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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.

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