DISCLAIMER: Today’s Advertiser helped make the production and delivery of this episode possible, for free, to you! But the themes expressed by the guests do not necessarily reflect the views of Inside Reproductive Health, nor of the Advertiser. The Advertiser does not have editorial control over the content of this episode, and the guest’s appearance is not an endorsement of the Advertiser.
Has research output in REI atrophied?
Dr. Kate Devine, Medical Director and Chief Research Officer at US Fertility, guides us through the current state of supply and demand for fertility services, and how Privademics could build the infrastructure to meet the growing demand for ART.
Dr. Devine shares her thoughts on:
Why, in her view, research in REI has atrophied
Her robust definition of a Privademic Practice (and their advantages)
How Privademics can adopt new technologies faster (with a higher standard of quality control)
The specific research she believes is needed to improve innovation
Current technologies she’s paying attention to
Academic programs (will and should they be Privademic programs)
Dr. Kate Devine
US Fertility
US Fertility LinkedIn
US Fertility Instagram
Transcript
[00:00:00] Dr. Kate Devine: I would argue that our field actually faces a little bit of risk as more and more graduating fellows go into private practice, that if we don't encourage them to continue to contribute academically or private emically, as the case may be our research output will atrophy. And I think that even Is happening a little bit.
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Announcer: Today's advertiser helped make the production and delivery of this episode possible for free to you. But the themes expressed by the guests do not necessarily reflect the views of Inside Reproductive Health, nor of the advertiser. The advertiser does not have editorial control over the content of this episode, and the guest's appearance is not an endorsement of the advertiser.
[00:01:19] Griffin Jones: Research output in the field of REI has atrophied. That's according to today's guest and her colleagues. We examined some problems taking place in the fertility field. The demand for ART services greatly outweighs the supply. We need to adopt technology that makes the clinic and lab safer, faster, more efficient.
We need to do that yesterday in order to start making a dent in the supply and demand issue. But clinicians and scientists need to be able to prove that those solutions are in fact safe and effective. And this is where Privatemics might come into play. Dr. Kate Devine is medical director and chief research officer at U.S. Fertility. She's an OBGYN clinical professor at George Washington University. She's the associate program director for REI, for the fellowship program, that is. and age. She's the chair of the SREI research committee. She's the chair of the SART QA committee, and she's on the editorial board for fertility and sterility.
She practices for Shady Grove in the D. C. area. And so I get Dr. Devine's thoughts on why research output and REI has atrophied in her view, what specific research needs to be done. done to improve ingenuity and innovation. How PrivateMX addresses the supply and demand issue by training more REIs, APPs, and OBGYNs.
Dr. Devine shares her thoughts on if all academic programs will and should be PrivateMX programs. And she talks about some massive advantages that PrivateMX programs have. She talks about the powerful research database that U. S. Fertility has. doing approximately 20 percent of the IVF cycles in the country and the collaboration that they have between research and fellowship programs being affiliated with five of them across the network.
Dr. Devine talks about how private emics can evaluate and adopt new technology faster and to a higher standard of quality control, and she talks about some technology she's paying attention to. We start with her definition of private emic practice, which is more robust than mine. Enjoy this interview with Dr.
Kate Devine. Dr. Devine, Kate, welcome to the Inside Reproductive Health podcast.
[00:03:15] Dr. Kate Devine: Thanks so much, Griffin. I'm thrilled to be here.
[00:03:17] Griffin Jones: It's been a little while since I've talked about the privademic model. We've introduced it on the show, but I don't know if we've ever done a podcast. episode dedicated to going through the privedemic model, to going through the future of what it looks like.
As I was preparing for the interview, I started to think, is this what academic medicine is going to become universally? Will all academic medicine be privedemic? And so I'll, I guess I'll start with what I think my definition of Prividemic REI medicine is, and you'll correct me, and and maybe give us a more comprehensive definition, but I think of prividemic medicine as an academic or health system REI division that has partnered often in equity partnership, but maybe not always with a privately owned fertility center network that maybe private equity back that maybe venture back that maybe just regular independently owned network if there still are some of those left, but I think of the R. E. I. Division from a R. E. University health system that is partly owned and if not partly owned, partly operated and operated in conjunction with a privately owned network. How close am I to the correct definition?
[00:04:56] Dr. Kate Devine: I think that's pretty accurate. I would be even more expansive than that in my definition.
I'd also quibble a little bit with the Equity portion being part of the definition. I would say that's pretty uncommon actually for the university based REI practice to be owners in The practice that is private practice that's participating and certainly vice versa It can happen, but I would say that's not really part of the definition.
Everything else is spot on. I'd say that essentially, we are in a position where a lot of the volume in terms of the practice of fertility medicine has shifted out of The university setting and fellows need experience and fellowships need funding. And so from the fellowship training portion of this and even residency training portion of this, universities have a need.
And private practices have the ability to fill that need. Particularly if they are practicing evidence-based medicine and have academically interested. REIs. The other piece of this, though, is I would expand private emics even beyond those practices that are necessarily affiliated with the fellowship or university.
I think of it as basically wanting to keep moving the ball forward. academically, intellectually, and in terms of the knowledge base of our field, whether or not you are at an academic institution. So wanting to practice evidence based medicine and do research. So contribute to academia, whether you're there or not.
[00:06:39] Griffin Jones: What does that contribution look like though? Because then can't anybody that just submits an abstract each year say I'm doing Privatemic medicine. I'm advancing research. What, how would you qualify those contributions?
[00:06:54] Dr. Kate Devine: 100%. And I think that's fine. There's no limitation to the number of card carrying Privatemics there can be out there.
And I would argue that our field actually faces a little bit of risk as more and more graduating fellows go into private practice. That if we don't encourage them to continue to contribute academically or private emically as the case may be our research output will atrophy. And I think that even Is happening a little bit.
And certainly our ability to train enough high quality REs will will atrophy if we don't have private practicing REIs contributing to education. And if somebody hangs a shingle, which you know as well as I do is a little bit. Harder and harder to do all the time in this field. And decides that they wanna do research, God bless 'em.
And of course, there's a peer review process to make sure that the research is legitimate, a legitimate contribution. And then hopefully that doc decides over time that they do wanna affiliate with the university and train up and coming OBGYNs and Reis as well.
[00:08:01] Griffin Jones: You said that the research output might already be atrophying a bit.
What specifically makes you say that?
[00:08:10] Dr. Kate Devine: They'll remain nameless but even speaking with some of my colleagues who work hard to You know make sure that our output as an, as a field in terms of our main fertility journals stays strong and again, contributes to advancing patient care and our technology and our abilities have told me that they think that the quantity and quality, more so quality of the submissions is
[00:08:39] Griffin Jones: I'm a lay person, I have no clinical or scientific background, so when the quality is going down, does that mean the robustness of what they're attempting to study, or does it mean that some basic tenets of research are not being followed?
[00:08:58] Dr. Kate Devine: I think both things. I think just the ingenuity the innovation in terms of just being bravely going out there and trying to answer the unanswered questions. There's maybe a little bit less of that going on as fewer and fewer REs see research as part of their vocation. So I would say in terms of how novel the body of research that we're producing that is.
Seems to be less. You'll, I'm sure you heard or have heard at some national meetings, people saying, Oh, it's all the same stuff. I, not learning anything. And part of that is we're approaching an asymptote as a field that we've gotten very good at this, right? But I think part of it is that while we are increasing in being entrepreneurial as fellowship graduates, that comes to some extent at the expense of fellows.
Yeah. wanting to do research. And, it's not a coincidence. They also are having lower and lower requirements for research as part of their fellowship training. Why is that? I think it's multifactorial. Part of it is The demand of the fellows saying that if they're not going to do research for their whole lives Why would they need to do 18 out of 36 months of their fellowship doing research?
part of it is Diminution in the number of an hour is available from university based faculty to mentor fellows in research but you know most immediately it's A bog and acgme who make the rules in terms of what's required to cipher boards Have reduced the requirement. I think they feel that they are being pragmatic and answering a need that's Based largely on also increasing Number of things to learn over the course of a fellowship and cutting back, therefore, on the number of months spent on research.
[00:10:54] Griffin Jones: This is happening at the same time as people are debating should the REI fellowship be three years at all? Should it only be two years, and then if it is only two years, What gets cut? What? What is condensed into those two years? How much does this need for research play into that debate?
Where do you stand on that side of the question?
[00:11:18] Dr. Kate Devine: I actually am of the mind that I think there should be a two year option. I do think More important than making sure that every single fellow comes out being an academic and a researcher is that we meet the demand of the population and we are not meeting it now and we sure as heck are not going to be meeting it as the demand continues to rise as has been predicted.
It's a very controversial topic, we just published this white paper in fertility and sterility just in advance of asrm We had about 27 reis or 27 authors including reis As well as app's Who really hotly debated this and there has been a expert panel that met that was convened by ASRM that came to the conclusion that it should be two years.
Our group by and large and. In garnering support from the various stakeholders, ABOG, ACGME and most importantly, SREI, ASRM, and SART ultimately decided that to recommend two years was too likely to just result in a diminution of the funding that's available that chairs of OBGYN programs would not allocate the saved monies from the program.
Going down by a year to additional spots That was what we heard from most rei program directors. And so basically it would just be less training but not necessarily more fellows I do think in programs where The feedback is they could get More fellows by offering a two year option That should be piloted.
That's my personal opinion. And I do think that if it enables us to train more fellows and I think it can be structured such that it could that should be an option. There are going to be those fellows that are extremely talented and driven towards research. And there could be three or programs for them, or they can apply for postgraduate K level funding with directed training.
So that We are focusing the resources on the most talented and ambitious people who want to conduct high quality research.
[00:13:40] Griffin Jones: In your view, would that option be based on program? Would every program have a two year option, or would some programs be two years and some programs be three?
[00:13:52] Dr. Kate Devine: I think it's, it would work best as the latter.
GYN oncology has done this for years now, where some programs are three years and some years our programs are four years. And so based on interest level fellows will opt in or out of a three year program, and the third year could be. focused on different things for different programs. Everyone has to meet a certain baseline level of knowledge base and curriculum, but then some programs would have an extra year that was focused on reproductive surgery.
Some programs would have an extra year that was focused on, obtaining an HCLD and learning more in the embryology laboratory. Some programs would have an extra year that was focused on research, whether that be clinical research or bench science.
[00:14:37] Griffin Jones: Tell us more about this paper. I've seen it circulated on LinkedIn.
You said you, there's 27 authors on the paper, even before we get to some more of the findings. What did the paper set out to do?
[00:14:50] Dr. Kate Devine: So the paper set out to define the scope of the problem in terms of the supply demand. Issue that we're facing as a field, both now and in the foreseeable future, and also to start to identify some potential solutions and then really largely to and live in this conversation because we're way late to trying to address this as a field as we both know industry is actively working on trying to solve this problem already in a way that will be as profitable as possible for them as REIs, we want to do it in a way that is as safe as possible for The population and so that's what we set out to do and it took us a year to publish what ultimately at the end frankly isn't An ironclad plan by any stretch of the imagination but essentially what it concludes is that we need to train more fellows.
We need to make appropriate use of other professionals in this field, especially nurse practitioners and physician assistants. And ASRM is hosting a meeting in a few weeks actually convening experts to try to figure out what's the best way to train and certify these professionals.
And then also we need to make responsible use of the available technology to make the process more efficient.
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[00:17:40] Griffin Jones: So how would you say that you defined the scope of the property? You talked a little bit about it. Likely involves training and certifying APPs, there's technology involved, but in terms of the words that you ended up all coming to, and when you think back to the paper now, how do you define the scope of the problem of supply and demand as it is now?
[00:18:02] Dr. Kate Devine: So Right now, 40 years into the history of ART Even a little bit more than that we've got 10 million kids that have been born from ART And if you think about the world population and the number of births per year, which is somewhere around 150 million, and the fact that the incidence of infertility is around 9%, And then there's lots of other indications for ART other than infertility.
We really, in theory, and this is a pretty conservative estimate, should be able to help 20 million children be born per year. Of course, we're talking globally and not all of these, the infrastructure is in place to make that happen any time in the, future. But if we really wanted to help everyone that needs our help I think that is the magnitude by which we're underserving the demand.
[00:19:05] Griffin Jones: I suspect that there's a role that private emic plays. And getting us to a point where we can meet that demand globally and the reason I'm pulling at that thread is not just because I want to weave the two topics together, but I actually I perceive them to be related partly because of the tension that you described of you've got the industry side that wants to go full tilter is incentivized to go At full speed.
And then perhaps you have an academic system that it has atrophied on its research capability. And perhaps the bridge between those lies somewhere in private demics. Where do you see privademics in this greater struggle, if for lack of a better word, to expand the supply to meet the demand for infertility services.
[00:20:05] Dr. Kate Devine: Yeah. I think it's in 0. 3 training more fellows is the responsibility of every REI. It's actually, otherwise we're going to put ourselves out of a job if we don't. To also be part of the conversation as to how do we most responsibly use and work with our colleagues that are advanced practice, practitioners, providers and then also to be extremely open minded and curious about the technologies that are available while also being incredibly rigorous about validating those technologies prior to implementing them.
And to the first point about training more fellows, people in strictly academic settings think of this and they like, start to have palpitations because they say oh, every RE in New York City is gonna just Open up a fellowship and Start training a fellow that they that just plan to hire they're not going to give them really high quality training and the field that we love is going to lose a knowledge of endocrine and genetics and everything else that is and I agree intrinsic to The richness of our knowledge and our ability to manage complex cases That in fact cannot happen.
And so many changes in our system would have to happen. There are so many checks and balances to prevent that. So first of all, you have to be affiliated with an ob gyn department as a residency to be able to train a fellow so you can't just like You know say i'll train you'll be certified and then by the way You also have to work for me afterwards or something like that.
I would hope that our ethical standards would Discourage that anyway, but there are other things to discourage it, too and in fact despite the increasing demand You know there have been Fewer the number of fellowship slots has not increased in recent years The number of new slots has basically evened out with the number of closing and it's incredibly challenging to get approved To open a new fellowship slot.
One of the recommendations of the paper is actually for programs Who are experienced in expanding a fellowship or opening a fellowship to help mentor and be a resource to programs that want to add slots Because there have been a number of applications that have been denied in recent years probably just due to an experience in the process and knowing how to apply for lack of a more complicated explanation.
So yeah, so at the end of the day, I too want fellows to have a, an extremely rigorous training and to have a rich knowledge to be able to. And I don't, I actually don't think that some of the requirements, including to be affiliated with an REI or an REI fellowship and to be affiliated with a residency should change.
[00:23:18] Griffin Jones: What role does Privademic have in training? OBGYNs outside of an REI fellowship, if any. So this is another debate that's going on concurrently, is how much should generalist OBGYNs be trained to do without having to be fellowship trained in REI. And still seems like a pretty contentious topic. I think that it's shifting it seems to be.
In the last few years but I was at an event at ASRM where there was a British REI that was perplexed that generalist OBGYNs aren't trained to do things like retrievals and even transfers and and this individual said, where I come from, if you can deliver a baby, you can suck an egg and and there was a number of In attendance that agreed with that statement.
There were there are still some that do not agree with that statement. But I'm curious without getting so much into that debate because it's its own topic. What role does private Demick play in training?
[00:24:24] Dr. Kate Devine: Yeah, my opinion is that the fellowships train OBGYN residents to know what they need to know about fertility medicine to be able to practice general OBGYN and hopefully to induce some of them to pursue a fellowship.
I am of the mind that. I think that generalist OBGYNs, should collaborate closely with REIs. I think that they are can safely do ovulation induction. I think that they can be a huge resource, especially our minimally invasive gynecologic surgeon. Colleagues and doing some of the cases that you know, REIs that are involved very deeply in endocrine or an ART maybe don't have the time or haven't maintained their skills to be able to perform.
I do think that it's a challenging question because We don't want to define being an rei as the ability to do an egg retrieval or an embryo transfer because that's not it That's a fair. Those are both fairly simple technical skills but they are not all created equal and Again, the management of complex cases is something that's well outside the scope of somebody who hasn't done a an rei Fellowship, which at this point is still three Full additional years of training.
[00:25:47] Griffin Jones: So that, that question ties into what is the future of the REI? What is the future role and responsibilities of the REI if more people are being trained to do retrievals and transfers don't comprise what a REI is or does, and ostensibly with a I. You'll have a much greater case load and R.
A. I. Is over more cases, and maybe it goes back to what you, you mentioned earlier in the interview of wanting more ingenuity and innovation from the research. So let's talk a little bit about that. What is ingenuity and innovation in the research look like and how does it develop the REI's role?
[00:26:37] Dr. Kate Devine: Yeah it's a great question. It's a great question. So there are lots of different fronts where I would where I think we hopefully will see innovation where I would like to see innovation I think towards that goal that we've also been talking about which is to Help the 20 million babies that would be wanted Be born, every year and so I agree with you in the setting of Ai and automation I think that in future decades the rei will likely be Overseeing apps who are appropriately trained and certified Managing a much larger caseload per rei And I think that and hope that more and more graduating fellows will take on a privedemic stance and see it as their responsibility to help train the next generation of REIs and also to do research.
There's plenty of scientists and entrepreneurs out there that are developing technology that hold great promise. For better or worse, given the regulatory environment in our country, the actual responsibility of validating those technologies falls on REIs, and that's not something that's likely to be done in a university based setting.
That is likely something that will be done in a privademic setting, if at all, and it's our responsibility not to just implement without validating. And so I think REIs and privademic settings. In coming years, in addition to managing more cases and overseeing, their team in managing more cases should also be actively involved in doing studies, appropriately designed studies, to validate technology before they're implemented
[00:28:35] Griffin Jones: I want to explore more about what validation of technologies looks like, but staying on the research that you'd like to see.
If you had your druthers, what would privedemic REIs be researching more of if we were to say in two years, you know what, it's no longer the case that research is atrophying an REI. It's no longer the case that we're not seeing as much ingenuity and innovation in the research as we'd like. We're seeing plenty of it, and here's what's happened.
If you had your druthers, what would that research be specifically?
[00:29:14] Dr. Kate Devine: I think there, there's a couple of different realms that it could that are my favorites, I guess I should say. Was talking about validation and, there are plenty of folks out there that are working on laboratory automation.
And I think that laboratory automation and the implementation of AI together have the potential to help us get to where we want to be in terms of serving the number of people, but it's super scary to, to, To let the machine, do IVF for us, right? And so one really important, and again, this is not ingenuity so much as being extremely conservative, right?
And cautious is to make sure that whatever it is that we are allowing to create embryos and manage our laboratories has been tested against the current standard of care as being just as safe. Effective in achieving success for our patients and also of great importance is, of course, safety.
So I hope that's something, and that's something that Privademics is ideally placed to be able to do. Other areas that I think are, hold massive promise but are extremely challenging to do research in academic settings in the United States because of the Dickey Wicker Amendment and because, no NIH funding can be used to do any research involving human embryos is, Again, the potential of genetics to cure and prevent disease.
And the applications of that are massive and varied but our field is ideally placed to be able to help to support and participate in that research, and again, even the smartest scientists in university based settings need foundation funding to be able to do it so I hope that's something that You know great scientists housed in universities and private practices will partner together to, to work on in the coming decade.
[00:31:17] Griffin Jones: Do you work on multiple research projects at once? Do you do like the paper that you just finished, do you do one of those and then do you take a breather and start the next or do you work on multiple projects concurrently? What is your privademic practice look like?
[00:31:32] Dr. Kate Devine: Busy. We have currently five REI fellowships that we're affiliated with at U. S. Fertility. And all of those fellows, as we discussed, has research as a requirement as part of their fellowship. And yeah, no, I'm doing. A dozen projects at once all with lots of help we have two phds in epidemiology a number of physician scientists at u. s fertility that are Really committed to research and education I'm working currently on industry sponsored trials NIH funded trials, the NAPRO study is focused on maternal fetal health following frozen embryo transfer.
Given how many kids are going to be born from frozen embryo transfers in the coming decade, I think that's one way that we absolutely must contribute is to make sure we're doing it in the safest way possible. And then, we have, with the help of AI and improved data analytics, really, in my opinion, the most powerful research database out there because we have so much granular information, much more so than, some of the databases that are amazing that they've collected in Europe over the years, or even that SART has collected.
Very involved in SART and SART research, but there's just, you're limited by the quality of the data entry and the number of fields. And so we have a database that has enabled us to answer. Really almost any question that somebody has about what if you change this or if you do this in ART how will it affect the outcome and there are myriad outcomes that can be evaluated And so it's a huge resource for our trainees and thankfully and we hope to get better and better over time, but we hope that it is also benefiting our patients because we're able to figure out the best way to do stuff.
[00:33:31] Griffin Jones: And so you yourself are working with all five of these programs. You don't work with, let's say, just Jones over here for this Shady Grove Fellowship partnership. You're saying you at a network level are working with all five, five of the academic programs?
[00:33:50] Dr. Kate Devine: I'm a associate program director for the NIH fellowship.
So I work most closely with that fellowship. And each fellowship program has its own academic infrastructure So it would be incredibly irresponsible for one person to be overseeing five different fellowships. That's not the case But my responsibility and really joy is to oversee the interaction between those fellowships And US Fertility so to help them with their u. s. Fertility based research projects as well as to help with their clinical rotations that occur at U. S. Fertility which are largely apprenticeships as is the tradition of training and academic medicine. And yeah, we actually started a new rotation, research rotation, which we've all been super excited about.
We've done it twice now, where all of the fellows from all of the various five fellowship programs come for one month and. They have the opportunity to come in person or attend virtually most do come in person to rockville And they have are paired one to one with a research mentor And they have a project defined in advance of coming to the rotation They have a data set a statistical analysis plan and over the course of that one month the four or five fellows that are there help troubleshoot each other's manuscripts with the help of their dedicated statistician and mentor.
It's been incredibly fun. They have structured didactics and they really learn soup to nuts, how to.
[00:35:30] Griffin Jones: So this is an interesting way of thinking about the future of private epidemic that I hadn't really thought about. I always thought about it one to one, Mount Sinai, RMA of New York NIH, Shady Grove, USC, HRC, always just thought about it one to one. But when you're talking about the network level.
You're introducing a couple more dynamics, one of which is the pure volume that you have to be able to study. You have a lot more data to be able to study because there's a lot more cycles happening over that many places, with that many labs, with that many docs. But the second is that a network can be affiliated with multiple university system, multiple fellowship programs in multiple areas, and and there's a way to bring those in the fellows and the researchers and the scientists from those institutions together.
[00:36:27] Dr. Kate Devine: Absolutely. Yeah. And honestly, it's a way for the fellows to network across a much broader swatch of the field with, as a national network, they meet, other trainees from all over the country were pretty dogged about making sure that they're paired with a research mentor that is outside their home institution.
So they get to know that person well and expand their professional network. Yeah. And yes, the big data is a massive asset that this provides, with somewhere around 20 percent of the cycles in the country, but with, every access nearly every data point that one might need for research it's extremely powerful.
[00:37:11] Griffin Jones: Do you think that for these reasons and the other ones that we discussed, that all academic medicine will have to be privademic in the coming years? That all of the hospital system and university system RAI divisions will be have to affiliate be affiliated with networks or at the very least large practices for these reasons.
[00:37:35] Dr. Kate Devine: I don't think And I sure hope not, honestly. I gave a talk recently at the fellow symposium in Park City. About private ems. And I said this and I really mean it, that if a fellow is graduating and just wants to be a basic scientist or do translational research please do it
We need those people who are really doing the basic work. That is the seed that inspires everything that downstream. And I think that's really hard to do in a private practice. Now, might there be a day where. Private practice is actually funding that research And that academic programs come to rely almost entirely on the big networks to train the upcoming reis maybe But I don't think so there is there are still things that can only be done in a university.
The converse is definitely also true, but I really think we need both things.
[00:38:38] Griffin Jones: So let's talk about the evaluation of technology as part of the crux of private and academic and. What can be solved for uniquely with private demic because you mentioned that if just at the academic level, a lot of this technology isn't going to be implemented, but you also need the research to evaluate it.
So talk to us about a couple of technologies that you're paying it to. You mentioned I lab automation, but talk to us about a couple of technologies that you're paying attention to. And what is the appropriate level of adoption. Okay. It's being adopted somewhere at the clinic level. While it's still being researched.
[00:39:24] Dr. Kate Devine: Yeah. A hundred percent. I don't think that anything should be adopted at the clinic level commercially and sold to patients until it has been proven to be effective and safe full stop. Our patients are desperate and they are They will do anything we say if they think it's going to help them have a baby.
And, we all took an oath to first do no harm. It's my opinion that if we are charging patients and exposing them to anything invasive or even any lag in initiating what is standard proven treatment, we are doing harm if we don't have really compelling reason to believe that it works.
And so I think that we should absolutely be participating in studies to do those things. And, we just published earlier this year a trial on ERA, which we all had great hope for that Was in JAMA, I think just because of this phenomenon, not because it's like such a groundbreaking thing to publish a negative study but essentially because it is really important that we don't implement add ons before we know that they work.
And so we are working with a number of AI companies and participating in their studies to validate. We are also working on with a couple of different sperm selection. Companies to validate those technologies, which I think hold great promise if they were to be helpful but until those things come to bear and I sure hope they do of course Anything that we can do to help us raise that asymptote that we've approached in terms of success rates be massive It also goes to our overall goal of helping people have more babies and being more efficient, right?
So if we have to do fewer cycles and fewer transfers, that's efficiency and that's helping the population. So You know, I think that we have to bear in mind in the meantime that people get desperate after one unsuccessful transfer. That doesn't mean that you start throwing the kitchen sink at the problem.
We know that after three optimized transfers, based on Pertea's data, we get up to 95 percent chance of a baby. And so we really need to take the time to counsel patients that these things are not validated and to say, Keep calm and do another transfer until we know for sure that these things work.
[00:41:50] Griffin Jones: What about partial implementations or maybe partial utilization? I think of if many of these solutions, maybe they're still working towards FDA approval, or they're still working on they're still working on Their studies, but they have a workflow component that that they solve for, that they can streamline things and require fewer man hours.
And and so how do you think about that when the clinical benefit may maybe yet to be proven but in the meantime there's a clear workflow benefit. How do you think about those types of solutions?
[00:42:29] Dr. Kate Devine: Yeah. The devil's in the details for sure. We could talk through specific examples, but at the end of the day, if it's no harm and it's improving workflow.
So one good example of this is quick warming, right? I don't know if you've heard anything about this, but used to take hours to warm an embryo for frozen embryo transfer. And now many labs and we're about to publish these data presented them at ASRM, yeah. We're doing it in minutes.
And there's enough data to show that there's minimal harm that I think that is completely reasonable to implement. And some things very much fall on the side of QA, right? And so if you are able to do appropriate QA in your lab, and every lab should Do this independently on these technologies, even if there's published data that show it to work in one center, you have to show it in yours to not everything needs a randomized controlled trial.
And yes, things that improve workflow and there's no biologically plausible reason why you think it would cause harm and you have enough data in your own center to show that it hasn't. I think that's totally appropriate.
[00:43:38] Griffin Jones: How about networks and centers paying to be involved in certain trials, or if there's some of these companies might be ready for prime time, some of them might not be, but at a market level, I, me just standing back and not having a clinical, Dog in the fight.
I can't. I can't evaluate these products based on scientific or clinical quality, but I can see there is a market issue where they're not getting the adoption because they're, they are they're not advancing, with their findings because they're not getting the adoption necessary.
And the centers want to see maybe more Proof from studies. How do you view if they've got low cost? If they have a low cost barrier to entry, and it looks like they've got something promising that centers paying these places that are still doing studies. These companies that are still doing studies.
[00:44:39] Dr. Kate Devine: Yeah, I haven't seen that particular model. I guess you're saying there is commercial update before the study's done or before approval comes through or maybe they're using it off label or something like that. Yeah, I think you got to be pretty convinced by those data before you would ever have your patient buy it, or even if you're buying it and it's a a cost that's passed along to them really the way that, that it should happen, and I think it mostly is that at a minimum, these Companies that are bringing these add ons to market that again, I hope that they all work together and create the miracle.
Solution to help us administer patient care more successfully but they should Be offering it for free under a research protocol Until the data are robust if they are Great by all means they you know clinical adoption is appropriate but that really the And this is a whole other conversation, but they can't afford to pay the centers because they're startups But they really should be paying The centers to do the research, right?
That's the way it works with more established companies like pharma, et cetera.
[00:45:51] Griffin Jones: I think it's a part of the challenge. And I think we'll see the rise of who's going to be the company's standing, but I think one of the challenges that they're facing is is that what their investors are looking for is, are people willing to pay for this?
But there's a huge upfront. Cost to be able to create something that clinicians are willing to pay for the reasons that you're talking about. And we've explored a lot with regard to privademic medicine. Will it will it make academic medicine obsolete? How is it involved in evaluating new technologies?
What is the specific research that you'd like to see to, that would? show more ingenuity and more innovation and stop the atrophy of research in REI. What is Private M. E. C. 's role in training APPs, OBGYNs, and REI fellows? We've covered a lot of ground. Kate, how would you like to conclude on the topic of private M. E. C. medicine?
[00:46:52] Dr. Kate Devine: I'd say that we need to Better serve the population of americans and people globally who need fertility services We are not training enough reis the Industry side and the academic side are both going to be instrumental in solving this problem together and we need to collaborate We should do so in a way that maintains a high Quality of research output and we need to bear in mind always that as industry is involved and should be and must be we need to validate any newcomer to patient clinical care to make sure that we are first doing no harm.
[00:47:39] Griffin Jones: Dr. Kate Devine, thank you very much for coming on the Inside Reproductive Health podcast.
[00:47:44] Dr. Kate Devine: Thanks very much, Griffin.
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