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Are IVF labs safer today than they were a decade ago? They can be, but much of the available safety potential isn’t being fully realized.
In this week’s episode of Inside Reproductive Health, we’re joined by Dr. Eva Schenkman, an IVF lab director and founder of ArtLab, and Dr. Steven Katz, an REI and founder of REI Protect, to discuss risk mitigation and safety in IVF labs.
Here’s what you’ll learn:
The biggest risks IVF labs face (and cost effective strategies to reduce them)
The non-negotiables for lab safety (The 3 must-haves)
How manual tasks in the lab increase the risk for embryologists and practices.
What younger embryologists are demanding for better safety and support.
What Dr. Katz and Dr. Schenkman each like about a company called XiltriX
The top causes of malpractice lawsuits against fertility practices (and how to avoid them)
Gattaca Genomics
LinkedIn
Transcript
Dr Steven Katz (00:03)
That is really the focus of human safety people can perform really well to a certain point and Then usually there's not a gradual drop-off. There's a cliff, All of a sudden you're overwhelmed you got too busy and a and that mistake can change a career it can end the practice it could permanently harm a brand and Sadly, it really hurts patients and that's what we're all about trying to protect patients. So that's my number one thing is really you know monitoring caseload.
Griffin Jones (00:47)
Are IVF labs safer in 2025 than they were in 2015? They certainly can be much safer, but a lot of that potential isn't being utilized right now. Relatively speaking, IVF labs are extremely safe, but we're not afforded the luxury of relativity in the IVF space, are we? We're with the likes of air traffic control and civilians in a battle zone in that regard, where even one incident can be a catastrophe. I have back with me Dr. Eva Schenkman, an IVF lab director from North Carolina, who's directed multiple IVF labs and runs her own embryology training program, ArtLab, and Dr. Steven Katz, an REI who now helps practices and networks with malpractice insurance and other risk mitigation through his firm, REI Protect. If you're an investor, you're going to hear how to protect your investment so you don't end up paying millions of dollars when you could have eliminated the risk for a fraction of the cost. If you're an embryologist, you're gonna hear about what percentage of labs have what types of equipment in these three main categories, electronic witnessing, cryo storage, and monitoring, and what young embryologists are demanding.
They each talk about what they like about a solution called Xiltrix and how that empowers and protects lab directors beyond the status quo. If you're a clinician or an REI practice owner, you're gonna hear about how the caseload and the tedious manual tasks that your embryologist shouldn't be doing are putting your practice at risk. You'll hear what PGT does to that embryology workload, as well as the number one set of causes for lawsuits against fertility practices. Enjoy.
Griffin Jones (02:42)
Dr. Schenkman, Eva, Dr. Katz, Steve, welcome back to both of you to the Inside Reproductive Health Podcast.
Dr. Eva Schenkman (02:51)
Thank you, morning.
Dr Steven Katz (02:53)
Griffin, thanks for having us. Good to be here.
Griffin Jones (02:56)
Steve Katz, are IVF labs safer in 2025 than they were in 2015?
Dr Steven Katz (03:02)
say yes. I think over the course of this podcast Griffin will break it down a little bit more. Dr. Schenkman will have a lot to add. But the lab itself, the workflow in the lab, the technology in the lab, the advancements in the lab have made it safer. I think you pose the question in part because labs are busier, there's more procedures going on. And when there's more units of risk, the risk can be higher. But overall, labs are significantly safer.
Griffin Jones (03:37)
Amy, can you talk to me about how volume increases risk other beyond the obvious? some specifics, if we're making 1000 pizzas, of course, we're likely to burn more pizzas than we were if we were making 100 pizzas. But be in with regard to specifics, what risks are added as volume increases?
Dr. Eva Schenkman (03:56)
You know, I think the problem is, you we can't scale up new staff as quickly as we've scaled up, you know, increase in volume. So, you know, and, you know, with, you know, new procedures, with freeze-all procedures, with PGT procedures, that's added, you know, much greater level of complexity to a lot of the cycles that we do. And, you know, basically it's just, like you said, with making the pizzas, you've got a lot more cases on the same level of staff.
So there's potential for more errors to happen with the complexity of these procedures that we're adding on.
Griffin Jones (04:27)
What do those errors tend to be?
Dr. Eva Schenkman (04:30)
You know, the errors can be, know, obviously with PGT, it can be, you know, the big one that we're most concerned with is you mix up embryos between patients. I've not seen that one happen as often as mixing up the embryos within a patient. You know, so you're trying to get, you know, you've got 10 embryos, 10, 15 embryos to biopsy for a patient, and you have to make sure that, you know, number one, you know, stays number one throughout the entire process. So, you know, lot of errors on, I shouldn't say a lot, it is very rare that we do have errors, but mixing within a patient, I see more often than mixing between patients. I don't know, Dr. Katz, if you agree on that, but I've seen a tremendous number of more of thawing the wrong embryo for a patient instead of thawing, mixing it up between patients.
Dr Steven Katz (05:20)
Yeah, I think that that's correct. Griffin, gave a talk this weekend at the Southwest Embryology Summit and I presented our data at REI Protect, our incident data for the last five years. And the number one etiology for errors in the IVF lab is or are related to PGTA testing and we may break that down later in the podcast, but Ava gave a snap picture. It's not just the test results, but it's the handling of the biopsies, the labeling of the biopsies, matching up the results from the genetic testing lab to the chain of command, chain of custody in the IVF lab. So that's the number one cause mismatching is the number one, number two cause, mislabeling. And again, Dr. Schenkman's correct. Our data does suggest that these errors are more intrapatient than between patients.
Griffin Jones (06:21)
And you said this is the most common coming from incidents related to PGTA testing. That's the most common within the last five years.
Dr Steven Katz (06:29)
by far.
Griffin Jones (06:31)
Can you explain to me the difference between mismatching and mislabeling? Because I might think of mismatching as a consequence of mislabeling, but can you explain to me the difference?
Dr Steven Katz (06:43)
Yeah, I mean, I think I can start and then Dr. Schenkman can add a little bit of a focused lab perspective. Mislabeling, the way I use that word, is more related to gamete egg sperm and embryo mislabeling. So that could lead to a mix up between patients, i.e. the wrong sperm was used to fertilize the correct egg.
mismatching I use intrapatients internally. So in essence, they were thinking of transferring embryo number three of the cohort. And somehow for reasons we may discuss later in the podcast, they transferred embryo number six. So that's how I differentiate between mislabeling and sort of mismatching.
Griffin Jones (07:34)
So how does that happen, Ava? Is it just a question of I think I'm grabbing number six and I'm grabbing number three? Or how do those mismatching incidents tend to happen?
Dr. Eva Schenkman (07:36)
Just a question of, I think I'm grabbing number six and I'm grabbing number three.
I kind of see those those errors happening, know, one of three ways. know, one is, you know, the labels that we put on these straws are very small. So sometimes it's it's, you you look at it, you thought it was a six and it was an eight. You know, the other things that I see is when you have patients that have multiple cycles and they have multiple cycles with embryos with the same number.
So if a patient banks some embryos and has four from each cycle that are frozen, they may have three or four embryos labeled number one. So it's also doing those multiple identifiers, making sure you got the right patient and the right date and then the right embryo. And then lastly, the other thing I see happen more often is when labs are renumbering embryos at biopsy.
And then especially because we had a few years where we had a lot of per diems coming into the lab or a lot of changeover with staff. And perhaps new staff not realizing that the lab was renumbering embryos. And where that happens is let's say you got 20 embryos, but you're biopsying number two, four, and six. And when you biopsy them, they're renumbering them as to now that's biopsy number one, two, and three. So if you've got embryo
But let's say you've got on the first day, you biopsy number five, that's now renumbered number one. And on the second day, maybe your embryo number one is being biopsied and now that's renumbered number two. So if that sounds a little confusing, you can imagine just that same thing is going on in the laboratory. And it's not common that all labs renumber. So I think when you've got a newer embryologist that may not be as familiar with that,
and you just quickly glance at the report and you've glanced at the record and you don't realize that the embryo's been been renumbered. And then also, it's like I said, you add the complexity that perhaps the patient had multiple cycles. So you've got multiple cycles with the same number and you're trying to match up the PDF from the PGT result, making sure you grab the right number. And the writing is extremely small and you're trying to keep them under liquid nitrogen.
while you're confirming this, if your lab doesn't use electronic witnessing and you're able to zap the barcode or the RFID tag, it happens that they've grabbed the wrong one.
Griffin Jones (10:00)
And so is you said that that practice isn't that common to renumber biopsies? Why does it happen at all? Is there other asrm guard guidelines or other guidelines that say this isn't perhaps the best practice because of the risks that you mentioned? Why are why is anybody doing it that way?
Dr. Eva Schenkman (10:18)
I actually find it, it's probably, find it more when I'm in labs either in the Midwest or on the West Coast, but I'm not gonna say that that geographically is done, but working here for most of my career in the East Coast, most of the labs that I've worked with did not renumber. The labs that do it think it's easier. And if they're constantly working that environment, it may be. So they have only embryos one, two, and three to deal with. And if you've got a single cycle, that may be
somewhat simple, but it's when you've got multiple cycles too that you've now got multiple embryos that are renumbered. There are no ASRM guidelines on this. There's really little guidelines as to how this should be. But with electronic witnessing or with some of these other RFID technologies, some of that could
could be avoided if we're able to just kind of have a secondary scanner of some sort to make sure that we've not grabbed the wrong embryo. Added onto this is the fact that most labs don't have a robust EMR, that we are still dealing with a paper PDF from the PGT results. I don't know, Dr. Katz, do you see more issues come from labs that are still using a lot of paper as opposed to ones that are
that are more electronic.
Dr Steven Katz (11:29)
You know, think I would. I see very few labs that are predominantly on paper now. So, I think...
Technology overall enhances safety. So the more paper they use, I would agree, the more likely it is going to be a problem.
Dr. Eva Schenkman (11:46)
Yeah, there's
a lot of EMRs that don't fully have their interfaces connected to the PGT labs. And you're either just getting the results via PDF, as opposed to getting discrete data come across through the connection, which then kind of locks down. Typically, even if you do have an EMR, somebody's having to go into the embryology module, take the PDF that they've gotten.
and then flag which embryo is normal or euploid or which one is abnormal, which in and of itself has some room for error for manual transcription data.
Griffin Jones (12:23)
That sounds very tedious. How often are tasks like that happening, Ava, whether it's the example that you just described or just tedious manual work of connecting things from disparate databases or disparate interfaces.
Dr. Eva Schenkman (12:39)
We're doing it all the time. A lot of labs are still entering into multiple databases to have their cryo inventory. They're entering into an Excel spreadsheet for their KPIs. They're entering, hand entering into the SART database. I think a lot of the EMRs are really trying to increase their robustness, but they're still...
I'd say the majority of labs are still putting data into multiple databases. Most of them are still using paper worksheets in the lab. There's very few that I know of that have gone completely paperless in the lab. So there's constant transcription of data into multiple systems.
Griffin Jones (13:17)
I wanna come back to how those systems talk to each other. I wanna come back to PGT volumes. I wanna set the stage for later on when we talk about some of the solutions. And Dr. Katz, you mentioned that technology makes things safer, generally speaking, or at least has the potential to. so can you set the stage for us for the different categories of technology? Like you've got monitoring, you've got witnessing, you've got cryo storage.
And so there might be embryologists listening that they know everything about that, but there's clinicians that are listening that know less about the differences in the overlap between each of those. And then there's investors and there's legal professionals and other folks listening that really don't know the technical differences. So can you set the stage of those different categories?
Dr Steven Katz (14:02)
be happy to. You know I think the most important category for those listening for safety now and moving into the future is electronic witnessing. This really helps prevent mislabeling issues and plays a role in preventing mismatching issues. So I think the electronic witnessing technology is crucial.
In our program, Griffin, we're really pushing all of our IVF labs to be working with electronic witnessing programs. And there's some really good ones out there. So I think all labs should be focused on that in 2025 if they haven't already brought one in. The second category that I like to really focus on is storage.
Storage is not just storage as we think about it in the tank, but storage allows for, in my opinion, better identification of tissues. Whether it's RFID or other technologies, there's very good storage platforms now available for use. And I urge labs to really focus on that.
Storage was never meant to be a revenue stream for IVF Labs. With the large amount of investment, it sort of has become.
but safety, I think, in storage is really of paramount importance. There's also advancement in storage itself, storage protection. There's a patented weight sensing device out now that we highly support because it's very predictive of the liquid nitrogen Dr. Eva Schenkmanporation rate.
So as you can imagine, if the Dr. Eva Schenkmanporation rate goes up substantially, the tank is showing you it has a problem well before there's a real temperature change or a physical abnormality that you can pick up on the tank. The third category for us is really sensor platforms, alarm platforms, monitoring platforms. There's a number of good ones out there.
You know, one in particular is Xiltrix. These platforms are really important for monitoring most everything in your laboratory, certainly air quality, incubator status. They play a role in storage, but again, there's additional technology, the weight sensing device technology that I think really is the future. That's sort of how I break it down in categories. And I think all of these technologies are cost effective. None of these technologies are expensive that should create a problem from a cost basis in running a laboratory.
Griffin Jones (16:48)
You mentioned Xiltrix, that's a monitoring solution as a service. How does that work?
Dr Steven Katz (16:53)
Well, I'll give my overview and then I'd like Dr. Schenkman to give her perspective inside the laboratory. But there's different parameters that can go unnoticed and silent. And then we all know the history in our space of alarms either going off too often or not going off at all or going off to the people that may not even be employed. So these alarm systems like Xiltrix, not only do they censor important aspects of the lab, but they follow up the alarms. So when the alarms ring, they're on top of the alarms so that they can make sure that a human being is notified in the proper way so the alarm can be addressed. It's a little bit like a burglar alarm in a house, right? If the burglar alarm goes off every night, no one pays attention to it because
Dr. Eva Schenkman (17:37)
you
Dr Steven Katz (17:46)
useless, but if it goes off, you know, it's important that people figure out why.
Dr. Eva Schenkman (17:51)
Yeah, definitely. think there used to be that we had very older system called a sense of phone. That whenever there was alarm that was triggered in the lab, the sense of phone would call us. But the problem with that is we didn't really know apart from it telling us what triggered, we didn't really know the state of that. It would say incubator one or something like that. But what I really like about systems like Xiltrix is they can also check the temperature, check the CO2 levels, check the O2 levels, check the refrigerator temperature, check the status, whether we've got electricity to the lab, and that they've got a dashboard that you can log on to remotely, either through your phone or through your computer, and you can kind of see the status of what's actually going on within the laboratory. You need to really make sure that you've got a system that's redundant, that's got multiple levels of redundancy. So whether it's sending you notification, a push notification, a text, an email, a phone call, and that it just goes down the chain until somebody answers and responds to that alarm. I think that's really critical to make sure. And systems like that do, like Xiltrix, do have that redundancy built in, which is really reassuring for the lab. Because the alarms always go off at about two o'clock in the morning. And if you just get a text message, you're not going to hear that, you're not going to answer it. So there's that really importance of having that redundancy and that ability to be able to log in without having to drive 30 or 40 minutes. You can log in, you can see what the problem is. And if it's a critical alarm, if you need to get up and go into the lab and address it immediately.
Griffin Jones (19:25)
What percentage of clinics would you say have at least one of these three types of solutions, meaning that they've got a good storage platform, they've got a good witnessing system, or they've got a good sensor platform? Do you have an anecdotal guess or real data if you have it, but can you give me a picture of what percentage have at least one of the three of labs?
Dr Steven Katz (19:49)
I can talk about that in my program, Griffin, and then Dr. Shankman may decide to add to it. I would say that 90 % of our programs have at least one, and I'm pretty confident within this year of 2025, all of them, 100 % will have at least one. I think 70 % currently have at least two, and I would say 60 % have all three.
And my hope is that we can get within REI Protect 90 % of all our programs that have at least three, will have all three by the end of 2025. It's been a paramount goal because you can imagine we're all about reducing risk.
Griffin Jones (20:38)
And you might have a, so therefore you might have a skewed sample, right Steve, because you, if someone's hiring you, it's because they care about risk and that's your job to help get them safe.
Dr Steven Katz (20:42)
Thank you.
Dr. Eva Schenkman (20:43)
Yep.
Dr Steven Katz (20:46)
Right. I totally agree, Griffin. Well said. I think this is a skewed sample size. And so I think Dr. Schenkman could maybe add more light.
Dr. Eva Schenkman (20:58)
Yeah, I was just going to say, you know, I wish the majority of labs had had that percentage. I would say that probably 90 percent have one of them because most labs have some sort of monitoring system. You know, unfortunately, a lot of those labs that have monitoring still have, you know, the older technology, you know, like the the the sense of phone, you know, where it's just, you know, alerting you that that something's an alarm. I don't think many of them have, you know, multiple levels of redundancy. I would add two more things that
besides your monitoring, your electronic witnessing, and your storage, that I think go a long way to improving safety and efficiency in the lab. One of those is time lapse imaging. And then the other is just having a robust fertility-based base DMR. I don't think 60 % of the labs, Dr. Katz, have electronic witnessing. I think that number is far, far less. Yeah.
Griffin Jones (21:49)
I think it's like 20%. It just
from my, that's from my guess of, but that's not based on data. It's just kind of based on talking to folks. But do you think it's that low, Ava?
Dr. Eva Schenkman (21:58)
I might
even say it's one in 10. I think a lot of the networks have definitely started to put this into their programs, if I just were to speak of the clinics that reach out to me for training or for other services, I'd probably say it's, and now that's US-based. I do work with a lot of clinics outside the US, and I think the US has been a lot slower.
at taking on a lot of this technology seems to be far outpacing us in Europe, for example. What do you think that is? One is a lot more regulation, some requirements. it's just, yeah, the patient safety, part of it is, and what's interesting is they charge far less for IVF, yet they have adopted.
Griffin Jones (22:29)
Why do you think that is, Ava?
Dr. Eva Schenkman (22:51)
more of these technologies, from monitoring, from electronic witnessing, and even time lapse. And the way that time lapses can make labs safer is you don't have to take those embryos out of their environment to go and look at them. You can look at them through in your office. Your physicians can check in remotely. So just that ability to not have to walk around with them and accidentally bump into something or
know, exposing them to the ambient air, kind of putting them in the incubator, leaving them alone, you know, for those five days is pretty important. But, you I do think it is where here we have kind of best practice and ASRM guidelines. They do have more regulation, which that regulation has more teeth attached, that they are mandatory requirements.
Griffin Jones (23:42)
You mentioned time lapse, Ava, and I don't wanna go too deeply into it because I am doing another episode just about time lapse and is it the standard of care now, but you can help me prepare for it a little bit. Do you view time lapse as a must have or a nice to have and why?
Dr. Eva Schenkman (24:00)
I would like to say it's a must have. I do find a lot of pushback from investors and from physicians when we're building new laboratories, just because the initial investment into that. But if you're a forward thinking lab and you see the efficiency that it can provide to your lab, I know a group at UCSF did a
did an abstract on how much time that was saved in their lab with the incorporation of time lapse. And it saved the equivalent of almost having one embryologist per day for how much, from walking back and forth, from having a double witness, checking things that the time lapse really improved the efficiency of the workflow in their laboratory.
Dr Steven Katz (24:49)
Griffin, maybe we should add a small category as well for artificial intelligence, for AI, and what it will mean moving forward in terms of best embryo selection or best algorithm for ovulation induction. While it's early, think, in the life of AI in our space, I do think AI will play a more prominent role and a safety role over the next few years.
years.
Griffin Jones (25:20)
And with that safety role, you envision AI being more involved in monitoring, the creation of labeling or of checking labels? And how do you see that working, Steve?
Dr Steven Katz (25:32)
Well, mean, I think from an ovulation induction point of view, know, cycle clarity, A-life, they have programs that really streamline ovulation induction.
there's still a move to bring in mid levels to perform ovulation induction either alone or alongside an REI. I think that will provide safety. Anytime you select a better embryo for transfer, that also means to me that, you know, there's a safety component to it. And so that is where a lot of these AI companies are also focused, using data to better predict
one of these embryos on a morphologic basis or a growth rate basis is the better embryo to transfer.
Griffin Jones (26:20)
You're an REI by background, Dr. Katz, not an embryologist or a lab director. As you've gotten into this realm of total fertility center safety, which obviously the huge chunk of that is the lab, and you're meeting with REIs, what do you find that you often need to illuminate them to? What's happening in the lab that they aren't always readily aware of?
Dr Steven Katz (26:45)
I think Dr. Shankman pointed it out at the beginning of your podcast. I think they may not be readily aware of the fact that their embryology caseload is too great.
That is really the focus of human safety people can perform really well to a certain point and Then usually there's not a gradual drop-off. There's a cliff, right? All of a sudden you're overwhelmed you got too busy and a mistake and that mistake can change a career it can end the practice it could permanently harm a brand and Sadly, it really hurts patients and that's what we're all about trying to protect
patients. So that's my number one thing is really you know monitoring caseload.
Griffin Jones (27:34)
part of the reason for the increase in caseload in addition to just rising demand and demographics is the number of PGT cases and the workload that those require. Is it simply that there's more PGT being done because the overall cases have increased and the percentage of PGT has remained the same or in this time span from 2015 to now has the percentage
Dr. Eva Schenkman (27:42)
Thanks.
it simply that there's more PGT being done because the overall cases have increased and the percentage of PGT is the same for in this case.
Griffin Jones (28:02)
of PGT increased with cycles.
Dr Steven Katz (28:07)
Yeah, I think it's both. And while I'm not on your show to predict, I think the use of PGTA has peaked. I don't see the percent of cycles using PGTA as growing really much higher than it is now. If anything, I think there's going to be a study of the literature, the study of its role, the study of its effectiveness.
how much it decreases remains to be seen, but I think we're really at the peak of the use for PGTA. And there's a lot of pressures to use PGTA. There's sex selection, the hopes of eliminating aneuploid embryo transfer, but as so many lab directors and
and researchers have pointed out, it's been unclear as to when PGTA is really effective.
Dr. Eva Schenkman (28:56)
Yep.
Yeah, and I think Dr. Katz, you had a really good point the other day at the talk you gave at SWESS about the importance of managing patient expectations. Because with PGTA, it would kind of make sense, you would think, like, well, I'm screening my embryos to make sure I only transfer the ones that are normal. But the studies that are out there are showing that the use of PGTA does not improve.
success. It may clearly decrease rates of miscarriage, it doesn't eliminate it, but that misunderstanding from the patients that this is not going to give them a guarantee of success or that a single biopsy is not truly representative of the entire embryo. And I think it's really important that we convey that message to patients to make sure that when they're choosing to do PGTA,
that it truly is an informed decision that they're making. And we're not potentially discarding embryos over that single snapshot of that single biopsy from the embryo. And I think that's what's resulting in this increase in lawsuits regarding PGTA.
Griffin Jones (30:09)
Does the flurry of lawsuits, does that coincide with the peak? Dr. Katz, or do think that that's causing it? I'm not asking you to comment on any litigation, but just as the headwinds are meeting in the public square, is that part of what you think is tipping the iceberg?
Dr Steven Katz (30:27)
I think there's a confluence of events. In our data that I presented this weekend, the number one etiology of a patient lawsuit at the practice level is misaligned expectations.
Now, misaligned expectations is a broad category, but if we focus that to PGTA, I think their expectations of the results of PGTA are still perfection. And I know my programs do a really good job in their informed consent and their discussions that PGTA is not 100 % accurate. I know they do, but patients sometimes hear 97 % to be 100%.
And so we focus on informed consent in this area, but I think my point is is that patients expect perfection right now. Unfortunately, we're providing medical care. We can't be perfect. There will always be errors. We need to reduce them as low as possible, but there'll always be errors.
So I think that's the confluence of events, that patients expected the PGTA results to be perfect. They're not perfect. Our community is questioning the role of PGTA moving forward. And yes, I think some patients have made clinical decisions with their doctors based on PGTA results that may not be correct.
Griffin Jones (31:55)
The number one ideology of lawsuits at the practice level is misaligned expectations. isn't some sort of damage to the gametes or to the embryos.
Dr Steven Katz (32:07)
So I separate that out. There's those etiologies related to the IVF lab, which we sort of mentioned a few minutes ago, and those etiologies related to the practice. Misaligned expectations, procedural complications, medical misdiagnosis, things of that nature. So that's how we've split it up.
Griffin Jones (32:27)
So as these different changes take place, and you start to think of 2035, what does 2035 look like in an ideal scenario? And what do we need to do to get there?
Dr. Eva Schenkman (32:44)
I think there's going to be greater integration of all these advanced technologies that are coming on board. Probably the complete manual nature of IVF will probably decrease. It doesn't mean that the embryologists are going anywhere. I think it's just going to empower them to work more efficiently, to work more effectively.
And I think through automation, like time-lapse through these AI driven tools, I think the price of these is going to come down so that they are going to be able to be implemented in more and more clinics. as Dr. Kat just spoke about, these more sophisticated monitoring systems, it's going to give us improved precision. We're not ever going to be perfect, but we're going to be able to...
reduce human error, to streamline our processes. And this shift away from IVF being mostly manual is really gonna give back valuable time to the embryologist to focus more on the complex aspects of their work and not be so much transcribing data into multiple systems.
especially as we talk about AI, these AI systems are going to be able to pick up things quicker than we would pick it up by eye and be able to analyze and troubleshoot data quicker. And that's going to improve our success and make everything safer for the patients is our long-term goal.
Griffin Jones (34:11)
You mentioned automation, and we don't have to get too deep into it because I'm also going to do an entire episode on automation. But what parts of the lab do you think are ready for automation? And some people are really trying to automate the entire IVF lab. And I'm going to talk about that in that episode as well. What do you think is ready for prime time versus what isn't?
Dr. Eva Schenkman (34:34)
I think definitely incubation is ready for automation through the time lapse. There's multiple options right now on the market. Crowd storage is either ready or just on the cusp of being ready, certainly for automation. just getting all of these, as these new technologies come on board, what we really need to make sure is one is that they're not rushed to market.
that they are properly validated and tested. And then secondly, to make sure that all of these different technologies speak well together. It doesn't do very much help, but you've got an automated crowd tank if it's not speaking to your EMR. Or especially if your time lapse incubator is not speaking to your EMR and you have to go up to it and manually type in all of your patient's information. So I think the technology is important, but then the integration of all of this technology is just as important or even
more important so that we really do make it more streamlined.
Griffin Jones (35:29)
You have something out Dr. Katz?
Dr Steven Katz (35:32)
And I'm really excited to see what the space, the IVF space looks like in 2035. I think the space in 2025 is amazing. In the early 2000s, we were hopeful that a patient's IVF cycle would be successful. Now, many or most IVF cycles under good conditions are successful.
I think clinical success rates will be even better in 2035. It'll give patients more options to decide whether they want to use assistive reproductive technologies to create their family. And I think the cost of IVF will be coming down over the next decade to introduce this technology to a new subset of patients who maybe are not doing it now.
I think the technology will make our space much safer. I spend my time trying to create a safer IVF lab from the seat I sit in and I'm very impressed with the technology. No technology is immediately incorporated. Auto technology, airplane technology.
but I see our space really incorporating technology and some automation like you just said. I don't know what the space looks like from a business perspective in 10 years or a management perspective, but from a clinical perspective, I'm very excited. We're all about patient care and patient success. again, I've said it a number of times.
I think it'll be fascinating to get there.
Griffin Jones (37:23)
Many of those safety solutions also seem to tie into the effectiveness of the workforce. Dr. Shankman has a training school for embryologists. And so as you're bringing on embryologists, do you see a world, Ava, where, to me it just seems wholly unacceptable that embryologists are transcribing data into multiple systems.
Dr. Eva Schenkman (37:43)
just seems totally unacceptable that embryologists are transcribing data.
Griffin Jones (37:48)
Do you see this as a necessary evil that is gonna continue in some way? Or are we going to be able to eliminate all of that transcribing, manual reporting to start, manually copying this over? Are we gonna be able to make that go away or is there always gonna be a piece of it?
Dr. Eva Schenkman (37:49)
see this as unnecessary evil, is it continue in some way, or are we going to be able to eliminate all of that transcribing?
So.
Yeah,
no, absolutely. think it can go away. know, there are companies that are launching tablet-based systems for the laboratory that integrate with EMRs. You can integrate your EMR to SART. And as I said, think what really needs to change, not only with this bringing on of new technologies, but is getting them to communicate effectively together. And there's absolutely no reason.
that in the majority of labs, from the paperwork standpoint in the lab, that has not changed much in 30 years. We are still, for the most part, entering things on paperwork sheets, and at the end of the day, we're typing into, or at the end of the procedure, we're typing into a system. There are very few labs that are entering it right away into a computer. Or if they are entering it into the computer, that computer doesn't do their KPIs very well, so they still have to...
enter it into an Excel spreadsheet or Excel spreadsheet for their cryo inventory. So 100 % I think that should go away. And I think we are at a spot where it can start going away. Now we just need the technology there to be able to communicate, to interface between these different systems.
Griffin Jones (39:17)
It also seems to me like not only do we need that technology to take some of this manual tedious work away from embryologists so that we can properly meet demand with the workforce that we have. Also seems to me though that younger embryologists just aren't going to tolerate that crap. I don't know if you if you you think the same way. But I have had embryologists reply to jobs for my company. a media company. I'm like, you know, somebody will pay you good money to do what you have been trained to do. And they say, yeah, but I don't want to
Dr. Eva Schenkman (39:34)
You
Griffin Jones (39:46)
sit in an IVF lab and be in a box and have to fill all of this stuff out and just be walking from that corner to that corner and feel like a human robot. Are you seeing any of that as well where the embryologists are like, I'm gonna go to the place that has the best storage system and the best monitoring system and the best and has time lapse so that I don't have to do all of this junk. Is that happening yet or?
Do you think that people are putting up with it?
Dr. Eva Schenkman (40:15)
don't think it's fully happening yet, but I certainly think that the clinics and the networks that bring on these technologies should definitely use that in their recruiting. I know that when studies have done, I think it was Dr. Beck Holmes that did a study on the witnessing, when they reach out to embryologists and question them, does this make them more comfortable working in the laboratory that has
electronic witnessing, the embryologist overwhelmingly state yes, that it makes them less stressed and more secure in their operations. Same thing with time lapse. The fact that you have to walk, go over to the incubator, walk across the room once a day to take a static image. I think, and that brings up an interesting point that I probably need to start encouraging my embryologist to
to reach out to clinics that have adopted these technologies as preferred places to work.
Dr Steven Katz (41:11)
I think you nailed it. think the younger embryology crowd is going to want to be using technology for all the reasons you just said. I see that already. I see in the movement of young embryologists, they want to be in a place where there's technology for all the reasons you said.
Griffin Jones (41:31)
It also seems to me, Dr. Katz, that there's a major safety issue with any time that someone has to duplicate something, any time that someone has to enter something manually, there's room for error. And so how much does that parlay into the legal risk that labs are susceptible to?
Dr Steven Katz (41:51)
It's massive. It's massive. I mean, the more human touch that you're describing, the greater the risk. As Dr. Shankman pointed out, you still need human oversight. But if you can limit the human touch, that's how you decrease risk.
Griffin Jones (42:08)
If I'm an investor, I feel like I have to calculate that I have to take that into account into the investment, which is, okay, things might look great from an EBITDA perspective. But if a certain lab has a number of manual procedures, then that puts me at a greater risk to lose a whole lot.
Dr. Eva Schenkman (42:28)
Yeah.
Dr Steven Katz (42:28)
investor
comes into a lab or an acquisition they should have a technology plan from day one.
Griffin Jones (42:35)
We've talked about a couple of the different solutions in that technology plan, going into the main categories of witnessing, monitoring, storage. It seems to me though that some people think that they might have a solution in place. Like Dr. Shankman said, there's maybe 90 % of clinics have monitoring to some level, but I forget how you described it, Ava.
those sensor platforms, what was the, that something phoned that you said how they're built on, you said most of them aren't like Ziltrex, can you explain to me the difference again?
Dr. Eva Schenkman (43:09)
Yeah, the older technology was something called a sense of phone, you know, yeah, sense of phone, which basically, you know, your alarms would be plugged into when an alarm was triggered, it would call you. And, you know, the new ones, like I said, with the redundancy that they have built in, you know, and the dashboards that they have built in, which are, you know, which are far advanced from what we used to get weak. It's almost like being in the lab. You know, lot of these systems can even incorporate in a camera as well.
Griffin Jones (43:12)
sensor phone.
Dr. Eva Schenkman (43:35)
So that, you from trying to figure out what's going on with my incubator, I can actually, you know, go into my camera. It's kind of like a Nest Cam and look at the front of the incubators and see what's going on. So I think, you know, the importance and one of the things I think it's partly educating investors as well, because, you know, a lot of places they're building a new clinic, they do want to keep capital costs low or, you know, they don't want to replace a piece of equipment until it's literally broken and it's unable to be serviced.
But if we understand that the incubators we have, the systems that we have, have an end of life and that we should be investing in technology. So if you're an investor, I wouldn't think, you don't really wanna be in the lab that doesn't have some sort of electronic witnessing. If you understand that that's gonna limit your liability, one lawsuit from a mistake that happens in the lab would probably pay Dr. Katz, what do you think? 10 years, 15 years, 20 years?
of having an electronic witnessing installed in your lab. So they're really taking a gamble when they say, you know what, we're gonna hedge our bets and we're not gonna put that $10 per patient into electronic witnessing. We're gonna take the risk that my staff is never gonna make transcription error or never gonna pull the wrong embryo. And I think that's really short-sighted by them because...
you know, one large mistake and you end up in the news and you end up, you know, on social media and you end up, you know, on, you know, with your brand tarnished and, know, even more importantly with, with, you know, the patients harmed and, know, the patient either getting, you know, the, you know, an affected baby or somebody else's baby. And, you know, that affects them for, for the rest of their life. And I think I said, it's just, it's education that these systems are out there that we need to,
to start demanding them, whether we're demanding them as this new generation of embryologists or as investors going in. If they realize putting the money into technology is in the long run going to make things more efficient, more streamlined, more safer. by going along with that, a more profitable venture for them. And I think if we kind of educate them to that.
Hopefully then we'll get an adoption of this technology.
Griffin Jones (45:53)
If they don't have engineering backgrounds, I doubt many of them know the difference between Sense of Phone and a solution as a service like Xiltrix. How does the Xiltrix dashboard look versus how things normally look? Why is that important?
Dr. Eva Schenkman (46:07)
You know, I think it's, one is obviously ease of use, but you know, being able to, the fact that it's got this remote monitoring, that I can know everything from, you know, from the VOCs in the air, in my lab, to what percent, you know, CO2, to what my gas levels are. You know, do I have an entire critical, you know, is my lab, you know, out of power? Is it just my, you know,
my refrigerator, somebody left the door open. It can sense if somebody didn't close the door properly on the incubator. They're really game changing. And I think just an understanding that these technologies exist and making sure that labs adopt these technologies, they're very, very modifiable for how you do, for your workflow.
can interface with lot of different types of incubators. And I think they're really a game changer.
Griffin Jones (47:08)
we get toward this path to 2035, where should folks start? So we painted a picture of what the IVF lab looks like in 2035, hopefully not having to do the manual entry, hopefully having witnessing a good storage system and a really good monitoring system. Where in your view, you think, in each of your view, do you think folks need to start?
Dr Steven Katz (47:36)
I would start Griffin with looking at the staffing model. I think if your embryologists are overworked and doing too many cases, that's literally immediate. It has to be fixed immediately. The second consistent area is to look at your lab and make sure that the space is a quality space. Is it big enough? Can you keep it clean?
Can you avoid embryologists from bumping into each other? Do you need a new lab?
I think I would then go to electronic witnessing because electronic witnessing is not just electronic witnessing. It sort of creates the proper flow of work in your laboratory. I would then go to safe storage. I don't just call safe storage a safe tank. I call safe storage identification of your specimens.
So not only is your storage safe, but when you put a specimen, a human tissue specimen in your tank, it's labeled, it's RFID'd correctly. When you go to use it, it comes out as the correct tissue. All of that goes into play. And then overall, I think you need to sensor monitor your space so that either during the day or at night if something's going awry, not only are you notified, but you're notified in a way that it's workable. Xiltrix in particular has a 24-hour service. They don't just let an alarm go all night. They're fully focused on making sure that human embryologists, lab directors, are aware that there's an alarm going on. That's sort of imprinted in what I do. But again, caseload is at the forefront.
Griffin Jones (49:29)
Where do you recommend that labs start? Dr. Changman.
Dr. Eva Schenkman (49:33)
I definitely think that electronic witnessing is one of the easier technologies to adopt. One of the things that I find very, very frustrating, and most of it is going to be even in clinical education for the physicians, is that even today, when I'm consulted about building laboratories and I talk to them about the HVAC system and the importance of filtering VOCs out of the system.
is it's one of those things it's something they can't see. So they don't really think it affects the embryos. And these systems to put in, life air systems and or units are expensive to put into the laboratory, but there still really isn't an understanding of how we hear about environmental pollution and indoor pollution and how this can affect cancer rates. These things affect our embryos as well.
If you don't have a well-built laboratory, if you don't control those VOCs in your laboratory, we don't know how that's gonna affect our embryos two, three, four, five decades into their life. And that's now what studies are showing. I go into labs all the time and I'll say, have you looked at your VOCs? well, my blast rate is just fine. You can still have embryos grow and make blastocysts.
but that are affected by the air quality in their lab. And I think we need our laboratories to have a good foundation, well-built, enough space for the embryologists to work in. You need to pre-plan this. What's the maximum caseload for this size lab? And also to protect those embryos. And I think we need to start at the beginning with how we build the labs and understanding that labs have lifespan. That if you built your lab in 1995, you probably need a new lab by now. But I think starting with the technologies that are out there, because obviously not everybody can just go and build a new lab, but adopting electronic witnessing, adopting monitoring systems, looking at that. And I agree with Dr. Katz as well, that weight-based system for poration for tanks, which is also a company here in North Carolina where I am, is fantastic. It can predict a tank failure weeks or months before any of the other systems that measure just temperature alone or liquid nitrogen levels would pick up on that. So I think it's education, it's doing things like you're doing, Griffin, doing these podcasts so that physicians, investors, and embryologists know that these technologies exist. And if we can get investors, physicians, and embryologists on board to insist that these are incorporated in their labs, or even getting patients to bring it up at their discussions with their physician. Do you have any of these systems in place? So when they're having their consultations and they're asking, they may be looking up where their physician went to school, but what sort of systems does their clinic adopt these new systems? I think it's really important.
Griffin Jones (52:36)
There's a reason both of you have been on the show multiple times and that you will be back each of you multiple times. I've jotting down notes of, that's a good topic for next, that's a great topic. Well, we could go down that further. So I look forward to having both of you back on the program together and individually. Dr. Eva Shankman, Dr. Stephen Katz, thank you both for coming back on the Inside Reproductive Health podcast.
Dr Steven Katz (53:00)
Thank you, Griffin, and thanks for doing these.
Dr. Eva Schenkman (53:02)
Yeah, thank you.
