahead and be the, the the hub everybody, they want to be the hub, they've got a real vested interest in being that and so you're sitting? Well, you so you're saying it's possible to have a workaround to a hub?

Dr. Cristina Hickman  17:16

Yes, so there. So this is exactly what we've built. So we, in our clinic using Embie, using Fertility, using TMRW, okay, so all of these different companies and their we are able to solve, none of these companies are offering a solution that goes across the entire span, okay, but they are the best at what they do. If I want to store an embryo that was my personal embryo, I want that stored in a TMRW's robot, if I were to better understand how my embryos developing to get better strategies for my care, I want this to be assessed by a fertility AI tool. So what we do is we, through the care provision, we have a digital strategy of how we're going to approach this. And what we're what we have is now companies are willing to have these integrations across across the platform, what we what that's going to create as a next step is the ones who are outside the community ecosystem will wane away, okay, because they won't be relevant anymore. If you're not part of this digital pathway, then you're not going to if you're if you're, and I see a lot of EMRs being in that category, if you refuse to integrate, or if you charge too much to integrate, make it too expensive, which that expense will be passed on to the patient, then the companies will find alternative routes, which which which make it more relevant to the patient.

Griffin Jones  18:40

So I was going to ask about the EMRs, because many of them aren't in the digital pathway, or they'll say, sure, we'll integrate, but you're gonna pay us a good chunk for integrating. And we're the hub. It's, it's it's our data. And so we've been saying this for a while that the walled gardens will eventually, the walls of the walled gardens will come down, those that keep their walls up will be rendered irrelevant. It hasn't happened yet. So what is, what are we waiting for? Why are these companies that are not in the digital pathway, it seems like they still have a lot, if they have a number of fertility groups, large fertility groups, they've got their data, they're entrenched with them, it's very hard to switch EMRs. It seems to me that it could be a long time, to me it seems like the only thing that would get them out is those big legacy clients not renewing and switching out. And that's a long sales cycle. It seems to me like the only thing it would be switching out is is there any catalysts that would come forth to make those EMRs that aren't in the digital pathway render them irrelevant more quickly? 

Dr. Cristina Hickman  19:55

Like there's a lot of clinics out there who you know, you go to a website and it says I am the lead in clinic, okay, or I offer a state of the art, okay? If you're if you're sending a stash of papers home with the patients and getting them to do the consents through paper, if you're if you don't have time lapse system, if you're not using electronic witnessing, if you're not creating a centralized data infrastructure so that you're having live and continuous KPIs, if you're not using AI for your assessments, whether it's for ultrasounds, whether it's for, then you're not state of the art. Okay, and I think that's, that's a big statement. And the same goes for the patients, if you're being treated by a clinic that gives you that experience, you are not being treated by a leading state of the art clinic. So I think it is the catalyst is going to come from two levels. One is the patient's noticing, because now there's going to be the alternative to go to the clinics that are using these technologies and are open to digitization. And who are who really are putting the work in to do that transition away from EMRs. I mean, we still have clinics out there that are completely paper based, okay, there's there's, there's some which are, you know, really far back, they need to move away from the paper, move towards the digitization, and start strategizing. How do I get to be better informed? How do I get better business intelligence, so that I can adapt to this changing world that we're going to be facing now in this in this next generation. So I'm here today to tell you that this is not talking about the future. There's nothing that I'm telling you today that is not available in the markets today. So there's no reason why we should be doing paper prescriptions, you know, we it should be electronic, there is no reason why we shouldn't be integrating with a wearable detail from the patient so we can better understand their how their behaviors are contributing towards a fertility success. So this, we've reached a new era, where now we're going to see the ones who are able to adapt to it. And then the clinics who won't, I think are gradually going to start disappearing.

Sponsor  22:04

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Griffin Jones  23:12

For those EMRs that have been the walled gardens thus far, and I'm not picking on them. I understand they've got costs, they've built their businesses, they're trying to think of the future value of their companies and they're trying to win their races. For those that have been walled gardens, is it too late for them? Is it too late for them to go the route of entering the digital pathway?

Dr. Cristina Hickman  23:38

No, definitely not. But the strategy needs to change. So I think COVID, of all the bad things that COVID brought to us, the one thing it did that did very well was it created this this we've evolved 30 years in a space of two years when it comes to digitization in healthcare. Okay, and this is something that has allowed us to evolve away from that siloed What's In It For Me concepts to now the company is already thinking what are the strategic partnerships that we need to be making, so that we can provide better service to our clients who can then provide better care to the to the patience. So this, this philosophy is already there? I think we're going to be involved evolving to the next level up where we're going to be seeing not just one or two interconnections, but how do we how do we maintain our strategic positioning within this ecosystem? So we've gone through a process where everything was siloed, this has all been dismantled. Now, people are trying to find their place in this digital world. And those that adapt will continue to have this community approach. And this is what I think is different that it's not just about technology, it's about frame of mind. It's about a curiosity towards evolving into the next position. How do you position it? It's having this realization of What are the strengths that you as an individual you as a company bring to the to the fertility care world. So many examples out there of big groups of clinics who have spent half a million, a million building their own EMR systems or building their own digital AI digital solutions, only to be third grade or fourth generation below what is the standard of care from from companies that focused on just that one thing. So I do believe that the future of our field is going to be a community of companies working together as opposed to one big company only acquiring or the smaller ones. And then there's mantling it and then figuring out how they grow in an artificial manner. So I think we have a new opportunity here to grow a different aspect of our care.

Griffin Jones  25:51

Interesting, because I just recorded an interview with Lou Villalba, new the new CEO of TMRW, and we made that topic about vertical integration and some vertical integration is going to be inevitable, you're painting a picture where it's not where not everything is vertically integrated, where you have a community, and there still is a value in having separate companies doing what they do best. And not just one company owning every piece of the value chain. There's so people should listen to both episodes, because they're both they both paint different things that will happen in the future. 

Dr. Cristina Hickman  26:26

I mean, what what what is different about the digital world and the digital technologies is the fact that the world moves very fast there, and things become obsolete very quickly. And therefore you need to have a very creative and innovative culture environment to be able to survive in that space. And this is why I do think there will always be space with smaller companies to kind of find find are treading because of the nature of the fast pace of digitization.

Griffin Jones  26:54

And the tension between innovation and efficiency. There's a book called The Innovators Dilemma, theory called The Innovators Dilemma, I've talked about it on the podcast a couple of times, and the incumbents often are disincentivizing from, are disincentivized from innovating, because they're trying to win the efficiency game. And you sure you a really good company will carve out a piece of budget time leadership focus to focus on future value. But inevitably, that tension is something that weighs on incumbents, and there's a space for new companies to win the innovation game. I want to jump on the digitalization versus digitization examples in other spaces within the space some more because I know that my some of my audience is not getting it there. They think they got it but they don't. And the example that you gave about the paper prescriptions, people will say, Oh no, no, we fill prescriptions, we just do that through the EMR or we do it through the pharmacies portal. We don't use paper, we use those but that's still digitization isn't it versus digitalization of having of having that that data in a place where it becomes business intelligence?

Dr. Cristina Hickman  28:11

Okay, so So let me explain the digitalization in terms of prescription. Okay, so how prescription is done in the past will be you, you put in the patient's history again. And then from that, you you create, maybe you have a template with so let's say you put in I want I want an antagonist cycle, I'll go with a low dose for this patient. And then you just kind of tweak what is the what you want. And then that generates an electronic hopefully, in many clinics are still paper and they still got assigned by ink. But let's say that generates an electronic. And then from that electronic concerns, the patient is able to take it over. In digitalization, we go a few steps further. So for instance, when you create all of these, the history of the patient, so So this is what I'm going to prescribe this patient, she's going to have an antagonist cycle, I want her to have the following egg options and sperm options and genetic options and so on when and she's going to be using donor eggs, or she's going to donor sperm or whatever, and you press enter, it then creates a template of all the appointments that this patient is going to have. So she's going, I'm a particular doctor that, I might prefer to have daily scans or maybe I just do two scans in a cycle, they maybe I'll do a baseline or maybe a day nine. So you kind of put in this is my template in terms of cycles. And from that you already get all the tasks that go to your your team members. For instance, I selected she's going to use donor sperm. So therefore all the donor sperm matching tasks get sent to the relevant team members. So all of these tasks are there, you can tweak it. So you have all the appointments and all the tasks are there. And with the click of a button, it then goes on to the prescription. And at this point you're not signing. What you're doing it is you're confirming it, and then you get a two step authentication onto your phone confirms that this was you because that's even safer than then signature nowadays. And then it gets sent over directly to the pharmacy so that this gets delivered maybe to the patient's home or with the ability to. So whilst you're doing this, that's it, the patient has a copy in their patients app, and the patients can see that prescription. And all you had to do was two clicks, one to confirm the appointments and the or under tasks going to the team members. And a second one to confirm the drugs. The prescription side, it goes a step further where you can use AI to suggest what would be the based on the BMI, based on the age, based on all the other patient demographics, and not just your template, but now using patients and tele data intelligence so that we can do true evidence based prescription. Okay, so this is digitalization. And then when you start thinking about prevention, and so on, let's say as you're doing your scans either side to up their their adults, it can automatically calculate saying, look, for this particular patient, she's only purchased or she was only prescribed a set amount of drugs, now that you increase your dosage, we need to make sure she's got enough stock. So it's preventing the patient running out of drugs before you even realize that she's going to run out of drugs. Okay, so this is the difference between digitization and digitalization.

Griffin Jones  31:24

So, we have proposed an alternative to the hub and that these different companies are capable of these business intelligence, they're capable of this automation, but when it overlaps, who does, who does the data go to like if it's if if donor sperm tasks are triggered by by something, maybe maybe a pharma order or something that happens in the clinic from smart hardware, then the next step when when the steps overlap? Who owns those business insights in a world where there isn't a hub? How does that, how is that workflow managed?

Dr. Cristina Hickman  32:07

I'll give you an example on the genetic side, for instance, okay, so I am doing an egg collection. And I know that this patient is going to be having egta. So the moment that I put the embryo in the time lapse incubator, the genetic lab can now see as early as like the second day of development, what is the chance of there being blastocyst for this particular patient. So the genetic lab is part of the care provision team. And it's already been allocated that this patient is going to this genetic lab. But now the genetic lab can see not just in this particular patient, but all the patients coming from that clinic, all the patients coming from all the clinics that are associated with this lab, they can see how many blastocyst am I going to be getting in the next three days, they can tell that in advance, which means they can now make a determination when's the right time that I should be putting my 96? Well, this for analysis, should I wait one more day, should I bring it down a day, because whether you're using the full 96 wells, or whether you're only running one patient is going to be the same cost. So you can better strategize, and therefore, just by having that insight of how the embryos are doing on the second day, and by the way, all of this happened without any human spending their time sending an email of I'm expected to send you blastocysts in three days time, all of that is completely unnecessary, because of this information. Now, the who holds what information and how that information flows, is determined through the regulations and the contracts between the different service providers. Okay, so for instance, in Europe, we have to comply with GDPR. So the patient's needs to be fully aware of who's handling your data, how is it being handled, and as an hfpa licensed clinic, it is our responsibility to ensure that everybody is being responsible with that data. So we have checklists that we go with each of the suppliers to make sure that they're complying with the quality of data handling that we expect them to be to be having.

Griffin Jones  34:04

How does the blockchain back all interface with this or or these platforms built on the blockchain?

Dr. Cristina Hickman  34:12

So at the moment, the particular projects are working on the moment, none of them are using blockchain. I have worked in blockchain before I came into the field through Apricity. So we did a collaboration with Okin, who is a specialist in blockchain. And we actually built a blockchain specifically for research so that we could bring data from different parts of the world. At the time, I was doing a lot of collaborations with China, a lot of collaborations with Russia, with Japan with the US. And each of these countries have very strict rules about data not leaving their particular country, especially healthcare data. So the blockchain is a fantastic solution, allowing the algorithms to learn in the different hubs without having to, without the data having to move. So what moves are the algorithms, not the hubs. So the technology exists politically, I wasn't able to get to that project to succeed. But the technology exists in allowing that that that to to work. But this was because the no money was involved. We're trying to do a and again, this, this reflects the whole What's In It For Me siloed data, this would be a project that would make perfect sense in a patient centric community. But when I was working on this five years ago, I think we just weren't ready for it, then.

Griffin Jones  35:30

Are we going to see more of the blockchain as the spine behind a lot of these platforms? Or is there a way of doing this without the blockchain over a sustained period of time? Because we seemed like we were only going to talk about the blockchain for about four and a half seconds. And then we started talking about AI. And we haven't talked about blockchain since though is is blockchain still an inevitability or now are there ways where we think that it's these types of platforms will exist for a meaningful period of time without it. 

Dr. Cristina Hickman  36:05

So I tried to blockchain wrote, and for those who are willing to do the collaborations, they preferred to do it by protecting the data integrity through contracts and through regulation, and through through cybersecurity. So there are alternatives to blockchain, which is what's the field opted for even today, so not not just at the time, but even today, so the technology is there. But there are alternative ways of doing it using logic using legislation using legal contracts. And I'm in full compliance with the with the multiple regulation, it just means that we're not moving huge hubs of data. This is data being transitioned through care provision in a safe and secure manner. So for instance, Europe has, in their list of places they don't want their data to go to, is the US is one of the top places where if you're sending data to the US, because of the regulations around data handling in the US being different to those in the in, in Europe, it's one of the places they say, if you're going to do this, you need to ensure the safety of the data. So what we can do is create cloud environments which are in the US, but which are fully compliant with European standards geographically in the US, but they're not interconnected. They can they can, they can demonstrate its security accordingly. Okay. And on top of that, if you're going to be doing that we have to inform the patient, that we're going to be moving data to the US. So this is effectively contractual ways of kind of resolving that challenge.

Griffin Jones  37:38

How did you find yourself moving so far down the clinical end of the spectrum of the solutions, like by the time you get to consent, you know, it's for things that are done in the lab, but it's happening in the clinic, your background is, as an embryologist, how did you end up going beyond just lab solutions to broader clinic solutions?

Dr. Cristina Hickman  37:58

Mostly because I started owning clinics. So now I start looking at the clinic as a whole as opposed to just a lab. But also because my initial focus was on embryology based solutions. But I quickly became aware that so for instance, when I'm labeling my data, which embryos become a baby in which embryos don't become a baby, I now have the issue of Wait a minute. Was it a good embryo? It just happened to go to the wrong uterus? Or was it a good embryo that just happens to have a doctor that made a mistake during the transfer procedure. And so this is called mislabeling where, actually, the AI did get it right. But other things outside that data form. Because I'm only looking at the time lapse information, I'm only looking at the embryo, I am missing the rest of the fertility care. So my interest started spawning, actually in both directions post transfer and pre transfer. So we've done a lot of work on for instance, how we make stimulation decisions, how do we determine the type of trigger? How do we decide the right protocol for this patient, and so on. And what I discovered when I went into that, because it was around COVID times that I started getting to simulation, everybody had moved on to antagonists. And I started to appreciate how little diversity we actually have in the clinical side, compared to the embryology side, there's a lot less options to choose from a lot less opportunities. But when you think about it, that's not because there's less options is because the technology for data capture wasn't there. So now we have AI solutions that tap into your ultrasound and capture a wealth of data in the same way that you have AI solutions and embryology capturing a wealth of data from the timelapse. So I think we're going to be seeing a lot more focus on the clinical side as well. Because on the embryology side, it's all about not making any mistakes. Once I get my eggs and my sperm, it's all about do no harm and try to not you know, as long as I keep them safe, they will hopefully have the viability that they were there seems to have it's all opportunities for error rather than ways to improve the egg. Whilst in the clinical side we have the opportunity to improve the egg, we have the opportunity to improve the quality of the sperm. And I kind of saw the pre embryology side as an opportunity of not just mitigating the risks, but actually increasing chances of success to patients.

Griffin Jones  40:24

Are you still fertilizing eggs you own clinics, you're involved in multiple ventures or starting ventures you're also the adviser to other ventures? Are you still in the lab fertilizing eggs?

Dr. Cristina Hickman  40:35

That's my that's my safe space. That's my that there's no better place than sitting down doing an exit doing a biopsy, doing a vitrification, you know so, so very much. Embryology is kind of like playing an instrument and you kind of need to keep playing it or you're going to lose your touch. So I have obviously I don't do it in the same volume that I did before. But I'm very much involved. I do workshops where I'm training embryologists as well on all these skills, but certainly yes, performing the procedures as well.

Griffin Jones  41:04

Just to keep this saw sharp. So sometimes you're going to be in the lab with a junior embryologist. And here you are owning the company and you're involved in all these other companies and there's some junior embryologist just out of university is their first real job and so that happens sometimes?

Dr. Cristina Hickman  41:20

No, definitely. I think there's many examples of embryologists who have gone out there to create they're out there to own their own clinics to wonder that they will actually to I saw today David Sable put an article in Forbes talking about how clinics should be owned by embryologists, which made me chuckle because obviously today being World Embryology Day, I thought that was quite quite timely. So I certainly think that we are seeing an era of empowerment of embryologist, whether it is because they own their own clinics because they are venturing into the the corporate space and I would really encourage many embryologist to go through this journey. For me it was it was a very insightful, both in terms of my own personality, my own characters and understanding myself, but also in acquiring new skills. So you know, now I'm involved in running, I'm running FDA trials together with fertility in the US, I am understanding how to how to get CE marking and FDA approval of products. I and this, you know, initially people say that you're venturing into the dark side, I have found it a very bright side into the corporate world. But obviously I never did a complete jump. I've always stayed clinical, I've always kept my hands on the clinical side. And I think this is kind of what has given me kind of a role in the field of creating communities, creating interconnection and creating a better understanding between both the corporate and clinical sides.

Griffin Jones  42:44

Well, being still in the clinic, is there a way that you see of balancing the physical space? Are there other changes that need to come with the physical space, not just the technologies being digitalized? But are there other ways that balance the physical space in the digital space? So there's sort of feels like one single environment?

Dr. Cristina Hickman  43:05

Yeah, so this is something that has been a big focus for us and ovum care. So when you're thinking about the branding, the marketing and the feel that your brand brings to the clinic, to not just the clinical but but to the to the patient to herself. It needs to feel like both the tech, the digital and the physical feel like one, there needs to be a consistency in your story in your look and feel. I think one of the things before as an embryologist, I never quite got the UX, UI and the look and feel. And I have a much greater appreciation now of how important that is to the patient and to their experience that they're going through. So what you want in your patient app is you want to have that ease that when you come in, you have all the information you have the transparency of your care, you have your own digital passport that follows you beyond the point in your journey where your care is complete, but you can always look back and it's they're accessible to you. There isn't a restriction on you accessing your own data, which is not just a legal requirement, I find it should be the ethical approach as well. But then you get that same feel when you walk into the clinic, where you have you walk in. So the way we've designed it, we didn't go the spa route. I found the spa route was too sedentary. I didn't want to go the big corporate route. It wasn't about walking in and feeling like Oh, I better dress up to come into this clinic. You know, so this has been some of the clinics I've done in the past. And when I did focus groups with patients, they said look, this place is beautiful. It looks like a five star hotel. But it's it, I don't feel comfortable in here, which kind of shocked us because you know, we had used the most expensive interior designer for this room. And turns out this is not what patients wanted. What a patient wants is to walk into a clinic and it feels like home. Okay, it looks and feel feels like they are in their own home. So for us, this meant that we use a lot of wood in the, in the decoration, we use a lot of a lot of texture. And we made the room, we have books around the place, we have lots of lots of plants, lots of trees, lots of making things look as natural as you can, and as far away from clinical and hospital feel as you possibly can get it. And definitely not going down the spa route. Because that's too relaxed, you want to get it to the point where they just feel comfortable in that environment. And this will reflect into their care. I didn't understand early on in my career, how important the space was, you know, so for instance, initially, the clinics I worked in had one office for the embryology team, one office for the nursing team and another one for the doctors. And this creates kind of competition between the teams, which is the opposite of what do you want to achieve. So open plan spaces, so similar to We Work offices. And do you have We Work in the US?

Griffin Jones  46:02

Did they go out of business? They were something happened with them? They were not. But yeah, they were they were a big rise. And then I think they weren't profitable for a while, maybe they're still around. But yes, we have them.

Dr. Cristina Hickman  46:14

But the idea is creating a space that's comfortable to work in. So what is the optimal environment that will allow me to achieve the best possible care to the to the patient? What is the type of ultrasound machine any to use the type of beds that the patient needs to be on? How do I hide the clinical field, and when I need to be compliant in terms of cleanliness, you know, for my CQC inspections, so there is we have spent a lot of efforts trying to find that right balance between feeling homely, not not feeling overly posh and feeling comfortable, yet compliance with healthcare requirements. And the way that we've approached this is by creating modular systems that will allow for clinic builds to be built up faster and therefore reducing the cost of care even further.

Griffin Jones  47:04

So as you started to talk more about the ultrasound machines that made sense of how that aesthetic translates to the digitalization in bridging the to the digital and the physical environment, but is that aesthetic that you chose? Is it a deliberate juxtaposition? Because otherwise the the digitalization just feels like you're in 2001 A Space Odyssey like I think of the movie Her? Did you ever watch that movie? 

Dr. Cristina Hickman  47:30

Yes, yes, it did. Yeah. 

Griffin Jones  47:32

For the audience that hasn't seen it, Jude Law, romance movie about he falls in love with artificial intelligence, it's really good. And one of the things that I enjoyed about the movie, it takes place in the semi near future, the undefined future where there's more advanced artificial intelligence. And in most movies where they do that, the aesthetic looks very futuristic. And they they counter position that with an older aesthetic, so it actually looked like the late 60s, early 70s in a in a kind of way, or at least that was that was marbled then throughout, and it it gave more credibility to the story in some ways, but it also made the aesthetic more realistic. Because it's not like I'm just in this like future pod like The Matrix, it felt like a proper balance.

Dr. Cristina Hickman  48:23

Yeah, and I think that's what, at Ovum our our tagline is where compassion meets technology, you know, and everybody associates technology with being cold. And I'm here to say that, you know, it doesn't have to be it's only cold if you use it in a cold manner. So how can we use technology to bring warmth to care. So for instance, whenever we're using the, our platform, we don't call the patient to tell them an update or fertilization we can face like, it's equivalent to FaceTime but directly inside the app through the security of the app. So we're able to see each other's face to face. And especially when you're giving bad news, you and you can read each other's face, and the patient can see the support from the facial expressions that you're giving to them. It's not just the tone of our voice, they can they can see us there, they have that option. And that provides that extra warmth, even though we're not physically together, you know, this, so so that approach of using technology to bring compassionate care has been also a big focus and has generated a lot of discussion of creating, for instance, different forms of communication that the patients can use. No more emails, okay, so everything. You can have email, like communications through the application. You can have WhatsApp like communications through the application. And the benefit and the nurses will love this is that at the end of sending the email, you don't need to then upload your email into your EMR. You just send it and it gets received by the patient. And now we have AI learning all the words that are being sent back and forth with the patients to try and identify things that we need to improve on. You know, do you have, are they complaining about there not being enough appointments available? If we start picking that up before the patient even gets a chance to realize as a negative. You know, there's, we try to fulfill that there's a Japanese feel words called Omotenashi. Do you know it? 

Griffin Jones  50:18

Nope. 

Dr. Cristina Hickman  50:19

It's about predicting what you're going to need before you realize you need it yourself. Okay, so what we are really using this as a true example of how technology can support compassion at a level where we can provide a care before the patient realizes their needs. By this point, it's already been fulfilled. And it's no longer a need.

Griffin Jones  50:41

Talk to me then in anticipating needs, how much is this technology? How much is artificial intelligence going to or should be, maybe not just treating infertility but maintaining reproductive health? And what's the difference in your view?

Dr. Cristina Hickman  50:59

Yeah, so I think that's a really important change in direction that we're going to be seeing, it's not there yet. We're seeing some early signs of it, but it's not quite there yet. So we are making that a core at both Ovum and Avenues. So in Ovum Care, it's not just about treating the infertility. So historically, we've seen infertility as a disease, we've made big points of getting the World Health Organization to recognize infertility as a disease. But I want to see if we can change that a bit. We're in a world now where we know our patterns of our sleep. Because of our wearables, we know we get beeped when we've been sitting too long. So go go take a walk, we know how many steps we've taken today, and what we've eaten today. So we're now at a stage where we know more about our bodies and our health than we've ever done before. Historically, what we associated with healthcare was going to a hospital, our children are going to associate healthcare with their smart ring or their smartwatch. Okay, so the perception of what healthcare is, is different. And because we are gaining a better understanding with tools that are available at home, we are we are have this expectation that we don't want to wait to be sick before we get treated, we want to see how we prevent the sickness and for infertility, that means not treating the patient when they have been trying for six months or 12 months, and then bring them into the clinic. I mean, can you imagine trying for 12 months and every month getting the, maybe next month, maybe next month, and trying again, and not being able to be treated by your National Health Service, because you don't fit the criteria, because you haven't been trying for 12 months. I mean, that's quite, quite tough. I had the blessing that I mean, I'm Brazilian, I had private care in Brazil. And as a consequence, I went to the gynecologist as a teenager, I understood my body from the age of 15. And I knew all my reproductive health issues early on, I planned my life. I had my children when I was 24 in my mid 20s, and I wouldn't have had I not known what was my reproductive situation. So in having this early in life, you go in, you understand your body, both the man and the woman, by the way, not just the woman, we understand, and we can do the appropriate plans. For me, the plan was just trying having babies early or earlier in life than I had originally anticipated. For others, this might mean freezing their eggs, or for others, it might be just coming to terms with the fact that okay, maybe babies are not for me. And this is something that if I ever want them, I'll go down the adoption route. But I know this early in my life, and therefore I can prevent the needs that I would have needed IVF I would have needed egg donation if I hadn't gone through that journey. So how many other patients right now are doing egg donation. And unfortunately, I don't have a time machine to give them to go back in time to tell them to change their reproductive plan. So this is the approach that we that we're taking, where we're not just treating infertile patients. We are combining infertility care with gynecology care with urological care. And we want to kind of see all of this throughout your lifespan even beyond in your menopause and andropause years so that we can have a better reproductive health not disease halfway.

Griffin Jones  54:27

How does something like Embie play into this and I'm picking on them because they hit me to you and you've mentioned them a couple of times but this is not a featured sponsor episode, they might do the brought to you by, but featured sponsor means the sponsor gets editorial control. They don't get editorial control. So you can say anything that you want about them we're not going to cut it that you can you can run him through the mud, you could say they're great. You could say that they're that they got a ways to go but what what what are how do they play into this dynamic?

Dr. Cristina Hickman  54:59

So Embie, I met Ravid, she's the founder, very impressive, anybody who has the opportunity to meet Ravid, this she's one of the stars in the fertility field. Her story is that she's had multiple IVF cycles, I can't remember the exact number. It's something like 10 or 12 cycles, something absurd. And she took that as a she learnt with her cycle that she went through initially being quite passive, and gradually being very data driven in her approach to the point where she eventually kind of told the doctor how she wanted to be treated based on the data she had collected. And she, what she learned from this is that she wished she had had this patient app to better understand her care at the time, so many other patients out there that she could support. So she's dedicated her life to create the solution to the patients. Now, before I met her, you know, she had this hugely successful app, you know, 1000s of patients data in there, patients are highly engaged with it, with her app. Her apps are beautiful, she she designs them, she has a marketing award winner, you know, she has an amazing background of skills, and she created the patient side. Now what was missing for me, I was like this poor patients are having to put things in manually every every time. Now, what was amazing about her data is that the patients that were using Embie app, compared to the patients that do not use Embie app around the same regions, you can compare that across geographies, across different demographics of patients, and so on. She founds that Embie app patients have reduced cancellation rates and increased live birth rates. So she presented this data at an estuary this year, you know that the numbers are astronomical, it's like they dropped from 8% cancellation rates are down to 1%. You know, so can't remember, like birth rates, I think it goes up from 46% to 61%. You know, these are these are we're talking about ends of like, 1000s of patients, you know, so so these are significant numbers, with significant improvements. And all that all that she's done, is empowered the patient with their information and provided them insights of similar patients to them, what's happened to them. You know, how powerful is that? You know, to be able, so the patient doesn't need to have a PhD in embryology and you know, I don't know how many fellowships in order to build the knowledge they need. All they need to know is that narrow information about them, to allow them to now participate and engage in the decision making. So this for me Embie app was very, very impressive as a tool. And we've been working together for for Ovum, as well as for Avenues. But this is the Ovum Care project. So we've been working together to create the clinical sites. And this is where all the things we've been discussing today. A lot of these are available within the Embie app. And this is the way that any other clinical they wanted to become an EMR free clinic. That would be the approach.

Griffin Jones  58:04

You've walked us through a number of solutions. You have explained to us the difference between digitalization and digitization. You have shared with us how the digital and the physical environments can blend you've also posited in alternative to having a hub in EMR free clinic would be an interesting follow up topic to bring you back for just a topic about that. But how would you like to conclude our discussion?

Dr. Cristina Hickman  58:32

I think I think we have reached a new a new world to embryology today is so different to what embryology was five years ago. The same goes to nursing and reproductive reproductive care as a whole digitization is the new buzz. You know, the investment in this in this area of fertility has skyrocketed, and the number of very innovative companies out there, they're here to stay. These are not digitized. It's not something that's going to come and go. And we can put the blinders on. And I think everybody who's who's listening in have a responsibility of really thinking through Am I really offering the best standard of care to my patients? Do I need to rethink how to modernize my care so that I can really put patient centered care as a reality in my particular practice.

Griffin Jones  59:23

Dr. Cristina Hickman, thank you very much for joining us on the Inside Reproductive Health podcast.

Dr. Cristina Hickman  59:28

Thank you. It's a pleasure to be here. Thank you.

Sponsor  59:31

This episode was brought to you by Embie. To discover where your time is going and how Embie can transform your clinics efficiency. Visit us at embieclinic.com/report. That's embieclinic.com/report. You've been listening to the Inside Reproductive Health podcast with Griffin Jones. If you are ready to take action to make sure that your practice thrives beyond the revolutionary change.

191 3 ways to increase fertility center revenue with genomics featuring Dr. Mili Thakur

DISCLAIMER: Today’s Advertiser helped make the production and delivery of this episode possible, for free, to you! But the themes expressed by the guests do not necessarily reflect the views of Inside Reproductive Health, nor of the Advertiser. The Advertiser does not have editorial control over the content of this episode, and the guest’s appearance is not an endorsement of the Advertiser.


Should you consider integrating an in-house genetics counselor into your practice?

Today’s guest, Dr. Mili Thakur, makes her case on the future of genomics and its place in the REI medicine space. She walks us through how an in-house genetic counselor can boost practice revenue and optimize patient retention.

Tune in as Dr. Thakur gives us insights into:

  • Her 3-point business plan showcasing the importance of genomics integration into REI practices

  • The number of cases she believes warrants an in-house genetics counselor [It’s not as high as you think]

  • Why Carrier Screenings matter [And her criteria on how she vets companies]

  • The future of Genomics [And why it’s the biggest investment opportunity even beyond the infertility space]

  • And more…

Dr. Mili Thakur:
LinkedIn
Genome Ally, website coming in May

Transcript

Dr. Mili Thakur  00:00

I think it would be dependent on the total volume that you're able to bring in to the practice. I would say if a doc is seeing about like 10 to 12 some of 15 new cases in a week, you know, there's going to be at least two or three of them that are genetics or their hidden genetics like they're not obviously I but like recurrent pregnancy loss if you're seeing five or six recurrent pregnancy loss patients in a in a week. You know, in about two weeks, you're gonna have a PG DSR case.


Sponsor  00:33

This episode was brought to you by bundle, you may be able to receive a free list of financially qualified IVF patients across the US and Canada. Contact bundle at bundlfertility.com. That's bundlfertility.com/contact-bundl. Today's advertiser helped make the production and delivery of this episode possible for free to you. But the themes expressed by the guests do not necessarily reflect the views of inside reproductive health, nor of the advertiser, the advertiser does not have editorial control over the content of this episode. And the guest appearance is not an endorsement of the advertiser.

Griffin Jones  01:27

A call for action amidst the turmoil of the reproductive genetics field now I didn't write that but my guest did her name is Dr. Mili Thakur. Dr. Thakur is double train. She was the first fellow to graduate from an ABOG ACMG combined fellowship in reproductive endocrinology and infertility and medical genetics. She did that in 2017. From Wayne State when she left fellowship and join private practice in Grand Rapids, Michigan, she made a business plan she made a business case for why they needed an in house genetics counselor at a four Rei practice in not a very big market. We go through that business plan having an in house genetic counselor and having genomics be a part of the REI practice today, Dr. Thakur supports that plan with three different points. First is the revenue that's generated downstream from genetic counseling, the additional cycles, the testing storage that might be necessary. Second is patient retention. Dr. Thakur argues that if patients really struggling with a genetic abnormality and you're the one that finds it, they're going to stick with you. Third is donor IVF cycles if you can prove that they're necessary from finding abnormalities then that patients going to need donor cycles. I pressed Dr. Thakur on why genomics is so valuable to the practice why it's so valuable to the patients as well. And I come across a point where her background might give her an insight that is not at odds with you potentially and that has to do with carrier screening and the variance in the quality of panels. I've got the impression from my nine non scientific polling of many of you that it doesn't really matter who does your carrier screening. There's a dozen or so companies out there. Many of you have told me it's one or the other doesn't matter too much. Being a geneticist, Dr. Thakur has a different opinion. Dr. Thakur thinks the carrier screener does really matter. And she shares her criteria for how she and her genetic counselor that carrier screening companies criteria such as actionable conditions versus non actionable conditions, and they have to be actionable criteria of the curation of data that labs have to be able to curate that data and I pushed afterthought core on how scalable these revenue upsides are for fertility networks that might be trying to cut the lowest possible deal with a carrier screening company that leads us to the question does someone with a genetics background have to be a part of the governance of a fertility network the same way a chief medical officer and a chief scientific officer are asked Dr. Thakur for a ballpark what number of genetics cases make sense to have one full time in house genetics counselor turns out not that many in her view, Dr. Thakur surmises, we have 10 to 12 new patients a week two or three of them might very well be genetics cases, she gives the caveat that you have to be looking for that which is at the crux of the whole conversation. And she shares more detail about that we talked about the future of genomics and art and how that might become so much bigger of a marketplace than the infertility segment alone. Dr. Thakur thinks that genetics is far and away the biggest investment opportunity in art. So I asked her why the heck doesn't it look like that now with genetics companies closing their fertility divisions? Her answer made sense to me. I want to see if it makes sense to you. Finally, Dr. Thakur talks about her new venture genome ally that she's beginning to prove concept for and bootstrapping my thumb to the wind test of all of this is that we are in an atypical role for genetics in the fertility field and then it's going to come roaring back my perspective. Isn't that interesting? I think Dr. Thakur is more so I hope you agree and enjoy this episode. Dr. Thakur, Mili, welcome to Inside Reproductive Health.


Dr. Mili Thakur  04:57

Thank you Griffin for having me. It's a privilege to connect to your audience.


Griffin Jones  05:01

It's a pleasure to have you on you've become a bit of a voice for genomics in the fertility center, I saw that you were quoted in an article that one of our journalists wrote a few months back about the changing business landscape of genetic testing and genetic counseling. And then I've seen you at a few talks throughout the field. And so let's start there, maybe how did you become a champion for genomics inside the fertility practice? 


Dr. Mili Thakur  05:34

So Griffin, I am a combined reproductive endocrinologist and a geneticist, which is great privilege that I had off training that way. So I am a OB GYN, I always took care of women I trained back in India did a residency there then came to Wayne State in Detroit did a residency and fellowship here. And that phenol shear force, namely, for me, was an opportunity to combine both the fields. So I'm the first fellow to graduate from a combined reproductive endocrinology and infertility and medical genetics fellowship. And that's what got me interested because I had a different perspective of both the fields combined together. So even though I trained in traditional genetics, and I know how to do cancer genetics, and pediatric genetics, and, you know, genetics for neurological conditions, and I trained for it with my fellowship, I specialized in reproductive genetics. And because I'm a reproductive endocrinologist, I do IVF every day, that's part of my, my practice, I take care of patients from the infertility struggles, and help them with both of these things combined together and merge, which is an amazing opportunity.


Griffin Jones  06:48

What's his specific use in your own practice in the way that you practice that you feel that you've benefited from having that genetics part of the or that genetics fellowship, that you feel that you wouldn't have been able to implement in your own practice of REI had you not had that fellowship?


Dr. Mili Thakur  07:09

So I think all reproductive endocrinologist or REIs do genetics as part of their job. But the advantage that I had from this additional training was that I was able to be well versed in the lab aspect of it, the moleculer aspect of it. So I understand the test, I just don't offer the test, I understand what's the science behind those tests. And I am also able to take care of like, complex situations that involve genetics. So because of our training, you know, we, during my training, I took care of like newborns who were diagnosed by the newborn screening program in the state of Michigan. So I've seen those conditions firsthand, and how they affect children. So when a couple comes back to us, saying that they have a child that's affected, you know, I've seen the other aspect of it. So the combined fellowship helped me hone into a specific area. So it's not difficult for an area to take care of genetics on a day to day basis, they do it all the time that traditionally it's been done. It's just I've been able to cater to a niche of patients, because I understand that complexity. And it's easy for me to say, you know, what needs to be done here and how to select the test. So there is this specialization that has developed based on that


Griffin Jones  08:36

I won't go too deep into the clinical, because it's not a clinical show is a business show, which is what I'm more qualified to talk about. But I am curious when you're talking about not just being able to read the test results, but to understand the science behind the test results. Can you think of an instance where it was really paramount that you knew the science behind those test results, as opposed to being able to just read the test results to any does any one instance come to mind?


Dr. Mili Thakur  09:04

So one of the common tests that all are used, and I know your audience is primarily people working in the reproductive medicine field is a carrier screening. So preconception carrier screening is a common test, it's been given by different companies. So there's like more than about 10 to 12 companies that offer that test, it may be even more than that. So each one of those companies uses a technology called next gen sequencing. And each one of those companies offers a panel of tests and that panel can range between sometimes 23 conditions to like now 600 700 conditions. So what advantage that that additional testing brought for anybody working in the field of reproductive genetics is that I understand carrier screening testing from a different angle sometimes i i unlike colleagues like myself, would be able to understand more than the medical representative or the salesperson who's coming to sell the test. So for an example, like for cystic fibrosis, you know when for cystic fibrosis is a common condition that we are carriers of that tests can be done by next gen sequencing, most labs are up to par and sequencing that gene and like looking at different spots on there. But then when a certain type of mutation comes through, there is another additional testing called five t testing. So to be able to ask the medical rep to say, do you do five t testing? Is there a reflex that we can do if needed? Same thing for like fragile X? Do you do AGG repeats? And how is your curation of radiant? How often do you guys look back? So we have another stringent layer that I'm putting any tests that I am wearing for my patients through? So it helps me serve my patients better? Because I have an understanding of what they're doing behind the scenes? How is that report being signed off? You know, what are the things that they are not reporting out, because they're not reporting out the whole gene to say, and so in genetics, you know, our colleagues in genetics will relate to this much more, we don't say, hh, you're negative for the condition, we say there is a risk reduction. So you being a carrier, based on an ethnic background is a certain number. So say one in 30, after the test, that risk slows down to being one in 10,000. But it's never going to be negative, because the science hasn't advanced to the point where they can look at the whole gene completely. So by knowing that back end workflow, and what is out there, I can challenge them and have them give us the best possible test.


Griffin Jones  11:47

So you can vet the tests better than you could if you didn't have this background, and you mentioned a couple of different applications for it. So you're ultimately getting more productivity from the test, you're, you're getting better results from the test, is it also to vet so are some tests? Did they have features that are unnecessary that are, that people are paying for? Is that part of the vetting or not as much?


Dr. Mili Thakur  12:12

It is. So basically, what we do is like for each of the patients that comes to me, especially with complicated, complex genetic history, we are able to find the right test for them. And then kind of streamlining the cost of it as well. So as, as one of your previous guests on the show, Dr. Arredondo, Paco, always says, you know, we have to cut the frills out of the thing. So sometimes with these complicated histories, you know, because we are in such a busy practice, you know, you might order five tests, but then if you had that understanding of the test, you would be able to go straight to the test that's right for that family, and be able to serve them. So a quick example is, I had a patient who will their their dad had a condition and five of the boys, you know, three out of those five had a certain condition where their hair nails and skin was abnormal. They now wanted to do IVF. And they wanted to do IVF, because they didn't know that genetic mutation in their family, their dad and mom had gone through some genetic testing 20 years ago, they didn't know you know what the mutation was, at that point, they just wanted to do IVF with PGT A and select for boy embryos, they said, We don't know what's affecting our family, three out of the five boys are affected by this condition, we don't look good, right? So let's just have a boy so at least he wouldn't be bullied in school or have issues there. And because now they were coming to see me and times have changed. Now I could look at him and say you have some form of ectodermal dysplasia, there is a panel available for it. And then we worked with the family and with our colleagues in genetics at a local hospital, called them the right test, we were able to identify a variant now variant of uncertain significance means that you know, we don't know if it's really the causing disease because it had never been reported before. We had a family where three boys who are affected to were not affected, we were able to segregate the variant test everybody in the family. And then not only that person, but we were able to identify a novel variant. It's never been reported. This is the first family in the entire world to report with that condition. And then that person and his brother went through IVF for selecting embryos that are disease free, they were able to transfer all different genders that they wanted to and also have a healthy child for two of the brothers that are affected. And so coming back to your point of like the business aspect of it, had I just gone and done IVF for pcta saying okay, we can't find the answer for you. We would have just finished up with one cycle, the patient wouldn't have been served to the best interest because their mystery would not have been solved their story would still be like, we don't know what's affecting the children in our family, right. But now with this additional testing, our practice, my practice got not just one, but multiple IVF cycles, because they were searching for the right embryos, they're coming again for another transfer each one of those families has had done now for transfers, right, they have two children each. So it's a long term relationship that you build. And the revenue generated from all of that is what then justifies that process. So I spend extra time because I'm extra trained and like, I have this additional training. So I spend extra time but then I make up for my time with that additional revenue that I generate from these cases. So the biggest thing that's driving us is patient benefit. Now they have an answer. Now they have a healthy family. But it took extra effort, it took some time to get to that answer. And you know, we were able to solve that case. So that additional piece is what makes this model sustainable. 


Griffin Jones  16:16

So we ventured into PG ta but back to carrier screening for a second, I had always gotten the impression from doctors that they didn't really care which carrier screening provider, they chose that many of them do care who they use for PGT A but for carrier screening, I'd always gotten the impression that doctors feel like that it's a commodity, is that less so in your view? Is it? Is it not as much of a commodity as doctors think it might be? And that there's a bigger difference between carrier screening providers?


Dr. Mili Thakur  16:45

Yeah, so actually, for from my perspective, and many of my colleagues in genetics, we are extremely thorough and careful in the products that we select, we consider them as products. And like any other thing that a clinician would be offering to their patients, you know, you have to understand what they are doing. Because the main things to consider is one, are there actionable conditions on their panel. And there are conditions that are not actionable, there are very, very rare conditions on there, and they are going to be reporting those out, you would have a very high positive rate, and you will have to deal with the back end of it. So first should be actionable conditions. Like I don't want a panel that has an MTHFR on it. MTHFR is a genetic change. That's very, very common. So I don't want a panel that has that change, because it doesn't change what I do clinically. And it kind of raises red flags for no reason. The second thing is how thorough is reporting, you know, of the different genes that they're doing? And then also about how is the curation? So some of the our viewers will, you know, be able to understand this? Well, it's like these changes that are being reported, some of them are very new, and they are being reported as variants of uncertain significance. We don't know if they're gonna cause disease or not. But because the science is advancing so fast, all of these labs have to curate, they have to keep every six months look back into the database and say, okay, now, is this mutation something that's deleterious? is causing disease or not? Is it something that's going to be causing problems? So if a lab does not curate their data every so often, then you're going to have gaps in there. And then in prenatal testing, or in preconception testing, if a variant is reclassified? Is the lab going to let us know? Because you know, for future, like if this couple is going to have situations where a couple came to us for second opinion, because despite a normal carrier screen, they had an affected baby, because they had a variant of uncertain significance, which was not reported out. So we went back to the lab, and we wanted them to look back at the data, reclassify the variant, and that's why, you know, it's important for busy clinicians, REI providers, doing high volume IVF, all of these networks, to consider working with somebody who's, who can take care of those extra genetic needs, like when you're picking up product, no matter which genetic product you're using. So some of the products that we use, one of them is carrier screening, another one is stereotyping. Another one is products of conception screening. PGT is another product, you have to know what you're offering to your patient. What are the gaps there and challenges there so you can counsel them appropriately. There are some companies that are not reporting out HCG repeats and FMR gene. So if you've got somebody in that certain situation, then you will have to request it extra versus there are some companies that will do the FMR gene, and if they found a certain thing, they will do the AGG repeats. So when the results come to you, you're able to say, yeah, this is something that's actionable or not actionable. So the complexity of it is being lost because of the volume terrible providers are seeing and you know, you were at some recent conferences, there is this shortage of REIs, like all of us are doing a lot of cycles. So in all of that, the piece that a single test is playing is so small that it can be overlooked. And you know, things can fall through the cracks. So there has to be safeguards put in place of like, okay, which, which tests are we doing, if we said to a patient, you are negative. And sometimes, you know, in practices that don't have that expertise, or leverage, a nurse might give out test results. And she might say, Oh, you're negative, and the patient who doesn't know the science of it just thinks, oh, they're negative for cystic fibrosis, but that's not the case, do the test that, that your risk of being a carrier has now been reduced. And now, you know, your partner has been tested and their risk is reduced. That means there is still a likelihood very, very small, though, that something could happen to a child, you know, so the understanding of it is a little bit different. Our viewpoint is different, basically. So I would read, I always read the test, I understand I sit down with the reps, you know, I would look at all the information before I will select the test.


Griffin Jones  21:33

With regard to understanding I read your bio, a little bit of it before we sat down for our interview here. And it seemed that your center, the your fertility center, the Center in Grand Rapids hired an in house genetic counselor in 2017. Is that right?


Dr. Mili Thakur  21:50

Yeah. Yeah. So I started out of my fellowship in 2017. So as soon as I landed the job, you know, I wanted to have an in house genetic counselor.


Griffin Jones  21:59

Tell me about how you made that case at that time, because at that time, you're an independent center. So now you're Ovation now US Fertility at least on the lab side of things, but the at that time, you were completely independently owned fertility center, is that right? 


Dr. Mili Thakur  22:14

Yeah. 


Griffin Jones  22:15

And Grand Rapids is not a huge market. And so how did you make that case that, that you needed an in house genetic counselor in the practice?


Dr. Mili Thakur  22:26

So I had to write a business plan. So like anything else, we wrote a business plan. And, you know, I had a strategy of how to make it financially viable for any practice to embrace a new set of paradigm, you know, you have to make the case of how we are going to make it financially viable. And the way we did it, and one of your previous guests, Amber gala talked about it, you have to work with whatever is happening in that state. So in some states, genetic counselors are able to bill at the time, you know, in Michigan, genetic counselors, were not able to build for it. So the way I did the things was one, in my mind, you drag generate revenue downstream from the genetic counseling. So if you are able to one, number one is engaged the patient, if somebody comes to you, and you're able to provide the right service and engage them, you're gonna have a better chance of them going through a complicated treatment. That's number one. The second thing is patient retention. If you've had somebody coming in for failed cycles, and now you're able to do some genetic tests, you find the abnormality, they will, the patient is not going anywhere else, no matter how long it takes. The third thing is because of all the support that you have from a genetic counselor, or that expertise that I have, because of my training, you aren't able to have them go through donor cycles, like if you found a genetic mutation, and they now know that there's something wrong, they're gonna do egg donor or sperm donor, and you're gonna be able to engage them. So when I wrote the business plan, those are the avenues that we were able to do and you wouldn't believe it. Like in the first three months of our genetic counselor working, we were audited, like any other practice with audit their new process, and we were we were cutting even because like I was able to see double the number of patients I like I was seeing my own infertility patients, and also seeing a patient with the genetic counselor at the same time. So her time and my time was build right and then I was able to feel a level higher than what I would with her support. So if you have a comprehensive visit, they are able to spend half an hour with me and then half an hour with my genetic counselor. We are able to provide the best possible care for them. We We are able to solve some of these complicated situation order the required amount of testing on that same day, and then I was able to build a level five visit. And because we were able to get them to write tests, we were able to engage them to do IVF with PGT M, PGT SR, which is like many, many cycles would come out of that one, one situation for that couple, they might do multiple cycles to find the right embryo, and then they will come back for their second and third children, because their embryos are stored with us. So if you are able to do the math there, you know, you did multiple IVF cycles out of that one console that you could do because of your expertise or your partnership with that, that genetic counselor. So and, you know, Amber, gamma had previously told you the salary that a genetic counselor would have, it's usually I heard her podcasts with you, and she mentioned somewhere around 100, 250,000 Is what she mentioned, based on their professional society survey, 100 or 150,000, you are able to do it, get that revenue back in a few IVF cycles. Right? So it's like, yeah, so it's the understanding of the best care for the patient, in a model that embraces that new technology. So you're freeing up your staff, you're freeing up the doctor to do other things they are able to do IVF practice while that person is totally every day doing complicated genetics for you.

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Griffin Jones  27:19

Maybe we should talk about that time that was freeing up for you because I'm understanding the picture of the revenue that is generated downstream from the genetic counseling that you're painting. I, if I were a hiring doc might look at you and say, well, I've got you, what do I need to hire a genetic counselor for you just did this double fellowship, you have this genomics experience and credentialing, so why do I need to hire a genetic counselor when I have a doc that also has this training?


Dr. Mili Thakur  27:49

Sure. So one of the key things pioneers in the field right now are talking about this, you should use or utilizes the right word, everybody at the top of their license. So for me as an REI, the top of my license is surgery. Right? So if I'm doing a hysteroscopy, if I'm doing an egg retrieval, if I'm doing an embryo transfer, nobody else can do it in my practice. The nurse can't do it, the genetic counselor can't do it. So that's my top of the practice. What the genetic counselor does is she works, she or he, you know, any they work on the top of their license, and their top of the license is to be able to take that information, break it down into an actionable plan, get the testing ordered, and then be able to give the test results. And then you're able to utilize the doctor's information of like, oh, yes, you need IVF. And you're able to use their expertise to take that patient through IVF. So the way we have it in our practice, and, you know, I'm about to launch a new venture where I would be working as a liaison like I want to uncover the case for the doctor to then take it through for IVF.


Griffin Jones  29:05

I want to ask you about how you would liaise with them and what you plan to do for that venture. I'm interested and it's making sense the type of license argument for your genetic counselor, there's four or five Doc's in your group four or five REIs? 


Dr. Mili Thakur  29:21

Yeah, so there's four, 


Griffin Jones  29:23

Do all of the docs utilize the genetic counselor or or just you?


Dr. Mili Thakur  29:29

The way we have it set up in our practice, or the way I set it up for our practice, is that the genetic counselor is available for any of the patients that are going through so we have tried to specialize in genetics for the whole practice. Nobody else except for we and the genetic counselor and we have an genetics assistant are the ones that are holding all the workflows of the genetics so the dogs don't have to worry about it. The nurses don't have to worry about it. They don't even give the test results about They don't even get a phone call, we have kind of streamlined it to just be our area. So it takes away from the headache that the other doctors would have to face. So if the complicated case comes through, we prep the whole thing for them. And then the IVF still goes under, through them, for whatever needs to be done, 


Griffin Jones  30:23

How does the way that the other REIs interface with the genetic counselor differ, if at all, given they don't have the double training that you do?


Dr. Mili Thakur  30:34

So they could take care of the case, as anybody else would, like, all of my colleagues in REI, without the extra genetic traces are, are able to take care of most cases, you know, unless there is new testing that's required, but they're gonna be able to achieve that at the cost of time, they're gonna have to spend four or five hours per case, at least in our practice five to 10 hours minimum to get that case to get through, it's a high stakes liability case, when you're doing a PGT M case, right? Because you they are not necessarily infertile, they're just coming to you to be able to have a healthy child. So it's a different kind of scenario. So that doctor will be able to still do it, they will be able to look up the mutation, go through all the history and everything, but then they're going to be utilizing the time, by having our model of like somebody specialized in genetic taking care of all of your genetic needs, you're able to free up that time, you know, I prep the case, I see all my cases with the genetic counselor, I understand it, it's easier for me, because I do that every day, I'm well versed in the technology and keeping up with the science of it. And the genetic counselor is part of a group of elite group of genetic counselors in the country. So she understands what is going on, we keeping up with the science of it, were able to prep the case. And then the doc can just meet with the patient and say, hey, go ahead and meet with our team, and they're gonna take excellent care of you, we prep everything. And then they go see the doctor again and say, you know, we have this is what we found. And this is what we are going to do, then you take them like a regular genetics case. And when it comes time to give results. Again, after the IVF is done, and the embryos been tested, which embryo to transfer, you know, it's a very critical decision making. And again, it comes back to us we meet with the patient, we give them the test results, and then you're back to transferring an embryo vision areas workflow anyway involved. So the doctors can rely with a lot of firsts on our team, and then get back to what they were doing. In the meantime, they're not spending extra time to be able to understand the new mutation or understand what needs to be done. Sometimes you have to call these genetic testing companies, you know, many of these countries have done more than 5, 6000 cases, right? So for 800, 900 disorder, but I feel like 901 disorder comes you sometimes have to call them and say, you know, is this something we can do for this family. So you're spending the back end time, it's just being taken away by this specialized group. So what I'm coming to, again, is that there is this need inside of our field to recognize that genetic testing is here to stay, it's going to become more and more complicated. The technologies are evolving day by day, the doctors in REI can lean on a group that is going to be just doing genetics all day. And they are keeping up with all the things and reading the different tests and the technologies that are coming through and then do what they do best, which is patient care. So they're not like worried about okay, they did get documented in the chart, that a certain embryo should not be transferred or should be transferred, right. It's like a busy practice for most of the areas that I know about, you know, they shouldn't be burdened with something that they're not doing every day. You know, these cases are special cases that require a certain amount of focus that has to happen. 


Griffin Jones  34:16

So I'm seeing the focus that's necessary and the support that's necessary from the genetics counselor, and even the revenue upsides that can come from it. I want to push a little because as we talk about scaling, I imagine that this is the people who do the scaling what they think about in that okay, so I buy your case for a genetic counselor, I see the revenue upside I see how much they help the doc why in house though, why isn't this something that we can outsource that we can do via telemedicine that if we've got a network we can you know, maybe you will maybe we got 100 doc's in our network across the country and we have four or five genetic counselors. Why is this something that has to be in house in your view?


Dr. Mili Thakur  35:00

For me, it needs to be in house because you know the type of volume that I do. So the volume justifies what you're able to build for and keep up with it. So if it is network, or if it is a high volume, practice for sure, they should have some sort of partnership with either an in house genetic counselor or a company that just takes this whole genetics and does it for their practices or you know, the clinics that they are. Or if you're a small practice, you're not going to be able to afford a genetic counselor at all. At that point, you could have a hybrid model. So hybrid model means that you know, you could do some of your regular day to day genetic results giving through the company. So all of these reference labs will have genetic counselors, and they can give easy test results. They're not based inside of the practice. So they're not able to tell the patient what to do or what not to do, they don't basically take away the work from a nurse or the doctor, but they are just a resource. So that can be some of the results that can be given. And then you could have a group of practices in sharing a genetic counseling service or telemedicine genetic counseling service, there's a few of them right now. And a lot of people are leaning on them after what happened in the IVF field with some of these big tech companies, genetic testing companies, you know, entirely dissolving their fertility units, there were no genetic counselors available for a short period of time. So telemedicine companies to con that extra work, and then if you're a big volume, practice, and you're able to justify a genetic counselor, you should have some partnership with either an in house genetic counselor or through a company that takes on that work for you and not worry about it. Because the revenue will be generated in no time, you know, I have no doubt about it. But if you're a small practice, you're doing like less than 100 cycles, you're gonna see maybe one or two generic cases in in a month that it doesn't make sense to have a genetic counselor. Although another thing that I wanted to kind of point out as if somebody has that genomics business aspect of it, we are only scratching the surface of what is the potential out there. So there is a lot of families that want answers, they just don't know that they want answers. So if somebody wants to build a bigger practice, they are smaller practice, but they want to do more cases, by building your genetics brand, you can like be stronger. So there's all sorts of models. And I think at this point for what I see in the field, a hybrid model is good. That means, you know, depending on what you can and cannot do you lean on a certain way.


Griffin Jones  37:48

So for you hybrid wouldn't work because your volume is big enough, can you give us a general rule of thumb, like a ballpark rule of thumb of what number of genetic cases make sense, where the genetic counselor should be full time in house,


Dr. Mili Thakur  38:03

I think it depends on the total number of patients coming through in a year or a month for a patient for practice. So if a doc is saying about, like, I would say if a doc is seeing about like 10 to 12, some of 15 new cases in a week, you know, there's going to be at least two or three of them that are genetics, or their hidden genetics, like they're not obviously I but like recurrent pregnancy loss. So, you know, if you're, if you're seeing five or six recurrent pregnancy loss patients in a, in a week, you know, in about two weeks, you're gonna have a PGT SR case, because you're going to find a balanced translocation in one or the other patient. So I think it would be dependent on the total volume that you're able to bring in to the practice. 


Griffin Jones  38:56

But that's not crazy, high volume, I suspect that the probably the median of people listening is probably doing that doing that about 10 to 12 new patients a week. And so you're saying of those 10 to 12 new patients, you're likely going to have two or three cases that,


Dr. Mili Thakur  39:11

If you're looking so the caveat to that is are you looking, you're gonna only find those cases, if you're looking very well. So like, in our practice, we have a protocol. And you know, for my new venture, I have a protocol that if you have a couple that has male infertility, and the count is lower than 5 million, you have to look for the karyotype of the male to find the translocation. And then if you have to do the Y chromosome testing, so if you did enough tests, you know, about 10% of them are going to be abnormal, and then you're going to find that one extra case that you solved. So you have to be looking, there are other ways of doing it. You know, the count is low, let's just do IVF. Let's just, you know, make embryos and that's why you have sometimes failed IVF cycles after failed IVF cycles, because the protocols that have been given by our professional societies are not being able to be followed. Because you know, it's like a cookie cutter type of model that's going through, like everybody comes in, let's do some IUI. And let's do IVF. And then if you don't get pregnant, that's bad luck for you. But there are these cases that are hidden, you have to go and follow the guidelines to be able to find those answers. So we look for them, and we find them. And then because of our relationships with geneticists in the area, just because of my interest and my expertise, you know, we get direct reference. So I, I don't find PGT M cases based on carrier screening alone or male factor testing alone, I get direct reference. So people will come to me and say, we just had an affected baby who was in the NICU, and this couple is thinking about another baby in two, three years, can you see them? So we are getting these other reference cases, which right now, most practices, and I've talked to all the big networks, mostly, you know, about what they're doing, there is no process right now of capturing those cases, which, you know, by having that genetics, specialization, you're able to get those relationships. And then another thing that we have kind of leverage quite a bit is oncofertility. If you have relationships with oncologists in the area, you're going to get to serve patients who have a genetic mutation for cancer. And then you're able to do IVF procedures for them, whether it be like egg freezing or it be sperm freezing, or it be you know, embryo freezing, and an embryo freezing with genetic testing for those. So you have to genetics is an all encompassing thing like it, it percolates different areas are male factor is one pregnancy losses. And other one, cancer is another one, we capture them from all different areas. And you know, we are able to bring it to the forefront, sometimes the patients don't even know they have the issue. And now the whole plan is changed. So sometimes they will come for like, okay, male factor infertility, we wanted to semi, but then you find something and you show them and say, this is a condition that, you know, could affect the children. And you know, we can test for it. And then you change the plan to an IVF plan.


Griffin Jones  42:31

And part of the all encompassing of what you're talking about is being used in ways that are applied beyond infertility cases, but simply for anyone that wants to avoid genetic disorder using genomic says part and using ART as a means of how they have their kids. I want to talk about that broader market implication, I have one last question on the carrier screening that I can think of because you've you've made the case for a certain volume, where it makes sense to have genetics counselor, where you've made the case for the the revenue streams that come downstream from generating that you generate with genetic counseling, you talked about the patient retention benefits, and you talked about the donor cycles is all of this enough at scale, for you to choose a carriers screen name company that might not be able to do a certain deal if another carrier screening company can cut a really low deal. So I'm thinking of the MSOs as they start to consolidate fertility clinics, as they start to broker these deals to ostensibly drive down costs. If they go with one that is they can do a really, really low deal. And perhaps one that meets your vetting criteria can't Is there enough in those three areas, patient retention, downstream opportunities and donor cycles, that makes that is enough to offset big deals being done at the enterprise level?


Dr. Mili Thakur  44:13

So the point of the whole discussion at this point, Griffin is that the experts in that field should be part of the decision making process. The reason being that if if a non clinical person takes the decision, and you know, makes it a low cost test is available to everybody and everybody binded is bound to use that test. Then at some point it's going to be affecting in an indirect way. So what I mean to say by that is if you have a non clinical person somehow cut a deal without understanding the test and its implications downstream. There could be an error that can happen or an oversight that can happen and then that one or two cases will suffice for, like a huge liability. And that's why you know, all all of these clinical decision making, especially in complicated areas, so some of the complicated areas that I see in, in IVF, or infertility care as such, one of them is genetics. It's like, really, really multifaceted, complicated. There should always be a person with specialized genetics training, be it like an IVF doc with genetics training, or a genetic counselor who's trained in that field be part of that decision making, they should be sitting on the table and saying why or why not? We can do that.


Griffin Jones  45:35

Let's zoom in on that for a second, because I think that might actually be more at the crux, because it could be a clinical person that makes that decision. It could be the chief medical officer, who is an REI, I've had multiple REIs, to me say they don't care who the their carrier screening provider is that it's all the same to them. And so does there need to be, does there need to be something in the governance of a large network where genetics is represented? Or is it simply the case that the docs and the genetic counselors with that experience need to make that case to their, their chief medical officer? Or do you think there needs to be something baked in to the governance of an organization where there's more consideration of genomics?


Dr. Mili Thakur  46:20

So the way I see it is like in any organization, the head of the organization or the decision making, they have advisors? So So a good example is the President of the United States signs off on a lot of things or, but they have like NIH chief, as being their advisor who sits with them and says, Why or why not they should be doing something, or they have a surgeon general. So if a Chief Medical Officer or CEO is going to be taking those decisions, they should have a clinical genetics train person when they are saying yes or no to a certain company and say why or why not? Because if you're going to have, say, $5 difference between which is like what is happening in the field, right now, genetics is becoming less and less expensive right now. And it's going to be available. There is a $5 difference, but there is a huge difference in the clinical strength of the test, you know, would you go with, the better test? Or would you go with that $5 deal? Because I think I in one of your previous episodes, do you know, one of the doctors who talked about how to cut costs in the in IVF talked about that they would never negotiate the price or go with a crappy incubator, because the embryos are going in there, versus a speculum is easier to make the decision making. So like, if you're going to be doing something. Right, and taking a decision about it, that's binding to multiple clinics, you should always have an advisor. So you know, I've been an adviser to a lot of those, those experts that are taking the decision in multiple different categories. And that's the way to go. Like you could have somebody who can give you advice and tell you what's happening in the field and why and why not that things should be happening. Because when a non clinical person or a clinical person who's not an expert in that area takes the decision. They don't know, you know, what they're saying yes or no to and the drug reps sometimes don't know, I've had multiple instances where myself and our genetic counselor is the one who's telling them, can you tell me this? And then they'll say, Oh, let me find out from the genetic counselor in our lab, she probably will, they would probably know better, as to what is happening. So the, and the salesperson is doing their best. They're not clinical people. You know, they're not doing genetics every day, they are selling the genetic tests, but their education is in marketing or in sales. So you know, the person. Any REI physician out there, who's now offering a test to the patient is going under their license, all the testing all the results giving all the downstream effect of it is under the REI who did that, that care. So sometimes we don't have the bandwidth to do all sorts of things. So you have to quickly decide how how you are going to navigate that whole system. Like if you have the capacity, there are some areas who might feel extremely comfortable, they have done 1000s of cases of this complexity, and they feel great, wonderful. But then if somebody has been practicing in the field for a number of years, and they are not kept abreast with the technology right now, they're better served with like having somebody else be their partner for just that little piece of it, and then you go back to doing what you're doing. But you consulting advisors, or I think the way to go, I don't take any of the network's would want to take decisions on a clinical thing. without consulting the right expert for anything like if I wouldn't set up an IVF lab without an embryology lab director, like I don't know what happens inside of that place, right? I'm gonna have an embryology person, a PhD in embryology, set by me and tell me and then we can do it together. Right? If I was opening the door for a new test to be brought into the system, I would want to know, you know, what does the test do? Why is the cost higher than the other company next door? Like what are you doing extra that other person is not doing? And they can like tell you they very well, the salespeople would exactly be able to pinpoint the difference. And then you say is the difference like something that's just a frill? Like, is it just something that's additional? Or is it like really something that's like a clinical change, it affects us, it has a huge patient advantage of going with a certain company. 


Griffin Jones  50:51

Well, let's talk about what it's going to be like as it becomes more of the marketplace. So Dr. Stable has been on the show, and he talks about genomics and ART as infertility just being a fraction of what that could be for the general population. I've had other people on like Jamie Metzl, the author of Hacking Darwin, who I don't want to paraphrase him too much, but he posited something like, within a few decades time, we would expect almost everybody to be born from ART and using genomics as part of that. Where do you see the marketplace going?


Dr. Mili Thakur  51:31

So I think in the next 5 to 10 years, you know, there is going to be emergence of a lot of new things. So what we're going to see in my mind, is whatever has been available is still going to be continued to be available. But there's going to be this emergence of new technology with all the big data analysis that's now going to happen with artificial intelligence, there's going to be new things that we are going to be suddenly be able to offer to patients. And that's why you need to develop the workforce. So if there is any listeners out there who are looking for the next big opportunity of like, where to invest, you know, genetics is one of those big areas. And that's because there's going to be this influx of information that's about to hit us, that's going to be all these new tests and all these new data analysis that is available, are we ready for it? Is there a company out there, you know, that's able to just handle all that needs that these doctors are going to suddenly have to face? You know, that's the, for the next 5 to 10 years, we're going to be in transition, like it's not going to be an overnight change. And artificial intelligence in all different forms needs to learn, and it's going to learn from humans. The second thing is that on the other side, have any of those tests like or any of that artificial intelligence, data analysis is a human, you're still going to give it to patients, and patients have physical needs, they have their emotional needs, they have their family needs. And you know, no, no deep learning language model is able to tell a patient or comfort a patient who's crying, you know, sometimes these genetic test results bring an overwhelming amount of information. And, you know, so there is going to be the transition. So we will have our traditional models still be there, and then this new emerging technologies are going to overlap. And then at some point, you know, hopefully, we are able to get to a point where everybody is able to benefit, like, I'm a huge, huge proponent of proactive genetics, like in my mind, at this day and age, a young person should never be in the blind, they may or may not choose to do the testing, or any of the IVF process to take care of it. But they should, they should not be a single young person in this day and age in the US who doesn't know that they have a high risk cancer gene in their family that either they are a carrier or they're not or that they're a carrier of a certain preconception genetic carrier condition that's available by a saliva test done in about two minutes, and doesn't cost too much. And they still don't know their carrier status, like we have to change that we have to bring genetics to the mainstream in an easy way. So everybody knows I'm a carrier of cystic fibrosis, and you know, I'm going to test the partner if they're going to ever be in a relationship before they have a child so no child is then affected.


Griffin Jones  54:47

You're making a really strong case that this is one of the biggest investment opportunities in this space, partly because, why does anyone have to be born with a chronic disease that could have been preventable and that pool of people is even larger than the pool of people that we're serving now. But if it is one of the biggest areas and opportunities for investment, Mili, why doesn't it look like it is right now?


Dr. Mili Thakur  55:14

So the reason why it does not look like right now is because the two fields are being seen separately. So the advantage that I have is that I see both the fields and I have this view, vantage point that's different. So IVF, doctors specialize in doing IVF and taking care of couples who are trying to conceive by non IVF processes, right, they are busy with it, that's what they do. The doctors in genetics are busy taking care of people who are sick. So any genetics department is mostly situated in an academic center, and they are taking care of the reference that they get to find answers after the disease has happened. You know, from my vantage point, though, there is this huge gap in between those two specialities that can be filled. So if there is somebody out there who's able to uncover the risk for individuals who are not sick yet, you know, we are able to prevent the disease from happening, and also be a partner to the IVF practices for something that they're not even getting a referral off. So the reason why it's not been seen as an opportunity is because it's an untapped market. It's not been tapped, because the two specialities are not being able to see that. But from my vantage point, and with the expertise that, you know, we are able to have, you know, I'm able to see it, like it's right there. And it's been pointed out by a number of prominent speakers, you know, preventing adult onset cancer in our child, it would be huge, like, they would not have to go through all these screening tests and risk reducing surgeries that, you know, adults now are going through, but you don't test for these conditions in a baby or a child you test for these conditions and a transfer a disease free embryo. The same thing for neurological conditions, you know, there is conditions that that can be prevented the same thing with newborn condition. So newborn diseases, you know, are inherited metabolic diseases, and it's preventable. It's like completely preventable, if we are able to merge those two fields, and that merger will happen. But the opportunity lies now because it's untapped.


Griffin Jones  57:45

These genetics companies that have closed their fertility divisions, are they going to be able to get back into this space, this merger of the two worlds as you describe it? Or are they going to regret closing their fertility divisions?


Dr. Mili Thakur  57:59

So I think what is driving their closure is not a disinterest in the field. I think it's the challenges that the financial world is facing right now. And, you know, if they're part of your audience, you know, I would want them to look at that, again. So at this point, when the technologies are emerging, you know, you have a better view of investing in that thing. So right now, you know, a good example would be the artificial intelligence field, it's not there yet. But all the venture capitalists are looking for the next best thing that's going to be there on the horizon. And in our field, you know, one of the there are multiple fields, multiple things that are important. One of those things is reproductive genetics. So right now, whoever focuses on reproductive genetics and builds a strong infrastructure around it is going to have a definite advantage, not at the current time, it would start to show in the next 235 years, so technology in genetics is not going anywhere else. The biggest advantage they would face is the same advantage that the practices that invested in genetic testing for cancers have so good analogy for some of the people who are thinking about jumping into this field or, you know, thinking about it, is that in cancer, feel you you are able to serve the patient by doing chemotherapy. And right now, there is a whole science and a field that has developed inside of the cancer field, oncology field, that banks on molecular testing for the right mutation and the cancer and then giving the right chemotherapy. So any pharma company who was going to be developing these new tests needs a genetic mutation, and anybody who's going to give that chemotherapy so that hospitals benefit by giving the chemotherapy to that patient and the insurers the insurance companies better become stronger. So everybody in that whole system that so basically what I'm trying to say is we need to develop an ecosystem that combines the different genetics inside of the reproductive field right now they are scattered, they are in different locations. And we need to create that ecosystem with the understanding and the nurturing under a specialist.


Griffin Jones  1:00:26

Where does the new venture that you're working on fit into that ecosystem?


Dr. Mili Thakur  1:00:30

So I want to create that ecosystem. So the new venture that I'm venturing in is is genome ally. So we want to be partners for anybody's genetic needs. The first phase of that venture is to be able to help patients uncover their risk. So proactive genetics, to be able to make them aware, have them do the testing, get the test results, and then you know, if the test results are negative, they go back to their normal trying or, you know, family building as they please. But if we uncover a risk and we find something, then they are able to go through the process of IVF to prevent the disease, that they are a carrier, often, it also helps them proactively take decisions to be not getting the disease that they carry. So if it has an adult onset condition, if we take care of somebody who's like in their 20s, or 30s, they're not going to be suffering from lung cancer, because you already picked the condition and you're able to do it, it's going to also benefit some of the other specialities in our field. So if there is an employer based benefits company, if they're able to provide that to their employees, you know, it's a huge advantage, you're going to have a person not drop out of the workforce, as a young person with an adult onset condition are you going to have a family not get affected by a newborn, who suddenly so sick, and then they can't come to work? You know, these conditions are very rare in individuality, but then when combined together, it's a very big group. So I was looking at the data the other day, you know, there are about 3000 babies born with a certain number of a certain condition, and then 3000, more and 3000, more and 3000 more of certain other things. So if employer benefit company is able to provide the service to the employees, we are going to find some some families that are going to not then use up a whole lot of insurance and have sick children or have a disease to themselves. And it's a win win situation, it's the biggest win for the patient, that now doesn't have a preventable condition. It's a big win for the child that is born that is healthy, and doesn't have to worry about it in the future generations. And then it's a huge win for the employer because they get the goodwill of the company plus also for the benefits company, because they are they were the one for you know, your listeners and Walt progeny and carrot and Maven and all of these employee benefits company, it's such a huge win for them


Griffin Jones  1:03:15

Will Genome Ally be a carrier screening company, as part of it, or is it partly genetic counseling platform that interfaces with any kind of carrier screening company? How does that work?


Dr. Mili Thakur  1:03:31

Yeah, so I want to partner with industry partners. So what I would like to do is I would like to be the one providing the consultation and ordering the test, giving the test results and then bridging them to the required specialist. But then I would work with the industry partners and select them carefully to see you know, which one we are going to be using. And it changes over time. Sometimes these companies as you know, are evolving, you know, they come out of a certain test and don't do that test anymore. So, you know, you should be able to do what you do best and not reinvent the wheel. So if there is a donor company, right, that has like egg donor sperm donors, they're only needed to like match the intended parents with the right donor, and then we would, we would be able to handle that little piece of it while they do their job of matching and doing the cycle and everything. So what I'm suggesting with this company, and you know, that's my vision of the company is to be able to develop that ecosystem of having different partners and being providing the service that is required for reproductive genomics in a wholesome way. The first phase of it is going to be direct care. So be able to see patients whether they are coming to us, you know, by direct marketing or whether they are coming through employer benefits, you know, with that would be a huge advantage for the patients.


Griffin Jones  1:05:01

How far along are you with this venture? Are you just proving concept right now? Are you raising money? Are you selling any early stage customers? 


Dr. Mili Thakur  1:05:09

Yeah, so we are about to offer the services to patients, you know, the website should be ready in the next few weeks. So by the time I think your episode will air we there should be a website that's available, you know, I have all the other required things. And because, you know, in this day and age, you have to be ready to scale up pretty quickly, the scalability, I might consider investors at that point, but right now, you know, I just want to take some patients through and to and to be able to, you know, be in the know, of like, how the whole system works.


Griffin Jones  1:05:49

Yeah, I think that it's also really good to have something that you know, is going to scale, when you get the investors to help scale it. I think there's been a lot of people in the era of free money that have had ridiculous valuations, just to prove a concept that was never proven, we might be going back to the era of you work hard to build something to prove the concept. And then and then you can get people to scale it. And so you've got something here in that school, that it's that right now. It's you, you know, it's your your venture, and there's no outside money in it. We've covered a lot of ground today, Mili, and we got deeper into carrier screening than I thought we were going to, but I'm glad we did. Because you've you've convinced me to the extent that I can be convinced I'm not a clinician, but you've convinced me that it isn't the commodity that maybe I'd gotten the impression that it was but of all of the topics that we covered today, how would you like to conclude?


Dr. Mili Thakur  1:06:48

So I would like to say that, you know, in your audience, there are different types of stakeholders, and they all have like a different vantage point of the field for reproductive genomics. At this point, we are at a point where there would be a lot of emerging technologies, we have to be ready for taking care of the patients as we are bombarded by these technologies. And we should be ready to take care of the physicians and the clinical staff in an IVF practice, to be able to support them and giving the best patient care is going to cause them to have better patient engagement and retention, and then it will help them generate revenue for the practice.


Griffin Jones  1:07:36

Dr. Millie Thakur, thank you so much for coming on the Inside Reproductive Health podcast. I look forward to having you back on in the future.


Dr. Mili Thakur  1:07:44

Thank you so much for having me, Griffin.


Sponsor  1:07:46

This episode was brought to you by bundle, you may be able to receive a free list of financially qualified IVF patients across the US and Canada. Contact bundle at bundle. That's bundlfertility.com/contact-bundl. Today's advertiser helped make the production and delivery of this episode possible for free to you. But the themes expressed by the guests do not necessarily reflect the views of inside reproductive health, nor of the advertiser, the advertiser does not have editorial control over the content of this episode. And the guest appearance is not an endorsement of the advertiser. You've been listening to the Inside Reproductive Health podcast with Griffin Jones. If you are ready to take action to make sure that your practice thrives beyond the revolutionary changes that are happening in our field and in society. Visit fertilitybridge.com to begin the first piece of the fertility marketing system, the goal and competitive diagnostic. Thank you for listening to Inside Reproductive Health.

184 Mastering Efficiency in the IVF Lab: Strategies and Insights with Dr. Liesl Nel-Themaat


Are you seeking ways to enhance the efficiency of your IVF lab and improve patient outcomes? We invite you to listen to the latest episode of Inside Reproductive Health, where host Griffin Jones engaged with Dr. Liesl Nel-Themaat, IVF Lab Director and Associate Clinical Professor at Stanford University.

Here are some key takeaways:

  • Identifying and addressing common inefficiencies in the IVF lab.

  • The importance of standardization and its impact on success rates.

  • Strategies for optimizing workflow and reducing turnaround times.

  • The role of technology in enhancing lab efficiency and patient care.

  • Overcoming resistance to change and implementing effective process improvements.

  • Best practices and practical tips for managing patient flow and scheduling.

Stanford Fertility and Reproductive Health
Dr. Liesl Nel-Themaat’s LinkedIn

Transcript

Dr. Liesl Nel-Themaat  00:00

You don't have to spend 1000s of dollars to implement very expensive new technologies to become more efficient. You can start tomorrow in your own lab just by making some small adjustments in your own workflow or products that you pick staffing models, things like that.

Griffin Jones  00:24

Ask 23, IVF, lab directors and embryologist. What the biggest inefficiency in the IVF lab is and get 23 different answers that was part of the talk that my guest a vet PCRs Her name is Dr. Liesl nelta Ma. She's the lab director at Stanford's IVF lab. She has been an embryologist and lab director at different labs throughout the country over the last 20 years. And her model was about the inefficiency or talk was about the inefficiencies in the IVF lab. And I started the conversation off equating that with automation, we sort of got into a little bit of a semantic discussion, I hopefully still wasn't thinking that I perceived her as being anti automation. But I also didn't think it was entirely semantics, she was painting something for me where I could see that it's not just automating things in the IVF lab that is going to make it more efficient that you could automate quite a bit in the IVF. Lab. And you'd still have inefficiencies in different areas. So she made that clear to me. And it's I'm also on this cake that you hear me talk about with David sable a lot about when does it just make sense to replace a model entirely? You know, we could have made faster cars, but eventually you come up with something that replaces that entirely with aviation, for example, when does the existing IVF model just become marginal at best with the improvements, you can make an efficiency versus scrapping it and starting with something all together? And so I was having that like, philosophical question in my mind while she was thinking of the particular inefficiencies that she was isolating. So hopefully, that didn't mean she didn't feel like I thought she was anti automation. I certainly didn't. But I moved on past that part of the conversation for your sake inside reproductive health listener. And we got into specific examples talking about plastic where how that became worse. During the COVID pandemic, we talk about paperwork and what paperwork could be automated. We talk about those times sets or inefficiencies in the IVF lab that should be eliminated altogether, because you should never delegate something that should be automated. It also should never automated something that could be eliminated altogether. Then I made the sole say what she thinks is the biggest inefficiency in the IVF lab and extend that to globally as opposed to being in the IVF lab because in her view, it's something that affects the IVF lab is related to the IVF lab, but isn't coming from the IVF lab after this episode. I would love it if you email me or comment on any of the social media platforms that you came across the episode on what you think the biggest inefficiency is, if you think we missed anything. I would love your opinions of what you think are the biggest inefficiencies in the IVF lab. But right now enjoy it from the viewpoint of my guest, Dr. Liesl Melton on Dr. nelta mod, Liesl, welcome to Inside reproductive health.

Dr. Liesl Nel-Themaat  03:40

Thank you very much. I'm thrilled to be here.

Griffin Jones  03:43

I became aware of you at PCRs you are giving a talk about automation in the IVF lab or maybe about the lack of automation happening in the IVF Lab is a very comical talk, you involved a lot of people, you had a couple of different things in your giving examples of things that are all, you know, antiquated in the lab that could should be automated should be improved. At least I want to go into those examples today. But maybe let's start with just a synopsis of what was your talk about and what were you seeking to educate the audience about?

Dr. Liesl Nel-Themaat  04:19

Well, in essence, actually, it was not pushing towards automation. More what I was going for is the base back to the basic lab efficiency. So a lot of times these days people are getting excited about the automation, the new technologies, robotics, fluidics AI, things that make very cool presentations. But what I was trying to more convey to the audience is that the vast majority of labs are still working with basic things, basic skills, basic supplies. In the lab, and there is a huge opportunity to make things much more efficient. If you just look at the things that you already have and work with, you don't have to spend 1000s of dollars to implement very expensive new technologies to become more efficient. You can start tomorrow in your own lab just by making some small adjustments in your own workflow or products that you pick staffing models, things like that. Automation would be a completely the next step. You know, if you want, I think there's a lot you can do before the automation,

Griffin Jones  05:38

I want to make sure I understand this difference. So what would a couple of examples be of just those basic skills or supplies that could be made more efficient?

Dr. Liesl Nel-Themaat  05:46

One big example, go to your staffing model. For example, in my talk, I talked about all these different types of personality get in the standard IVF lab, and that is heavily influenced by the size of your program. So the more IVF cycles you perform, the more people you need in the lab and a basic small program, maybe would have five embryologist and maybe two juniors maybe to seniors and a lab director. But then at the as this practice grow, are you going to one of these larger networks where you have a hub and spoke model, you might end up with, like 20 Different people in your lap. And it's the range from on site lab director, there's managers, supervisors, team leads, seniors, juniors assistants, shipping coordinator per DNS. And all of these different roles have different costs associated to it when it comes to your staffing model, right. And I shown in my presentation, just by adjusting how you put your team together, you can have enormous savings, and bring down your lab expense significantly, just by being wise with how you build your staffing model. So that's one example. You don't need any technology for that. Right.

Griffin Jones  07:03

So what maybe we'll get into a conversation about it, if that's necessary because of automation. But first, let's dig into those examples a little bit if we've got a hub and smoke model with a need for 20 people in the lab, how do you restructure that team so that you don't need as many people are so that you're getting more out of each of them?

Dr. Liesl Nel-Themaat  07:27

So a classical example is, a lot of times, senior embryologist, you know, as a practice grows, they small practice have limited number of staff and they can do up to a certain number of, you know, cycles, same average is about 150 per embryologist starting with minimum of two. But then what happens sometimes is as this practice grows, we need another embryologist, we need another embryologist. But the reality is a lot of this stuff that embryologist have been useful these days is data entry, administrative tasks, filing paperwork, retrieving paperwork, shipping coordination, all these things that you really don't need a very expensive, senior embryologist to do. So by replacing some of your high high cost center neurologists by more specialized people, like a lab assistant or shipping coordinator, or even using some per diems for when crunch time comes, you can actually significant, reduce your overall, you know, expense on your staff, just by redistributing the tasks and the responsibilities.

Griffin Jones  08:37

So wouldn't the proponent of automation just say well, yeah, but you shouldn't be giving those tasks to even a more junior person, if you don't have to the if you could totally automate the data entry. For example, if you could totally automate the renewal of ordering of supplies, then why give that to any human being? Why not just to have that as a part of the system? So why is efficiency important if automation seeks to make the efficiencies that we would gain by restructuring, pale in comparison?

Dr. Liesl Nel-Themaat  09:12

So just to you know, if there was any misunderstanding, I'm not against automation at all right. But let's say my program, we decided, you know, what we're going to automate that How long do you think that will take for the companies whoever is working on automation to complete developing, tasting, getting approval, then bringing it to market? Implementing it like, Yes, great. If five years from now, I can eliminate four of my staff members by bringing some fencing automated automation unit into my lab. Right, but I have five years that I don't have it right now. vast majorities of labs are not automated right now. So what can I do until I did get that technology. Again, I'm not against bringing in technology, I'm just trying to make efficient what we have and what you can easily achieve right now, before these next big things come into the picture, you know,

Griffin Jones  10:14

so I guess it depends on which next big thing is here and how now they are actually now actually present and ready there. Because I'm guessing that concern that you have is, which is we can automate. But there are things that we can do right now to be more efficient. If I'm a salesperson for any one of these companies, I'm thinking you trying to be more efficient is the waste of time, you should replace it entirely with our solution, whatever if whatever that solution might be for a particular thing. I'm thinking of one example, where I was recently speaking with the venture capitalists behind this new solution, that closets to be able to build a lab that can do 500 cycles a year with five techs, and nothing more. And so if that is the case, then I guess where I'm struggling is, is how do you know if the process of making it more efficient is worth the squeeze whether rather than trying to eliminate and automate the process? And,

Dr. Liesl Nel-Themaat  11:22

again, I don't know why there's that idea that I'm against automation. I'm not trying to eliminate it.

Griffin Jones  11:28

I'm not I'm not starting any I'm not starting any rumors on on this pocket? No, I know that you're not I'm asking because I'm thinking I'm trying to make the MCAT that calculus because I imagine that many of your peers are thinking, say, Well, should we do something or not? And I don't know what that what that calculus is for deciding, okay, we should try to just restructure and spend some time trying to restructure or we should seek a different solution. And how you approach that I

Dr. Liesl Nel-Themaat  11:58

think you should do both. I don't think it's one or the other, I think and even if you get your automation, there's still going to be places that the automation is not really touching, that you can still be more efficient paper usage. Let's talk about that. The amount of trees we are killing by doing paperwork and not going more electronic, you can have a machine that can automatically make your dishes it's not gonna resolve your your paperwork, wastage issue, right. Or you can restructure your staffing model, but it's not going to do anything for the plastic ware that you're using. So there's no one solution that's going to touch all the different areas that you can make more efficient. Like I played video, where I had asked multiple experts across the industry, what is the biggest lab inefficiency, not two people gave me the same answer. And that's the point I'm trying to make is yes, there are big ticket items that we could bring in new technologies. But there are so many places where you can be more efficient can save money for your organization can make your processes more streamlined and be friendlier to the environment. If you just conscientious and have this overall mission to be more efficient in everything you do, not just the one or two big ticket items that companies are trying to sell us right now,

Griffin Jones  13:27

as those examples that I want to make this conversation about, maybe we got bogged down in semantics for a second. But the you talked about paperwork as one of these examples. Why what's stopping the lab from being paperless right now, and what specifically should be paperless? And

Dr. Liesl Nel-Themaat  13:45

I think change is hard. I think everybody knows and use less paper and transition to all electronic and a lot of groups are moving towards that. But it is very difficult to make such a big change in a lab that you are used to I have my patient chart right here. This is where I document everything I do. It's first of all a big expense on the program. And then there's something about having a hard copy. And people just don't like change. It's difficult. I think we are definitely steadily moving towards it. But it's not something that you overnight going to be paperless than any practice right. So but you can make small steps towards it. And you can maybe double copy some of the things that you have at the moment still paperwork maybe the practice is not comfortable going completely paperless yet, but if you have the right mindset, you can move towards it or at least cut your paper usage in half like every time you print something Do I really need to print this is there a way I can have this electronically but doesn't interfere too much with my that workflow because there's always a balance, right?

Griffin Jones  15:02

Are there examples that you can think of, of things that shouldn't be printed almost categorically that, that that's just a waste

Dr. Liesl Nel-Themaat  15:10

consents, definitely. And I think COVID actually helped a lot with some of this where traditionally, patients would have signed paper copies of consents and get it notarized if they're not in the space, or gonna be able to come to the clinic. And I think COVID has forced the whole industry to become more electronic from telehealth visits to online consenting to, you know, explaining the treatment cycles, everything, instead of now giving paper handouts or welcome packets, and all that everything is done electronic. So we actually have COVID, to thank for some really good things that have come to our industry, I believe, the paper forms, I think sometimes there's a lot of duplicate things that might be recorded on forms where you could make it more concise, or just maybe have, if you if you're not comfortable going completely paperless, you can be wise about what has to be on a paper and what does not. So I think it depends on each practice, what kind of forms they do have, you know, when I was surveying a group of embryologist online and asking them, you know, how many pieces of papers was on average it 15 sheets? That would be things like, you know, your neurology worksheet and then you have your individual in row tracking sheets, you printing out your order, because you want it Do you really have to print out the order, you know, if that's electronic PGT worksheets that the company saying you print that out? Do you need to have a print out of that and your own PGT worksheet? You know, this, it really depends on every practice. But again, it's it's all about the mindset and the the, the vision and the mission to try to become more efficient. I'm sure every lab can go and look at the paperwork they use and identify at least one sheet of paper they can get rid of, you know,

Griffin Jones  17:02

can you give an example of where else it would go? Like, if you think back to the last five years or so where you were using paper? And some example it did it was? Was it something that changed to the EMR? Or was it something in a different type of workflow software? How did you eliminate paper?

Dr. Liesl Nel-Themaat  17:18

So we have not, we're still using a lot of paper, in fact, my my Kayla bow about six trees a year at the moment,

Griffin Jones  17:28

do they now listen to your talk? Yeah, you don't just you don't just sit them down and play the same talk for them.

Dr. Liesl Nel-Themaat  17:35

Now we started mentioning it, I haven't given this presentation to my whole clinic yet. But that gives you an example. So we have not but we started the conversation. Because when I had to find out how much does our whole clinic use, obviously our practice manager, I told her why wanted to know and say how, you know, we started the conversation, how much paper do you use? And now he's on the table. And then I say, Do you guys realize we kill six days a year? And now we're talking about it? So yes, I like I said paper consent to something, I think probably the majority of clinics I've gotten laid off, we still get copies in some instances. But we should not that that's the easiest for me to think of is that anything that can be electronic. And the good thing is this is not a form that we are generating on our end, when it gets difficult is when you have to do data entry. But you're not sitting at your computer while you're looking at, for example, embryo grading, right? I have I'm sitting at a microscope and looking at each embryo one at a time, and I have to write it down. And then I can take the computer and put it in my EMR. Now you could argue well, if you have the AI technologies with the live imaging, you don't have to do that, which is true, but most labs don't have that yet. Right. So can you get around that? Can you get comfortable enough that you might be can use the iPad instead of a piece of paper in real time while you're writing your embryos?

Griffin Jones  19:01

Oh, did COVID make plastic were more or less of a problem if it made paper less of a problem? What did it do with plastic where because you know where it didn't make plastic were any better? The whole effing rest of the world, you know, plastic everywhere. Now we have now everything's takeouts in styrofoam, it's in their individual wrap masks that all go everywhere. And so it seems like the plastic were got problem got worse in so many other areas of the economic sector. Was it better or worse after COVID

Dr. Liesl Nel-Themaat  19:40

classic where we've gotten much worse but for a different reason. It's because suddenly we have such big supply shortages because everyone was buying it at such a rate because they were worried we're going to run into supply shortages and then we created this superficial shortage or this this it wasn't real


Griffin Jones  20:00

Do you toilet paper and yourself? The IVF? The the IVF? Lab field toilet paper themselves said it.

Dr. Liesl Nel-Themaat  20:06

Yeah, you were listening to my talk. It's my cousin's analogy. You know, yes, we, it's not like suddenly all the labs, were doubling using dishes, they were just not available because big, people were just ordering more than they actually needed because they were worried they were gonna run out. And then we created this to a certain extent, artificial shortage of plastic where so people were scrambling, trying, you know, just to find get their hands on what ever plastic they wish they could find not necessarily getting the true and tested and, you know, validated plastic containers and dishes and stuff, but just, you know, open it up more for whatever we can get. But I do think that it did make us or at least for myself, so thinking, you know, where can I eliminate some of this plastic usage in the lab. And so part of my presentation, also, I use an example of one of my previous labs, how many pieces of plastic we were using per cycle, and it was 27 pieces. And what can I do in my workflow? Where can I maybe reuse some of the plastics instead of throwing every you know, when you're doing retrieval? Do I really need a new tube for every follicle that gets asked to write it? For example? Do I really need to pour it into a new dish? Every time I search for an egg, you know, where can I reduce the number of plastic that I use. And by doing simple things like that, you can really make a big difference in that now, of course, again, people don't like change. And it's difficult to implement something like that, you might think it's such a simple thing. But if you have a shortage of whatever that thing is, you use you very quickly have to out of necessity, make that change. So I'm actually curious to know if labs started using less plastic due to COVID? Because of the shortages? And would they maintain that going forward?

Griffin Jones  22:04

As far as you can tell, are we still living with the consequences of that over ordering in the beginning?

Dr. Liesl Nel-Themaat  22:10

Now we've sitting with boxes full of expired product, because people over order, because they were worried they're gonna run out. And now, you know, we in during my talk, I surveyed the audience and several people raise their hands on ask how many of you have supplies that you ordered during COVID? Because you were worried you're gonna run out and now it's sits in your storage room, and it will expired? Which shows that it was really an artificially created partially at least crisis.

Griffin Jones  22:43

Is there any application for those expired product? Like, can they be used in different kinds of applications?

Dr. Liesl Nel-Themaat  22:50

Oh, absolutely. You can use it for research purposes. You know, we all know that plastic dish is not suddenly toxic. But because of regulations, you have to follow the manufacturer's expiration dates, but any research lab would welcome it, you could even try to sell it to, you know, the research labs, but what we would do is we just donate it to Stanford's, you know, whatever lab wants to take it, I have people that some of my fellows that do research in my lab, and I would just give it to them, and they would use it for whatever research they're doing.

Griffin Jones  23:27

How do you make some of that reuse some of that limitation of usage into a system into like protocols that and processes that staff follow? I think your example of freezing a retrieval tube for aspirating follicles are maybe one of the other examples you gave. Is that up to the individual embryologist to figure out is there a way of standardizing that. So that's a process to get the whole lab is using less plastic ware.

Dr. Liesl Nel-Themaat  24:00

And that's a very good point. Actually, it's not just up to the lab, right? It is really the whole clinic. It's the physicians, it's the nurses, it's, you know, everyone, it should be like a joint vision. But for example, when you do a retrieval, there is a physician amazing is the geologist, there's a medic or a nurse, you know, there's a team of people and, you know, putting your heads together and thinking, Okay, we typically use 25, round bottom tubes. How can we reduce that number? Is it possible to you know, we take the first five, we d canted and we give it back to you and you reuse those tubes. You know, this is just one thing I can think of we full disclosure, we haven't done it. But that is one example or

Griffin Jones  24:46

we're going to play this podcast episode for everyone that you work with the whole leadership team will pass on that will go to that will go beyond the division chief to the dean of the medical school or whatever they Is it Stanford circulate this, will LinkedIn, target everybody at Stanford and play this episode.

Dr. Liesl Nel-Themaat  25:07

I think when I show the financial part of it, then I would have some big fans on my side. And when I hit the green, the environmentalists, you know, so they are people that love me people that will hates me. But the truth that we can be much more efficient, especially with plastic use, I would even go as far as saying, Have you heard of glass? You know, do you know that in the good old days, we were washing glass tubes and autoclaving them. Now by no means am I saying we shouldn't be doing that. But just at least open your mind and think about, there was a time when we didn't have any of these things. Right. And it is my one year anniversary at Stanford today. Just FYI. So if I get fired,

Griffin Jones  25:48

often there's a two year anniversary after this episode comes, this is

Dr. Liesl Nel-Themaat  25:53

a big project. And it's something that you need to get buy in from many different parties. I'm not going to say that I have made or implemented all of the changes that I'm suggesting that it's possible, but I'm trying to throw ideas out there. Because every program is set up differently, something that might have worked in my lab, that's an easy improvement in efficiency might not work in the lab next door who has a different workflow, they use different products, or they'd like a different culture system. So that's why I say that every lab person has to walk in their own lab and look at every component and ask yourself the question, is there a way I can do this more efficiency? Is there a way I can do like, Can I not use so much paper towel? Can I get away with you know, switching off some of the electric components of my lab at night and but only only the person working in that lab, the lab director, supervisor, the biologist only they can really identify it. I can't identify in someone else's lab, what efficiencies they can implement. I can just give ideas and hopefully try to get people to think about these things more.

Griffin Jones  27:03

So plastic ware was a big area paper work was another big area of those. Yeah, I think you said 23 or something suggestions of what what the most, the biggest inefficiency in the IVF lab was and you have 23 different answers. What were some of the other ones that you can remember,

Dr. Liesl Nel-Themaat  27:20

time is like a half hour. But biggest resources as you know, and that's one of the things that we have the least amount of. And I think there are a lot of things that we do in the lab that takes a lot of time that we don't necessarily need to be doing. There are procedures, for example, trimming of your egg osios side cumulus complex after retrieval, just for background for you and an egg comes out. It's surrounded by these little cells called cumulus cells. Now a lot of labs routinely use syringe needles or some other device to trim it. And then later on, take all the cells off with the enzyme anyway, to make it clean or make it easier to strip is the term we use for cleaning of the egg. But a lot of labs don't do it. And one of my questions to the audience was, how many of you people are still trimming? And I think it was about half of them. And then the question is, why is it necessary, it takes so much time it takes resources, it takes more plastic, if you can eliminate that step, you can use your embryologist for something else, and eliminate how many ever minutes from that workflow. Another thing is how many times do you wash your sperm? Right? They are practices that wash everything twice after doing a gradient. They are devices microfluidic devices, that saves you a lot of time because it's you the way the procedure works, you basically put the sperm into this device, but even culture and you don't touch it again. Now that device is pretty expensive. So you have to decide for your own workflow. What is more valuable for me here to save my embryologist time, or to not make this big expense of using this expensive device? Right? So there's always a balance, but the main Time is money. We know that. But you have to think how much does it cost me to save this amount of time? Is it you know, Palin's a doubt?

Griffin Jones  29:20

So the the device itself it doesn't automate the process? Does it circumvent the process altogether to tell me more about that. It's just a different

Dr. Liesl Nel-Themaat  29:29

technology that instead of doing manual nation steps that someone have to come back repeatedly, you just can use this device and put it in the incubator and let the sperm swim through it. But there are cheaper ways to achieve the same thing. And I don't want to go into speaking about specific products or brands or anything like that and they are things that for example, changing out your biopsy. When you do low your biopsy fragments. They are programs have changed out that tip every single time between every single biopsy fragment. And there are groups that don't. And there hasn't been any apparent difference. If you just rinse it out, you're saving on plastic you're saving on time, because a lot of times, switch out these things. And then there are ways techniques that you can use when you're doing some of the procedures. For example, XE is a time consuming procedure. But if you look at how different people are doing xe, probably everyone does it slightly different the way you set up your dish, the way you move the eggs around the way, you know how many spam you catch at a time. And by adjusting some of those things, you can actually save a lot of time I actually showed a video during my talk of I actually wouldn't play unfortunately, the technical difficulties, but there's a way that this embryologist Lisa Ray, she she she manages to hold on to an egg and then just roll it with a very swift movement, like five, six eggs in a row, just injecting jig, it takes like two minutes where, you know, if you have a differently organized, it could take you 20 minutes to inject the same amount of eggs just by adjusting how you do that procedure.

Griffin Jones  31:14

So you're in that talk where you also asking for examples of things that still don't work was that was that a segment that I'm remembering correctly? Where you ask people? If for however many years you've been in the lab, what's one thing that still doesn't work properly or, or work the way you want it to was that was that a segment that you did

Dr. Liesl Nel-Themaat  31:35

to video was on pet peeves and frustrations that people keep doing that really can be quite irritating, for example, leaving bubbles in your culture drops, you know, or using the last of a pipette and not replenishing in the in the hood, or using too much paper napkins and put it in the Biohazard. Which when it's not biohazard, and just this again, small little things that can become really irritating or people that complain that they are always the only one that does this, or does that. And if you look at the distribution, no, really, it's not that these were just complaints or pet peeves of some of my peers that were quite funny. Not writing open data, little vials and, you know,

Griffin Jones  32:28

and so some of them might be sort of comical. But other of those might point to bigger process efficiencies, you know, the writing on the vial, for example, could be something that is, is changed or automated in some other way. And as you're going through a lot of these examples, I'm thinking of the acronym, eliminate automate delegate, I don't know if anyone's put that into an acronym that is more that sounds better than EAD. But, you know, you're you're focused a lot on the elimination or because while one could say well, don't delegate anything that should be automated, you could also make an argument that says don't automate anything that should just be eliminated altogether. Are there a couple other examples that you think of either from your talk or just from your day to day work that you think, are pretty easy to just simply eliminate in the IVF? Lab? And if so?

Dr. Liesl Nel-Themaat  33:26

Absolutely. You know, you talk about delegation and automation, and elimination. There are delegation, I think, is extremely important, not only for streamlining things, but also for team morale, I really believe you have to have a strong, solid, happy team. And if you give different people specific delegated duties that they can take ownership of, I think it's healthy for the team in general that everyone knows who's responsible for what, who is the go to person for any particular thing. But then I think a lot of the things that ultimately fell on the IVF lab to handle really should not be handled by IVF. For example, sort of data entry or sorry, the initial cycle initiation, when a patient's first come through, should really be falling on the clinical team and shipping coordination. There are many of these things that really should not be handled within the IVF lab and can be eliminated from the IVF lab. Now, if you don't have a person outside of the lab, to do it, then delegate it to someone that has protected time to do that role, because it becomes quite chaotic, and it becomes a sore point if, if no one has that specific role in the lab and whoever has time has to just do it and then people that well, I'm doing it more than this person and this stuff isn't didn't have a turn yet. If you delegate everything just becomes more organized. Of course, if you can eliminate it all together, if it's not something that appropriately should be in the lab. That's even better.

Griffin Jones  35:01

I can also see though, it's sometimes easier to know what to eliminate when you do a better job of delegating, because you're isolating that particular things. And one of the things that I've started doing with my own company in the last year is it just started jotting out and mapping it alongside our accountability chart, all of the outcomes that the company is responsible for doing, you can break those into more junior outcomes, and then section those off to more junior people. And then you could take bigger outcomes that are more complex and assign those to senior people. And those often require more resource. But by mapping it in that way, it's, it's clear what can be eliminated after some time. Because if if you just have it as part of someone's job, that isn't really part of their job, and it's also kind of somebody else's job, then you don't even really see what can be eliminated. Whereas if, if you start to parse these things out, you, it's easier to eliminate? Have you found any things like in the last year or two by ft after you delegated it that you were like, No, I think we could actually get rid of that altogether.

Dr. Liesl Nel-Themaat  36:17

You know, actually, but em our integrations with SAR has done that where, you know, in the old days, something like three, four years ago, you would have to manually enter data into sources, we talking about data entry, and you know, who should do that. But most of the EMRs now will talk directly to salt and will send the data directly to salt or to NAS. And that is actually a automation step. Yes, your data entry still has to happen somewhere, but at least it is. It's in one place. And these two systems talking to each other has made a huge difference, which is also why going to electronic medical medical record system is very valuable, because a lot of clinics honestly still don't or paper,

Griffin Jones  37:06

which is amazing to think about to begin with. But put please go off. Yes. But

Dr. Liesl Nel-Themaat  37:10

I'm telling you, it's a massive investment. It's not just oh, we're going to switch to EMR. And we're going to just do it. I mean, I lived through a transition recently where we had to start a brand new EMR and it is a very, very difficult process. And there's a reason why clinics are not just jumping on it, you think but it's such a no brainer. But yes, once you get on the other side, it's great, but it's a difficult process to go through. And if a clinic already doesn't have the bandwidth, people are hanging on edge. And you know, there's budget issues. And it's not that simple. And so again, back to my point is okay, well, if you don't if you're not ready for that big step, what can you do? That's easy, that still makes a difference.

Griffin Jones  37:55

But how do you model the costs? For example, like if you so you, we started the conversation talking about different staff models, and ways of making that more efficiency more efficient? How do you model the costs so that it's easier to see for someone that has to make that calculation of should we replace this system with that? Should we should we move from paper to an EMR? How do you model costs?

Dr. Liesl Nel-Themaat  38:23

Well, it really depends on the system you're talking about, right? And let's use cry storage as an exam. Because I know it's such a hot topic right now. And I'm sure some of these automations, you're referring to refer to that component. There are various different routes you can take if you want to restructure your price storage system. But there are so many different factors to consider everything from your staffing model, you know, does your staff have the capacity to keep managing it in house? Is your practice dependent on the revenue that you are hopefully getting from your patients, those that are in fact paying? You know, at what point does it make sense for me to outsource the entire thing, but then I'm giving up a big piece of revenue, but I'm also giving up a big legal liability. And we're actually in the process of that right now. And Stanford is building this future for our careers storage systems. And we haven't come up, you know, decided exactly where we're going to go yet. But it is a, it, there's so many different components. And at the end of the day, you know, you have to have your spreadsheet and say, Okay, this is this is what I'm gaining, this is what I'm sacrificing, but how do you put a monetary value on your legal liability, you know, and what your insurance costs you every year and like Stanford is extremely risk adverse, right? Every clinic has a different tolerance for that liability. So it's not a very simple question. Something that's more that's easier to do is like the use of plastic for example, Which dish do I want to use? And I showed a table where, you know, I have two different dishes. This is what these dishes cost. The one dish might cost more per He's but then the amount of volume of oil you use for this dish is this much versus that dish. But then the media that you use cost this much, and then how long it might it takes to make the dish that's a time component. And then then in the end, you make a table and you add it all up and say, Okay, what is the most what makes the most sense, economically? And is that what we want to make our decision on workflow wise? I mean, it's, it's complicated.

Griffin Jones  40:29

How do you factor people's time into that table? As an estimate? Is there any time tracking in the lab, like how a lot of client services firms, a lot of remote companies will use apps like Harvest? Or I think another one is tea sheets? And so harvest can go in your browser? Anytime you switch windows, it can say, are you working on a different task, you record at a time it integrates with a project management software, I suspect that it's it's pretty inaccurate, or at least that it's, it is it is far from purely accurate, because it still requires so much human use to say, this is what I was working on at this time. But you can get an idea, a lot of remote company, a lot of tech based companies, this is how long this task takes. And it's just once AI takes that over, then we could really get a good idea of what people are actually working on for how long is there any kind of time tracking like that happening in the lab right now?

Dr. Liesl Nel-Themaat  41:30

Are some of the witnessing systems or try starting to track that and look into that? Obviously, it can be met with some resistance. Because there is a balance, you know, I was talking the intro to my talk was really the difference between efficiency and effectiveness right. Now, when you start going down to that granularity, I think you do run the risk. If your staff knows they are being timed, every time they do a procedure, they may start going too fast, and then start making mistakes, or, you know, maybe you see more eggs per minute, but your fertilization rate goes down. So there's a sweet spot and my my hesitation to embrace this kind of tracking of staff is exactly that is I would rather have my staff workout is a comfortable pace. And not everyone is equally fast with everything right. But it doesn't mean one that is not as fast it's less effective in your overall outcome. So yes, it is that is coming into the market, I don't know how many clinics are actually using it. I know some of the bigger networks would have their staff much more a day much more structurally. With time, at 745, you can start doing this at 752. This should be done. Now you're going to do that I can see the necessity in very, very giant big programs and how that brings in that efficiency. I don't think any embryologist particularly likes working like that. And so that could touch your team at all.

Griffin Jones  43:11

The concern that you have is one that client services firm share with their own time tracking of that, if I'm am I being monitored on this because it's down to the billable hour, and you can err on either Sen, either end of the spectrum, you can err on work completely, we bill everything down to the hour, and everything has to be tracked. And that causes a lot of stress on the team. Because one they're worried about what it is that they're spending their time on. And it can affect quality, but too often just it can be inaccurate. And they spend so much time just doing the tracking itself and the logging of the tracking that it's it's it's futile. And then you could also err on the other end of the spectrum where you do no tracking and you just don't have any. So what we done in the past, is it say listen, you're not so we never aligned it with incentives, and we never aligned it with billable hours either. And I think that helped because it was just we're doing this just to get an idea just to be able to practice, but it wasn't against the billable hours. So they didn't have to feel like it was it was for that exclusive purpose. And I also didn't want them just every single time they were switching from one little task. Well now I'm checking email minute one, but I'm checking the project management software minute two, and I'm back to email minute three. And so if you did that in the lab, and you just kind of got an idea. What do you suspect is the biggest inefficiency in the IVF lab.

Dr. Liesl Nel-Themaat  44:46

Their biggest inefficiency is not based on a procedure. In my opinion, it's scheduling. The biggest inefficiency that I think is hurting our IVF lab the most is in with consistent scheduling on the clinical side, that the lab has to absorb, that you don't know how many procedures are going to come your way at any given day, which day they're going to fall on. We know there are ways that we can do this can be done more efficiently. But this is not up to the lab. You know, that is the problem. So I know you want me to say in the lab, the most inefficient thing is how we stripping our eggs, but I don't have an answer. But I think globally, what affects us the most probably, is inefficient scheduling of procedures. And that's a big pet peeve of many, many lab directors, where there is no template with X number of slots with only these types of patients can come through on this day. And once it's full, they have to wait for the next month. I think for me, that is a big one.

Griffin Jones  45:54

I could just say I will save that topic of how to fix it for somebody who speaks on scheduling. And that's their topic, but let's try to give them a little bit more to work with how, how do you suspect that can be improved? Yes. So

Dr. Liesl Nel-Themaat  46:08

what I have seen was very successful was when scheduling is outsourced, where it's centrally controlled by someone that is not emotionally pulled into the decision or have to make a decision on the spot. Because what we often hear is, Well, this patient is so nice, and she wants to go to Italy for her vacation, can we please add her. And now I'm standing there with the person making the request. And I have to make the decision right now. And the problem is for other very nice patients to scold three of the other doctors. And before I know it, I have five more patients than I can safely managing the lab. So by taking that off of the labs plate where this is centrally controlled, only the lab can make kind of proof an addition but I'm not dealing directly with the physician or the nurse or whoever has emotional relationship with the patient. You know, I think that has made what I've seen when, you know, during transition that I lived through that made a huge difference. When you

Griffin Jones  47:19

say centrally controlled, you mean like that scheduling function outsourced altogether, or simply concentrated somewhere within the clinic that it's not just the doctor doing here, the

Dr. Liesl Nel-Themaat  47:30

example I'm using is, you know, in a network and a big IVF practice network that was centralized by scheduling department that was not even on site where we were. But in a standalone clinic, you can have a person responsible for that. That's not part of the clinical team that doesn't have a relationship. And that person should have the authority to say yes or no and follow the rules. There's a reason we have a template, we know what would be an exception. For example, if I have a cancer patient coming through that starting chemotherapy next week, and we need to freeze her eggs 100% That is a legitimate reason for an exception, someone that wants to go to Italy and she doesn't want to wait till next month, that's not a reason, insurance expires, you know, but that needs to be written down in a policy. And if an answer to make a change, or to deviate from the rules is no then that should be no and everyone is on the same page. And it shouldn't come become emotional decision between the lab director or lab supervisor and the doctor

Griffin Jones  48:41

is that where the bulk of the problems are coming from with regard to scheduling and your view just from trying to fudge in different exceptions at different times?

Dr. Liesl Nel-Themaat  48:54

A lot of it is yes, also communication, you know, you hear of patients that suddenly appear on the schedule and that patient was never presented earlier or was not planned in advance. And somehow there was a communication gap that the lab somehow didn't know that this person was coming until the day before. Also just you know, the clinical practice. Now, I'm not a physician, I do not, you know, have no input in the stimulation protocols or the treatment plans at the patient's other than what happens in the lab. But we know there are ways to manage the volume of patients how many FTEs and which days they fall on by just doing program cycles, right? So and same with retrieval cycles, you know, do we do birth control or not we you know, some patient wants to be on natural cycles. But that is something that really the clinic should be everyone should be on the same page and the physicians, not everyone likes to change the way they've traditionally practiced medicine and there is still in the list. The chair, not there's not really an agreement on if if it affects outcomes or not. But I know that most of the large networks do have better workflow because they have these scheduling rules and templates. And the majority of the cycles can be predicted because they use program cycles instead of natural cycles. But a lot of divisions are are not comfortable with that yet.

Griffin Jones  50:32

Is this an argument for batching? Or is that something different?

Dr. Liesl Nel-Themaat  50:36

batching is something a little bit different. But for batching, you definitely need that's not natural cycle, right, because you have true batching, you do one week of basically, sometimes it's just two or three retrievals data retrieval days a month. And then the lab is very, very busy. But you know, what's coming your way you can plan accordingly. And then people can, you know, during the downtime, catch up on a lot of the administrative stuff, and, you know, ordering and setting up the lab and get ready for the next cycle. So true. batching is a little bit different. This is just basically managing if you're not a batching clinic, just managing the flow of your patients coming through.

Griffin Jones  51:22

Well, I want to let you conclude with what you how you would summarize remedying and efficiencies in the IVF lab where you would like to see things go we have a lot of lab directors and embryologist that listen to especially when we bring on someone to talk on a laptop, but we also have some CFOs listening that are responsible for p&l, and we have practice owners. And so some of that support on the clinic side. And we do have some DIVISION CHIEF So there are people thinking about how they can get through the red tape, but their health system? How would you like to conclude?

Dr. Liesl Nel-Themaat  51:57

Definitely saying that, you know, we talk now quite a bit about, you know, stimulation protocols. And you know, whether it's programmed on program cycles and how that affects scheduling, every clinic is different, right? What works, one clinic is not necessarily going to work for another clinic, which is why it's important that you have to within your own practice, put on the hat of what can I do to be more efficient in all these different aspects of my practice? What will work for me may not work for you, right? If if I say I can eliminate this process or delegate this process out of my lab, the way in a neighboring clinic is set up, it might not work at all. So the most important thing is to just be searching for ways that you can make your practice more efficient. The one is not right and the one is wrong. It is very individualized because everyone is doing things differently. Just wear the glasses off. I want to be more efficient. What small changes can I make sometimes mighty big changes, but what can I do right now to become more efficient? That could be my message.

Griffin Jones  53:09

Dr. Liesl Nel-Themaat, thank you so much for coming on inside reproductive health and sharing this for your lab colleagues and your colleagues and the rest of the field

Dr. Liesl Nel-Themaat  53:19

is a pleasure.

Sponsor  53:20

You've been listening to the inside reproductive health podcast with Griffin Jones. If you are ready to take action to make sure that your practice thrives beyond the revolutionary changes that are happening in our field and in society. Visit fertility bridge.com To begin the first piece of the fertility marketing system, the goal and competitive diagnostic. Thank you for listening to inside reproductive health

182 6 Barriers To Automating The IVF Lab, Featuring Eva Schenkman and Helena Russell



What is stopping IVF labs from becoming fully automated? Tune in to this week’s episode of Inside Reproductive Health, as Griffin Jones sits down with Eva Schenkman and Helena Russell of ARTLAB to breakdown the six main barriers to automating the IVF lab.

Listen to Hear About:

  • Why automation isn’t happening in certain areas of the IVF lab.

  • Risk and inefficiency of data entry.

  • Lack of trust that comes from business intelligence software.

  • Lack of adoption of the Vienna consensus.

  • Which metrics are meaningful for safety that don’t necessarily improve clinical outcomes, but are required to improve safety and productivity.

  • Delivery vs operations- what needs to be prioritized now vs. what should be prioritized for the future.

Website: www.artlabconsulting.com

Eva’s LinkedIn: https://www.linkedin.com/in/eva-schenkman-ms-phd-cc-eld-hcld-6121778/

Helena’s LinkedIn: https://www.linkedin.com/in/helena-russell-5aa60214/

Transcript


Eva Schenkman  00:00

They're missing the point that you know I think UCSF did some data where they showed that having an embryo scope in their lab saves them the equivalent of one embryologist time per day. And if you look at the cost of an embryo scope which is probably akin to about you know, one year embryologist salary that is becoming more efficient with these devices will in the long run, save you money, especially now when there is no embryologist to be found.


Griffin Jones  00:32

All of the change that is not happening in the IVF lab we talk all about the automation is coming to the field and seemingly every talk at every conference many episodes on, I want to know why hasn't it happened already? Why isn't it happening faster. And so I explore those obstacles and barriers with my two guests on today's program. That's Dr. Eva Schenkman. She was a lab manager for a number of years to different practices. She has been a consultant. She now runs a program called ART Lab. And I bring in her colleague Helena Russell, and we talk about the barriers to implementing automation categorically. In the IVF lab, we talked about the risk and inefficiency of data entry, we talked about the lack of trust in the data that comes from business intelligence software, if estimates that fewer than 10% of IVF labs have fully automated their data entry with business intelligence software, we talk about the Vienna consensus. Why has there been a lack of adoption in the Vienna consensus again, I asked Helena and Eva just a ballpark how many labs they think have adopted the Vienna consensus. And I'm asking them to do this off the top of their head, but they think it's about half that have adopted some meaningful level of the Vienna consensus. We talk about other metrics that are meaningful for efficiency and safety that don't necessarily improve clinical outcome, but are necessary for improving safety efficiency. And for activity. We talked about this person dynamic between delivery and operations where you are on the hook for doing a certain number of IVF cycles, you're on the hook for serving a certain number of patients, you have to do that to make payroll to keep the lights on to keep the patients happy. Meanwhile, there's the operational systems behind that which are another entity another chore to solve. And those two things are at odds of each other in terms of what is prioritized now in the moment, but what needs to be prioritized and improved for the future and for ongoing delivery. Finally, Helena and Eva say that some solutions are not ready for primetime and boy do they go to town on naming who those folks are? Now they don't try to get them to but of course they go hard and ideas and soft on people as is generally good advice. So it was a constellation for myself, I have to detail what they would like to see from RCTs what they think is missing from solutions that are coming to the via what they think needs to be proved in order for solutions to merit much wider adoption and what IVF centers could do in the meantime to help prove the concept. Enjoy today's episode with Helena Russell and Dr. Eva, Schenkman, Dr. Schenkman, Eva, Ms. Russell, Helena, welcome to Inside Reproductive Health.


Helena Russell 03:19

Thank you, it's great to be here.

Eva Schenkman 03:20

Thank you.


Griffin Jones  03:22

I've finally fulfilled the promise or I'm living up to a promise where I said it was going to create more IVF lab content than I have in the past. I think, this year, we've already done more episodes about the lab than we did in the first three years of the show, combined. So I'm starting to have a rudimentary level of knowledge to where I can maybe start to ask more interesting questions. And one of the things that I want to talk about today is the obstacles behind the automation for the lab. So at a high level, on the show before I've talked about the automation that's coming to the lab, and like to take advantage, speaking with each of you about why it isn't happening faster, and probably have you unpack and give specific examples as we go. But maybe we start at a high level, with just the automation that you're seeing in the lab happening right now that you weren't seeing five years ago, and maybe not even two years ago, what's happening with regard automation.


Eva Schenkman  04:25

Now, one of the ways in which, you know, I've been involved in some of my consulting activities in some of the automation is through data analysis. You know, we spend an awful lot of time in the lab, you know, crunching numbers. And in most labs, we still do it the same way we did 30 years ago, which is, you know, we've usually got two or three different Excel spreadsheets, we've got one for data, we've got one for cryo, you know, we may also be entering something 20 or more, and we used to sit there at the end of the month or the end of a quarter and spend, you know, 234 days to crunch all those numbers. So not only counting the amount of time that embryol Just spending putting in all that data, you know, risking all those data transcription errors, you know, now we've been using things, you know, business intelligence software, like Power BI, to pull that data automatically out of the IVF EMRs, to run that data in real time, so kind of call that real time analytics. So that I see is one of the key ways into which we can save, you know, an enormous amount of time making the labs, you know, a lot more efficient, is on a data analysis standpoint, you know, one of the big talks now with a lot of the meetings or on automation in the lab and efficiencies in the lab, and, and, you know, I think we can talk a little bit more more about that, what the roadblocks are, you know, to those. And, you know, to a long way, I think a lot of the roadblocks are One is cost, you know, a lot of these devices, things like, you know, an embryo scope, for example, are very expensive. And, you know, a lot of physicians or a lot of practices expect to see, oh, I'm gonna get this device, it's going to increase my pregnancy rates, oh, it doesn't increase my pregnancy rates, well, that I'm not investing that kind of, you know, money into it. But they're missing the point that, you know, I think UCSF did some data where they showed that having an embryo scope in their lab saves them the equivalent of one embryologist time per day. And if you look at the cost of an embryo scope, which is probably akin to about, you know, one year embryologist salary, that it becoming more efficient with these devices, will in the long run, save you money, especially now when there is no embryologist to be found. You know, and I think some of the other issues I see with the automation is things are rushed to market quickly, you know, at at a very high price, and they don't necessarily have you know, a lot of the data behind it yet, that you know, that it is going to be you know, just just to save for just the same as a senior embryologist. So I think kind of got, you know, a couple of issues there, you know, between the cost and, and the efficiency, and, you know, making sure that you know, that we can get get current staff to adopt, you know, this new technologies,


Griffin Jones  06:59

because you give me a couple of different avenues that I could further explore. Let's start with the spreadsheets. You mentioned, having two or three Excel spreadsheets previously, for which you need for your data analysis. What were they what what were their roles, those those spreadsheets and the information that they contain


Eva Schenkman  07:19

everything from, you know, you're doing your pregnancy rates, your competency assessments, also your CRO inventory, you know, we typically, for the most part, still keep paper worksheets in the lab, very few of us are using, you know, tablets or have gone paperless. So, you know, we've got that paper, you know, we're either scanning that paper into an EMR or, you know, retyping that data into an EMR. And then typically, a lot of the EMRs, don't do data analysis very well. A lot of them don't have reports that follow the Vienna consensus, you know, guidelines. So we're then keeping separate spreadsheets, so we're putting things into the EMR, putting things into, you know, Excel spreadsheet for data analysis, and then typically having a third sheet for, you know, cryo inventory. So we're entering everything, you know, typically three times, and then taking having somebody you know, typically higher up, then do all of that data analysis, like I said, usually typically the end of the month, sometimes at the end of the quarter,


Griffin Jones  08:17

how is QA done in this instance, when you have three different sources of information, but they're all in different places? How, how is QA done so that the duplicate of information is correct, because anytime you have information, different sources that isn't uniformly exported, you always risk you


Eva Schenkman  08:37

typically an Excel worksheet, you hope you catch it, there's not really a lot of a lot of formulas in there to kind of automate to to pick that up. You're always gonna get data, transcription errors, some of the things like Power BI can can pick that up for you. But I think, you know, honestly, a lot of times it gets caught when you're giving a patient data off of your cryo Inventory spreadsheet and a patient, you know, or nurse, correct shoe, you know, will will that's, that's wrong. That's not what we had, you know, so that that is a problem, you know, with data entry errors, is we really don't have a good mechanism to ensure that the data is accurate.


Griffin Jones  09:14

So when you have three sources of info like that, you got your spreadsheet for cryo inventory, you're scanning into the EMR, and then you've got a separate spreadsheet for the data analysis. There generally isn't like an overarching QA for the data entry to make sure they're all uniform. Now, okay, so even without regard to efficiency, there's still there's a risk there.


Eva Schenkman  09:36

Yeah, absolutely. You know, your data is only as good as the information you're putting in.


Griffin Jones  09:41

You mentioned that is an area where clinics are starting to automate more and those spreadsheets are being supplanted or that's something that you envisioned in


Eva Schenkman  09:51

the know there actually is is a few systems out there. Several of the EMRs have been using business intelligence software either through Tableau or through Power BI and linking those with their EMRs to that automatically pull that data out of the EMR. So as soon as you've done your first check, you know, as soon as you've done, you know, your, you know, your observation or the pregnancy data is entered in, it's pulling it into those Power BI sheets. And those not only that are automated, but they can even be set up to then watch you when there's a problem. So they can send you notifications that, you know, Hey, your XC three P and rate is starting to creep up. So you can, you know, definitely not only from an efficiency standpoint, but also from a troubleshooting standpoint. So I know, you know, recently one of the media companies had an issue with with some oil, for example, you know, and that, you know, typically tends to take a little bit of time until you're able to pinpoint what the problem is. And you know, the hope is that these automated systems would be able to pick up on something like that much quicker than you'd notice by eye or, you know, you got to wait till the end of the month, you know, obviously, something's killing all your embryos, you'll notice that pretty quickly, but let's just say you've got, you know, 25%, drop and blast conversion rates, that may not be something you pick up so easily, maybe you had some bad patients in there. But you can use a lot of that business intelligence software, it's been used by the, you know, financial industry and other industries for for years, you know, now we can kind of harvest the power of that, and and use for the IVF labs,


Griffin Jones  11:20

do you have even a ballpark guess, of what percentage of IVF labs are now automating their data entry with business intelligence software?


Helena Russell  11:30

Automating? I'd say, single digits?


Griffin Jones  11:33

That's a very, very low, yep. What's stopping it from being at 90 100%?


Eva Schenkman  11:39

I think one is trusting in the data. Two is, is, you know, we, for as much as we like to think we're ever changing, we don't actually like to change that much. You know, we don't want to let go of our paper worksheets, we, you know, this is, this is what we've done for 30 years, you know, we don't want to make mistakes, and what we do we know that, you know, an Excel spreadsheet, you know, as long as it's not, you know, sorted wrong or tampered with, you know, it will get you the, you know, the data that that you need, you know, a lot of the EMRs aren't necessarily don't necessarily have the best fertility modules. So, you know, even, you know, a lot of people in the lab, they're, they're still using the paper worksheets, and they're only scanning in their sheets. So one is, is, you know, if you're going to use something like Power BI or Tableau, you really have to have a dynamic EMR, to be able to use that with so. So that's something a lot of the clinics struggle with, you know, and I think just just trusting, trusting in the data is a bit of a learning curve, you know, to to get going with it. And, you know, I think slowly it's, it's starting to come come about, but, you know, slowly,


Griffin Jones  12:46

by the way, Helena, anytime that you want to jump in, I tend to just riff off questions, because I


Helena Russell  12:51

just want to say a couple of things to, to kind of, you know, kind of chime in with Eva, one thing, that's what's really challenging is learning curve, because it's not just trust, it's taking somebody who works with their hands, and putting them into a situation where they're going to have to be working with computers more. And that can be a little daunting. But again, having the right tool and the right support from that tool, helps us something else that even just said, is that they're not, not all of these EMRs are created the same. And that's true across healthcare industry, in general, you know, they're very unique, there are so many out there. And they do different things differently. And so there may be some that are a little bit better for gathering all the information that needs to be gathered, and also to be flexible enough. One thing that you may or may not realize about IVF is that not all IVF centers do things exactly the same way. So you have to be flexible. And the learning curve is one of the one of the things that I think is challenging for people and trust, like Eva said, another way of automating that kind of tails into EMRs. And specifically EMRs built for IVF is witnessing, which is an automated system these days with barcode reading or with radio frequency. And even might want to chime in on this one as well. She has a lot of familiarity with these. And those are also tying in with some of these IVF databases, or electronic medical record systems. And again, pulling a lot of really good valuable information from the lab into that system helps with once we get to that point where we can do the analysis via you know, Power BI, what we can then do is really target quality control, quality enhancement, and quality assurance.


Griffin Jones  14:56

Let's stay on that thread for a second before we get into workflow variance and And the barrier of change. You mentioned one of the issues apart from that is trusting the data itself. So what is the cause for mistrust and data? Or what is the risk of inaccurate or incorrect data in using business intelligence software for data entry,


Eva Schenkman  15:18

when you're pulling data from from an EMR, you know, one of the problems is, these EMRs are all structured differently, you know, they're usually large back end SQL databases, they may not be, so you can't take, you know, three different EMRs take the same Power BI software setup and plug it into these three different systems, they won't work, you know, so these things have to be customized, you know, unless it's something your EMR is already offering, they, they would then have to be customized to each setup. And a lot of it is just in that analysis, knowing you might have two or 3000 different fields on the back end, to pull from, you know, how are you? How is each lab recording that data? Where are they? Where is that data sitting in the SQL? databases for analysis? I think some of it might be generational, you know, I think, you know, the first first generation of embryologist, you know, even though we're we're, you know, we are pretty good at using computers, you know, we, for the most part for the last 30 years have done everything on paper, have done everything, you know, simply the second we have to trust, setting up those scripts and setting up something to to the IT department, you know, it's these things are very difficult to validate. So it's a lot of time, and one of the things we don't have right now is a lot of time in the lab. So I think part of that is, is having the time to validate these systems to trust them, it would be very hard for company to come in to develop, you know, a Power BI software, that's, that's applicable to all EMRs. Because the EMRs are all structured differently. So they need to be done, you know, on a customized or bespoke, you know, level between between each system. But I think it's just as I said, I think it'll be different with this new generation of embryologist coming through, I think they expect it, you know, they practically live with a phone, you know, in their hand, you know, I think they're going to be a bit more comfortable with with having this data. Automated?


Griffin Jones 17:11

Tell me a little bit more about what you mean, by the time it takes to validate systems? Does it mean to like pilot the program to check the…


Eva Schenkman  17:20

Yeah, you know, I'm actually involved with one, you know, right now looking at at some of these, these automated reports, and I have to go into the EMR and I put in test cycles, and I'm putting in, you know, different complicated ones with day one xe or with late for some with thaw biopsy, refreezes, combination cycles with fresh and frozen eggs. And all of these data sets are stored in different tables in the back end of the CMR. So that I have to sit with the IT people and structure each of these queries. And, you know, we tested on these cycles, and, you know, these, how do you tell an IT person, you know, when they're doing a competency for, you know, good day three cleavage rate? You know, for example, you know, what does the word good mean? You know, if you asked, you know, for embryologist, you're gonna get five different answers, you know, and that's part of why, you know, we rely on things like the Vienna consensus, you know, as a standard, you know, guideline to go through, but then, you know, each and every clinic, we roll these things out to, has to validate it on their own, because none of us are doing recording data the same way, you know, there's, you know, we all record it a little bit differently, we're all using different templates, we're all using, you know, different embryo grading criteria. So I think that's part of, you know, a bit of a problem with it, you know, I think but, you know, as clinic start to see the benefit of these systems, I think it'd be easier and easier, you know, we get these things validated, we get a couple of hopefully, key key labs, you know, incorporating them into their workflow. You know, I think we'll, you know, we'll kind of get the message out there, that the systems are, you know, are reliable or trustworthy. And, you know, that'll go a long way to really making the labs, you know, more efficient. Everybody's talking about, you know, lab on a chip and everything else. But, you know, I think, you know, when you're embryologist are spending a significant amount of their time being admins, you know, hand entering data is still using paper worksheets. Were a long way away from talking about, you know, lab on a chip.


Griffin Jones  19:18

How much chicken and egg is happening here, like, if part of the reason why labs are slow to adopt the technology, they're slow to validate the systems because there's so much variance in workflow, people report data differently, they grade embryos differently, how much of so that's the barrier, but it's also the result, isn't it? Like if you had the universal systems implemented, that you might have a more universal way of recording data, you might have a more universal Is that happening?


Eva Schenkman  19:51

We have the Vienna consensus, you know, the paper that was written for KPIs. I think that goes you know, along A great deal.


Griffin Jones  20:01

Okay, what is stopping people from categorically adopting this Vienna consensus across all labs?


Eva Schenkman  20:10

I think for the most part, it's been very well, you know, received, I think it's just it's that the woods that way, we've been doing it for 30 years. You know, it's, it's that belief, it's, it's worked for all this time, you know, this is, you know, in that belief that, that, you know, we're kind of all homegrown cooks in each of our labs, that, you know, we kind of, we kind of do it our way, these are the KPIs that, that that worked for us, there are still some labs that are doing d3 biopsy, you know, as opposed to, you know, blastocyst biopsy and slow freezing, it's just that ingrained, you know, because we don't want to make mistakes and in what we do, so in some ways, we're very reluctant to try new things. And, and part of that comes with doing it the same way it's worked, we don't want to change it, but and


Helena Russell  20:54

so much hinges on it, right? Yeah.


Eva Schenkman  20:59

And that first generation of embryologist is retiring. They're leaving the field. So, you know, I think it's, it's, it's important to, you know, this new generation, they're not going to sit there for the, you know, the amount of hours and hours and hours that we spent typing into three, you know, three databases, they want to enter things on a tablet, you know, they don't want to enter things on on paper and then transcribe so, you know, I think there is a lot of push from, from these newer embryologist to to automate things, you know, and, and hopefully, you know, we'll get some significant changes. They're


Helena Russell  21:31

more comfortable trusting the data, as Eva has said,


Griffin Jones  21:35

what percentage of labs is, if you can even ballpark it? Do you suppose have adopted the Vienna consensus to? If not to the letter, you know, 90%?


Eva Schenkman  21:46

I'd probably have to say, maybe, what do you think Elena, close to 50? Probably


Helena Russell  21:53

I still they're not accepting all of them. They're probably focusing in on a few Don't you think? Eva?


Eva Schenkman  21:58

I think so. I'm still surprised how many lab people I speak to who haven't heard of it. And, you know, as I said, each one typically has their own KPIs.


Griffin Jones  22:06

Thank you, Eva. Now, I don't feel as dumb for asking.


Helena Russell  22:08

Yep. It's unfortunate. And I think it's a lack of communication in our field. But I also think that what we're doing is very difficult. And so the challenge is making sure that we continue to be able to produce what it is our patients need. And to meet our patients needs. I mean, there, there's, there's no excuse for failure. And so when you have something working, it's difficult to hear what somebody else is saying, if it doesn't mean an improvement, which I think you've kind of hit on earlier, unless you can show a, you know, a positive outcome. And it may be that they'd rather spend that extra money to have somebody do something in a less efficient way, then trust in something that may not may or may not give them the outcomes that they are looking for. Yeah, is


Eva Schenkman  23:06

it’s difficult to trust in the scripts that are written by, you know, by someone with a computer background that, you know, you as an embryologist don't really understand. So as I said, that's why the validation of it is so important, get them seeing that this data is accurate, and is pulling correctly. And, you know, I think, you know, to be able to have an automated system like that, then alert you, not only when something is out of range, but as deviating towards being out of range, I think will be you know, will be invaluable. And, you know, this, you know, one issue that recently developed with oil is now resulting in a class potentially, you know, class action lawsuit. So, I think, you know, anytime we can develop something that would pick up on these things, not only tell us our what our pregnancy rate is and what our our individual embryologist competency rates are, but to be able to then alert us to any troubleshooting issues in the lab, that we don't have to wait six weeks, you know, now we see something in our data analysis. Now we have to try to figure out, you know, figure out what it is, you know, that's where we're using AI is also going to help at some point, you know, with analyzing this data.


Griffin Jones  24:11

So I'm understanding if there's not a clear clinical outcome that lab directors can see of in terms of success rates, that there often isn't the impetus to impose a change, and I see the agents working against change. We've done it this way forever. It's worked this way forever. We have a big variance in workflow from one place to another. So just because it worked for these guys over here doesn't mean that I know that it's going to work over here, but at this point, why isn't the shortage of embryol embryologist and the constraint on embryologist time enough to have made a bigger catalyst for change? seems like to me it seems like okay, if success rates are equal, but I can get back an embryologist day. Every time that we use this solution, or I can get back this many hours of embryologist time, why is that not enough of a catalyst to be seen way more automation than we're currently seeing?


Helena Russell  25:22

Part of it has to do with time, it takes time to train somebody to do something new. You know, if you're so overwhelmed in your lab or your IVF facility, and you don't have enough time to train a new person, you don't have time to learn something new, don't you think? Eva?


Eva Schenkman  25:44

I think so. And I think it's just that you know, exactly that you don't have time to train something new, it's that chicken and egg, you know, scenario, again, you know, I'm so overwhelmed, I not only have time to not train somebody, and then you say, Oh, well, you know, get this piece of equipment or whatever, for automation, there is going to be a period of time where that, you know, system is going to actually take you more time, until you you know, you wreck it, you know, you're able to be proficient at it and you're able to, to realize its efficiency. And, you know, not all people have the patience for that much time for adopting it and the cost, you know, all of these, these automated systems are very expensive. So getting physicians in groups and practices, it's easy to say, I need another embryologist and they'll pay, you know, six figures. Plus, for an embryologist who see a body sitting there, you know, to pay six figures plus for a piece of equipment sitting on the counter, you don't see the efficiency savings as easily as you see another body sitting there. So I think that's part of it. And without them seeing, you know, like, as I said it, you know, I go back to time lapse, you know, they there was just, you know, paper recently that, you know, basically is, you know, we shouldn't be, you know, looking at time lapse, because there's we didn't see an improvement in pregnancy rate, but you're missing, you know, the picture of it, you're missing, you know, the safety of it, you're not having to take the embryos out to look at them, you can monitor embryos remotely, you know, so if there is, you know, more COVID outbreaks or another pandemic, you know, you can check fertilization from from home. And, you know, just that


Griffin Jones  27:18

you could centralize embryologist could knew or at least part of that workflow,


Eva Schenkman  27:23

you could do you have offsite lab directors could monitor things remotely, they can log in and look at the embryos look at how they're growing, you know, pull the data, you can see these Power BI apps, you can see all of your data on your mobile device, you can even see the images of your embryos on your mobile device. So I think it's, it's, it's, it's that cost barrier, but it is that learning barrier, that it's just not something new that we've done. And, you know, I think you'll I think next years, there'll be some workshops, at some of the meetings that are going to be focusing on future of technology and innovation, and where where things are going to be, but not just theoretical, but actual practical, what's here, what's now you know, what can we kick the tires on now, and part of that is, is training and having these new innovative systems launched at the at training centers, and having a rail just come in and use them because nobody wants to practice on a real patient. You know, you need to be able to have a place that's comfortable, that you can go in and you know, learn this in an environment that's not stressful, you know, not while you're you're trying to, you know, to do real patient samples, that you have a place to get comfortable with these devices and, and to you know, learn how they work.


Helena Russell  28:36

And we're all monitoring is integrated. And I mean, yeah, looking at your incubator, your temperature, your co2 level, your oxygen level, looking to see if your liquid nitrogen tank is got enough liquid nitrogen tank, liquid nitrogen in it, making sure your refrigerators are performing up to par. And having those be part of your automated, automated integrated system so that you literally have every function that you would normally assigned to possibly, you know, an intern or a novice embryologist, somebody who's a junior who's just coming in. Instead, you can have continuous monitoring, which I think is extraordinarily reassuring. Probably there's a role for someone or company out there to help clinics bundle and to become efficiency experts. I think one of the things that our training center does is helped expose new embryologist and even in workshops where we're opening up our center to experienced embryologist to come in to have one or two day workshops, they will be exposed to those kinds of integrated systems as well. And you know, a lot of it has to do with you know, I can I can hear about it all day long. I can read about it all day long. But if I can touch it, and I can move the dials and nobody's sample is going to get hurt by that. And I can actually download an app and do it on my own phone or my, you know, my iPad, while I'm in this Training Center. You know, the


Griffin Jones  30:13

exposure that you're talking about in the training center accounts for some of the issues, the distrust in the data, the lack of familiarity, the validation of the system counts, for some of them. Some of the things that it doesn't like, what you've been talking about is something that I've been obsessing over with regard to my own business and business in general. And I think we can apply it to the IVF lab, and that is delivery versus operations. And often when you hear business books, or you hear business talks, operations, and delivery are almost used interchangeably, like delivery, meaning the fulfillment of the good or service, which we've sold or promise and operations is really the system behind it. So we're roofers, our delivery is we're going to have a new tear off roof on your house by the end of April. That's the delivery. And we have an obligation once that roof is sold to fulfill that deliver, you could use delivery and fulfillment interchangeably. But operations is the system behind that delivery. So delivery is getting the roof on the darn house getting it done by the date, we said we were going to get it done by but operations is what types of materials we buy the workflow behind it, who we assigned to the job, how the job is assigned and accounted for and reported on the QA that comes after it the what what we automate or don't automate. And, and all of that is operations. And there's a tension between delivery and operations, because you have delivery obligations that you have patients cycling through, and you have a finite number of embryologist that can work on those embryos, while those patients are being served while you need to make this institutional change at the operational level. So how do you solve for that how, in this specific to the IVF lab, how do you begin to relieve some delivery obligations, while investing in the operations that will ultimately result in a virtuous cycle.


Eva Schenkman  32:35

Part of what we have here as opposed to just also having, you know, kind of a training facility is is you know, our training facilities a fully functioning mock IVF lab. So one to have all of these different systems communicating here. So that when people do come and try them, it's not just trying one piece of it, it's kind of seeing, you know, the entire system working as if this, this was a functioning lab, the other thing we have to convince them of is, is you know what to do when it goes down, because that's one of the most common things, you know, I hear that if we're going to be entering things on a tablet, or we're going to be entering things, you know, when our mobile device, you know, data patient data is potentially going up into the cloud, you know, nobody trusts that. So, you know, it's, it's the redundancy that's built in, you know, are we going to do you know, backups to, you know, to, to our local desktop, or we're going to print out, you know, a daily report, because what are you going to do when, you know, there's a hurricane that comes through retreating, like, what are you going to do, if a natural disaster comes through, I always have my paper, I always have my paper chart, you know, but there's that trust and what you can't see. And you know, we're all used to the internet going down the Wi Fi going down. But as an embryologist, you still have to do your job. And if everything is up in the cloud, and you come in, you got no Wi Fi, you know, how do you know what patients to do the first checks on or how do you know what patients to, you know, to do the freeze on or which embryos to thaw. So, you know, we do need to get better at that, you know, ensuring you know, what we're going to do from redundancy standpoint, to be sure that those concerns are addressed. And, you know, I think is, is, you know, manufacturers out there, we need to play a bit better in the sandbox with each other, and, you know, working on ways to get these systems communicating better with each other, because each one, you know, is kind of fine on its own, but there are these own little islands that aren't interacting very well with each other. They're very clunky, you know, not not not very quick. So, you know, we do need a lot of development still in those areas. But and I think, you know, the only way is to have kind of testing labs, you know, where where we can kind of kick the tires on these things and bring embryologist in to use them?


Helena Russell  34:40

Well, just to add to the you know, a lot of what we see in other industries, like the banking industry, a lot of what they do is done in the cloud. And you know, they have to have their very, very strict rules and regulations and other health care branches of health care industry. These people are doing a lot of commerce in the cloud, a lot of data storage in the cloud, and those redundancies have to be backed up by a robust IT support system. So they do exist for some of the systems that, you know, we've been talking about, you know, sort of loosely, but the really good ones are going to have that kind of support and structure so that you can, you know, assure those who are using it, hey, that information is going to be there. And they have to have an offline, you know, like a holding place at their own facility, a server that that information can be stored on,


Eva Schenkman  35:36

I still see a lot of doctors practices, their servers are in a closet down the hall. Yeah, and, you know, a lot of clouds. Yeah, that, you know, and, you know, we don't really hear it's not really openly discussed, but you know, we get a lot of clinics, there's a lot of clinics that are hit with ransomware. And, you know, a lot of that is kind of kept swept under the rug. And that's something that we need to, you know, why why do we not have a strict regulations as the financial industry, as far as how we're keeping this data, you know, where we're keeping this data redundancy,


Helena Russell  36:05

if you're thinking about automating, and you're thinking about going down this road with an EMR ask the really important question. And that is, how is this stored? What is your security structure? How is it done and who's handling that? Because, I mean, you have to, you have to have a very robust system, and it has to be redundant, can't just be stored in one place and must be stored in multiple places. And how that is done is actually critical, not only to the, you know, the security of your data, how you trust your data, the validation of the systems, but also whether or not you can move forward and practice one day, you know, if somebody holds you for ransom, you're stuck.


Griffin Jones 36:47

Well, that solves for the issue of redundancy, it solves for a lot of the issue of implementation. But a lot of what you described is still the challenge of delivery versus operations. A lot of the reason why people have their server in a closet down the hall is because they've been so busy fulfilling delivery commitments, meaning seeing patients doing retrievals doing transfers, and all of the lab work on the other side of that, that they have not had the time, money energy, to focus on the overall operation systems, you happen to have a program that takes care of a lot of the risk that allows people to visit allows people to do this without putting their own things at at risk or and taking their own, you know, having to test everything within their own system. But they still have to say, alright, well, I've got you know, maybe I've got four embryologist and I need seven. And so how am I going to send you one of my foreign biologists when I'm already half staffed? And, and so how do you how do you begin to solve for that


Eva Schenkman  37:56

one of the things we've been doing is offering you know, several, kind of intensive lengthy courses a year, you know, we, we, you know, and Elena primarily has been going out to to the universities we have someone who's also worked with us doing you know, on tick tock, you know, doing tick tock videos of getting those students out here to, you know, for training, so they typically come to us for for 10 weeks and we teach them everything from Andrology to biopsy, you know, we don't expect that these these these, these new embryologist could go back to their clinic and you know, be doing biopsy on day one. But you know, the typical in the old school apprenticeship style, it would take between two and four years to train one embryologist then we're losing embryologist at a much quicker rate than we can replace them. So if not only, you know, the training school that we have, but the other ones that exist in the country. You know, we are we believe that we're able to now get that training, once they're at the clinic down to under 12 months, so that we can speed up their training. So if you've got four you need seven. Well we can send you you know, you know, we're churning out embryologist, every embryologist that has been through here. I know everyone else had been through, you know, the, you know, one of the other firms California has had a job offer, you know, they're all you know, getting employed. And you know, we need to to, you know, bring through more embryologist and you know, and replace somebody even even a faster clip and that's the only way you know, we can't any longer do this, this apprenticeship, where it takes two to four years to get one new embryologist it's, it's not it's not sustainable. You know, we need a better way of of bringing them bringing them up, bringing them through quicker getting them trained. And you know, the style that we do it here which is very intensive, you know, they spend probably close to about 500 hours, you know, doing every literally every procedure and you know, over the course about two and a half months,


Helena Russell  39:52

hundreds of times they do each procedure hundreds of time. So what we're doing is set adding them up to make it easier for those who are doing the training on site in the IVF lab, making it easier for them to get the embryologist they need. I do think that part of the operational pushback is there needs to be kind of somebody who could bundle I really do believe that there's a there's another role out there for it, an IT biologist or something, you know, somebody who could go into a lab and do a consultation and say, you know, an EVA really has that kind of perspective, she may not be the IT expert, but she has, you know, a really good perspective on, you know, hey, you're doing this, this, this, and this, here are some products and, you know, we can put all these things together and deliver them to you. And you know, here's our IT redundancy expert, you know, can come in, look at your system right now, and say what needs to happen? And what tools can we bring in here that are going to meet your needs? What need do you have? Do you want to do all your quality control remotely? Do you want to do your embryo analysis remotely your embryo culture analysis remotely? Do you want to bring all your data together so that you can meet your KPI with a click of a button, review your your KPIs, and then bring all of those things together, and act as a liaison between all these different groups? Because it is a little mind boggling when you look at what is happening in the IVF field. And you have you know, this automated system and this automated system and this automated system and this automated system, how do you bring all of those things together? That's the challenge. And not everybody's going to want all those things. So how do you do that? That's that part of that operation could be someone who's an expert at all these different things, helping to give advice, consulting, and charging a fee to bring it all together for them and stitch it together.


Griffin Jones  42:01

Helena, you were talking about the challenges in having so many different automation solutions, one solution to that problem of having so many is having a consultant or an umbrella solution of some kind that can bring them together. How much of the problem is also those solutions not integrating with each other not integrating with the EMR? How common is that


Helena Russell  42:28

it's happens all the time. And Eva spoke to that earlier that people in these different realms need to play well in the sandbox, they need to be able to open up their their systems a little bit, so that they can speak to each other push and pull data, because a lot of times you'll see, well, one company will let you do one thing, but not the other. And you need both. And, you know, I think it's a little that's an operational hurdle. And again, an integrator, somebody who really is quite savvy and knows, you know, how to communicate with these folks could hopefully bring some of this together, I know of, you know, at least one company who's doing things like that. I'm sure there are plenty of others that are attempting that, you know, it's it's a daunting task, we know that we know it's very difficult to change. But one of the things that the light at the end of the tunnel, you're never going to stop changing. And IVF though that's just plain and simple, it, you're not going to reach a pinnacle and say, Oh, we're done. Now we've reached the pinnacle, because something new is going to happen down the road, something new, some new way of doing analysis. And so you're going to always have to change you're going to have to learn to live with that. And like Eva has said some of the newer generation, they're used to maybe looking at things a little differently, maybe not so much always changing. But at least the electronic aspect of it doesn't seem like it's so that was daunting, not as daunting not as as much of a trust issue. Now I can't trust my computer gets viruses, right, or I can get malware. So I think that, you know, if you if you have the right systems and the right checks and balances the right security systems and redundancies, as we've said, you will begin to you know, get over that hurdle. That's one of the biggest ones.


Griffin Jones  44:20

But if they don't integrate, aren't we back to the same challenge of the spreadsheets?


Helena Russell  44:25

A lot of them are integrating. Yes, we are if they don't integrate a lot of them are seeing the handwriting on the wall. I think Eva, wouldn't you agree?


Eva Schenkman  44:35

I think so. Now,


Griffin Jones 44:37

seeing the handwriting on the wall and that they're not being adopted, if they don't integrate


Helena Russell  44:42

They’ve got to make themselves a lot more malleable in order to be adopted. Like you just said, if if we're trying to show people how to use a KPI and the system that is is giving you your best data and is not you No handing it over that you have to actually export it and upload it a different way that may be not as user friendly, you might do it. But if somebody else down the street will integrate, guess who's gonna get pot?


Griffin Jones 45:14

So there might be a market response that forces people to integrate more you had in the beginning of the conversation, you alluded to some solutions, maybe not coming to market, but not having the scientific proof that they have a great benefit. What are some examples of that?


Helena Russell  45:36

Well, I think even would agree that there are some products out there that we need to more closely scrutinize and names. I'm not going to do that. But I will say that their artificial intelligence base, but the the issue with some of these is, you know, the gold standard in scientific medical research is the randomized control trial. And some of these products, they may have them in progress, but as far as I know, not really have published as much as they should, or at all. And so one of the things that I think we need to as a scientific community, which is what IVF is a part of, is that before we fully buy in, or spend an awful lot of money on something, that I mean, maybe we volunteer to be part of that study, you know, if you're an IVF center, and you're interested, you know, say, okay, all I'll be part of this study in order to help advance this field so that we'll know one way or the other, what they're promising may not be that we have better outcomes, necessarily, but that we might have more efficient outcomes, which might lead to better outcomes, because maybe your embryologist won't be so incredibly stressed out all the time, because they can't function because they can't get all their work done. Because there's not enough of them. And this automation could become part of the workflow that holds an answer for them, at least part of an answer.


Eva Schenkman  47:13

And I think that I agree with Helena, you know, the biggest issue is, is you know, especially, you know, right now, you know, the flavor of the month is kind of anything AI. And you know, each of them have some some papers coming out that they're showing that that, you know, this system is the best or that system is the best. But there's really a lack of well, plans. Well, well, rigorous setup. Yeah, what very rigorous those randomized controlled studies. And that's really, because what happens is people that adopt it, and they don't see the same benefit in their hands. So there's a big distrust of it, when you have for profit companies, who are then also sponsors of these papers, we're putting out data saying that this is the best thing ever. And then when somebody pays the money and adopts the system, they're not seeing, you know, the same, you know, Return, return to there. And so, you know, I think, you know, that's probably the one thing in this field that that I think is hurt us that we don't do, you know, as many well planned RCT studies, that, you know, we do a lot of retrospective, a lot of, you know, prospective, but not necessarily a gold standard, you know, stuff, which is hard to do.


Helena Russell  48:22

I mean, in IVF, it's very difficult to do that. Now, it's very difficult to do certain kinds of randomized control trials, because you do not have, you know, that many chances for fertility, in many cases who are coming to you for treatment. You know, if you're going to do a randomized control trial, it's got to be planned in such a way to limit the harm or potential harm for the patient. What's harm harm is, maybe they didn't get pregnant. And so, you know, in these cases, when you're looking at artificial intelligence, as long as you have a good check and balance, like you're having, you're having your own technicians review, and re and, you know, respect what's coming out, but review what's coming out of the AI. And make sure that well, whatever it is, it's telling you, you have the human aspect that you've learned to, you know, know, you know, and love, and you trust, then, you know, oversight is good, but what does randomized control trial mean? And what is blinded mean? Because a lot of times bias, unfortunately, you know, enters into these things and how do you create a study where there's limited bias, meaning that you're not overtly influencing the people who are conducting the study? The doctors, the even the patients, and certainly the embryologist, how are you ever going to blind the embryologist? Probably not never, you're probably never going to blind them because they're going to have to keep the numbers straight. Somebody has to protect the patient's embryos and make sure they really truly understand they know this is embryo 1234. And this is embryo 3456 and make sure everything is working properly. So blinding, the embryologist is almost impossible.


Griffin Jones 50:07

Which RCTs? Would you like to see happen with regard to AI companies entering the lab space? Like, can you detail what you would like to see an RCT or a couple of RCTs?


Helena Russell  50:18

I mean, even you talked about this the other day with the AI that you were thinking about that, that I think one of the things that we need to see is more numbers, also consistency and how the training database is working. So how you build that artificial intelligence is by having, you know, a large enough number of input and outcomes, you know, so you have something that you're observing, right, and you're applying an algorithm to it. And then what comes out the end is, hey, do it this way, or, or select this embryo. And so if you have a large enough database, you could potentially apply that one of the biggest problems that we have, is applying it across the entire world, probably not doable, because in each and every lab or each and every IVF. Center, there may be some variables that we really have no control over, that we have to kind of focus in on that particular lab and having enough data to have an artificial intelligence algorithm built may not be possible on a center by central basis. So some of these things, I think it takes time to develop the algorithm and then apply that to a randomized controlled trial, where you're looking at either isolating the artificial intelligence and doing it with sibling embryos, for example. So you have to have a special population of patients who have enough embryos that you could put them into different systems and compare them, or potentially looking at, you know, larger populations, if you don't have those sibling embryos to look at, you could look at groups of individuals in those two different, you know, isolated, different ways of producing the embryo, for example. So it goes beyond what we're currently doing in the lab, which is observational, when we even when we look at time lapse imaging, we're looking at changes over time that those are very interesting markers. Because you could see slow development versus fast development versus abnormal development. And you can see all that in a time lapse imager, this is something that you could never see as a, the traditional way of analyzing embryos to pick for transfer is a, you know, a one, a particular time point. And looking at an individual, you know, time point is, is not as superior as looking at, you know, time time points throughout the developmental process over the five to six or seven day period, that we have them in culture. And what Eva's talking about is even more specific and more precise. And that is going after those molecular markers, where you look at gene regulation, you know, those kinds of subtleties are almost impossible to you may not see anything, but and they made the embryo may be developing perfectly well, you know, it's just looks like a normal embryo. But when you actually look at the molecular profile, and look at the genes that are upregulated or downregulated, compared to the perfect environment where you can't replace something like that, you know, and and in past times, some of the things that people have looked at are metabolomics. I don't know if you've ever heard that word, but it's okay, the embryo is growing, and we're looking at metabolites of growth, and you siphon off some of the culture fluid and you look to see oh, is it metabolizing? Well, but actually looking at gene regulation, and and looking at markers that are very fine detail of the health of an embryo could be a potential answer.


Griffin Jones 54:15

I appreciate you both giving these so much insight into the different obstacles that are inhibiting automation from fully taking the IVF lab by storm. How would you like to conclude with regard to what needs to happen in order for automation to take its full rightful place in the IVF lab?


Helena Russell  54:37

I think what we need to do are some very detailed studies, where we look at how the impact of these automations on you know, first adopters, you know, there's always going to be a group of people who say, I'm there with you, I want to go automation all the way I want to do these things that are going to assist us in in prevailing and thriving and And moving forward, those first adopters should be studied. And efficiency should be studied, we should study all aspects of, you know, their turnaround time for troubleshooting, they're, you know, catching things on the on the fly when there's a, you know, a detail that's out of place for their QC, their daily Qc is messed up and they get an automated announcement. And, you know, there are people who are malleable to this, you know, they will be early adopters. And so those are the folks that we really need to study we need to present at meetings, we need to maybe create the perfect training environment like we have here at Art Lab, where you can bring people in, expose them to this integration and say, Okay, this is how it could work in your lab. You show them something, and that barrier is may not be eliminated, but it's gonna come down a little bit.


Griffin Jones 55:55

Helena Russell. Eva Schenkman. Thank you both so much for coming on inside reproductive health.


Sponsor  56:01

You've been listening to the inside reproductive health podcast with Griffin Jones. If you are ready to take action to make sure that your practice thrives beyond the revolutionary changes that are happening in our field and in society. Visit fertility bridge.com To begin the first piece of the fertility marketing system, the goal and competitive diagnostic. Thank you for listening to inside reproductive health

179 Chat GPT Has Arrived In REI: Conqueror Or Collaborator? With Dr. Ravi Gada and Manish Chhadua

DISCLAIMER: Today’s Advertiser helped make the production and delivery of this episode possible, for free, to you! But the themes expressed by the guests do not necessarily reflect the views of Inside Reproductive Health, nor of the Advertiser. The Advertiser does not have editorial control over the content of this episode, and the guest’s appearance is not an endorsement of the Advertiser.






Please Note: We recorded this episode two months prior to release, and Manish and Ravi have already been pinging me about changes that have happened since. I will do another episode with them because this topic is constantly evolving!


Chat GPT is here to change the future of your job in the fertility industry, or maybe even take it. Is this a stretch? Dr. Ravi Gada and Manish Chhadua discuss how Chat GPT and its predictive technologies has the potential to revolutionize is already revolutionizing the fertility space. And what may come next.


Tune in to hear:

  • Uses for Chat GPT in fertility clinics and the Open AI source behind it.

  • How Chat GPT is being used to share data with patients, aggregate data, how it may be used in the future to generate prompts and consult notes.

  • The elimination of scribes and schedulers.

  • How Chat GPT will be able to interface with patients to provide 27/7 availability and access to care.

  • Griffin push Manish and Dr. Gada about what the second and third order consequences will be from this development, and what significant long-term impact it could have on the future of REIs.



Dr. Ravi Gada:

LinkedIn: https://www.linkedin.com/in/ravi-gada-md-mba-a2307527/

Manish Chhadua:

LinkedIn: https://www.linkedin.com/in/mchhadua/
Website https://reuniterx.com/




Transcript


Dr. Ravi Gada  00:00

In the fertility space, what we're going to deal with is who owns the data inside the EMR. So, when we talk about regenerative AI and language modeling, we're talking about being able to talk back and forth with a patient, maybe summarize a chart, create a summary of a consultation and put a note in the EMR. But we also talked about in AI, this whole idea of helping predict outcomes for IVF, as well as dosing for medications for a cycle embryo growth and development and who owns that data.




Sponsor  00:31

This episode is brought to you by Univfy, email Dr. Yao at mylene.yao@univfy.com, or just click on the button in this podcast, email or web page for your free IVF artificial intelligence tips and strategies. Today's advertiser helped make the production and delivery of this episode possible for free to you. But the themes expressed by the guests do not necessarily reflect the views of Inside Reproductive Health, nor of the advertiser, the advertiser does not have editorial control over the content of this episode. And the guest's appearance is not an endorsement of the advertiser.


Griffin Jones  01:13

A monkey can do an IVF egg retrieval. That's something that more than one REI has said to me. That's a euphemism. That's not really true. But will we be saying that what Rei is can do today is like the intellectual capacity of monkeys, based on what's coming with artificial intelligence? That's the topic of today's episode, you might listen to today's episode and wonder is Griffin high? No, the topic of today's episode is exactly why I don't get high. I talked to Ravi Gada. Dr. Ravi Gada and Manish Chaddua. Both of Reunite RX niche is the founder. Dr. Gada is their medical director, Dr. Gada also practices at Dallas Fort Worth Fertility Associates, we talk about chat GPT, which many of you have heard of some of you may have not the open AI source behind it, we talk about the applications that it's having. In the greater context right now the applications that it's having in the REI practice, how it's being used to share data with patients, how it's being used to aggregate data, how it will be used in the future for prompts and generating consult notes, how it will replace the work of scribes and schedulers and nurses how it will be able to interface with patients as an avatar of you. Because of technology that already exists. Today, I pushed Dr. Gada and Manish To explain what they think the second and third order consequences will be from this and what the REI will do when half of the communication half of the tasks that they're responsible for today are done by artificial intelligence tomorrow, at least half depending on what length of time we're talking about. And if we're talking about a long enough period of time, does it become everything that an REI could possibly do in a way that they couldn't possibly add any more value over what general artificial intelligence can do? You'll notice throughout this conversation, we really tried to keep the conversation about the applications of what happens in the REI practice, at least for half of the episode. But there's almost no way to contain it to just that open AI is Chat GPT product is just the tip of the iceberg and it has implications for every single aspect of the human experience. I might sound dystopian or pessimistic when I'm trying to get Manish and Ravi to think about this during our conversation. I don't think I am I think I'm pretty neutral. I'm not making a value judgment if it's good, bad or neutral, but follow along as we discuss how this conversion of technology not only replaces workflow that happens in the REI practice, does it replace the concept of human production altogether. Buckle up. Don't even consider consuming anything that has cannabis in it and enjoy this conversation with Manish Chadduaand Dr. Ravi Gada. Dr. Gada, Ravi. Mr. Chaddua, Manish. Welcome to Inside reproductive health.




Dr. Ravi Gada  04:06

Good to be here.




Manish Chaddua  04:07

Nice to meet you.




Griffin Jones  04:09

Manish , do you know how many times Ravi has Monday morning quarterback my show and I get a text or an email something that I should have said or something I should have asked. I've always asked him to come on. He says no, I don't want to rock the boat. I don't want to shake salts. I don't want to stir the pot. And finally I got a text from a couple like a month or two ago saying okay, I got a topic let's talk about yet. GPT. And I said all right, great. This'll freak people out. And he said companies government I said Yeah, so I want to freak people out about chat GPT. But we were speculating before we even started recording how much of our audience knows what chat GPT is how many of them know about open AI the platform that it's built on? So why don't we start Elementary and just give context for what we're even talking about? 




Manish Chaddua  05:00

I think a lot of people have read a handful of articles maybe about chat, GPT. But you know, it's an endeavor that kind of started probably about five years ago. It's often invested heavily into it. And then, you know, really just back in November of this year, last year, they basically launched this first kind of forward-facing view for consumers of what exactly it's capable of. And so the founders behind it are, you know, a handful of guys, Sam Altman, Peter Thiel, Elon Musk, I think are some of the original core for it. But since Microsoft has invested upwards of $10 billion into this product,




Dr. Ravi Gada  05:38

well, and Griff just, I don't know if people know what I mean, Sam Altman is the former CEO of Y Combinator, Peter Thiel, former founder of PayPal, Elon Musk, obviously everybody knows. So it's got some pretty big backing behind it.




Griffin Jones  05:54

People know those names but tell us about what Chat GPT is doing.




Dr. Ravi Gada  05:59

Chat GPT is an AI language modeling platform, it's probably considered a SASS platform where users can go onto the web, create a login, it's absolutely free to use, there is a paid version of it that you get a little bit more priority. And you can ask it just about anything. And it has over 100 billion different data points. But you can ask it, you can just talk to it. If you're like, Hey, how are you today and go through a conversation, you can ask it? What's the reason for having an Hmh of less than one, you can ask it to draft legal documents that you can ask it to write a poem. So and really, it puts this together and you can iterate on it back and forth to get to the point where you're happy with the answer, copy paste, but it into your platform and use it a lot of people are saying it will be used to augment the workforce and make our lives easier.




Griffin Jones  06:54

Manish, How does that work? Like how is Chet GPT using open AI to be able to do that?




07:01

So chat, GBT is called the term that's being used for it as generative AI. And so what chat, what they've done is they've basically created, you know, in the term is a caucus of data of about 170 billion data points, which is articles, publications, all sorts of data points across the internet, they stopped collecting that data in about 2021. And really, the way that it works is actually through algorithms and just math, it's predicting the probability of the next word or the next most likely word in how it's generating this text. And so that's kind of the clever thing about it is that it's this large, large data set, it's able to basically look at that data set, and then predict the profitability of the next word. And that's how it turns into the text that gets outputted when you're asking your questions and the context that it actually receives when you follow up with that question, and things like that. So it's a predictive model,




Griffin Jones  08:01

Doctor Gada, give some of the use cases that Chat GPT is being used for what are some of the funky ones that you've seen, one of the funky examples that I've seen was, like, talk about a certain type of story in the tone of comedian Tim Dylan, and it was the comedian, Tim Dylan reading it. And it was pretty close. And even he says, like, wow, this is, this is pretty close. And it clearly wasn't there yet. But it's more than just write a poem or write an article, you can actually say, write an article for this certain type of audience or write it in the spirit of x. And so what are some of the wacky examples that you've seen?




Dr. Ravi Gada  08:43

People are predicting this year, chat GPT, or any other language modeling system is going to write a screenplay for a movie, it's going to give it some input data on what type of movie at once and who the characters are, it's going to write the movie from start to finish finish. And they're going to take that storyline and put it into an animated AI platform dollies for pictures, but there's some animated ones in the background, and it'll create the animated movie and that by the end of this year, we'll have a movie in which the screenplay and the animated movie are all done by AI with minimal human input. Wow. So even




Griffin Jones  09:21

the characters, the action of the animation is going to be created by artificial intelligence.




Dr. Ravi Gada  09:27

Yep, completely based on the language of the screenplay, and it'll make all the action of the characters, the voiceover to voiceover as well. So you can there's voiceover you can do now, so I could probably record all of your podcasts, uploaded it to chat, GBT right what I want Grif to say and replay it, and it's going to sound like I'm doing a podcast with you. And we can call it something else.




09:48

Well, I'm going a step further from that they can actually model based off of a handful of pictures of you an actual animation of your face and have that talking as the actual animation for that. Voiceover so that's so they can mimic like real life people and things like that. And that's not just GBT. But that's other AI solutions that are out there.




Griffin Jones  10:08

Sure. What is that? Is that the deep fake? What is that?




10:12

It's related. I mean, it's in that vein. Yeah, exactly. Yeah.




Dr. Ravi Gada  10:15

Deep fakes, probably the most popular one.




Griffin Jones  10:17

Is that a different type of artificial intelligence? What's behind that?




10:23

Yes, sir. I don't know a whole lot about what's exactly behind that. But it is using AI to basically evaluate facial expressions and things like that, like deep fakes, specifically takes my facial expressions, and it superimposes your face onto it. There's other versions of that that basically will just take text and known kind of vernacular and how mouths moves and things like that, to basically create video or animations of a person actually talking.




Griffin Jones  10:51

Okay, well, I could just totally dive into this part where I'm deeply concerned about someone making a podcast episode.




10:59

That's a really weird edge case, or not weird, but just kind of scary, is that even hackers are using chat GBT to generate clickable content so that way, they can send email blasts out and they'll just ask it things like, hey, create a email that's basically has a link in it, that's the most likely to be clicked by users. And it'll actually generate and so this is another edge use case where it's like, okay, well, you know, the malware the ransomware type of folks out there using it to help move their cars.




Griffin Jones  11:32

Well, I want to come back to this and talk about what we think second and third order consequences might be of all this, but let's talk a bit since this is, after all, a show for Rei is it isn't Rogen were talking to fertility specialists and the people that own fertility practices? What are the applications that open AI can be used in the REI practice at this time?




Dr. Ravi Gada  11:59

So I think at large, right, we've, we've seen in our space companies that come in just using AI for data mining for embryos, look grading eggs, grading embryos, there's companies trying to predict what's the outcome of an IVF cycle. But we haven't really seen too much movement in the linguistics modeling or the language modeling. So in an REI practice, could you create a chatbot that basically communicates back and forth with a patient answering simple questions. So if a patient calls, or has a question about what's my Hmh level? Or what's this thyroid function test, could could a language model reply back and forth with that patient just enough to answer as many of their questions as possible? In healthcare, you want to be very careful in what we call follow up criteria. So if the if the bot doesn't know the answer, then say, Hey, let me get one of the nurses for you or one of the doctors and then someone picks up the conversation from there. But you could think about that in a way where patient has free access or 100% 24/7 access to a chatbot that's been trained by us in the REI community. We've given all the language the data points, the conversational pieces to have. So that's a use case. Interestingly, I did a did a thing the other day I put write a male male couples gestational carrier contract, and it spit out a gestational carrier contract immediately. And then I said, Well, can we add language for what happens in the first trimester if there's abnormal screening, postpartum does the gestational carrier provide lactation and milk for them and and it added all these sections in there along with by the way, an exhibit page to add the financial conditions of all of these things, so I can have it write contracts for third party reproduction pretty easily. I had a patient asked for a work excuse the other day, and I had chat GPT write a work excuse after an abdominal myomectomy for six weeks, and it wrote it for me. It leaves blank so you know template so then you copy paste it and then you add the patient's name, sign your sign it and send it.




Griffin Jones  14:12

Let's talk about the EMH level example for a moment, the thyroid function example for a moment, how would we know if the bot gives the wrong answer?




Dr. Ravi Gada  14:21

So this is the part that gets complicated, right? So what's interesting is there's plenty of companies today that have language modeling, ai, ai ai, so chat. GPT is owned by open AI, open AI is primarily going to become a Microsoft based company. Recently, Facebook launched one called llama and then Google launched one called Bart and so everyone's going to have a version of this. You have to then take their AI language modeling and input your own data set. So perhaps that's recording the next 1000 hours of calls with nurses and physicians with their patient. inputting that data. And then running tests to see is it doing what it's supposed to be doing? And if it is perfect, if it's not, you have to give feedback to the system always. And that's how it's why it's called machine learning or regenerative learning is it has to learn from itself. The patient either has to tell it, it's wrong, the nurse has to tell his strong, but you've got to feed that system enough to be smart enough to give the right answer and smart enough to know when not to give an answer. But that's going to be the biggest challenge in our field is making sure it doesn't overstep its bounds.




Griffin Jones  15:33

And so at what point do we expect it to be able to be a better judge than a human being?




Dr. Ravi Gada  15:41

I think in some cases, we might already be there in certain language modeling. I mean, when we in you open up your Gmail, or Outlook, and it practically finishes your sentence for you when you're typing up an email now, and sometimes I'm like, well, that's better than I would have wrote it. So let's just go with that. But in the healthcare space, I think we're I think we're a bit of ways I think we always are later adopters, for new technologies for that reason. But if I had to guess, I mean, we have to be three to five years from being able to really, I hope within three to five years, where they're where we can leverage this type of technology.




16:14

And the biggest challenge is going to be what Robbie's talking about this Fallout criteria. So when we think about AI, and basically, you know, creating the answers are basically predicting what the answer should be. The probably the, the hardest part is going to be that aspect of just knowing when not to answer and AI is not there yet, or doesn't seem like it's there, which is why a lot of stories are online about how they're tricking chat GPT and providing wrong answers to math questions or, you know, doing a handful of other things like that. So that's probably going to be where, you know, some, the physicians in general, will view this as a tool that helps them get to the answer faster. But it's still, you know, we're far away away from between us getting to the point where we can blindly trust that to do that.




Griffin Jones  17:06

Have you read anything about the regulatory bodies or the agencies thinking about how we're going to regulate this either from ama or from Fe cog or from is anybody talking about this? Rob?




Dr. Ravi Gada  17:19

I don't think anybody's talking about him. I was listening to a couple of podcasts about it. So in healthcare, it's not interestingly Moniece mentioned to me earlier today, chat, GBT did certify that their HIPAA that they have a HIPAA compliant API version to it. I don't think any of the society organizations are talking about it. Even in this sense of copyright. People haven't really quite figured out when chat GPT pulls language from the internet, essentially rewrites that language and spits out an answer. It's not giving attribution for where that came from. And so there's even concern that could chat GPT ultimately get stuck in lawsuits with copyright? And are they just rewriting someone else's language or or verbiage that's out on the internet without site citation of credit? And Google does it right you type a search? It gives you an answer. But there's a link to where it goes from they might summarize a little bit in the in the description part. But ultimately, it gives credit through a link which chat GBD does not. So there's some people looking at this, but I mean, no society organizations from a medical standpoint, no, I don't think anybody is even digested what this technology means




Griffin Jones  18:31

until they hear this podcast. And they're like, Oh, crap, we have to have a board meeting.




18:36

And one of the counter arguments to the copyright thing that Ravi just brought up is that, you know, do humans in general do anything different? Are we just basically absorbing information and data from a variety of sources, and then basically mimicking what we hear with some amount of, you know, how much innovation is actually being produced? Out of what we regurgitate? Right? Some attribution




Griffin Jones  18:59

and some innovation, but very often isn't even possible to totally attribute everything because like the machine, you might be saying, in this case, money's we're aggregating and it's an amalgam of everything that we've consumed. But I was I was going to ask you that question about intellectual property, too. And you brought up the example of Google Ravi. And I wonder if if case law is still been established about that? Because sometimes I think like, is that enough when a creator is putting out information or creating something, and Google just kind of takes it and they put it on a Google search? And yeah, they give it a little bit of credit, but very often, what does the Creator actually get from that credit? If that person gets their answer right there in the search, they don't ever have to go to the creators website. They might see that little URL at the bottom, but they're pretty much just getting their answer from Google. Is there any kind of case law that, you know, Manish that has been established? Or is there are there battles going on about this




20:07

definitely is something that's been brought up even just about how the way Google works. Now Google gets a little bit of away with it, because they are actually providing that attribution. And I think that's where chat GPT will be very different. Because, you know, it's not the Texas generating is somewhat unique, but it's not actually sourcing that direct place of where the data is coming from. Even Ravi and I have had conversations about this as well, just to say, you know, here are the different differences. And then, you know, Google is a little bit different of an animal as well, because it's giving that attribution, it's giving hope to those creators to actually get the clicks or get the referrals. So I think it's a little bit of a different scenario altogether.




Dr. Ravi Gada  20:48

But there, but there is, there is case law for this. So there is something called fair use for copyright. So fair use has been established that our case law underneath that there's four criteria for violating fair use, but one of them is not citing the person, but it has to affect their ability to monetize. So if you have a company that has a bunch of articles about fertility, and you're regurgitating their data and putting it there, and their whole business model is to get links, have people click on that? And then ultimately buy something or lead them down something, then? Yes. And that's where Google pays people for that link. And so there is it's called fair use. I mean, I don't know that it applies to copyrights. Specifically, it's not going to apply to what we're going to deal with in the fertility space. I think in the fertility space, what we're going to deal with is who owns the data inside the EMR. So when we talk about regenerative AI and language modeling, we're talking about being able to talk back and forth with a patient, maybe summarize a chart, create a summary of a consultation, and put a note in the EMR. But we also talked about in AI, this whole idea of helping predict outcomes for IVF, as well as dosing for medications for a cycle, embryo growth and development. And who owns that data? Is that the patient is that the clinic? Is that the EMR? Is that everybody? And I think there will be a little bit of information that comes out from probably not the fertility space, but probably more on a higher level of internal medicine or diabetes of who owns this data.




Griffin Jones  22:27

I wonder if this affects people like me even more so than it might the general public and that those that are in deep niches, and are based around information are in deep niches, part of the reason why anybody picks a niche, whether it's a client services firm, or media company or software company is so that they're delivering specific needs to a small group. And that's where they that's the entire reason why they do it. And if something can just say, hey, take everything that inside reproductive health has gathered and created from original sources, then it could be the small niche companies that are most vulnerable, don't you think?




23:16

Yeah, I mean, content creation is something that's going to transform quite a bit. I mean, even if you look at the way, you know, traffic gets generated, and Google and even beings a algorithms work right. Content Creation is like, been the pinnacle of how they judge what's what's good, what's not what's new and fresh. And so that's definitely a large area of impact. I mean, there's, there's sub companies from chat GPT that have already been created that just create copy, and they create everything from sales, copy, marketing, copy, blog copy. So that's definitely distinct part of I wouldn't call it a threat, but a possible, you know, a rethink of that approach of copy creation or content creation.




Dr. Ravi Gada  23:59

I think the niche markets will get saved in this because when I look at health care, people focus on cancer, diabetes, hypertension, obesity, and fertility, and very small sectors get overlooked. And so all of these companies I think, are going to be focusing on the big three, you know, in terms of hypertension, diabetes, obesity, and then add cancer, and infertility kind of gets overlooked. I think that's why actually, as a field, I feel like we're very technology deficient. We don't have enough technology infused into this space, and maybe will be saved. I don't know.




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Griffin Jones  25:57

We talkedabout a couple of the applications that you're using right now what applications do you expect that aren't quite there yet, but that open AI chat GPT will be able to do in less than three years.





Dr. Ravi Gada  26:11

Imagine a day that we're I'm sitting in a consultation room with a patient, there's a TV screen behind me here. And I say well, let's take a look at your Hmh level today. And on the screen, it hears me say that and pop to the h a m h up on the screen behind me for the patient to see that. And then I say, you know that's numbers normal, you know, that should mean that you have a good ovarian reserve. We also do a follicle count to look at that. And here's me say follicle count from your ultrasound. And it puts that up on the screen. And I have this now interactive conversation with the patient. They're asking me questions, we're going back and forth through a return visit or new visit. And at the end of that visit, we walked out of the room, I hit done on the recording device. And it generates the entire consultation note immediately on its own because it's regenerative language modeling gives me You know, I can then sit at my desk take 30 seconds to read it finalize it done, by the way, any edits that I make to that note that I didn't like the way it writes, it's recognizing that I edited it and and learning from that. So I think at the highest level, you could look at that you could look at it basically, you know, every six months, every three months, it reads the entire chart for a patient and summarizes it in a note on a three month update or a weekly update depending on what cadence you want to do that in. So there's things like that there's things that I could have it recording all the calls that my nurses do to patients, right, I rely very heavily on my nurses to communicate back and forth with patients. And I can and the language model can tell me if there was inaccuracies being presented or something that is different than what I would have said based on its understanding of the conversation. And then we can we can retrain that nurse, we can improve things, you know, it goes beyond nursing, to imagine the day that all of these things are just used as tools to make us better, more efficient. And ultimately, it will probably take over half of the I wouldn't say conversation but communication that we have back and forth with our patients.





Griffin Jones  28:24

At what point might we expect to see the avatar Doctor Gada, having that follow up. And so if all of those things are just different data points, and it can compare it to all of the data points from every piece of scientific literature, fertility and sterility is ever covered. And everything from all of the medical colleges, if it can just deliver that type of information, and we can use your video we can use your voice at what point are patients just seeing a virtual Doctor gotta





29:00

so I think the humanity and US will fight that pretty pretty well. So I think if you look at telemedicine, a lot of things like that, I still think the preferences is face to face communication, I don't think you can replace that for some people. Right. And I think for places where we're underserved pay at places where we're trying to get into that aren't getting quite the availability of health care. I think those are the areas where you'll see this kind of really explode or really thrive is to care for patients in in those particular areas.





Dr. Ravi Gada  29:32

But I mean, I've talked to Manish about this you know we have a lot of pilot projects in this area of where where will this technology take us and how do we get in a lot of it's in the datasets that are fed into the system but when I do think does the day come that you asked the patient would you like to see the human doctor or would you like to see the avatar Doctor initially or virtual care models are already there today. Many patients are going online and wanting to order their her own tests and get their information at home or through virtual care. So I think there's a version of it today, I think there's going to be a more sophisticated version of it in the future.





Griffin Jones  30:10

I'm a little skeptical on Manisha is hope for the humanity aspect. I think people want the humanity when they feel that the robot is insufficient. So the reason I yell into my phone when I'm talking to the the banking teleprompter is because it doesn't understand that I'm saying, talk to an agent or review account balance. But if I actually could do that as easily as I could correspond with a human being, I think it has more to do with convenience than humanity.





30:42

Yeah, for sure. And grip, I think my my point of view on that is more for general, for healthcare, I do think fertility is a little bit different, because of the age of the patient and kind of, you know, the fact that every fertility patient coming through as either a for the most part is Millennials or younger, right? You definitely could see this avenue of I'd rather text with my doctor than, you know, talk on the phone with them, or, you know, have to go and show up at a clinic and actually have that face to face interaction. So I definitely could see that scenario.





Dr. Ravi Gada  31:13

You think about this, there's a YouTube video out there, if you type robotic reenact the Moses of bow, using artificial intelligence, there is a cadaver. So it's a pig model of a robot, taking bow and sewing it back together without any human doing it and it healed intact. And then obviously, they checked it sacrifice the cadaver and checked it. And so, I mean, if we're getting to the point where cars can drive themselves, robots can do bowel reenact the most surgery on their own, we will get to the point where communication back and forth with the patient or consumer will get there. The question is how far right do you get to the point where you just do the intake form? And asking a few questions for clarification? Or do you deliver lab results deliver? Do you deliver positive and negative pregnancy tests and that way? That's the part is how far will it take it? I think it's going to go. If you fast forward 30 years from now, there's going to be a way different version of doing this. The question is in the next three to five years, or while we're all around, how far are we going to get?





32:17

And that's absolutely right. Like you take any technology, any innovation like this, and it's all a matter of a timeline, you assess some rate of improvement, and every tech pundit will say that is whatever the rate of improvement you select, that means at some point in time, you know, the technology will surpass the reality.





Griffin Jones  32:36

m&e, as you said, this has been in the works for some time now the technology behind chat GPT. But it seems like there has been an inflection point recently though, no, like, just how good chat GPT is itself. And then I practice with it. And a couple other like, think of translate for exam I, I don't remember the last time I used Google Translate for language, but it used to suck and not too long ago. And recently, I when we were covering the KKR story for buying ie vrma. And their only media coverage was in Spanish. And I speak Spanish pretty well. I put it into Google Translate to see and it was good. I like almost as good as as a native speaker who had been natively raised in both languages. So what's the inflection point when he's what happened recently?





33:28

Yeah, so this is common, right? This is common in a lot of technology, whether it's the smartphone or the internet, or, you know, even AI. And really, it's a byproduct of technology from 1015 20, even 30 years ago, becoming more accessible, less expensive to use, and basically more awareness, right? So you take smartphones from, you know, back in the late 90s. And they existed, and they had a lot of functionality. But it wasn't until the advent of the iPhone, where it really was the right time in place. And the cost equation made the most sense to where it can actually rapidly grow inside of that. And by the way, my background is telecom. So that's why the analogies there. But then pass that chat. GBT really is the first very consumer facing version of an AI model that showed the rest of the world everybody, including, you know, guys, like you and me, as well as you know, just college students and everybody else in between, right, what the capabilities of AI is. And I do think that AI has been in place for a long time. I mean, it wasn't, it was a number of years ago when AI beat, you know, IBM Watson mini in a game of chess. And this is just that acceleration. And I do think in AI, right, if we look at any of these revolutions that have happened, or major disruptions in technology, you know, it keeps happening faster and faster. And so So I think chat GBT has really opened everybody's eyes to what's capable? And now, all the thinkers and innovators are out there? Basically saying, Oh, I didn't realize we were this far along. How can we employ this as a part of, you know, a core model? Or how do we adopt this and find out what the right solution is that's really chasing this already, and integrated into our workflow.





Dr. Ravi Gada  35:18

And Griff real quickly to add on that. So the inflection point was I don't know if sometimes we will realize Chat GBT launched in November of 2022. So the inflection point was the first real launch of a major language model. And it obviously caught fire. And that's why we're all talking about it, or a lot of people are talking about it, interestingly, in that, but it was founded, I think, in 2019, four years, something like that about four years ago. And they've been working on it up until now, interestingly, post chat GPT launched, let's call it circa November of last year 2022. That put a lot of pressure on Google and Facebook to launch their versions. And so Google launched Bart, and they did a commercial about this. And in the commercial, Google asked, or someone asked the chat bot, to tell them about the James Webb telescope. And it was listing some bullet points. And the last bullet point said that the James Webb telescope was the first telescope to take a picture outside of our solar system, which was actually false, it was actually not yet planet and people picked onto that. And as soon as it did, Google's actual market cap value dropped by $100 billion that day, attributed to this error, because everybody said, their language model and their regenerative AI is not as good as Microsoft's, and they're not ready yet. And it lost some around seven to 10%. Market cap $100 billion because of that, but I think chat GPT launching in November is why we're at that flexion point today,





Griffin Jones  36:52

to the point that is a can take over half of communication that's currently happening between the REI practice and patients right now, maybe more than half so when that happens, Rafi not if because it will happen. It's only a question of time when that happens, what is the RBIs role going to be?





Dr. Ravi Gada  37:12

And you know, I mean, I think people worry about this a lot, right? People talking about not just the role of the RBI, but the workforce is these are these technologies going to replace the workforce. I mean, whether it was the calculator, whether it was Microsoft Word, whether it was, you know, all these different technologies that keep making us better and better. But we talk about this all the time in our field, that there's a under underserved population, there's, you know, we're at the tip of the iceberg. Maybe we're only meeting five 10% of the populations need. Does this actually make us better? Ultimately, we're still proceduralist we still do a lot of procedures in surgical procedures, egg retrievals, embryo transfers, IUI. Guys, so I hope or I think this is not going to replace the average ra i think it's going to make us more efficient. I think it's going to make our nurses more efficient embryologist more efficient. But you're right. How does it allow for us? And we talked about how many are the amount of retrievals that an REI can do in a year. And beyond that point, there. It's it's not beneficial maybe to the patient or the ER, and it depends how many nurse practitioners do you have underneath you? How many nurses? Well, this is going to be another adjunct to that technology have an honestly a checks and balance. I mean, imagine the day where we have going into an IVF cycle. And I'm going to do for the physicians and nurses that listen to the podcast, a Lupron trigger. Well, there's certain things for Lupron triggers that you want to know you want to know that that patient has regular menstrual cycles and that they have a normal FSH level. And so the second you order a Lupron trigger, that the that the AI actually scours the EMR and actually pings you and says, Hey, I don't see an FSH level on this patient. Are you sure you want to order a Lupron sugar? And I say, Oh, I'm glad it caught that. Let me order a FSH level real quick and make sure. So I think it'll make us more efficient. It's, you know, replacing us I think we're all going to be replaced one day, you know, whatever, whatever, you know, sector you're in, you're gonna get replaced 100 years ago, everybody was a farmer, or at least knew somebody was a farmer. Today, I don't really know that everybody can say I have a first degree relative. That's a farmer. So machines have already replaced, farmers machines have replaced manufacturing jobs. And that's the worry about this type of AI technology. It will replace jobs, but it will also create jobs. I mean, we didn't have the jobs we have today that, you know, that didn't exist 100 years ago. In fact, I don't know what the population of the US was 100 years ago. Let's make it 100 million people. Today were 300 million people, no manufacturing jobs, very few farming jobs, and everybody's still employed. So there will be new jobs created. Maybe we'll figure out newer ways to help people get pregnant, but things that are replaceable at Everybody should be looking at saying, you know, how do we either make ourselves better to stay ahead of it? Or how do we use it to, you know, augment what we do today?





40:09

And there's there's a lot of people out there far smarter than us that have kind of pondered upon this question as well. One of the other things that I think is kind of changed recently, is initially they thought a lot of low skilled labor would get replaced fairly quickly by automation and AI and things like that. I think chat GPT tests that a little bit and saying, Hey, listen, well, you know, if your job is sitting behind a desk at a computer, basically, replying the emails and doing things like that, there's a lot of risks there, probably more so than a surgeon, or, you know, even a mechanic at that point in time. So I think that's what it's changed kind of some of the view of what would get replaced by AI first, but I do think we're still a fairly long ways away from that, like, years, at least,





Griffin Jones  40:56

well, for now, and I do want to talk more about that. And we'll definitely end on a note where we're really freaking people out, but, Robbie, I want you to think a little bit about what it is that the REI will be needing to do in these coming years as Chat GPT gets an AI in general gets more sophisticated, like how I'm envisioning it is there's human Gada overseeing a hunt the capacity that robot Gada can do and robot Gada is helping to treat 100 patients and human Gada just needs to oversee robot Gada or is that not the right way of thinking about it? Because the human will soon not be?





41:38

Grip? I think the jury's still out on whether or not Robbie's a robot or not.





Dr. Ravi Gada  41:43

It could be it could be, do you wanna see dr ga da, or Dr GA D Ay ay ay.





Griffin Jones  41:50

Oh, it's already there. And and so what's the relationship supposed to be? Yeah,





Dr. Ravi Gada  41:56

I mean, I think ultimately, that relationship kind of goes back to, you know, we already use or have our staff help us accomplish what we accomplished in the day, I don't accomplish in a day, you know, very much if I don't have a nurse, an embryologist, a medical assistant, a billing person. And this will do the same. I think that, but I do think you know, we've managed to have talked about there, I'd love to do a commercial where I have four consultation rooms running with a iPad in there that's actually has my own avatar, speaking back and forth with that patient, one patient, it's their new patient console, the second room is their return visit with their lab results. And the third patient is coming back for another FET after a successful delivery. And all the while I'm actually over in the operating room doing the retrievals all day. I mean, so that day is coming. Now the question is, is that coming tomorrow? No. Is that coming in the next three to five years? Probably not? Is that something that we can work towards in the horizon of a 10 year type cycle? I think so. I mean, I know that might not sit well with some people. But I think you have to embrace this technology. We are looking at this very heavily. We're investing a fair amount of resources to figure out how to do that. And I think that the people that do will do well, I think the people that resist it may do well. But I think there's a high chance that they're not going to be able to be as efficient if they don't adapt to technology, which is the story over the last 100 years.





Griffin Jones  43:30

You talked a bit about it's some of this like data entry type of work that is most vulnerable. And I was hearing one expert on this topic talk about that it's actually more white collar work that is vulnerable rather than blue collar work because blue collar work tends to be more manual. But Manish when are we going to see an intersection between robotics and this type of AI because once that happens, then we don't need human God at all, once we have a robot that can do the very sensitive maneuvering in surgery that the best surgeons can do right now. And we have the artificial intelligence of all of the data points gathered from every surgery ever electronically recorded. When can we what progress are we seeing towards robotics and artificial intelligence? converging?





44:31

You know, it's actually something that's, that's familiar, before even AI right, it's the separation between engineering and technology or software. Right. And so this is I think, why we're seeing this is because replacing things that are soft like on a computer or something like that becomes a lot easier once you can get over a kind of the intellect or the brain of it, right? The biggest issue with robotics right now is probably the expense and so when In the cost of robotic arms, robotic equipment and stuff like that, that's reliable and high precision and things like that start coming further and further down. That's when you'll see this kind of cannibalize even those types of industries. And so that's where I feel like, you know, this low skilled or blue collar laborers, you said it, you know, as a little bit more protected, because the cost of those robots has not come down. And the functions that they pervert perform, and the accuracy of what they do, just isn't quite as inexpensive as, you know, your email solution of being able to message back and forth with patience or something to that regard. So it's going to happen, but it's just, you know,





Griffin Jones  45:42

so maybe there's a silver lining to all of this supply chain crap that it's slowing down the inevitable





Dr. Ravi Gada  45:49

grip. I don't know. Are you old enough to remember the Jetsons? I mean, that's where Yeah, remember





Griffin Jones  45:53

the Jetsons Flintstones crossover?





Dr. Ravi Gada  45:56

Yeah. So you know, I mean, imagine I mean, the Jetsons is looking forward to, obviously, if robots robots replace what we do, and we work, everybody's concerned on what would we what maybe we start enjoying life again, you know, we worked so hard, we, you know, is a society. And I'm not talking about just fertility, I mean, globally. And maybe we actually, you know, a 40 hour workweek becomes a 20 hour workweek. And we actually are able to read and spend time with family and travel. And maybe I mean, robots taking over and doing certain things. I'm not saying they're taking over the world. But maybe we get back to the point where society actually has time to do the things we do rather than being in this hamster wheel that we are in today.





Griffin Jones  46:38

Before it does, what other applications do you see elsewhere in the fertility industry and quote, so you talked about the applications that can happen in the practice between fertility providers and patients? But where can what other applications are we seeing right now with open AI, if any, in the fertility industry, and what more should we expect?





Dr. Ravi Gada  47:01

Yes, I don't think we're seeing I mean, I haven't seen it, I tried to keep a pretty good pulse on what's going on. I haven't seen it. There's some chat bots that are out there. But overall, in terms of chat, GPT, I don't think so we've seen it in obviously, in the lab, there's a lot of work being done to robotics and, and automation and AI. But what's interesting is, I don't, I think also no one in the fertility space, or even a lot of other spaces are going to actually be able to build their own technology on this, they're going to have to leverage I mean, think about Microsoft, Google, Facebook, Amazon, few other companies, I'm probably leaving out, but they have the best of the best, the brightest or the brightest, and essentially unlimited budgets relative to ours to do this. So a lot of this is going to be creating API Interfaces into their technologies. And using our datasets. I wouldn't be surprised if the EMRs that are out there are looking at this today, right? The electronic medical records, they're fairly technology forward, they are probably looking at their datasets, because they have actionable datasets. You asked me hey, you know, Hey, Ravi How much does DFW fertility associates? What kind of data do you guys have to feed into Chad GPT. And I've looked at you and say, I haven't even I don't have data. Like, I haven't started gathering that. But maybe I should, maybe we should start recording every conversation we have in the office with a patient and with each other, myself and my nurses, myself and the embryologist to feed this dataset, and is one individual, clinic or user or even an MSO going to be able to create enough data, perhaps but but likely not, it's going to require a collective effort amongst the industry. So I don't think we're there in terms of that. I mean, like I said, there's the earlier stuff, I was telling you writing a letter writing a contract for third party reproduction. But in terms of the high level stuff, it's got to be a concerted effort of gathering that data, putting it in, and then really, ultimately, you know, garbage in, garbage out. So if you put garbage data in, you're gonna get garbage data out is what that term is. But you've got to do that, then you've got to test the model over and over and over again, because in healthcare, we demand 99% excellence, right? In other industries, they might say 80% lunch, this, you know, we've all talked to a, a answering machine bot on a customer service line, they'll get to 80% and be satisfied with the quality of that work. We have to exceed that above 99%. So no one's there yet, but the question will be how do we get there? I think that a lot of people like us and others are looking at this. And I think that it's around the corner. If you ask me what does around the corner mean? I can't tell you the answer.





Griffin Jones  49:54

So I was going through Dr. Rudy Giuliani's workflow with her and I How she did 1300 retrievals last year and I was thinking of each of the points, she was talking about listening well, I could impact that I could impact and I told her, I said, You should listen to this episode that I'm going to record with Ravi and Monique, because she was talking about her scribes. And I was just thinking your scribes are gone, man, they're not they're not going to have a job in a couple of years. There's no way in schedulers to right.





Dr. Ravi Gada  50:23

Yeah, yeah, exactly. Or are their job changes, right? You know, they, you know, they either they're either gone, you're correct, or it changes, right. So we still like concierge service, right? So they, the bot kind of does that. I mean, Google right now, I think has a platform that you can order a pizza now through a bot or make reservations at a restaurant. And it'll actually if the restaurant doesn't have something like open table that you can go online and do it will call the restaurant and make the reservations for you and interact with the hostess without, without a person, it's a robot talking to a hostess. So those jobs will be either replaced or used in a different way.





Griffin Jones  51:03

Sometimes those applications come and they circumvent solutions that you would think need to happen, right? So for one of the things that we've been saying for many years is that millennials don't want to talk on the phone. But Gen Z absolutely won't talk on the phone. So you guys have to figure out your scheduling, you got to figure out this digital scheduling as well. Maybe you don't, because this Gen Z person can just input into chat GPT called the fertility clinic and make an appointment for me.





Dr. Ravi Gada  51:34

Yeah, that'd be ironic, as we keep focusing on how can we get the clinic to be the Chatbot. And we find out that the Gen Z is actually or the chat bots, and we're still interacting with them on the human side? Well, unfortunately,





51:45

they're not gonna go to the metaverse to schedule appointment anymore. So





Griffin Jones  51:50

well, it's just kind of one of these principles that you think of that we often it's, we have to build a certain type of infrastructure. And there were many countries, for example, that never really built out a telephonic infrastructure never had landlines at scale. And that was probably in their government central plan that, okay, 10 years from now, we're going to build telephone poles and have the wires out to the rural countryside. And they just never had to do that. And so there can be a number of applications that we're thinking of, for artificial intelligence that just circumvent the need for us to build out some other kind of solution.





Dr. Ravi Gada  52:31

So the other day I took I had an Excel sheet, it was a financial Excel sheet. And I took it and I was just curious, because I had heard people were doing this, I copy and pasted it, I didn't format it. And I thought what happened, so I just copy pasted into chat GPT, it looked awful. And I hit submit. And it summarized the Excel sheet for me without even having cells or columns or anything, it was very oddly formatted. So imagine taking the entire data set that we have for IVF patients and outcomes, and just dumping it into this thing. And just at first go saying, What do you think of this? Or tell us in patients less than with a Hmh? A 42 year old with an AMA H of 1.2? Whose BMI is this? Who has unexplained infertility? What what what what should we do? I don't know if that will be the answer that we're looking for today. But that's what we're probably looking to strive for. And, and that's literally just copy and pasting an Excel sheet. Imagine once you get these API's start working with these companies, and you really integrate with them to provide this type of data. I think it's, I think it's also like people, it freaks people out. But I think that when literally, when the calculator was invented, people thought, no one is going to know how to do math, we're all going to be stupid, nobody is going to use their brain anymore. And they're just going to rely on this device. And here we are today doing way, way more amazing things and advancing technology. And the calculator is a tool that you just use, and honestly half of us have moved away from that to things that are on our computer now.





Griffin Jones  54:15

Okay, so we can spend the next 10 to 15 minutes concluding this topic with going down these rabbit holes, because this is going to be fun, what you just brought up Ravi, the example of the calculator, how it's going to make people dumb, and people aren't going to know how to math do math anymore. Ravi, that did happen for probably 80% of the population. They can't do math anymore. And May and 20% can do math into levels of application that we had never even anticipated before. And probably a square root of that number is, you know, has just magnified the Einsteins of the world. But isn't that number getting smaller and smaller and smaller. smaller and the, the applications are greater and greater and greater. But eventually doesn't that number just become nil, because there's nothing that a human being can do to add value to collective general artificial intelligence,





55:17

definitely the edge of what we're talking about, I think Robbie talks about, like these alternative purposes for humans, and basically, what's going to create our, you know, Will and an ability to keep driving forward and stuff like that. And I do think that that those things will happen. But I do think there's a lot of fear around just that, which is, hey, listen, does the population as a whole get less intelligent? Or does a proportion of the population become less intelligent, and then you have this, you know, small niche of the population that continues down the road of research, and basically innovation and stuff like that. And that, you know, that's entirely the storyline of that time machine movie. So so i think i digress to the point





Dr. Ravi Gada  56:02

where it is, right. I mean, people have, maybe, maybe people have become worse at math worse at spelling, because Microsoft Word and everything auto corrects your spelling. And the older generations, like, gosh, we knew how to do all this, I feel like that sometimes. But the newer generation says, Well, you might know how to do math, and you might know how to spell. But these influencers are able to create a whole new, you know, industry, and they're able to create content, videos, edit it with through a computer that does it all with them. And it would take me eons of time to do that. And they can do that in a matter of an hour. And it would take me days, and I still might not get it right. So I might know what you know, the square root of 256 is and they're like, well, that doesn't matter. I've got a computer to help me do that. But you can't use the computer the way I can. So smartness is dependent on the tools that we have, I think that it, it forces people to be resourceful, and be able to use the tools you have. So just like you use a calculator, just like you use Microsoft Word, you're gonna have to learn how to use AI, and whether it's chatting GPT, or some other platform. And someone else might say, well, I could have written a beaut, I can write a beautiful act or essay on my own. Well, that's great. But if someone else can use a tool to do it 10 times faster and 10 times cheaper, they're probably going to win the race.





57:32

And we've seen this from a software point of view, we've seen this over the last, however, long, 40 years or so, right? Where software is now becoming easier and easier to produce, even what developers can accomplish in just a day versus what we had to do to do you know, back 20 years ago, just to get the same type of thing done has has totally changed. And so there's a rate limiter at some point in time where it's not going to matter that they can do more faster, because there's just not more to do. But we're not there yet, either. So, you know, our developers use chat GBT already today and just in the last few months, right? It helps them solve problems faster, it helps them optimize code that code faster, and a lot of things like that. But we have a long way to go before it replaces any of the developers. So





Dr. Ravi Gada  58:19

by the way, for for like normal people speak that like language model. This thing can code because code is a language so it can actually code software. And people are estimating 10 to 20% of software at at big companies is already being written by platforms like Chen GPT.





Griffin Jones  58:36

I see what you guys are saying human intelligence, resourcefulness, resilience, that's only one category of concern that I have. Let's pause it for a moment that we remain committed to innovation that we use this time, Robbie, like he says the possibility to be free to pursue other creative pursuits to enjoy life. Let's pause it for a moment that we don't actually get worse at anything. There still comes a point right? Where there is nothing that human intelligence and creativity can do to surpass that which a general artificial intelligence can think of let's let's think of ancient hominids, for example. It's some point they were equal at some point, humans parted with chimpanzees, and they parted ways with other previous hominids. But then not we live in a world where there is nothing that a chimpanzee can do to add value in a human being world other than be observed and be a pet. So doesn't that happen at some point? Where Yeah, no,





Dr. Ravi Gada  59:36

I mean, it's a great point. So what's interesting though, remember, AI and regenerative learning is data. Data input. So right now, someone estimated chat, GBT has 190 billion data inputs and it regurgitates it out. But it doesn't know what to put out unless it's been put in. So Chad GPT, for example, is likely or any AI is is likely not to figure out How to create this nuclear fusion between protons to generate energy, human intellect still is able to do that, right? They call it the neural network inside of AI. And what's in there is what's been inputted by humans. So a lot of people are saying that what's inside of the datasets, there'll be able to, you know, AI will be able to find it faster, regurgitate it, remodel it continue to do that. But it's always going to need to use or I say always, I should say, as of today is it needs source data, it needs innovation. So innovation is still going to come from humans. And we're going to do that. And then we submit it into a platform such as AI, and go from there. But as of today, I don't know that anybody has any great use cases of AI solving a problem that humans needed to invent or get to, it's really regurgitating all the things we have. And it's just gathering it faster and spitting it out faster. Maybe one day, we'll be able to have, you know, its own neural network that actually generates new ideas, but new ideas are still created by humans and put into the computer software system.





1:01:12

So I do think that there's some places where we're getting there, right. And that has to do with the sheer sheer compute power, right? This ability for it to go after large, large sets of data, right, and basically go through every permutation, right? So it's a little bit different from what we would think about as like new ideas. It's not necessarily a new idea. It's just a, hey, we've gone through every permutation of possible outcomes. And that's how we get there. And so there's, there's this, you know, looming threat or looming kind of, you know, fear of the fact that hey, listen, there's not anything more that we can do that hasn't been done by AI. But I do think that's right now, it's science fiction, at some point in time, it probably will become reality. But hopefully, it will be past my time.





Griffin Jones  1:02:02

The operative phrase that Dr. Gaga was using was as of today, and I think it's okay, as of today. But even Manish can think of a couple of applications where it's starting. And so what about what how long is as of today lasts for? Is it 10 years? Maybe? Is it 100 years? Probably not? Is it 1000 years? Almost certainly not? Almost? Certainly not?





1:02:26

Yeah, in grip. The interesting thing about that is that it's not a conversation about RBIs at all right? No, it's, you know, it's a





Griffin Jones  1:02:33

human race. Yeah. But it's the relevance of the human race.





1:02:37

Yeah. But even before that just passed, are you guys it's, you know, a cure for fertility, right. It's basically, you know, what's the pursuit? What's the purpose for, you know, humans and its happiness, and, you know, procreation and all these other kinds of facets. And so yeah, we'll get to a cure to fertility probably sooner than unnecessary need for humans.





Griffin Jones  1:03:02

I actually think it's going to be the thing that puts us all out of business, because I think it could even it could happen before a cure for fertility. I've said this for years that my long ball sci fi outcome is that,





1:03:16

but it'll be sustaining, right? It's putting us all out of jobs in order to sustain us otherwise, even the AI has no purpose without humans, but





Dr. Ravi Gada  1:03:25

it puts us out of business for what like we all are doing things so that we can be productive and earn money and then use that and enjoy life and have a purpose. But purpose will be redefined as it just as it was 100 years ago, where it is today. And it will be redefined again and another 100 years.





Griffin Jones  1:03:44

So I actually think it puts us out of the business of production. I mean, the the intersection of artificial intelligence and of virtual reality, I think that's what ultimately puts us out of, of the business of human production. Because when we can live in a world where we can augment our intelligence with artificial intelligence, so human beings are already cyborgs. This these devices that we carry around on us help to us to augment our intelligence and our communication abilities and all of our memory and then once that becomes further integrated with our brains with our nervous systems, and there's a virtual world in which we're able to participate, then eventually, what do you even need to reproduce physically in this physical world for you can have your augmented intelligence baby in your augmented reality world that never has to worry about dying that never has to worry about sickness that doesn't have to worry about human suffering. And I'm not saying this to you guys are smiling. Most people are going to be listening to this episode and not watching it so they can't see you smiling right now. I'm not saying this to be dystopian. I think this is just what's actually going to happen.





Dr. Ravi Gada  1:05:00

about maybe it puts us out of the business of being productive production, but it actually puts us back into the business of relationships and, and, and leisure and lifestyle.





1:05:10

And, and just to just to touch a little bit on the philosophical side of this, right, is just keep in mind the lifespan of a human is part of evolution. So,





Dr. Ravi Gada  1:05:24

that was pretty deep. I don't even know what that means.





Griffin Jones  1:05:26

Yeah, explain that many.





1:05:29

Yeah, so just kind of getting to the point that like, humans live the span of life that they live as a part of how we've evolved to become where we are right now, there's plenty of animals that live many, many years longer than humans and plenty of animals that live much shorter years than humans. And so, you know, that's, that's part of the equation as well. And, and the second thing that's kind of goes into that is it like, listen, we might have purpose with AI, but AI has no purpose without humans, either. Because what does a bunch of bots running around, servicing themselves and doing things for themselves me, either, that's a, that's a purposeless kind of function in that vein as well,





Griffin Jones  1:06:13

maybe, but I'm not convinced of that, they may find a purpose because the purpose of any living organism is just to continue existing. And human beings might be the first one to evolve itself out of existence. You talked about our relationship to other species in terms of how long we've been aren't, we haven't been around very long. It's been 200,000 years, I think, since humans separated from the last hominids. And when you look at our, our growth, it's been it's, it's a hockey stick, compared to the first years of leaving the canopy. And now civilization just in the past couple 1000 years, industrialization 200 years ago. And so I don't think this stuff is too far away. And I'm not trying to be dystopian, I just, I just don't think that I don't think there's any way for us to be able to contain it and control it. And so far you guys ever given otherwise?





Dr. Ravi Gada  1:07:09

You know, I think that people thought that when assembly lines came about, I think that they thought that when tractors came along, I think that is always been a worry. And it will always continue to be a worry. But ultimately, in a philosophical sense, humans are resilient. And like I said, we seem to stay ahead of the technology that we create ourselves. You know, at what point do we are we not able to stay ahead of it? Well, up until today, we still have I mean, people thought the world was over when assembly lines came in, and manufacturing jobs just got crushed, and what are we going to do and farming got replaced by equipment. And here we are today, three times the population with you know, 2% 3% unemployment, I mean, people are still employed doing something?





Griffin Jones  1:07:56

Well, if they said that, in the 1860s, as folks, were moving from steam to coal, you know, the late 1860s, or somewhere before the early 1880s. Whenever that happened, if they said, This is the end of humanity in the in the next five years, yeah, they would have been wrong. I think it's the amount of time where people get things wrong. I don't know if this is going to happen in a century or in a, or in an eon or a millennia. But I think it's inevitable that it will,





1:08:31

from that point of view, right? There's a this is not a country point, right? This is, you know, a we're never going to know, or we're not going to know, anytime soon. But in addition to that, yeah, I mean, it's definitely a possibility. And we'll have to figure out something else to do or something else to be or some other purpose to have, at that point in time. But, you know, it's, it's a tricky question, and probably well beyond our scope. So





Griffin Jones  1:08:59

it makes the premise of matrix a lot more interesting, doesn't it? You will never know except, and then and then what will happen? Well, if if you could, if you could evolve yourself out of existence, and then the only thing you had left to do was to recreate a previous existence? What period would you go back to accept the end of the 20th century? And it makes the promise even better,





Dr. Ravi Gada  1:09:22

right, right. Now, I've thought about the matrix A lot, you know, in looking and hearing about AI and its evolution, and it really makes that movie a lot more relevant.





1:09:31

Yeah. My only claim is I don't think they'll need us for batteries. So.





Griffin Jones  1:09:35

So you guys are optimistic. And I know that I might sound pessimistic, I don't think I'm being passed out. And I'm not making a value judgment. If all of this thing is is good, bad or neutral, but I want you guys to think a little bit about second and third order consequences. So Did either of you watch any of the interviews that Brett Weinstein has done about chat? GPT I bet but most of my audience doesn't know who Brett Weinstein is though. Those of you that do, I bet it's half and half about half the like, really critical thinkers really like him. And then other people might not like him because he's like the guy in the movie that is worried about everything. And he's always trying to warn about the media coming. And he's, he's, you know, he's worried about civil war. He's, he's very worried about the entire scientific and medical apparatus and feels that vaccines were rushed in that, you know, that that system was compromised, even if the vaccines themselves are safe, he feels that the the system was co opted. And one of the things that he's worried about is chat GPT given our fragile social relations right now and human beings, general incompetence to assess expertise already, you know, your peers, Ravi are very What are your peers often complained about is Dr. Google? And so if Dr. Google is them, though, and it's a avatar of them pulling from collective data points and, and its expertise that may or may not be scientifically grounded, then what are some second and third world? I'm sorry, second, or third order consequences that you might be concerned about?





Dr. Ravi Gada  1:11:15

Here? I mean, Brett Weinstein, he goes into things like it's able to pass exams, it's able to actually change GBT our licensing exam, as physicians is called the USMLE. It has passed both of those exams. And so if it's able to pass those exams, and people can access it on the internet very quickly, how do we discern who really knows? And who's just using chat GPT to present the answer? And I mean, there's two facets, I think, to that. dilemma. One is, you know, we all have been in oral exams, we've all taken exams in classrooms. I mean, the tool is only as good as you can access a computer and internet and be able to ask it those questions. But there's still a way to assess in education, because his big issue is education, and how people are using it to write essays and pass tests and do these things. Well, we've moved to a virtual education model post COVID. And maybe this brings us back into the universities, doing oral exams. I mean, you know, we've all been there. And and, and you can assess that in real time, you can assess an essay when you have Chad GPT able to write an essay for you, and how do you discern who's a good student and who's not. But again, in person education, we'll do some of that. The second part is, we already have things like chat GPT. Today, as physicians, we have up to date that we use as a resource. I have my partners, I have my colleagues, if I have a case that I'm not sure about, I pick up the phone, I talked to somebody, I get some information. I mean, it's a resource to augment and help our ability, but I think he does a lot of fear mongering, I think he likes to just the world is ending and everything. And that's okay, itself. But ultimately, there are ways in the education system to figure out who knows the right answer, and who doesn't, without having them taste, take tests at home. In the real world. You know, he gave an example, I think, at one point, have an auto mechanic and you just go in the auto mechanic asked Chad GPT. And he just sounds really smart. But how do you really know he knows, versus an auto mechanic who's been around for 20 years? And at





1:13:26

what point in time? Does that matter? Right? If I can get to the right answer, either way, right? It doesn't matter if the auto mechanic use chat UVT or not.





Dr. Ravi Gada  1:13:34

I mean, sometimes when I see someone come to the house for work, or you know, we're interviewing someone, one person might be really old school and has 20 years of historical knowledge. And the other one's a whippersnapper who uses all the resources around them to get to the answer. Which one do you want? I don't know. But that, you know, that depends on you know, what you're looking for?





Griffin Jones  1:13:53

Well, you talked about the assembly line, the farmers, you know, how those jobs have gone away, and how a lot of wealth was created by better jobs. And it really depended you. You all live in Texas, where you have a low regulation, low tech state that saw a lot of growth, but I live in a part of the country where many cities were decimated because they didn't adapt. And so you see different types of trajectories, I guess we would have to have a whole other conversation beyond our pay grade of what is the equitable distribution of, of benefits after chat GPT How do you even materially divide the spoils? And is that something that's possible to so that everybody can enjoy life as opposed to some of the people being able to enjoy life more from chat? GPT Are either of you guys? truckies





1:14:47

when I was a kid, I watched the soundtrack all the time. Yeah, the original





Griffin Jones  1:14:50

are next generation, next generation eyes. So next generation all the way what I'm hoping for is the holodeck. If we can all get the holodeck out of this you Then I think that's where the where the trade off. This has been the closest to any kind of Rogan episode I've ever done with you this is we're recording at almost 1130 at night on the East Coast. And I really could talk to you guys for three and a half hours about this. But we'll save that for another time because people are gonna listen to this, they're gonna Monday morning quarterback me just like Dr. Gowda doesn't say you should have asked them this you should have. And so I'll compile that I'll and I'll happily have you guys back on for a second time because this has been a blast. We've talked about the applications for the REI practice and for fertility patients. But we've also talked about the potential implications for the human race because you can't possibly contain this topic to just the REI practice, even when you're focusing on the applications for our field. It just goes so far beyond that. So how would you both like to conclude?





Dr. Ravi Gada  1:15:57

No, I mean, thanks for having us. Griff. You know, I know we've talked about coming on this before. But this was finally a topic that I feel very passionate about. I think that healthcare in general should embrace this. And I think that health care at a high level, will we as people in the side, the fertility industry have to figure out how do we take the data that we have, and not just data inside of the EMR, but all kinds of data to make sure we keep up and so we are working on this, you know, continuously, I think that others will join in and it will make us better, it will make our patients better, it will make outcomes better. So I'm not worried about the technology of the consequences of what does it do to jobs or do to us, but more how much it's going to improve our efficiencies and our outcomes. So those are the things that I think that technology helps. And technology is deflationary by nature. And maybe this also helps bring down the cost of IVF, which could help us be able to access more of the patients that are out there seeking care. So that's how I would, I would leave it.





1:17:04

And just that on the roof. Absolutely. This is a fun topic. You know, it's one of the ones that I think, you know, I can talk about tech all day long. This is one that, you know, definitely over the last few months has definitely been top of mine. Something that's just interesting has so many implications in fertility as well as far beyond, you know, any of your users that listen to this, if they haven't had a chance to even just log in, and just play around with. I mean, it's a different feeling right? To read an article about it versus actually start asking your questions and see what you'll understand a little bit why we're so excited about it. But appreciate you bringing us on the show. This is a lot of fun,





Griffin Jones  1:17:45

Manish Chaddua,  Dr. Ravi, Gada thank you both so much for coming on the inside reproductive health podcast. I look forward to having you back already.





Sponsor  1:17:54

This episode is brought to you by Univfy, email Dr. Yao at mylene.yao@univfy.com or just click on the button in this podcast, email, or web page for your free IVF artificial intelligence tips and strategies.  

Today's advertiser helped make the production and delivery of this episode possible for free to you. But the themes expressed by the guests do not necessarily reflect the views of Inside Reproductive Health, nor of the advertiser, the advertiser does not have editorial control over the content of this episode. And the guest's appearance is not an endorsement of the advertiser.

You've been listening to the inside reproductive health podcast with Griffin Jones. If you are ready to take action to make sure that your practice thrives beyond the revolutionary changes that are happening in our field and in society. Visit fertility bridge.com To begin the first piece of the fertility marketing system, the goal and competitive diagnostic. Thank you for listening to inside reproductive health

94 - How Modern Fertility is Changing the Patient Journey, an interview with Afton Vechery

After her own experience with fertility testing, Afton Vechery set out to make the testing process easier for millions of women across the country looking for a better understanding of their reproductive health. From day one, Modern Fertility aimed to provide quality, peer-reviewed information to empower young women to have the knowledge they need to make more informed decisions about her fertility.

On this episode of Inside Reproductive Health, Afton shares the Modern Fertility story. She shares how she brought her vision to life, including how she has been able to raise funds from Venture Capital companies. Griffin and Afton also discuss how Modern Fertility hopes to work with fertility clinics to improve the patient experience across the board.

90 - The Best of 2020

As we head into a new (and hopefully better) year, we wanted to take a look back on all the wonderful, inspiring guests we had on Inside Reproductive Health throughout the year. We talked about affordable care, mentoring new staff in the clinic and the lab. We learned about independent clinics and how they thrive despite heavy network competition, networks and how they continue to provide personalized care even after becoming publicly-owned. We talked about reducing physician burnout and increasing patient communication. And so much more.

On this episode of Inside Reproductive Health, we highlighted your favorite episodes and compiled the best clips into one episode for you to enjoy as 2020 wraps up.

85 - Venture Capital and Its Interests in the Fertility Field, an interview with Dr. David Sable

Venture Capital has been slowly making its way into the field over the last several years. But just what is it looking to improve?

On this episode of Inside Reproductive Health, Griffin talks to Dr. David Sable, a retired REI and current serial investor in biotechnology and other companies that aim to make the field more efficient and accessible by the patients we aim to treat. They discuss what it is going to take to scale to a million cycles in the US and 15 million around the world. From lessons from oncology to bottlenecks holding us back, Dr. Sable shares his biggest hopes for the fertility field and what entrepreneurs need to do to get it to the next level.

Dr. David Sable co-founded and served as director of the Institute for Reproductive Medicine and Science at Saint Barnabas Medical Center in New Jersey, was founder of Assisted Reproductive Medical Technologies, and was co-founder of Reprogenetics. In addition to serving as a reproductive endocrinologist, Dr. Sable also sought to help the field as a whole by finding investors to create new technology to increase the amount of people served by the field. Today, Dr. Sable is a life sciences portfolio manager, an adjunct at Columbia University, and serves as director, advisor, and board member for a wide range of biotech and advocacy organizations.

Learn more about Dr. David Sable at www.dbsable.com or find him on Twitter @dbsable.

81 - Ethical Implications of Physician Investment in Fertility-Related Businesses, an interview with Dr. Kevin Doody

Despite busy schedules taking care of patients and often running clinics themselves, it’s not uncommon to see doctors getting involved in ventures outside of their clinic’s four walls. From investing in pharmacies to serving as medical directors for new ART companies to starting software companies, REIs can be found doing a lot. No matter what the venture is, there is always the potential for creating a conflict of interest. So how do doctors draw the line? How are they able to ensure they are keeping the patient’s best interest at heart, and not just making decisions that are beneficial to the physician?

On this episode of Inside Reproductive Health, Griffin talks to Dr. Kevin Doody. Dr. Doody founded Care Fertility in Fort Worth, Texas with his wife, Kathy, in 1989. He is also co-creator of Effortless IVF, which is a new ART technology treatment that uses INVOcells. He is also the Chief Scientist of Global Fertility and Genetics.

Together, Griffin and Dr. Doody talk about entrepreneurship in the fertility field and then, we dig into conflicts of interest in the field: what is acceptable and what isn’t.

73 - The Academic Fertility Practice: Pros, Cons, and Its Place in the Fertility World Today, an Interview with Dr. Kenan Omurtag

omurtag thumbnail updated.jpg

On this episode of Inside Reproductive Health, Griffin talks to Dr. Kenan Omurtag of Washington University in St. Louis, Missouri. Dr. Omurtag shares what he views as the pros of working in an academic clinic, as well as the downsides to working in an academic system. They also discuss the history of the model and what it will look like in the future as the world of fertility continues to grow.

2005 Article from Fertility and Sterility on Academic Medicine

The Ultimate Guide to Fertility Marketing

To get started on a marketing plan for your company, complete the Goal and Competitive Diagnostic at FertilityBridge.com.

***

Welcome to Inside Reproductive Health, the shoptalk of the fertility field. Here, you'll hear authentic and unscripted conversations about practice management, patient relations, and business development from the most forward-thinking experts in our field. 

Wall Street and Silicon Valley both want your patients, but there is a plan if you're willing to take action. Visit fertilitybridge.com to learn about the first piece of building a Fertility Marketing System--The Goal and Competitive Diagnostic. Now, here's the founder of Fertility Bridge and the host of Inside Reproductive Health, Griffin Jones.

GRIFFIN JONES  0:55  
Today on the show, I'm joined by Dr. Kenan Omurtag. Dr. Omurtag is a dual board certified doc in both OB/GYN and REI--takes care of all things related to pregnancy, infertility and reproductive hormone issues. His normal day consists of minor and major surgery cases, diagnostic testing, and procedures such as IUI all the way to IVF to retrievals and embryo transfers. His practice focus includes PCOS, unexplained infertility, male infertility, recurrent pregnancy loss, third party, and--

DR. KENAN OMURTAG  1:31
What’s left?!

JONES  1:32
--advances and treatments. If there's something left, we're going to have to uncover it in the show! Dr. Omurtag, Kenan, welcome to Inside Reproductive Health.

KENAN OMURTAG  1:40  
Griffin, thanks. It's an honor to be here. I've really admired what you've done with this platform.

JONES  1:44  
I appreciate that! What I didn't include in the intro is part of our focus today, talking about the academic practice, because I come up with guests and topics for the show very often when I'm at one of the meetings and I run into someone that I haven't seen in a while and I think, Oh yeah, that's something I need to talk about and that's a person that I need to interview. And on my show because it is focused on the business side of our field, I have left out the academic centers in much of that conversation. I've only had a couple episodes with guests from academic centers on the show and you're one of the very first--I’ve scheduled a few more--but I ran into you and we started talking about this and I wanted to talk about the future of the academic center and how it is today. And maybe to get to that I'm interested in why you decided the academic route as opposed to partnership at a private practice, as opposed to employment with a large network.

OMURTAG  2:53  
Right. Well, I mean, first of all, again, great to be here. I mean, it's been really fun kind of watching your rise in this space. So it's really cool to talk about this topic. I mean, I think if you want to just jump right in, I mean let me jump right into it! If you want to understand where the future of the academic medical center is in reproductive medicine, I think it's important to kind of look at what the history of the academic medical center is in reproductive medicine to understand kind of how we got to where we are. So just for example, you know, one of the first IVF cycles in this country was done with the Joneses at the Jones Institute, an academic center. A lot of the innovation in early ART was in the academic center. Prior to the advent of ART, it's important to point out that reproductive endocrinology and infertility was actually an OB/GYN boarded subspecialty, but it was called reproductive endocrinology and then the infertility was kind of like a lowercase “i” and the reproductive and the endocrine were kind of like the capital letters and kind of drove a lot of the focus of the subspecialty. So in the late 70s, the specialty of reproductive endocrinology was largely focused on steroid hormones, steroid biosynthesis. How do you actually measure an estradiol level, an LH level, an FSH level? And how do you do it effectively in a timely fashion to help augment, among other things, fertility care? But there was also an emphasis on medical endocrine things. But when IVF became a reality in the early 80s, and a practical reality at that, there became somewhat of a schism. Let's also not forget a lot of reproductive endocrinologists were the early laparoscopic surgeons. So what you have with ART is, Oh, we can do this? Oh, there's this divisionary of people who kind of said, Okay, I think this is going to be big. We should invest in this and we should still be REI, but we should maybe focus on the “I” a little bit more, because quite frankly, no one's gonna pay us to take care of patients. I mean, there are medical endocrinologists who take care of patients with diabetes and thyroid issues and all these other things, where our space is probably better suited for this IVF ART thing. So that's where I think the divide starts to happen in the 80s. And then it kind of goes--

JONES  5:17  
As the divide is happening, does that mean that you chose one of the forks in the road or at least--not that they're mutually exclusive, but that they do have different focuses and you wanted more endocrinology in your practice area? How did you make that decision?

OMURTAG  5:42  
Well, to me--so I became interested in Fertility Care in 1996. When I was a freshman in high school and I took a class on genetics, I did a nerdy summer camp, I guess, at Duke. Shout out to the TIP program at Duke University and at the time, they had cloned Dolly, they were talking about gene therapy. And I was like, Oh, this science is fascinating. What's the future medical application? Or what's the medical application because I didn't want to be a science--like a basic scientist, I wanted to be a physician. And IVF was like, oh, this is a clinical application of the frontier of science. Let me explore that. So it was actually the in vitro fertilization, the future of reproduction, that is what attracted me to the field. So in essence, it's kind of the IVF component. The surgery component, the endocrine component didn't really mature until I went into residency and I understood more about the field.

JONES  6:42  
And so now we're at a place, however, where I see that differentiation in practice areas, but I also see, maybe, is there a reconvergence as well? Because to me, it seems that some academic centers are also really powerhouse IVF centers. So is that more--is that still just further stratification of the differences that we have? Or is there a reconvergence because of its practicality and also probably because of its financial impact?

OMURTAG  7:20  
I think is a combination of both. A lot of--so, honestly, the ability to move egg retrievals outside of an operating room into, like, an ambulatory setting is what moved IVF out of the academics. You didn't need to be in this kind of, like, hospital setting, you just needed to be in an ambulatory center. And then this is the late 80s/90s people are kind of managed care is changing. Physician-owned ambulatory centers are popping up as a result. So you have all this, this new delivery care and IVF and the visionaries who were like this is big, we need to do this, are the ones that were were also able to either politically or through their ability to influence their local hospital leadership to help support the new delivery model of this ART fertility care service. So I think what we're seeing now is we're seeing the academic centers are trying to figure out, I think, people are recognizing that there's a niche that in an academic center that can be had. And one of those niches could be, quite frankly, the fact that these academic medical centers have their own employees and their own self-insured policies. And there might be opportunities for academic medical centers to provide benefits that are exclusive to their fertility clinic center, allowing them to kind of provide immediate market to their own clinic. So I think--just kind of meandering back to where the academic medical center might find future benefit--it could be there.

JONES  9:00  
Well, I want to talk about that future benefit, especially related to the prospective physician employee, and pick your brain about some of the pros and cons about working in academic center. And I can think of a few! And I want to see what readily comes to your mind and then I want to further explore them.

OMURTAG  9:23  
Not all academic centers are the same. I think that's the--I mean, honestly, not every private job is the same. They're all very different. But the pros and cons of academia, in medicine, mirror largely the pros and cons of academia of other industries. You know, in medicine, when you're in academia, the primary goal is to do some sort of academic pursuit, whether that's educating or doing some research. And when I say doing research, that's actually you're getting paid to ask--you're relying on grant funding to pay the majority of your salary. That is an opportunity for academia. When you're in private practice or when you're in any industry, your source of income is your labor as it relates to clinical care. There's a lot of that in academia and the nice thing about academia is you can have people who, I just want to focus on clinical care and that's how I want to get paid, but I want to have an opportunity to kind of maybe dabble in these other things. So and I think that's what attracts me to this kind of model is, really good at seeing patients. I can see a lot of patients. I'm efficient with my time, but I can also make time to do stuff with medical student education, resident education, and then every now and then I can dabble in a research project that I don't have to worry about getting grant funding, but I can incorporate in my routine, so it gives me variety.

JONES  10:51  
What I would like to find the answer to--or better said what I'm interested in to just see what plays out in the next 15 years or so is how millennials and Gen Z shape the nature of or the routine of what happens in the academic practice. Because I want to share one of the cons that I see is very often the autonomy of the division--of the division chief is so limited with what goes on relative to the rest of the health system. And it's so bureaucratic that they get very little special attention. If they do get extra attention, it's often top down. They often can't even make decisions on very--on starting an Instagram channel, for example, or they want to do a Facebook Live event. Someone needs to sign off on that, right? So I see it all the time when I'm talking with division chiefs, and I just don't see millennials and Gen Z employees and physicians are taking to that. So are they going to change the bureaucracy of the system? If that is the case is going to take a long time? Or are they just going to say, you know what, I can get a lot of these benefits working for a larger fertility network, and I don't have to deal with as much bureaucracy. And are the academic centers gonna lose out because of that?

OMURTAG  12:26  
I think there's a threat that they will--that they could lose out on talent. So that's something that has to be that is something I'm very sensitive about. The question is, though, what like, what is the mission of the academic department? What is the mission top down? And where does the reproductive endocrinology and infertility division fit in that mission, and that is always subject to change kind of on whim sometimes, it feels like. But also if you're just looking for, like, hey, I want this job. I want to just see some patients, a bunch of patients. I want to be around some collegial people for a couple years, I'm going to build my brand on Instagram by myself where I'll have more flexibility to talk freely without having to get any approval. You can do that in academia. If you want to manage--so I had this experience managing our WashU Instagram, Facebook page, etc, like it is there's a lot of layers, but I was also doing it at a time when they didn't really know how to do it. So they were kind of learning with us. I think the institution will flex with time, but obviously it's not as nimble. A large organization is never going to be as nimble as a small outfit regardless of how devoted they are and what kind of lip service you get. I also think though, with time, I think the--because IVF units, they make a lot of money for their hospitals and I think with time as hospital leadership and academic medical center leadership evolve, I think more and more of those new leaders will have personal and at least know people who struggled with infertility and needed IVF and will have an intimate window and they'll be more sensitive to making the unit a priority or at least advocating for more tomorrow than they did today and yesterday. 

JONES  14:26  
When you mentioned that exercising the autonomy as an individual, that I can start my own Instagram handle, for example, and promote my own personal brand, but is that always possible even if--it sounds like it's been possible for you. I've spoken with others and granted, some of the people that have been in training, but they have had their own social media channels. I don't want to say anything about where they are or who they are, but they did a great job of promoting awareness and educating and it just included their program at a very peripheral level, like maybe they were wearing something that had the insignia of the institution or it was at this setting. And something came down from their boss's boss's boss that said, Stop, delete this immediately. And they're not even sure why, but they've got this mandate to cease and desist from superiors that are further up the chain than they've even met before. And that seems really discouraging for intrapreneurial physicians, for talent, that want to take ownership, that want to educate, that really want to participate, and, in my view, only benefits the program overall. I guess, how often do you see that or what are the implications of that? Because to me, it means Okay, well, I guess I have my answer if I were thinking about continuing with this institution or joining up with someone else in private practice or in a large group, right?

OMURTAG  16:12  
I think, again, all the institutes, every setting is different, but you need to also figure, you kind of also need to be wise about things. If you're going to say, Okay, cool. I'm in an academic setting. I know there's medical public affairs or some sort of office, let me find out who that person is. Let me let them know this is what I'm doing. And let me figure out what the ground rules are for the institution. There are going to be some people who are going to meet some resistance and trust me, I have encountered those people, but after you explain after you figure out what are your what are the rules, okay, you want me to fill this form out and make sure if I'm going to include a patient's picture, I just need to write fill out this form. Okay, cool. You know, two years later, oh, I haven't been filling the form out correctly? Okay. How do you want me to fill it out? Okay, you want me to fill it out this way. Okay, done. So incorporating these things. Yeah, it's annoying when some-- in a private practice, I could just say, hey, is it okay? Presumably, you could just say, Hey, can I use this on social? Yes. Okay, cool. I don't need to have this written documentation, perhaps. Some clinics, some larger private clients may require it to have something in writing. So I think--so I've encountered these things, they can be turn-offs, but they can also be opportunities. So for example, if you're in an institution, and you have skills with social media and patient education and engagement on your platform, you should highlight that and promote that and say, Hey, Dean of Education, hey, Dean of Curriculum, hey, department head, and I would honestly focus on the medical school apparatus. That's what we've done here and say, look, this is a tool, we should do a faculty development workshop, I can help lead it and that's how you leverage your skill and it's not so much, Hey, let me build my platform, you won't let me build my brand, or you won't help me build our brand. It's let me teach everybody in the institution how to build our brand and their brand. Because an academic center, they want to know what can you do for the center-at-large? Not so much what can you just do for your slice of the community? Even though that's what you want to do, you leverage the whole institution to get buy-in about what your skill set is, and then you cash out later to get whatever you need to do your divisional thing.

JONES  18:33  
Does that contradict that potential benefit of just--well, I mean, you mentioned before--if I just want to build my own personal brand, I can do that. But in this case, I have to sell it back to the--or I can't and then I have to sell it back to the group?

OMURTAG  18:51  
I wouldn't say it’s so much I have to--like okay, I want to build the WashU REI division’s Facebook page. Okay, there's some bureaucracy I gotta go through, I figured out what it is. I just have to fill out these forms, I set up the account, they made me an administrator. I’ve just got to use some common sense and recognize that when I post on here, I'm talking about the institution and give me free rein. They're not going to give someone free rein who's just like, I've never done this before I want to do it, they'll probably want to know a little bit more about what your messaging is. And I would have a--if you're a novice to it, then I would say, these are the things I want to talk about, here's the content I want you to post. And here's how I want it. I mean, I'm happy to advise anybody out there on this, because I think this is so important. And I think there's a good path to do it. And there are other paths that can get you shut down, which again, can be discouraging and be a reason why people might not want to deal with it. But I promise you it can actually be very rewarding.

JONES  19:54  
Great, because I don't want to advise anyone on that! So if you're looking for a consultant on managing approvals through a university setting, Kenan Omurtag is your consultant and he's expensive, but it's worth it.

OMURTAG  20:09  
It's free 99 for the first hour!

JONES  20:12  
Can we go through a hypothetical situation? 

OMURTAG  20:15
Sure, let's do it. 

JONES  20:17
And maybe it's not hypothetical, because maybe you've done it. But I think that every fertility center in North America, possibly the world, should do a baby reunion. I think it's one of the best marketing tools that you can use. And it's also so foundational for every marketing strategy that can come from that. When I consult with practices, usually it comes up early on in strategy sessions. The timing of when we do it might depend on its priority for project, but it doesn't take me too long to convince private practice owners of the value. And it's like, great, all right, well, we're going to pick the venue. We're going to get the food, we're going to get the videographer, and here's what you're going to do, here's the strategy. And it's not terribly difficult to implement. It's logistically involved, but approval wise, it's a thumbs up from the practice owner or the executive director. And that's it. We're doing it. If you wanted to do that within an academic center, what would we need to go through in order to have it become a reality?

OMURTAG  21:29  
So we've talked about it here. And actually they did one for, I think the 20 or 25 year reunion here. They did one at the science center, it was a big production. It was, in talking to our division head, he said, you know, it wasn't really that hard to set up. They just told medical public affairs and then the hospital outreach folks and they arranged it for us. That was in 2005, though, how would you arrange it today? It would be very similar. We would reach out to our--so like, I have liaisons that I'm in contact with that I contact and say this is what we want to do. This is what the game plan is. Let's make it happen. And they will ask some questions about it. And then they'll set it up based on what--who they think is going to show up and whatever their experience is in setting things up. So I agree with you. I think these things are--they're very sentimental. They're amazing emotionally on a number of levels. And yeah, I mean, there is a marketing benefit to it as well.

JONES  22:29  
Does the Dean need to approve it or does the Dean's office need to approve something or elsewhere in the university? Or they say yes, you can have a reunion, but if you want to have a videographer there, you need to have this approved or if you want to have it at this venue, we need to put out a purchase order to pay for the venue? What else is involved?

OMURTAG  22:53  
That's a good question. I think it would vary by institution. So for example, I don't know if the university would have some regulatory things. And this is where it can get frustrating. The university might have some regulatory things, or the hospital might have some regulatory things. It's just variable and I think it just depends on the institution. I think in some places, it'll be more seamless than others. I think it always comes down to who's paying for this is always kind of, like whoever's paying for it is ultimately going to be the one that gets to decide what the process is, whether it's the hospital or the academic center, and that can vary. The Dean may not care, the Chairman may not care. It might be a solely divisional process that's led and paid for. It might be the division that drives it and the hospital pays for it. It is so variable. But you're right, if you're in a private practice, there's fewer layers of bureaucracy that are there. So you can just say, yeah, we're doing this, this is what we're doing, we're paying for it and let's make it happen. I mean, that's the thing when you're in the academic center a lot of things are not coming necessarily out of the division pocket, they might be coming out of other people's pockets. And that's what leads to the bureaucracy.

JONES  24:08  
I'm emphasizing these cons or exploring these cons because I'm an entrepreneur. I have a tilt to a certain way, which is I want to have the control and not have the--that isn't important to everyone. I think it is important for entrepreneurial and some intrapreneurial docs to consider. But let's talk about some of the pros as well, because you outline them, but let's talk about the the passions that you have for the Academic Center, that if you're speaking to a certain profile of a physician that's entering the workforce, you would really want them to consider what the academic IVF center has to offer that might be less common in private practice.

OMURTAG  25:00  
I mean, it kind of comes down to really two principles. And that's, for me, at least, it’s variety and opportunity. And when I say opportunity, it's opportunity for leadership. So you have--in an academic medical center, you have a lot of variety. If you wanted to just grind out and see as many patients as you can, do as many cycles as you can, and that way you can get your experience quickly, there's an academic center for you that can help you achieve that. Because trust me, they want you to see patients as badly as anybody else. Because, as they say, no margin, no mission. You have to see a lot of patients in order to generate the revenue to help support the other missions of the institution. So clinical care and the revenue that's generated is very important. And there's that, but you can also have other variety so that you don't get burned out so quickly. Because you can be out here and within two years see 5,000 patients, and then you're like, okay, I'm like totally burned out. I need to explore something else. That might require you to either leave your current situation or try to find something within your current situation that allows you to have variety. And many people often find it, but the academic center provides you more structured opportunities for education and research that may not be as prevalent anywhere, or at least have the infrastructure or the depth that some people want to explore.

JONES  26:38  
So what do you mean by opportunity for leadership? What exists in the university setting that is a track for leadership that one wouldn't necessarily find in private practice or a fertility network?

OMURTAG  26:53  
Well, if you want--so I mean, just kind of starting,if you want to start at the top--if you aspire to be a administrator In a big academic center like a Dean, a Chairman, I mean, take it even all the way up to a Provost or Chancellor, you got to spend a lot of time bouncing around or staying in one academic institution and gathering a lot of experiences over time. That's not to say you couldn't do those things if you were in private practice and came back. But if you want to be a--I wouldn't say necessarily a Residency Program Director--but if you want to be in hospital administration, if you want to be a Chief Medical Officer, if you want to be a Vice President of Clinical Affairs for an OB/GYN department, because you really know how to see patients very efficiently, you know how to implement an electronic medical record, you know how to engage patients with social media. You can have a bigger impact on the institution at large and the community at large if that is your desire. Now, obviously, if you're just, you're like, you know--I'm seven years out these things were always on my personal radar, but my first five year goal was I'm going to be the best reproductive endocrinology and infertility specialist I can, reevaluate with the next five years will be at that point. Here we are, we’re at the next five years. I'm going to push myself to be the most efficient reproductive endocrinologist and fertility specialist and learn how to incorporate an electronic medical record and social media engagement in my daily routine. And I'm going to try to be the best at that. And I'm also going to advocate for those skill sets within the institution to at least promote the possibility that, hey, this is the future of medicine, I might have a skill set that could be valuable to our division, department and institution at large. So can you come over here and listen to what I have to say?

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JONES  30:42
I see that leadership track as something that I--there's definitely a profile of doctors that that’s what they're interested in. I don't think that it's--that type of track exists in parallel with or exists at the same level at a fertility network, let's say. But one benefit that we haven't talked about is the case, I think that had been made for a long time, which is, there's less to worry about that is not related to medicine in the academic center. Meaning you don't have to worry about payroll, you don't have to worry about choosing the HR company, you don't have to necessarily worry about marketing. Whereas if you're a single physician, practice owner or even a partner in a two to four or five group, you do have to worry about those things. And that was very often considered a large benefit. I wonder, are we talking about that less, because there's a third group now? It's no longer a dichotomy between the academy and private practice, but I break private practice almost into two groups entirely, which is the independently-owned, let’s say 1 to however many docs, and then fertility networks, multiple groups, multiple doctors, multiple labs and multiple states, sometimes multiple countries. And now, that might be something that they can offer, the fertility networks can offer, that the academic institutions still offer, but used to have as one of their cardinal selling points. I can go work for this larger group and I don't have to worry about payroll, I don't have to worry about HR. There's a CEO, Chief Human Resources officer, they've got the C suite and the processes in place. Does this new rise of the fertility network disrupt the recruitment appeal of the academic center in any way?

OMURTAG  32:41  
I think it does, but also I don't think it really--I mean, I think it does, just in the sense that you have more job opportunities as a result of the business model. But I agree with you. The “I don't have to deal with payroll, I don't have to deal with my malpractice, I don't have to deal with all these ancillary things,” I think most people are not really interested in doing that any place. And that had been academia’s calling card, you're right. Now that there's this kind of third party or third method, but this has kind of been around for a while now. And a lot of physicians are getting used to--like I came up of an age where, you know, physicians were, it’s kind of like, okay, yeah, cool. I'm an employee. The idea that I would just be under these shingles by myself and setting up the whole thing was something I saw with my own uncle who struggled with that transition. So to me, it was never--I mean, I always viewed my job as being an employee. Now, what I will say though, is the fertility networks may provide new opportunities for leadership over time, not immediately, but there may be new opportunities on the leadership side that had largely been and still are traditionally held by academia. One of the other things that academic centers, you know, talking about a pro, the fertility network will provide you your fringe benefits and all these other things and make it pretty easy for you to just plug and play. But the academic centers, specifically the private academic centers, usually have fringe benefits that are very valuable to a lot of people and the biggest one is a tuition benefit. So for here at WashU, for example, if you've been an employee for seven years, you'll get a tuition benefit, so that your children can go to WashU for free, or they can go somewhere else with 40% towards the cost of that tuition. And that's a big deal. But you could argue, I could go work in private practice, make more money and make that up pretty quickly. So it's, again, you can kind of go back and forth on that pro and con.

JONES  34:53  
I want to go back to convergence because we're talking about fertility networks as one path as academics is another, it seems that they may be coming closer and interweaving in ways that we weren't seeing 10 or 15 years ago. You know, we see certain university systems that their division is owned by a private equity firm or partly owned or they're part of a fertility network. We see private practice groups that have fellowships in concert with large university systems and so-- I'm not too familiar with this area, maybe you can help shed some light on it, but is it possible for any REI division to be sold to a private equity firm or can Fertility Bridge come in with some private equity money and broker a deal with Washington University and say, Okay, now we've got 40% of it and so it is private, but it's also through the university. How does that work and what's the trend that’s happening if there is one?

OMURTAG  36:00  
Yeah, I mean, just purely hypothetical, right? Like, I mean, the example you gave just for the record, purely hypothetical.

JONES  36:09  
Yes. I do not have millions of dollars in Wall Street money yet, unless the right private equity firm is listening!

OMURTAG  36:17  
To your point earlier, yes, we are not trying, we are not scheming something. This is purely hypothetical! No, I mean, seriously, though, again, it comes down to all politics is local, right? I would encourage anyone who's interested in the relationship between Chapel Hill and UNC Fertility Clinic and Integramed, to talk to Mark Fritz and he's told his story about how that relationship came about. I think it really just depends on does the institutional leadership feel like a third party, be it you know, private equity firm or just a practice management firm or whatever--is it better equipped to do the day-to-day operation or satisfy the needs of the division and its clinical services and or its other services for that matter, more efficiently than the current infrastructure? And I mean, I think many times the answer is probably, but it's so different from institution to institution that there might be a financial disincentive in the long term, there might be financial incentives up front that may not be good in the long term. So I think these contracts and these relationships have to be dissected individually. My guess is it always comes back to you know, what's in the best interest of the institution? You know, if the REI division is going to fold, if this doesn't happen, that's a big problem for the department. That's a big problem for the residency program. It's a big problem for the hospital. It's gone down the line, so then it becomes an issue. If it's more we think we can do this better, we think maybe we can make an extra $250k a year based on this and profit wise, maybe the administration is like, yeah, let's do it. Because whatever the negatives are, are outweighed by that benefit. So it's just a cost benefit analysis that each institution has to do based on the relationship and the negotiation between the two parties.

JONES  38:20  
Maybe this is a question for Dr. Fritz or others in similar situations, but does that change the financial relationship or potential for employment agreements or what's in employment agreements between the physician and the system? If, for example, are there partnership opportunities? Can you be an equity owning partner, a shareholder in that institution? So now that you're--does that happen?

OMURTAG  38:50  
I'm sure it does. But I'm curious who gets to be a partner? Maybe not everybody, maybe certain people do. Maybe only one person. Maybe the most senior person who drove the whole project is the one that gets to benefit the most. Maybe a small cadre of people. Maybe everybody does! Maybe everyone is now, you know, university employees, but the hospital runs the whole operation and is responsible for the entire operation and the university is nothing but a symbolic thing and oh, all the physicians keep their University benefits. But the entire project is run and operated by either the hospital, some third party, and they collect all the money, and then they just push it to the University. These relationships can get very complex quickly, because of all the different parties involved, especially in large academic medical centers where you're usually dealing with the university system, the hospital system, and then whatever this third party is. You know, like many places those systems are aligned. Might take partners in Boston, the Harvard Medical System, you know, Harvard Medical School has three partner hospitals and together they are all called partners. But, you know, in a lot of systems, those two entities are wholly separate and they're aligned, largely aligned, but they still have different pieces--they're different components, like our IVF lab is owned and operated by the hospital, but if you walk through a different room, the laboratory that does semen analysis and runs all the bloods is owned and operated by the university.

JONES  40:35  
We have, we have a few guests this year that might be able to share some insight on their experience. And, and I'm going to look for a few more because you've raised some more questions that I'm really interested in and this convergence and divergence of private equity of the of private care and now the university and the health system in a way that I just--this wasn't happening 10 years ago, was it?

OMURTAG  41:06  
It was happening in 2005. I could go back even further. There's a good article--let me tell you this. There's a good article--this, what we're talking about today, as far as kind of the limitations of or kind of like, what is it like practicing our infertility care in an academic center--was talked about by Michael Soules in Fertility and Sterility, Richard Reindollar, Richard Paulson in a 2005 issue dedicated to this question of what is the future of the academic REI practice? At the time, a prominent, I don't really know, Dr. Soules I think he was at University of Washington--and I apologize if I'm getting this incorrectly--but he writes in his article, and I would encourage anyone who's interested in this topic to read this article, he wrote an editorial about talking about the challenge she was facing in the university about promoting his clinical mission and all the bureaucratic layers and everything. And then everyone kind of wrote their own editorials kind of in response. So check out that Fertility and Sterility issue because it shines a light, the same conversation they're having 15 years ago is kind of what is being had today.

JONES  42:21  
Okay, so it has been happening for longer than I had considered. If we're seeing more of it now, it means that there's different types of career paths for people that are going into--whether they're going into a fertility network or private practice or through a university system, there's more. I want to talk about some of the traditional ways that employment agreements are structured or compensation is structured in academic centers. Can we talk about that? 

OMURTAG  42:53
Yeah. 

JONES  42:54
So are most academic systems is there--are most of them RVU based? Or are they all RVU-based--relative value unit for those that might not use that?

OMURTAG  43:08  
Yeah, many of them are. So I get, based on my RVUs I get--we are salaried employees and I get bonus based on clinical production and academic production. So a lot of institutions that will do this thing where they'll have academic RVUs, where you'll get certain points for publishing, teaching, being on a board for something, being on a committee, etc. And then they'll also give you clinical bonuses based on your production that are RVU based. So your base salary can, you know, if the base salary for someone coming out of fellowship is $250 in the academic center, you could get, depending on the structure of the institution, your clinical bonus if you're very pretty productive could get you well into $300 and above, depending on region and all this other stuff.

JONES  44:06  
So if I understand correctly RVUs are typically broken up into work RVUs, which is what we're talking about here. It's mostly what we're talking about when we're talking about RVUs. There's also practice expense RVUs and malpractice expense RVUs. Is academic RVUs and clinical RVUs, is that to say that there's four as opposed to three and each of those two are sort of fill in for work RVUs? Or are clinical RVUs, work RVUs, and academic RVUs, something separate?

OMURTAG  44:44  
The latter. Clinical and work RVUs are the same. And then academic is you know, proprietary.

JONES  44:52  
Got it. And so how are academic RVUs measured? Is that by courseload, or--

OMURTAG  44:59
Point scale.

JONES  45:00
Can that be labs, courses, if you’re the attending for a certain group of physicians--how does that point scale work?

OMURTAG  45:08  
Let me give you some examples. I wrote a, I'm the first author on a paper, I get five points. I'm a co-author, I get two points. I gave a lecture about primary amenorrhea, I get two points. I run a course for the medical students and coordinate 23 hours of whatever content and have to deal with faculty and their schedules, I get 20 points. Those are some examples. I am a board examiner, I get 10 points. And I mean, this is random. But you can see there's like some sort of scaling as to, you know, if you just go give a 30 minute lecture, that's less points than if you spend time managing or you’re the editor-in-chief of a journal, that's 20 points. Oh, you got an RO1 Grant? 50 points. So there's a scale that then everyone's academic RVUs are tallied. And this is again, there's a lot of variety on how this can be done. But people are like, Okay, you got this. So based on the profit for the division or the department or the school, however it's laid out, here's the algorithm that, you know, based on this is how much we have per RVU based on how much total profit, it's so distributed accordingly.

JONES  46:24  
Okay, that makes sense to me. I've seen other systems use what is called--I've seen it called forgiven time or protected time, where let's say a physician has an RVU target and then the institutions say, Okay, but this percentage of time is protected. So that means that they only have to generate--you know, if 10% of the time is protected, they only need to generate 90% of their RVU target or if it were 25 percent and they only have to reach 75%, is that in lieu of having academic RVUs?

OMURTAG  47:06  
No, that would be in addition. So, like, a common scenario in an academic center is like, for example, the medical school will pay 15% of my salary. They'll pay for 15% of my time. Because I educate--I spend time educating the medical students. So in order to get the quality that they want, they have to buy my time. So not only are they supporting my salary--I'm not getting additional money, but my department just has to pay me less because the rest of what they're supposed to pay me for my base is coming from the medical school--coming from another revenue stream. 

JONES  47:54
Okay, yep.

OMURTAG  47:55
But that's how--that's how it works. But I still, on top of that, you know, charge academic RVU time. So I say, hey, look, I'm doing this, I'm still doing this, I'm still doing that. And I'm still seeing all these patients too. So you can generate, depending on the structure, you can fight for kind of your time like, hey, look, I spent all this I spent six hours a week managing a social media account for the division. Maybe it makes sense for me to ask the department to pay for 10% of that time, because I'm going to also manage the entire department’s social media account. You want to do it right, you’ve got to pay me for that time. Oh, we don't think it's important to be paying this person. Okay, fine. Well, then, you know, I'm going to--you don't have a category for it in the academic RVU, make one or I'm just going to put it as 20 points, which is what I did.

JONES  48:43  
Yeah. So does it typically happen when there isn't a category in the academic RVU? Is that typically when time is bought back?

OMURTAG  48:52  
Well, the nice thing is most of the--again, I'm only speaking from my experience, you can just fill in what you think you deserve and they can decide if they think it's worth it. If this is worth giving, like, obviously I'm not going to say, Hey, you know, I drew this picture of how IVF works, 4000 points you know,? Like I'll probably say five points. I made a video, I put it up on the web, it took me some time, so it’s five points. I tried to calculate how much a point is worth, but I wasn't able to get to that, but it was actually worth a couple hundred bucks. So, I think the scale actually works nicely.

JONES  49:35  
Who does calculate the points and then who calculates, this is this service is this many RVUs and then who calculates the compensation for that?

OMURTAG  49:45  
The department management does that and it's subject to change depending on the profit of the entire department. Is typically how--

JONES  49:55  
Do they vary widely from university to university? If we’re at Stanford, would we expect to see something very different at the University of Iowa or in Florida? Or do they tend to do--is a retrieval generally this many RVUs and a transfer is this many? Are they similar?

OMURTAG  50:17  
So for those CPT--yeah, they should actually be the same as far as what the RVU multiplier is. As far as I know, I'm not gonna pretend like I'm an expert in this. RVU multiplier for the procedure should be the same largely, although I don't know if the multiplier changes by region, or if the dollar amount changes by region. There's probably some calculation of that--

JONES  50:43  
I believe it's the latter but I would love for anyone that's listening to correct me if I’m wrong and they'd like to speak on that. I think that's very useful. How many academic RVUs and how many clinical RVUs can a new doctor let's say it's a doctor that's maybe in their first or second year of employment, expect to produce each year each day?

OMURTAG  51:07  
How many academic ones?

JONES  51:10  
Yeah, so how many academics and how many clinical?

OMURTAG  51:14  
Okay, so well the work RVU is obviously just a function--again, like, hey, we're going to start you with four patients and you're like, no, I can see five, that will help drive your downstream work RVUs because if you see that extra patient a day, or a week or two to three a week, those are going to generate more opportunities for a procedure, which is going to generate an RVU and again, depending on--or an ultrasound, which is going to generate a clinical, you know, work RVU--again, all of these are wholly dependent on the local fee structure and how things work. But if you want to boost your work RVUs, you just see more patients, and you figure out a way to work it in.

JONES  52:03  
So are the targets set? You know, let's say if like, I don't know, let's say the average doctor’s expected to produce 9000 RVUs a year and then maybe you take out 100 weekend days and maybe you take out 65 vacation, sick days, etc. Maybe you've got into--you're dividing 9000 by 200. I guess. I don't know what that number that would substitute for 9000 actually is or if you have 45 work RVUs as your target per day, how that is balanced with academic RVUs?

OMURTAG  52:46  
Well, I think it's--you’ve got to figure out, Okay, what is probably the most value. Like what am I going to get? if your work RVUs are dictating your salary and/or your bonus more so than your academic ones, you're going to focus on how can I maximize my work RVUs?

JONES  53:10  
So are you saying that that target is constructed by the individual? They can say I want to spend more, I want to have a higher clinical RVU target than an academic target? Or is it set by the department? They say this is your target for academic and--

OMURTAG  53:27  
You know, I'll tell you, it is variable. All I can really speak to my experience which has been, you know, usually the clinic will tell you, these are how many days of clinic a week you're supposed to be doing. So they may not have a work RVU target. They might say you need to be in the clinic, four days out of five, seeing patients eight to four, and then you can have this fifth day off as an administrative day to do whatever it is you want to do. Like, some of these contracts from the academic center might say, your contract is for four half days a week and then you can kind of do whatever. That's all the contract says. There might not be an RVU target in that contract, which is crazy. It’s not in the contract, but someone will tell you, hey, you're not seeing enough patients and you can be like, but I thought you said I just needed to do four half days a week?

JONES  54:36  
Well, this is one of things--I often criticize employment agreements in private practices that, particularly with eligibility for partnership, eligibility for buy-in, it's not enumerated very often in employment agreements. And so I thought, Well, certainly systems that use RVUs would have that enumerated, but you’re saying that’s not always the case where targets are enumerated.

OMURTAG  55:02  
No. I mean, no one has said--I mean, I get monthly updates as to where my targets are and how I'm doing and I usually compare it. And I'll tell you the first year I was like, What the hell is this? I don't know what this is? Can someone explain it? I mean, I conceptually know what it is, but I don't know what it is, honestly, let's be real. So then I kind of said, Okay, I did this amount. So I guess, okay, this amount of RVUs led to, and academic RVUs led to this bonus plus my base. Okay, that was my target. Alright, cool. So maybe I should stick with that or maybe cool, I wasn't that busy, there was some other stuff. Let me push it next year and let me change the schedule. So I have some autonomy in my current setting to kind of set A) let's do a little bit more here or let's kind of back down a little bit on this side with obviously a sign off from leadership.

JONES  56:04  
Well, you taught me a lot more than I knew about that subject. And hopefully for the listening audience as well, especially those that are mapping out their career path within the next few years. I'd like to conclude with just how you see the future of the Academic Center and the participation of entrepreneurial physicians because I very much include you in that group. You and I met at my very first meeting in the field. So a lot of people don't know this about me, but I had moved back to the United States in 2015. And I didn't know anyone at that time. I went to MRS, which was the Midwest Reproductive Symposium, a meeting that I was unfamiliar with at the time. You were speaking. We started talking because your topic was about social media. And that's how I broke into the field was originally just through Facebook community management, which grew into social media, which grew into digital marketing. And a lot of people are familiar with my book, The Ultimate Guide to Fertility Marketing, because it's what they download. But there was actually a book before that. I don't even know if I still have a copy of it digitally anywhere! It was called Digital Marketing for Fertility Centers.

OMURTAG  57: 23
I remember that!

JONES  57:25
In which you were a contributor, and your name is on that as well. And so I think you may have been the very first person that I ever collaborated with someone on content within the field. Then we didn't talk for three and a half years and now you're back on the show, but I do consider you one of these people that's very intrapreneurial. And so I'd like your thoughts on including of how that intrapreneurial profile, someone who wants to add to the system, not just say I'm already following an established process, but rather contribute to it. What's the future for them and consequently, for the Academic Fertility Center REI Division?

OMURTAG  58:14  
Wow. I mean, I appreciate the shine, man. I mean, I'll just say real quick. I remember after the talk I gave in Chicago, you were like, Hey, man, you should maybe think about this Instagram thing. And I was like, is that what people take pictures of their food and stuff? And you're like, Yeah, and I was like, What about Twitter? And you were like, Nah, man, that moves too fast. You should check out Instagram. And I came back to Instagram like two years later and I'm like, yeah, Griff was right. This is where the action is. This is the best platform for this. So shout out to you man and what you've been doing with Fertility Bridge. I do also remember reading some other blog of yours about and it probably was on Fertility Bridge, just about the future of the field. I mean, I think your insights are pretty accurate and kind of the way I see it is pretty, like--what I read from you is like, I'm like, yeah, that's pretty spot on. So anything I can do to inform the academic side, and really the field in general to add to your knowledge and your community, happy to do! So as it relates to the future, I don't think I'm the first person to say this, I know I'm definitely not, but I think the future is going to be for the field in general, is going to be about consolidating and using IVF as a treatment tool and a prevention tool for disease. I think we'll see more of that. And I think that will be regional at first, but I think over time, that will become more widespread, given the ability to test embryos and the potential use of CRISPR. While terrifying for a lot of folks, maybe inevitable for others. I think that's something we'll be dealing with in our lifetime, for better for worse. But from the academic--I think the other thing to point out is what is the role of the academic medical center in medicine specifically in reproductive care? Because a lot of the innovation, and a lot of the tinkering in science usually comes out of the academic centers and then gets pushed into practice. That's not--like in our field, that doesn't really happen that much anymore. I think ICSI was probably the last thing that came out of a purely academic pursuit. I mean, there might be other things I'm missing, but I think the biggest role the Academic Center has to play in pushing forward the progress of Fertility Care is in its ability to provide access to Fertility Care. Academic institutions are large. They have 15-40,000 employees. State institutions are big. Times are changing. And employees want a fertility treatment benefit, who better to give it than their employers. And I think fertility clinics and reproductive endocrinology divisions have an opportunity to lobby university and hospital administrators to make carve outs for institutional employees that are exclusive to the institution’s fertility practice. I think that will be the future of the academic medical center and how I can leave its best imprint on the reproductive endocrinology and infertility division and its surrounding community. 

JONES  1:01:27  
All capital letters. Dr. Kenan Omurtag, thank you for your kind words. Thank you for your contribution to the content over the years. And thank you for the insight that you gave us today on the show.

OMURTAG  1:01:39  
Yeah, thanks for having me, man.

***
You’ve been listening to the Inside Reproductive Health Podcast with Griffin Jones. If you're ready to take action to make sure that your practice drives beyond the revolutionary changes that are happening in our field and in society, visit fertiltybridge.com to begin the first piece of the Fertility Marketing System, the Goal and Competitive Diagnostic. Thank you for listening to Inside Reproductive Health.

68 - Secrets of the Affordable IVF Model and How it is Poised to Win Market Share Post-COVID-19, An Interview with Dr. Robert Kiltz, Dr. Paul Magarelli, and Dr. Mark Amols

It’s not often that people relate the word “Affordable” with IVF. But the Affordable IVF Model is a thriving business model in a world full of expensive treatments. Despite questions about their revenue, rates, and processes, the model is growing and providing high-quality care to a vast amount of patients across the country. What can all clinics gain from this model, especially heading into a post-COVID-19 world?

On this special live episode of Inside Reproductive Health, Griffin spoke with three leading doctors whose clinics follow the Affordable IVF Model: Dr. Robert Kiltz of CNY Fertility, Dr. Paul Magarelli of Magarelli Fertility, and Dr. Mark Amols of New Direction Fertility Centers. Together, they talk about just how they make the Affordable IVF Model work, as well as answer common objections to their services.

64 - Consents in the Age of COVID-19: Using Digital Solutions to Protect Your Patients and You

“...this is an unprecedented time for everybody. We all have our expertise in different areas and our experience in different areas and now's the time to be talking about our approaches, what we're doing, sharing our ideas, and really, really working together to try to get through this and to put practices and patients in the best positions possible.”

It is business as unusual right now. Patients everywhere have been told that treatments have been put on hold and have been left in limbo. Thankfully, there has been a surge in interest in using digital technology to keep some semblance of normal for patients seeking treatment. Thanks to applications such as Zoom, clinics are able to conduct consults or relay testing results. And thanks to new innovations making consents available online, clinics are able to get patients ready for treatment, while remaining in good legal-standing.

On this special episode of Inside Reproductive Health, Griffin talks to Jeff Issner and Taylor Stein of EngagedMD, a company that has developed an application that not only provides digital consent forms, but also goes the extra mile in patient education. Dr. Steven Katz of REI Protect joins in the discussion, offering his perspective on risk mitigation and ensuring your practice reduces liability in any way it can during these unprecedented times.

This episode was recorded during a live webinar. In the coming weeks, we will continue to provide webinars with updated information on relevant topics. Learn more about our upcoming webinars at FertilityBridge.com.

Please note that all information included in this podcast is not legal advice and is simply to provide fertility clinics with information on the use of digital consents. Before using any advice in this podcast episode, please consult with your legal team.

Find Jeff Issner and Tayor Stein at Engaged MD by visiting Engaged-MD.com.Learn about Dr. Katz and his services at REI Protect at REIProtect.com.

Need help navigating marketing through this unprecedented time? Check out our COVID-19 Toolkit from Fertility Bridge.