Episode Transcript
This transcript was generated using an automated transcription service and is minimally edited. Please forgive the mistakes contained within it.
Patrick Kothe 00:32
Welcome. We're covering a very interesting but difficult topic today. But I believe it's going to open your eyes to some new possibilities. Pediatric devices or pediatric indications for existing devices have always been challenging for medical device companies, mainly because of market size. Every company goes through a process for selecting the projects to work on. Projects are identified, they're analyzed and then force ranked. And it's based on financial and strategic goals. And then the company comes together and decisions are made on what are the approved projects. And you know, there's often an emotional pull for pediatric products, but they often don't make the cut as other projects are more profitable. Today, we're going to hear from a physician who is working hard to change the game, and has developed programs designed to help bring these urgently needed devices to the market. Our guest is Dr. Chester Koh, who's a professor of Urology, pediatrics and OB GYN at Texas Children's Hospital, Dr. Koh attended medical school at Tufts, trained in general surgery and urology at the University of Southern California and did a fellowship in pediatric urology at Boston Children's. He's the director of the pediatric robotic surgery program, is a co- founder and co-PI of an FDA supported pediatric medical device Consortium, and the founder of the Texas Children's Baylor College of Medicine based Consortium. We're gonna hear more about these programs and others, he's either developed or is utilized that help incubate ideas or incubate companies in the pediatric space. Please listen carefully to this conversation. You may pick up some strategies you can use with your current products. Or if you're an entrepreneur, it may be interesting to look at the pediatric market. Here's my conversation. Dr. Koh, great to have you join us.
Chester Koh M.D. 02:52
Thank you very much. It's a pleasure to be here.
Patrick Kothe 02:54
You've been at the forefront of developing programs and partnerships for pediatric device development. So the main focus of the conversation today is really how we overcome the challenges and treating children both from the physician standpoint, and also from a company standpoint, because there's two different sets of challenges. But to get us going, let's start off by better understanding your practice. Can you explain to me what pediatric urology is all about?
Chester Koh M.D. 03:25
Yeah, so I'm a pediatric urologist, which means I take care of only children, and I take care of their urologic conditions. And that has to do with the kidneys, the ureters, the bladder, and the genitalia. So you know, there's a, there's many conditions that we take care of in children and and basically, we specialize in that. I do have a subspecialty within pediatric urology, minimally invasive surgery with the use of a surgical robot, as maybe many of you know, there is one dominant robot currently, and that's the Intuitive Surgical Da Vinci robot. But I think that's also a great story of the challenges we face as pediatric specialists about not having pediatrics, size devices and instruments for our smallest patients. So in nutshell, that's what I do. I love taking care of kids. So that's one reason why I'm in medicine. We say physicians in general like to take care of patients and feel that we're making an impact on the world.
Patrick Kothe 04:32
So what are most most common types of ailments that you see and how does the patient present? What are you trying to fix?
Chester Koh M.D. 04:41
Sure, we do a lot of smaller routine type surgeries like circumcisions or bring down testicles that not to send it on their own. We do take care of kids with your infections, especially if they're secondary to anatomic conditions like vesko reflux, but I think one of the Is that we do the most in terms of using technology. And that's really with Da Vinci robot, our kidney blockages, and that may present with a child who has hydronephrosis, or water in the kidney. And that's usually secondary to a blockage. And that's a blockage in the ureter near the kidney, where the urine can drain. And hence you see the swelling in the kidney, the hydronephrosis. And that's what we fix using the robot. And we take out that blocked section and we put those two ends back together with a robot through small incisions where we used to have to make very big and painful incisions that would cut through several layers of muscle that would take time to recover from that. They require pain medications, where nowadays we do this all through tiny incisions with instruments that are as small as five millimeters. And even the laparoscopic conventional instruments even as low as two or three millimeters. But in general, you're fine with a robot. And that's really the point of minimally invasive surgery is to do the things that we know how to do with open surgery, except you do that through smaller incisions.
Patrick Kothe 06:11
How much is still being done with open surgery?
Chester Koh M.D. 06:14
I'd say we as urologists all need to know how to do open surgery still. But there are many things especially maybe you can call them more the routine, the ones we do a lot more of with the use of the robot. You know, we have very high success rates when we take care of children for open surgery. And we need to have the same when we do minimally invasive surgery on kids. You know, the expectation is that we have high success rates, low complication rates, and kids go home quickly. That's what we try to do with open surgery. Definitely what we try to do with minimally invasive surgery as well.
Patrick Kothe 06:50
One of the challenges when robots first came out is people wanted to do everything with a robot. How did you develop the types of criteria for doing different types of surgery?
Chester Koh M.D. 07:03
I've been very blessed to have great mentors. You know, I did my fellowship at Boston Children's Hospital, I had a great mentor, who's still a mentor colleague and friend, Dr. Craig Peters, who was at Boston Children's, and he's currently at Children's Hospital in Dallas. But he's the one that taught me robotic surgery. When we were both at Boston Children's he was a faculty member, myself as a fellow. He was at the beginning of his career in robotic minimally invasive surgery, and so forth. I was there. And then I took his teachings and built programs both at Children's Hospital Los Angeles, as well as here at Texas Children's Hospital, and really taking the lessons learned in Boston and bring to other areas. And so those that's, you know, I think that's a typical pathway you see in medicine and really learning what you can and build new programs elsewhere.
Patrick Kothe 07:55
So aside from the robot, what other types of devices are using?
Chester Koh M.D. 08:02
A lot of surgical instruments and we we need ablation type devices, energy sources. For example. We use a lot of telescopes, we don't have to make incisions because we have access to the body with telescopes. And that means pretty small instruments such as you know, wire like instruments that can pass through those telescopes to take care of a blockage, say in the urethra. So we deal with minimally invasive surgery in many different ways. Some with robots some with telescopes, we call that cystoscopy. But going through very small openings, to take care of internal blockages without making big incisions.
Patrick Kothe 08:46
So Texas Children's Hospital is a world renowned institution. Could you tell us a little bit more about what Texas Children's is all about?
Chester Koh M.D. 08:55
Oh, happy to do it. I mean, I'm very blessed to be here. Very thankful. I arrived here in 2013, after moving from Children's Hospital Los Angeles. It is the primary pediatric teaching hospital for Baylor College of Medicine. And there are a couple claims of fame. You know, we are the largest Children's Hospital United States about 1000 beds. We do have three campuses here in the Houston area and we actually have a new campus that's been built in the Austin area. We have specialty care centers. So were the specialists go to the community and see patients there to make it more patient friendly for them where they don't have to travel into the main campus. And we have all the specialties represented. We are one of the top children's hospitals in terms of research funding for the NIH. So it is an academic medical center for children.
Patrick Kothe 09:55
I've noticed when I come down there, there's kind of a special feel there. What what causes that? And what what is it about Texas children? That's special?
Chester Koh M.D. 10:07
mean, I would say first, you probably going to get that feeling at all children's hospitals, you know, we are just a different breed in terms of taking care of children and the way we conduct ourselves in general. But it's something special also about Texas Children's. I mean, there's great leadership, Mark Wallace, who's been our CEO for more than 30-35 years, as well as the what he's built over those years work in conjunction with other past leaders of Texas Children's, to build really what is a great institution that serves not only Houston, Texas, but the nation, you know, in terms of being leaders in cardiology, and cardiac surgery, in urology, in pulmonary lung care, you know, so many different aspects where they have leadership, but we also are a Women's Hospital, we do have a pavilion for women's so mothers can deliver children, we're very active neonatal ICU, where children with who are born with congenital anomalies are well taken care of both before delivery with fetal interventions. And then after delivery in terms of the standard things that we do as pediatric specialists. So we do have a lot of aspects covered, you know, all the specialty clinics, the Children's Hospital women's house, I think the one important thing I also add is that is very vertically oriented, or integrated, sorry, vertically integrated in that Children's Hospital also acts as a pair, they have their own contract with the state to be a Medicaid pair, so they act as their own insurance company. And that does provide the resources to take care of children in all aspects for both mothers and children.
Patrick Kothe 11:54
Interesting. So you're also part of the Texas Medical Center, and many people have never had the privilege of being down there in the city that is the Texas Medical Center. Can you explain a little bit about what what the Texas Medical Center is all about?
Chester Koh M.D. 12:11
Yeah, I'm very happy to do it. I mean, we really are a medical city. And I have to say that we're likely the largest medical city in the world. And that may not be as well known unless you stepped on this campus. But Texas Medical Center is an area where there are probably 12 hospitals, two medical schools, multiple institutions here that are all dedicated to health care, and is really a major factor for Houston, as well as for Texas in terms of providing top notch, high level medical care. And it's really unique, I mean, all these hospitals next door to each other, that are providing top level care, as well as research and education. And I think that's something that the city and the state are very proud of. And I think we all are very blessed to be here. Texas Medical Center itself is a corporation that owns a land, as well as runs two parking garages and other infrastructure here. But I do think that I've been fortunate to have come here in 2013, when in roughly 2011 2012, they started to make this transition really towards innovation. And hence we have this the new institutions here, such as the TMCx, which is the Texas Medical Center Innovation Institute, they were able to track one of the Johnson and Johnson j labs. So there's a che labs at TMC, as well as other vehicles and institutions that make up the new innovation ecosystem, they'll eventually lead to a new campus, what's being called TMC, three,
Patrick Kothe 13:51
For those of us in industry, we recognize that there's a lot of patient care that goes on there, but there's a ton of product development that happens down there. Not only in TMCx and J labs, but different companies bringing technologies out of the Medical Center, independent of that as well. So what you know, what a great institution to, to have down in Houston.
Chester Koh M.D. 14:18
There's so much clinical activity here. I think that's what really those who are innovating, need to have that clinical activity, do the pilot studies to have the expertise with a key opinion leaders. So it's been really a great ecosystem to become part of. Great.
Patrick Kothe 14:37
So let's let's talk about pediatric device development. And I'll just say from a company standpoint, it's always been a challenge. It's been a challenge because when you are developing products, you're looking at the product development costs, the time to do it, and and also kind of what the clinical pathway is going to be and what the regulatory pathway looks Like, and what type of product claims that you're going to go after and on the pediatric side, you know, if you're going after a pediatric pediatric indication, you need to do patient studies with it, which is difficult to to do as well. And then, you know, when you, when you get to the endpoint, then the market is smaller than other types of products that typically, you know, larger companies are developing, we all know that many of us have have children, and, and some of us, you know, hit the genetic lottery where our children are all healthy, and some of us don't. And we all would love to be able to provide as much technology as possible to treat every single patient that comes comes here. But there's some, there's challenges and, many people have overcome those challenges. But that's kind of from, overall from a, from a company standpoint, from a physician standpoint, what kind of challenges do you see in developing products for your patients?
Chester Koh M.D. 16:04
Yeah, I mean, you know, I always say the shortage of medical devices for children is a public health problem. And this has been recognized, both on the physician side as well as device side as well as the government side. And so we understand there's a problem, we know that we cannot follow the adult device pathway. And much of the adult device pathway, which, you know, really innovation, at least in the United States is really driven by the market. And the hard part about children and the pediatric population is that we are a smaller population. You know, if you take the population that really is zero to 18, or in the eyes of FDA pediatric, pediatric is up, you're 22nd birthday. So zero to 21. That is only a small portion of the population as opposed to zero and 80 for the rest of us. So when you have that smaller population, and you also have relatively less use of devices in kids, that makes it a very small market, that a lot of large device manufacturers may not spend a lot of time in, and it's hard to blame them for that. Just because you know, they are driven with stockholders and shares, they're driven by the business. So they need to keep their business running, employ their people to have the innovative activities continue. With a small market, that's quite difficult. But the thing is that kids still need those devices, you know, and we see that as physicians, because, for example, myself in the operating room, always saying, I wish I had this, I wish I had that, because we don't have it, you know, we need that device that's going to help me take care of this child. We know how to work around things for now. And that's really off label use of adult devices. And we are allowed to do that that's perfectly legitimate that that is our solution for now. We know that if it's approved by the FDA that we can use in kids off label, but we want to see more devices that are developed with kids in mind from the beginning that they very well could be a pediatric device that can use in adults, but we know that we need more attention paid on the device needs of children.
Patrick Kothe 18:25
Yeah, and the thing is, children are not little adults, right, they've got their own physiology, they've got their own anatomy. explain that a little bit more to us and, and how we view children versus adults for their medical care.
Chester Koh M.D. 18:42
I think one thing for sure is, You know, when, for example, I talked about treating a kidney blockage in a child, you know, who has signs of hydronephrosis, or water in the kidney? I mean, we do robotic surgery in three month olds using the robot. And we're talking about very small spaces to use what is a very large robot, and that's Da Vinci robot, which is the main robot being used clinically, around the world, at least for urologic conditions. And so that's a challenge. We see that and it is difficult things that we still need it, you know, kids still need it, we need more of these devices.
Patrick Kothe 19:20
So one of the things about Dr. Koh is he is looking for solutions, and really has done a tremendous amount of of coordinating of people and resources and programs to be able to attack this challenge. So in 2017, you publish a paper and it was called pediatric medical device development by surgeons via Capstone engineering design programs. Can you talk to me a little bit about what this is all about?
Chester Koh M.D. 19:50
It's perfect. I mean, I think part of being in the TMC and in Houston and in Texas, is that we have a lot of great institutions all next door to each other So, I'd say that for us for sure, with Rice University across the street, and it's very strong engineering program, as well as Texas a&m University, which is only 90 minutes away from Houston with a very large engineering program. And both of them in Texas a&m, being 90 minutes away, they have also a growing footprint here in the Texas Medical Center as well. We have two great top notch engineering schools. And with that, we've been able to partner with them. And that's what the capstone program does. You know, I, myself have knocked on doors and engineers say I need this, I need to ask what what can do to work together. But we found that a lot of engineering professors have their own projects, they have their own funding, and they have their own priorities. So how do we get in front of them. And I think that's where the capstone programs are. I mean, these, these are required programs for all accredited engineering schools, and what they what you are working with engineering teams, and these are usually senior engineering students before they graduate. So they have some experience under their belt. And what we've done is have had pediatric surgical specialists who are the key knowledge gathers and they, they see what the unmet need is in the operating room. They're the ones that are identifying the problems, because they deal with it on a daily basis. And once they described that problem, and not solution, the solution for the engineers, but they describe the problem. And they may have some general goals, whether that's devices you could be they put those on a piece of paper. And then we go to our engineering professor counterparts, who are running the capstone programs at both rice and Texas a&m. And we present these unmet needs to them. And then they partner them with teams, if they're selected. The pediatric specialists, the faculty members, and their fellows and other trainees get to work with engineering students to start building a device and we're talking about first clinical immersion for the students, so they get an idea what the problem is, then they start coming up with idea generation throwing 1000 ideas on a paper, then willing down to a handful, that then they're gonna start building prototypes, and usually come down to at least one major prototype. And that's really for the fall semester. So this is within an academic year. So that's usually September to December. And then when you get to the spring semester, then they start taking that prototype and start building it as you start testing. So it's a great prototype building process that used to be considered just an educational tool, but actually, it can be a prototype development pathway within academics. And we know that's one of the solutions that we need in pediatric devices is that we need to stay within academics a little bit longer to de risk to further develop it before we go out into the external world, just because we have we need a longer incubation within academics to make advances to make it more attractive to the large device companies or to investors or other aspects who are supporting device development in general.
Patrick Kothe 23:13
So let's go back to the front end of that, because I find that that that is an area that is the most difficult it's defining the need. It's It's It's coming up with what exactly the need is, and and then translating that to somebody who can help to design what the solution is, how do you train your clinicians to identify what needs are? It's not just, you know, I need I need something, you know, it's a little bit smaller, or you have an angle, but really deep needs for treating diseases that don't exist.
Chester Koh M.D. 23:50
Yeah, I mean, I think I think this process has worked out quite well, in that first you got to find the committed clinicians and surgeons who are willing to work on that. So they have to, they see these unmet needs every day, but they have to put them to paper. And that kind of tells you that they're committed to it. And then we have a several ways to evaluate that, you know, in this case, I'm going to engineering professors, and they are going to the team and they have to be selected. And so we have quite a few, I can tell you that we have approximately 10 projects that Texas a&m chosen every year, we have to at Rice every year. And so I think that's at least one way for an evaluation process to say this is an unmet need that's identified by key opinion leader like a surgeon or a pediatric clinician, and then hence, also take it to the engineering analysis and see, can this something that can be done within this program to start building solution and really, we're talking about the early stages of the pediatric delight device lifecycle, which is really concept to prototype.
Patrick Kothe 24:52
So students, students have this as a capstone project and then they graduate so Sometimes these, these projects just kind of die at that point. And sometimes they're they're moved on and companies are formed, and ideas continue to grow. So what kind of success mean? How has that transition been from the end of the capstone program to taking the technology forward?
Chester Koh M.D. 25:18
I think it's a win win situation right there. Because those students are graduating, they've done great work, they really considered to be a class. So it really is an educational opportunity. But that's where then the project goes back to the surgeon, or goes back to the medical school. And I think that's what maybe was, it was not being done before. And that's all reason why we wrote the paper, that this can be a great prototype development pathway that may not have been fully realized. And in many cases, it has been other institution. But at least from a programmatic standpoint, we saw that this could be a great low cost, prototype development, that you got a very, you have a very experienced clinician who's identify unmet need. And then you also have a team that's starting to put together a solution to it, at least the beginning stages. So we found that it goes back to the surgeon, and we're not taking every project. I mean, of course, there are many projects that don't move on from the capstone stage. And so there are a handful, but there's some that get provisional patents, there's some that may move into the master's program for further work with even more experienced students for the later stages of that early development process. And then we'll move on to other ways because a lot of things need funding. And that's where we start getting into, we can also apply for NIH funding. And that's something that may or not aware of the NIH funding that supports pediatric device development or any device well, and that's really the with the commercialization grants that those are the our 43 or 44, spr STTR grants. And so I think that's a new area, at least for clinicians, you know, we're so used to seeing NIH r1 grants, and our 21 grants, but not these SPR STTR grants.
Patrick Kothe 27:04
So we're kind of moving on to the business side of things. We've got the clinical side. So there's some business, things that are occurring there. There. You talked about IP, you know, different different patents that need the ownership of those patents. You know, who's who owns the technology, so to speak in this early phase? because now you've got your institution? University, you've got different people involved? How have you navigated that?
Chester Koh M.D. 27:31
I think the thing about IP for pediatric devices that we are dealing small market, and if I see that perhaps these concerns are, that could be slowing down the process. I think, for the most part, my suggestion is, you know, we have to allow these things to move forward. It's challenging enough, that we shouldn't let any concerns for IP. So a lot of times, you know, especially when you stay with academics, at least for the faculty members, we are employees of a medical school. So anything that we develop as faculty members really belongs to the medical school, really, as part of the Bible act. And so I'm not so concerned about intellectual property, at least from a personal ownership standpoint, just because I know that it's going to be owned by the university, of course, if something down the line, of course, the fact they get to share in that, but for the most part, we just want to see new solutions be developed to help kids I mean, we're all in it for taking care of the kids. I think that's something that's especially true for the pediatric specialties is that our focus is really on treating kids and helping kids so
Patrick Kothe 28:44
so you finish a capstone project. It's a it's a promising technology, people want to see it go forward. Now you've got and you've got a prototype, an early prototype, but there's a lot that needs to happen to bring a product product to market. So you mentioned the SBIR. NIH STTR grant grant funding, and Dr. Koh was gracious enough to share with with me a paper that he's submitted now for for publication on that program. Can you talk a little bit about how that can help people bring technology forward?
Chester Koh M.D. 29:22
Okay. Thank you very much for the opportunity. I mean, this is a paper that was accepted by the Journal of Pediatrics surgery and will be coming out soon to the public. But this base, we talked about a cohort that for the capstone paper, really the 2015 2016 cohort about how they developed their their projects. The second paper is really a follow up to that and really some of those as well as others moved on to SPR STTR funding. So you take a project that started in the capstone, many cases, to build a prototype. They did some further work, perhaps in the master's program, I think the partnership has to arise at some point, because there has to be some type of what's called a small business concern. And it could be a local device development firm. It could be one's own small company that you want to build on your own. But basically, that's what the SBIR STTR commercial commercialization grants are about. These are NIH funding to help with a late a little bit later stages of device development, including pediatric devices. And so what we've done, we've had some great partnerships. So we have, it's really a three way partnership between the Children's Hospital Medical School, between the engineering universities, of course, so the children's hospitals do by providing the especially the clinical side, the engineering schools are provided the engineering side, but then we have these local device development firms of which one of our strong partners is all been fin in innovation studio, who has a very strong track record of SPR grant funding. They've been a tibits Award winner from the SBA for their track record SPR funding. So we've had, you know, a few examples of those obtaining SPR phase one and even phase two funding, and that we're talking about grants that are helping layers a little bit later stages, you know, in terms of the commercialization steps, a little bit later stage prototype development, we're talking about animal lab, and catabolic lab testing, towards even manufacturing. Talk about some of the regulatory concerns that need to be addressed or reimbursement concerns, those are all things that the SPR STTR activities can be supported with that type of grant funding.
Patrick Kothe 31:48
What kind of dollars are we talking about for those those funds?
Chester Koh M.D. 31:51
if if those are not aware, that's that is what the paper was written about is to make pediatric clinicians aware of this grant funding. And it's about I'd say about 150 for that phase one grants. But then for the phase two, you're getting to the 1 million or more. And usually, you can, I would say most are start off with a phase one. It's one, one year of activity, maybe two, with a no cost extension, and then you apply for phase two, if you do it two separate steps. And that's another one to two years, maybe more for those later stages with, of course, a larger amount for that grant. So I think it's a great mechanism. I think it's not it may be well known to engineers, because they're very similar programs through the NSF, the National Science Foundation. But I do think many clinicians and collision scientists are not aware of this type of funding, or the specifics of it. And I think it's a great funding mechanism that they are not aware of, especially, you know, with as difficult as NIH funding is now with impact scores and paylines being sometimes the single digits, I tell you that the index score paylines for these SPR STTR funding are sometimes 25 of the buff. Yeah, that's unheard of, at least for the other type of a science grants. So I think really is an untapped resource that needs to be better utilized to get better devices in general, but also for kids.
Patrick Kothe 33:22
And for you entrepreneurs out there. This is non diluted funding. So these are these are true grants, major, major benefit in building, building technology building companies. So there's a there's another program that you're intimately involved with. And it's it's the pediatric device Consortium. And that's another way of of helping fund this area.
Chester Koh M.D. 33:49
As we talked about, we know that this is a public health problem. And it's been acknowledged by the FDA, for example, they know that pediatric device element lags adult devices by 10, five to 10 years. It's been recognized by major advocacy groups like the American Academy of Pediatrics, which is the professional society for pediatric pediatricians and pediatric specialists. And so what happened in 2007, is that a lot of good work went towards passing at the Congress, you know, the saying something that takes an act of Congress to change things. That's what happened this case. So there's a 2007 Act of Congress that led to many improvements for pediatric innovation in the country. And one of them was the creation of the FDA, p 50. Grant Program, the that is called a pediatric device consortium program or PDC. And so it's a committed funding you apply. I was able to apply for this grant. When I was at Children's LA I did leave that because that's also when I left to move to Texas Children's. And so when I moved here to Houston And I did a very similar way of doing that lays bring together a lot of people to build a consortium. And then we apply in 2018 gather funding to create what's called a South West national pediatric device innovation Consortium, or short SW PDC, Southwest PDC. And is one of the five national consortium funded by the FDA p 50. Grant program. We are the only one in the middle of country there are two on the east coast and two in the West Coast. But we call ourselves a virtual accelerator in that we help pediatric device innovators to help build their devices. And we provide everything in a non dilutive no strings attached free manner. And so that could be grant funding, or I'm talking about see grant funding from us. It could be assistance with regulatory consultants with your FDA filings, it could be assistance with reimbursing consultants, you know, if you have any regulatory matters that you want to try to address. And so there are many ways that that the consultant can assist. You know, we also are all based at major children's hospitals. So we do have access to experts in every specialty, I think that's one of the things we love to do is really connect pediatric device innovators to pediatric specialists. So these are engineers and entrepreneurs, partnering with clinicians to build better devices. And I think that's something that may not happen easily. But I think that's one thing we definitely try to do is make those connections.
Patrick Kothe 36:34
So you've been going since 2018, with this program?
Chester Koh M.D. 36:38
for the one here at Texas Children's, that's basic text, Children's Hospital and Baylor College of Medicine. You know, the consortium is our institutions plus, University of Houston, Texas a&m University, Rice University, infinite animation studio, we also have a couple other hubs, with our colleagues, both in the San Antonio Austin area such as yourself, Patrick, as well as in Phoenix, Dallas, and we just opened a new partnership with Arkansas children's. So we we a lot of times we provide information, we do have an annual symposium business meeting, all are invited to that Tuesday, the first week of December, including in December 2021. And so I suggest you come learn about us. So we do have a website, SW PDC dot o RG. org. And you find information about the programs that we support, and we we have free money, we give it out. Of course, you know, we had to make sure that if he wants us to make sure that we're giving out to qualified recipients, but yes, we, if you're a pediatric device, innovator, we want to help in many ways.
Patrick Kothe 37:45
So in the three years since you've been going, how many companies have you helped?
Chester Koh M.D. 37:50
Yeah, so we have have over 100 companies in our portfolio. Now, of course, not all of them are active. And some are have been very early stage at the concept stage. You know, many are the prototype stage. And there are several, and I'm hoping even more that will become those commercialized products that either exit to A large industry player, or what is the majority of pediatric devices are really are small businesses. I think that's where pediatric devices ends up most of time is in small businesses. I know that at the med does have a pediatric device working group. And I probably say perhaps 80% of the members are all small business members, because it's pdfview devices. You know, of course, they have a large industry players there as well. But Piatra devices is a little bit smaller market, which means small businesses.
Patrick Kothe 38:41
So you've got kind of a pathway right now. So you've got the capstone program, we're looking at really early stuff, you can get early to mid funding with SBIR programs, the PDC programs, and bringing technologies along. Have you had any graduate and be on the market at this point?
Chester Koh M.D. 39:03
Yeah, I think we're very early. I mean, if you think about how much we can give out and we are limited by the legislation to not be able to give out more than 50,000 a year that's that is by legislation,
Patrick Kothe 39:15
That's $50,000 to any one company, one
Chester Koh M.D. 39:18
company, right. And we usually end up giving 25,000 to spread out the helped more than others. So when you're talking about those amounts, we're really talking about the early stages of commercialization. But there are several examples, both in the past as well as up and coming, some of which I may not be able to disclose, but I can give you a company that was developed here in the Houston area and that's visual aids. And our colleagues at biotechs are the ones working is really came through the texting system and that we're talking about EMI MRI, safe ablation catheter, and this case was done for epilepsy. And I think that's a great segue. success story they exited to Medtronic for $100 million in 2014. I think those are type of success stories, you know, the big stories that get out that hopefully will drive many more into pediatric device development with the more innovators, we need more funding sources to help develop better devices for kids, and they're starting to come. So but it's sooner rather than later.
Patrick Kothe 40:24
You've done a tremendous service to the pediatric device community as well as your patients, obviously, in in driving a lot of these programs and a lot of people have have you to thank, for really, really helping out in this area,
Chester Koh M.D. 40:38
we're happy to do that. And if I may, maybe mentioned, there is a national meeting coming up in February. That is called the ship MD. consortium meeting sh IP dash md.org. And really, it's really trying to develop a new ecosystem for pediatric device development. And a lot of it will be based in the children's hospital system, but of course, working with the FDA with industry with Abba med. And so that's coming up. So that is just a single meeting, but to move on to future work. So I think it's not just us, and we have the other four consorting sites. But I think we really are seeing a national movement towards building better devices for kids, I hope you can jump on that train.
Patrick Kothe 41:24
Great, thanks. So I'd like to go back to something that you're speaking about earlier. And that's the the robot and your director of the pediatric robotic surgery program. So I'd like to, I'd like to explore that a little bit further about what the program is all about. And specifically, two areas. One is your training and how you train physicians. And secondly, how you work with industry. With that, so could you explain what the program a little bit?
Chester Koh M.D. 41:55
Oh, sure. That's right. I mean, you know, we are a major Academic Center, and the Texas Children's robotic surgery program, the second one I built so after I left Boston Children's, with new knowledge, after learning from my mentor, Cray Peters, I first went to Tokyo to LA built the program and then moved here to the 13th, when they asked me to come build a program at Texas Children's. So it is for pediatric robotic surgery. We do surgery with small incisions using the robot. And part of that is really train the next generation. I think that's one thing that medicine is well known for is that we are trying to always try to train the next generation doctors, because we ourselves will become older. And we need to not only train the next generation of doctors who are providing care, but also those are developing that next innovation. So we have a very strong fellowship program. I am actually also served as pediatric urology Fellowship Program Director, I took over from editing consoles who had been the program director for that for 30 to 35 years. We're one of the original six fellowships here in the United States. And so it's been a real honor to take over. But they Dr. Gonzalez, and textural has had a very strong Fellowship Program all these years. And so we have fellows coming every year. To the weather, it's really the clinical fellowship, but there's a two year fellowship where the first year being in research or academic activities, and the second being very busy clinical year. And I tell you from the research standpoint, of course, exposure to the basic science, they'll have also time for clinical research projects. But also definitely try to get the fellows involved in the pediatric device innovation projects as well. So when we have Capstone teams working on a new device prototype, the fellows are definitely involved with that. When we have Master's work being done, the fellows are definitely involved. Some lot of times spearheading that. And of course, when we have animal studies, and hopefully eventually clinical studies, of course, our trainers are going to be very much involved with that. So having trainees and next generation being trained to be the future doctors and innovators and even entrepreneurs. I think that's very important about what we do in medicine. Remember your second question about working in industry? So I think I mentioned before that we need better devices for kids, including in robotic surgery. There are some rallies that we face currently. So I mentioned before that the major player for robotic surgery currently is into surgical. They do have an SI model. And that's what we use. It is an older model, but that is the one with five millimeter instruments. They didn't make the next generation that's the exci however, that was produced without any fuss. five millimeter instruments. So they're using eight millimeter instruments. And I tell you, I mean, I'm not a fan of larger instruments for kids, it's already big enough, as it is with five millimeter, I'm looking for three, two, and maybe to a point where there'd be no instruments. But unfortunately, that's all we have. And that's in the older model, si. Now, we know that si will be retired at some point soon, we already know that the five millimeter instruments for the SI model are no longer available as of December 2020. That's a challenge that we face. And that's unfortunate. So it's just an it's my personal example of why I'm in pediatric device innovation do what I can't help because as it stands, now, we face these type of challenges. We need smaller devices for kids, we need better devices for kids, and unfortunately, can't get them. And so we do what we can to do that. So I think I mean, into surgery, at least for me has been a great partner in terms of I'm glad to see that they're continuing to innovate, to bring in new devices, new models, new instruments. But I think we also need to have that push towards areas in needs such as pediatric devices, you know, smaller instruments, especially for our smallest patients.
Patrick Kothe 46:21
So let's talk about that a little bit a bit further, because sometimes industry can do things, and sometimes they can't. And so there's, there's certain times where a company is investing in one technology, and they just have all of their resources put that way. So when you have those conversations, you say, Hey, this is what I need. This is these are the needs I've got, this is how I can serve my patients best. Can you help me? And and and the company has that conversation with you. What do you what do you expect out of that conversation? Whether they can do it or not do it?
Chester Koh M.D. 47:00
right? It is a challenge. I won't. I won't belittle that at all. It's a challenge, especially with pediatrics, because we are a relatively small market compared to the adult market. I think we talked about some of the solutions already. I mean, things like further de risking, and continued development within academics before you go to our large industry partners, I think some of the things that need to be done. So that when you get to then start having those conversations, you have more of a development developed product, we need to be at a later stage when you come in front of our large industry partners, because they need to see that there's the economic benefit for the company. And that is really the reality. I mean, these are large companies with shareholders and stocks and they're there, they are beholden to the business model. And we all talk about the market approach, they are subject to the market. But I do think that we can help with that by bringing layer stage projects. I think philanthropy takes a larger part in pediatrics. So there may be things that may not be paid for with business dollars, but but instead with philanthropic dollars. So there are different ways to help address that. Sometimes we have to tug on their heartstrings you know that maybe they have a child and they see it. And there. There are actually some very good examples. I can tell you one, the dialysis unit in beady barn in Arizona working on pediatric device catheters, new ones, smaller ones. And they actually, we partnered with them, they came out a couple years ago, they won some meetings with our pediatric nephrology and pediatric surgery, and pediatric interventional radiology experts. And so they got to meet with them a couple years ago, then they went back with that advice and the feedback. And they came out with a smaller pediatric dialysis catheter for kids with end stage renal disease. You know, they they're very happy to share that with me how they got to a 510 k this year. That's how we have to do it. We have to find those who are most interested in helping kids and have the resources and we're really talking about management leadership being committed to kids. And that's where that so we just need more of those. You have to find them and really cherish them.
Patrick Kothe 49:23
I think one of the big differences that we're talking about here is that you're not just coming and asking for something to be developed, you're coming with solutions as well, with the programs that you're talking about. You're really helping to bring those solutions and helping industry not only with funding, but resources within your institution, that different different specialists, different physicians who can help to bring that again. Yeah, there's some business things that need to be worked out. But the primary emphasis is let's bring a technology together. Let's bring a technology forward together. That that can serve our patients.
Chester Koh M.D. 50:00
That's right. And I think one thing that may not be realized is that everyone's trying to go for the big market. But you could have 1%, or your goal may be 1%, or a point 1% of this very large market, I would tell you that most likely, your advices you may be the only player, of course, in a smaller market, but you can have a niche in a very large niche in your own market. What better place would you want to be when your business you know, I think you would control all the strings, instead of constant competing for a very small piece of the pie. So that's what we try to say, are the benefits of Piatra devices, being in a small market, that you have much more control, that you're going to get a lot of help along the ways, because they are established programs, they're helping innovators, move those projects forward, that don't have to come from the business side. And so we're gonna come to you with something a little bit more fleshed out, you're gonna have a great story as well, you're going to help out kids, I can't tell you your turn from the business standpoint is show that you have a empathetic side, I think that would be a positive for a company.
Patrick Kothe 51:06
So let's talk about the future a little bit. You been involved with looking at different technologies, and you've got your your fingers on the pulse of what's going on? What excites you about some new technologies that you're seeing on the horizon?
Chester Koh M.D. 51:22
Yeah, well, I tell you some of the biggest ones, especially because it's My clinical specialties, robotic surgeries, I'm looking forward to seeing more robotic systems come on the market. And we've all heard the stories, verb surgical, j&j, Medtronic. And so I think it would be very interesting to see what those BAE Systems are, as with anything innovation, to have many different companies all competing, you know, in a good way, because I think that what that does is helps bring the price down, and helps to bring the pace of innovation even quicker. And so I do think that's some of the exciting things that we we will see. And so if there's a robotic company, that's going to make smaller instruments, you know, in the three millimeter size, even the five millimeter because that five millimeter mark is already gone. You know, I'm wide open to that. So that's what I'm looking for. And actually some out there that make three millimeters ribs, so of course, we should be looking at them. But if you think other things, you know, there are certain areas, pediatric devices doesn't, doesn't serve kids in all specialties. But some areas for sure, as in surgery, in the emergency room, in the ICU, whether it's a pediatric ICU or neonatal ICU, of course, it serves in radiology either as a diagnostic or as a therapeutic, you know, like an ablation energy source. Diabetes is a very big one, as well. So I think there's certain areas that devices hits. And so when you say you're gonna do pediatric devices, you'll need access to all pediatric clinicians, you need to just a certain aspect, I think that's what we try to do that we have a Rolodex of those who we know, can provide very pertinent information, and we try to make those connections.
Patrick Kothe 53:14
Dr. Koh, is there anything that I didn't ask you, that you think is important in this discussion?
Chester Koh M.D. 53:20
I would say also, but funding, you know, we need to keep the funding going. It could be philanthropic, but also trying to get the investors that we need to see them interested that not only be looking at the market or the return on investment, that the whole other part, I mean, people are investing with good cause in mind, and pediatrics is one of them as well. I'm fortunate enough to sell the Advisory Committee for one of those funds. That's the TMC venture fund. It's another aspect of the whole innovation ecosystem that has been built here at Texas Medical Center, and like to give a lot of praise to those on the Texas Medical Center, but they had built a really excellent innovation innovation ecosystem, including the venture fund, and we're talking about larger amounts of investment to help device devices and digital health and any innovations moving forward. So I think I think it's a very good time to be here in Houston and in Texas.
Patrick Kothe 54:21
So Dr. Koh, you know that our audience works in medical device, and it could be in any any functional area anywhere from people working and during the manufacturing of products or regulatory quality sales, marketing CEOs and companies. Is there anything that you'd like to say directly to people working in industry?
Chester Koh M.D. 54:42
Yeah, I would say keep your mind open to pediatrics. You know, I know the accountants may give you a tough time on it. But I think that pediatric devices is where you need to be. So the kids need you. We need you. I think the markets wide open and you could have a niche In a small market, but you'd have the whole niche. And so I think that's what you're trying to get across. And we do have a lot of no strings, attached free programs to help these innovators to get these products to a later stage. So keep your mind open, and we're here to help. We help out innovators, we help an industry to make those connections, but we also have access to the hospitals, you know, we are in the hospitals. And so I think that's definitely the win win part. You know, just like the BD Bart's story, I just told you that very grateful that they're the rd for ologists are very happy that they're there for the kids. We need even smaller Catholics and one they just build. So those are things are still being worked on. I think there's a niche. And I think it's great to see that all players large and small, are interested in helping. I think we keep that going forward.
Patrick Kothe 55:54
What a great conversation and message from Dr. Koh, a few of my takeaways. First, some people complain about problems others look for, and then implement solutions. Dr. Koh is dedicated to finding and implementing solutions for pediatric devices. So what kind of person are you? Do you complain in leisure? Or do you take action and become part of the solution? Second, I'd like you to revisit the pediatric space and open your eyes to some of these new opportunities. There are pathways for innovation and pediatric devices as we talked about today. Whether it's a new indication for an existing product, a new size for an existing product, or a completely new product. There are clinicians ready to help and university and government programs ready to support you. Finally, what these programs can mean for startups. I want to share with you firsthand how easy and beneficial one of the programs that we talked about the pediatric device consortium is. As many of you know, I'm the CEO of EM Device lab, where we've developed a new product for treating abscesses, the product will serve both the adult and pediatric populations. And as you might expect, the adult market is much larger. However, there's some unique benefits when treating kids. We've received over $100,000 in grants from three of the pdcs, which we use in early development, we also tapped into experts who helped us with specific problems or issues that we ran into, I can tell you that the program made a significant contribution to our company. And we're proud now that we'll be bringing a solution for abscess treatment to both adults and children. Now for your action item. Think through your product line and identify one product that you suspect could benefit pediatric patients if it was modified. Then either talk to your marketing colleagues about what you learned from Dr. Koh, or talk with some pediatric clinicians to see if your device could make a real contribution in treating their patients. If you don't know where to start, I've included links to the pdcs in the show notes and I'm sure that appreciate you getting in contact with them. Thank you for listening. Please spread the word and tell a friend or two to listen to the mastering medical advice podcast. As interviews like today's can help you become a more effective medical device leader. Work hard. Be kind