Avoiding the Valley of Death | LSI USA '25

Ivanny Franklin  0:05  
All right. Well, thanks everyone for joining. So we'll have, I'll run through introductions and our thesis here. But just by way of logistics, we'll have 40 minutes for this session. I have allocated about 10 minutes at the end for Q and A, so we've got a mic set up here, so we'll walk through some discussion, and then feel free to ask questions at the end. Maybe a good place to start is introducing kind of why we're all here today. So bridging the gap between early innovation and achieving commercial success is amongst the hardest challenges that startups face in the med tech industry. We're endearingly calling this panel the valley of death, which or maybe not endearingly dangerously. But you know, once startups achieve funding, they have to navigate ever changing regulatory environments and fundraising, achieving reimbursement, generating clinical evidence that needs to satisfy multiple stakeholders, so payers, CMS, regulatory bodies, investors. What we're going to focus here on is tips and tricks as well as strategies that people from all different perspectives in the industry, you'll hear in their introductions to help startups as they're navigating and really commercializing the device. So with that being said, Adam, if you want to introduce kind of your background of expertise, and we'll come down the line, and then I start with some Q and A Sure.

Adam Saltman  1:37  
Thanks, Shivani, and I was hoping that a title like the valley of death would get a few more people here. It's an intriguing title, I think. My background, well, let's see, my parents said I had to be a doctor. So I went and became a cardiac surgeon, which I did for about 25 years. Along the way, I got very interested in medical devices, not just as a user, but as someone who also was helping small companies, large companies, et cetera, do things like bench top work, pre clinical investigations, clinical studies and so forth. And so when I saw that FDA had a fellowship in regulatory science, I decided I didn't have enough school, so I went and I took that fellowship, and I ended up actually working part time for FDA, like nights and weekends while I was still in clinical practice. And I did that for a while, ended up leaving clinical practice in about 2017 or so, went full time FDA, got involved in all kinds of pre market, post market activities, the Digital Health Center of Excellence, so forth. Left FDA in about 2020, and went into industry. Became chief medical officer for some startup companies, small companies building AI products to identify cardiac disease and other like in vitro diagnostic type tests and so forth. I joined NAMSA and Ivani about two years ago, originally as a principal strategy consultant trying to help companies get through this valley of death type situation, you know, putting things together for them as much as we could, telescoping things as much as we could. And, well, I guess today is my two month anniversary as their Chief Medical Officer, so I guess they like what I'm doing and gave me more, gave me more work to do. So there. So anyway, that's me, and thank you for staying awake during that,

Omar M. Khateeb  3:23  
Omar. Well, that's me next. Hi everybody. My name's Omar Khatib. I'm the founder of Khatib and Co. We're a growth and marketing agency, so we work with Medtech startups on raising awareness to investors and commercializing products. I'm also the host of the state of Medtech. I'm sure I popped up on your feed at least a few times today. It's a great podcast you should check out. We're very proud to be now partnered with LSI. So a lot of the episodes we're going to be having are going to be powered through a lot of the great market intel that LSI has in a previous life, similar to Adam, actually, I was in medical school down in Texas. Unlike Adam, I actually saw the from forest beyond the tree. And I said, you know, I don't think this is for me, so I should try something a little bit different. So I actually left about halfway through, so I only ended up with an M and joined it, and during it, I'm glad you guys got that joke. Never lands sometimes. And I joined industry. I started off in sales, carrying the bag at Missouri robotics, and then went to marketing. As I say, the rest is history. I worked at a lot of emerging med tech startups and robotics AI and beyond. I think, probably a hallmark of my career is that I've been a very, very early voice and advocate about using social media to your eye product adoption, and, more importantly, nowadays, the use of dynamic media, like content and other things

Dawn Bitz  4:33  
don right. So I'm Dawn bits. I've been in the medical device industry for the better part of the last, gosh, 29 years. Don't almost want to admit that, because I'm only 29 today. But no so my career, I've really been honored to have a career in the medical device industry. It's really spanned from very large organizations, you know, having opportunities to have leadership roles in businesses that were worth anything from a. Quarter of a billion to half a billion dollar businesses, and really the whole kind of gamut, 510, K, all the way through to p and A being bringing products to market, and really being able to have kind of the entire vantage point. But about nine years ago, I decided to leap to the right side. So all of that's a slight dig to all of my friends who are still in the big company side. But being able to be an entrepreneur and having a footprint either in operationally helping companies grow and kind of navigate this ideation all the way through to commercialization, or being able to be on the board and doing advisory roles.

Ivanny Franklin  5:35  
Sean.

Sean Cheng  5:36  
Great. Hey everyone. Sean Cheng, Managing Director at Ascension Ventures, and I lead the Medtech the life sciences practice. We are a Strategic Fund that focuses on anything that really touches hospitals. Our limited partners are the 13 largest health systems in the US, including ascension, which is the largest covering 150 hospitals and 12 others that are really non profit, IDNs that focus on care delivery. And so innovation is something that's desired, but certainly not a focus for a lot of these systems. And the venture fund that we run is, you know, filling that purpose as well as providing the financial returns we're investing out our fund five, which is 280 5 million, and write checks between five and 15, so slightly later stage, but we really play at all stages. Prior to this, my background is I came from corporate mentoring, leading investments at Phillips ventures as a partner looking at both digital health as well as devices. And prior to that, I had a couple of stints in strategy consulting US FDA as well, and did a PhD focus on the design of medical devices. So before that, valley of death helped launch a couple of companies and eventually end up where I am so based out of Boston, and very happy to look forward to this conversation. Great.

Ivanny Franklin  7:07  
Thanks everyone. And I'm Ivanny Franklin. I'm the global commercial director at NAMSA. Maybe let's start this question is probably geared most towards Adam. But can you speak a little bit to some of the pitfalls and associated timelines with achieving reimbursement in general. I love statistics too. If you want to throw in some of the stats from kind of a pair perspective, FDA perspective as well, and how that overlays, maybe with product development and REG approval as well.

Adam Saltman  7:35  
Okay, so I only have 32 minutes left, but I'll try to make it quick. Yeah. Yeah. I mean, it's an, it's an interesting finding that, especially now that things are changing in the sense that a lot of startup companies are being founded by three smart kids in a garage, right? And they don't know what to do with their product, and they don't know what potential it has. They, they, they're not business people. And so, you know, there are statistics that have been run on companies like that that say that 99 0% of those companies fail. They never actually make it. And so the question is, why, you know, why are they failing? And you're all familiar with, for example, the NSF and the NIH, and they have a program called SBIR, right? You're all familiar with that. So about 10 years ago, they took a look at why 90% of their fundees were failing and all this money was essentially going into nothing. And what they found out was that the number one cause, which struck me as amazing is that there's not a product market match. There's not a product fit match. And so you see, and we see a lot of these people in NAMSA as well. They come to us and they're asking for help, for guidance, and we look at it and say, that's an amazing technology. That's fantastic, but I'm not sure anyone's gonna buy it or pay for it. And so the companies are laser focused on getting through regulatory and that's great. They have to be. But FDA doesn't care if you sell a single product. That's not their job, right? So you get through it. And the first company I worked for when I left FDA was in that situation. They had a product. It was on the market, 510, K cleared, et cetera, and nobody was buying it because they hadn't really gotten reimbursement, so nobody was paying for it. They hadn't gotten clinical adoption, so no physicians were interested in it. So what the NIH did was they set up this I Corps Program, which is kind of like an MBA in seven weeks. But the point is you have to consider all those things and then go out there and figure out, am I on the right track for all these things? And that's really what's not being done. And so when you look at the last statistic I'll give you before I shut up, is that the average company spends 5.7 years almost. Six years between getting FDA marketing authorization and a coverage determination. Now, how many startups do you know can live six years with no revenue? So that's why they're falling into this valley of death, at least most of them. So I'll stop there, and those are the challenges that we see. So

Ivanny Franklin  10:18  
on that note, let's maybe talk about timelines too, because we all recognize startups have to juggle, you know, wear so many hats and juggle so many things, especially in the early stages. So you know how, what advice? Or maybe this is a good question for Dawn, what, what advice would you give for startup companies on when? And I don't want you to say yesterday or but you know, when is too soon or when is too late for startup companies to start the reimbursement strategy piece that they're also juggling. You know, product development, managing burn rate, all of that reg strategy, too. So how you know, what's the suggestion? Or

Dawn Bitz  10:54  
Yeah, so the right answer is, like, two weeks ago, five nights ago, six years ago, right? Just because you know, really what, what Adam just said about how long that it takes. But again, we don't always have that time. However, if you think about and again, we have multiple different hats that we're having to wear. You're having to think about product development. You're having to think about just getting your data and your QMS systems up and running, and working through the regulatory hurdles and clinical hurdles, right? But the earlier you can start to think about the economic story, right? And how do you develop that economic story? Well, there's a lot of different areas, right? You can do your literature analysis, and you can look at the current data that's in the current, you know, peer reviewed publications, and start to build what that economic story looks like that oftentimes, will help inform what you do with your clinical strategies, right? And as you are thinking about your end points, your primary secondary endpoints, your efficacy, your safety and everything that you're navigating to get your data built to be able to not only take it to the FDA, but also to get it on podium in the publications and for commercialization, think about how you can feather in the economic data points that you can start to generate. Then you take on and you look at, you know, data sets that are existing and out there. So who's used medpar? Who knows what medpar is? Okay? Medpar is the Medicare data set, right? And that's, and it's, it's available. It's publicly available. It actually is based off of DRG codes, but it gives you regionalized data. You look at the reimbursements, it can set up that data set can be very, very important for you to take a look at prevalence of your disease, state or where your hospitals are, how much they're getting reimbursed, or how much it's costing them. So you can build both reimbursement or, you know, profit opportunities or cost reduction opportunities for your hospital. Medpar is a great data set, Premier, anybody know, Premier data set, Premier, right? So the Premier is, is really the payers about a, you know, 1000 hospitals IDNs across the country, and they collect all of the data, right? And you can look at hospital trends. You can look at actual costs. You can really start to get granular in those. And when you take the power of those two data sets and you really start to leverage those, you can build really important healthcare economics models. Those, of course, are publishable. So you can start to build really the cost or the reimbursement opportunities or the profit opportunities that that you know your technology could build. Now, of course, that takes time, but it's a very important piece. And again, all of those pieces start to add up when you put them all together. Now you can start to make really important cases for reimbursement, for new CPT codes for new DRG codes for actually end taps and those kinds of things. So those are ways that, again, when you begin with the engine mind. Because really, what do you ultimately need to do? You need to get through the value analysis committees. You need to build compelling Economic and Clinical stories to be able to get your product on, you know, into the supply chain, ready to be ordered, to be able to generate those first orders and then, of course, ongoing orders from there. But how do you start it? You start it with a big end in mind, and you think about how that all gets related. Doesn't have to be individual and different activities, but think about how you can integrate these things across all your actions.

Ivanny Franklin  14:12  
That's great. So let's talk about data. Then a little bit more from you know, how do startups determine what type of data they need? How are they going to get that data? And maybe Prince of me, tech, is that what we're going to how do you, how do you best, 

Dawn Bitz  14:33  
He's kind of dapper, isn't he?

Ivanny Franklin  14:36  
How do you best display data as well? So what type of data, how do they get it? How do you display it, and to which stakeholders, and maybe from an investor point of view. Shawn, you know, What expectations do you have and when? So maybe everybody contribute to that. 

Omar M. Khateeb  14:52  
I'll take the lead on it. I think, you know, from a marketing perspective, you know, we have great tools that are available to our disposal these days. Aside. From just social media, if you think about these llms, like perplexity, chatgpt, and the reason why I mentioned this is because the old way of our industry used to be, Hey, let's go to the conference and see who's up on podium, or just look at the PubMed and who's published the most. And the problem is, if you look at every single, let's say just a regular surgeon, think about every single part of their procedure. Do you not think that there's at least one or two startups trying to embed in that part of that procedure, and then talk to that clinician to say, hey, you should, you know, do a study for us. And so it becomes very, very crowded, and it's very often that you get somebody who isn't fully committed to you, they're they're dating other people at the same time. And so I think what's really important is that to start telling that story earlier on through social media, in terms of the prototyping, some of the things you're doing in the lab, and maybe some early clinical data. For those who get freaked down, they're like, oh, but Omar FDA, the FDA has draft social media guidance. You can read it, or I can just tell you right now, just don't make any stupid claims, like, that's it. And the reason why you want to do that is that it allows you to sort of crowdsource at scale who might be a great clinician to partner with, do these trials for you, and at the same time, take maybe some PubMed data, take people who have published, people who have spoken at conferences, just talk to chat GPT or perplex communities, and feed them this data and say, based on our company, what we're trying to do, who do you think might be a really good early adopter? And you might be very surprised to find somebody that you never heard of, and every single company included including intuitive you know, where Gary guthard spoke this morning, some of their best early adopters, clinical adopters that changed the trajectory of the company. Wasn't somebody that was the chair of surgery at HSS or anything. It's usually some random surgeon that's in private practice or small academic institution no one's ever heard of, and they didn't really involve themselves with industry, but that one company fit a worldview that was resonant with them, and then they adopted it and made that trajectory much, much bigger. 

Adam Saltman  16:53  
I think that also goes beyond clinicians, though, right? I mean, you can get people from all different walks, so you could talk to people have regulatory experience or reimbursement experience, and understand what they would need, or they would want partner with them, etc, 100%

Omar M. Khateeb  17:07  
and I think the other thing to keep in mind is that compared to 20 years ago, when, like, I was in like, high school, and you can just walk up into the hospital, I remember I used to walk into the or or into the surgery center and not announce who I was, and just say, Oh, I'm here to see Dr so and so do surgery. And they're like, Yeah, take some scrubs. You can just sell the doctor right there. But these days, you can't do that. There are other people involved. You think you have to think about nurses, supply chain. And all these people, believe it or not, are online, curating and consuming this information. I had somebody who's the Director of Procurement supply chain for a large surgical center, and he actually came on my show and talked about how he actually checks things out on LinkedIn to learn about new companies and everything. And that's actually one way he decides who he should meet with, because he's able to get that information ahead of time, versus getting a rep or a founder coming in with no background at all, no understanding, and then he has to spend that meeting understanding everything that they're doing. 

Ivanny Franklin  18:02  
So Adam, how do you determine what type of how much data you need, what endpoints you need? You know, from a CMS or a payer perspective versus regulatory because we see sometimes even at NAMSA, sponsors will run a pivotal trial with endpoints to satisfy the regulatory body, and they'll often have to even repeat a study to gather more endpoints, because they didn't consider what clinical endpoint payers might add expectations for. So, you know, how is that kind of determined,

Adam Saltman  18:36  
right? So that is really kind of getting to the bridging of the valley of death thing in the sense that, you know, we telescope that, that gap. And so it's important to understand that the regulators have one audience, and the payers are another, and the clinicians are yet a third. And actually, you brought up value analysis committees too. I mean, that could even be a fourth in there. So really, you have to talk to them. You have to find out what they need, and they're open to these discussions. So, I mean, FDA is very open to it. You can also approach CMS, it's they're a little more resource constrained, but you can certainly talk to them, or try to talk to them, get as much feedback and input as you can. Don't go to them with an open What do I need to do? You're not going to get anything out of that discussion. But if you say, I'm proposing to do this, then they have something to think about, to chew on and give you feedback, and then you can hopefully telescope that as much as possible into as few efforts as possible. So for example, if I'm doing a study that are driven by regulatory evidence for safety and effectiveness, well, can I add one or two or three more endpoints that would cover medical necessity and reasonableness. Now I've covered CNS in the same study as I've covered FDA, so that kind of thinking, and yeah, it might make your study a little bigger. It might take a little more time, but not a whole second study or a third study. And so. Yeah, that's, 

Ivanny Franklin  20:01  
I think the answer is helpful. 

Dawn Bitz  20:02  
and if I can just add a little bit to that, because I think you made really important points, because oftentimes we're cost constrained, we're time constrained, and so you get a little bit myopic in I need to get this amount of sample size in order to get through the FDA. And then, you know, you add in the reimbursement piece. But also, how is that going to resonate on podium? Because, from a commercialization standpoint, you've invested all this money to generate the data. But is it robust enough one to get into peer review journals? Because, of course, that's gold, and that's what you'll need to arm your sales teams ultimately downstream to be able to go and carry your message out with but also, is it compelling so that you're going to want to get your Kol or your PI on podium talking about that data, and as the audience going to appreciate the fact that it is a, you know, a 20 sample patient study, or is it a 75 or 120 patient sample? So again, what is the audience that you're ultimately going to go to, and the specialty of clinicians that you're ultimately trying to get your message to resonate with. Is it compelling? Because, again, if it's not compelling on podium, if it's not compelling in the peer reviewed sort of journal space, but it gets you through the FDA, you're kind of missing the downstream pieces that are going to make you commercially successful. 

Adam Saltman  21:19  
Yeah, I totally agree with that. That's an excellent point 

Dawn Bitz  21:22  
Good, because that would be bad if you disagree with me right on stage.

Ivanny Franklin  21:26  
That never happens in panel. 

Adam Saltman  21:27  
I'd probably have a black eye right now, but the point is, but don't, but be aware of the trap of doing it the other way around, which I see a lot of people doing right they're like, they're almost, they're almost thinking of it as like a research project that they'd go and they publish papers, and then they come to FDA or other other audiences and they say, Well, look, I published these three papers. It's great to publish those papers. Don't get me wrong. I'm not trying to discourage you, but what I'm saying is make sure you think again about the end in mind. And so if you're going to publish in journals, think about I might want to take this data to FDA. It has to be regulatory quality as well, because nobody wants to do these studies. Pay for these studies. You get free journal articles, and then FDA tears them apart, right? So think about that. And if you're early in this, in the development stage, you know, take advantage of like the pre submission discussion pathway, so you can run all these things by FDA and get some feedback, and if they say you're crazy, you know, pay attention to that. And, you know, pivot. So, yeah, I think that that's great, just a trap to be.

Ivanny Franklin  22:33  
Shawn from an investor perspective, at what point in the fundraising cycle. Do you have expectations to see either coding or data or landscape, you know, and what? What's the minimum amount that you're looking for and what? How does that impact your decision making?

Sean Cheng  22:56  
Yeah, I think it's, you know, always depends. And I sit at the juncture of both the hospital side as well as the investor side. So I'll go over both. I think on the investor side, you're really looking for a lens of risk Sprite. So how much can we invest here at the lowest risk profile for a company for the return that we're looking for, and we underwrite that. And what that really means is that the risks that are there is clinical risk going through the FDA, and then there's reimbursement risk, which is the stuff that goes afterwards, and there's probably some value debt there too. And we're at a point, I think, with a lot of funds that are able to take out one or the other, but not both. And so you want to think about it as a operator, well, events with that lens of mind. And there's ways to, I think, you know, plan for and mitigate against that. You know, one is look for, if you're a new innovation, you have a lot of clinical risk. And, you know, the patient recruitment enrollment is going to be hard and expensive, steer the company towards a established reimbursement at the end of at least, just to get started. Then you can expand out from there. You know, Trojan horse, it get, you know, you know, the technology, codes and things like that. If it's a, you know, pretty incremental innovation, which is not wrong. You know, we underwrite that all the time. It's a 510, K, maybe you can take a new, a little bit more risk into an adjacent area and go through a lot of that. And so we, you know, as we make decisions around underwriting, it's a holistic mix of those. And if you're, you know, blinking red on clinical risk and blinking right on reimbursement risk, it's really, really hard for me to champion your company in front of my partners and investment committee. So. So that's how I see it. On the investment side, I think on the hospital side, which is also where we underwrite and do a lot of diligence, we see the speed through vac committees right of your competitive products, I sit on the board of a new product that was just approved last year, and their average through the committee is 40 days. That is whopping. That's amazing. And I've never seen angle like it, and and I remind myself that these things do happen. Miracles do happen if you're innovating and you're, you know, invested on the end of it, but it takes a lot of planning, and it takes a lot of, I think, championing both through things like social media as well as relationship development with KOLs, and, you know, they will then start to pick up momentum. And so I think, you know, looking at things around the value analysis committees and being able to use leading indicators like these champions or clinicians is really, really helpful. Have those conversations with these hospital you know, vac committee members. They're more than willing to talk, actually, and it's very porous in terms of how they think. And so it's not a black box, but it does take a lot of thinking. So all in all, I think, you know, plan ahead as soon as possible and leverage some of those indirect resources, like the vac committee members, as well as thinking about it from a risk point of view is going to be really helpful for getting that check from an investor.

Dawn Bitz  26:36  
And just just to add a little bit about value analysis committees, because, again, I understand, appreciate, have lived right that hole where you're just trying to get your next milestone from a product development and your next pre submission with the FDA. You're just kind of, you're just so myopathy focused. The value analysis committees are such an important, I was not going to say newer, because it has definitely been around for a long time, but you really see, you know, so many products have absolutely a mandate to have to go through value analysis committees. And these value analysis committees are multi disciplinary in the hospital system, so you're going to have, you know, potentially quality members. You've got the kind of bean counter finance people you've got, you know, the clinical advocacy is, you've got risk management, you've got kind of all of these different entities that are looking at your product. And if you can't really continue to make a compelling argument for why a hospital will allow you to get through that, essentially the valley of death at the hospital level, then it doesn't matter how, in so many ways, how much of a champion that physician is or that healthcare provider is that wants your product. If it can't meet the baseline requirements of the value analysis committee, it's not going to get put into the supply chain in the hospital, and it's not going to be able to be ordered. So, you know, don't lose sight of that piece as such an important piece in the healthcare buying process for, you know, really, most, if not all, of the products that we are innovating against today. And think about building the story to be that you're going to be able to convey, and it's going to be a multi disciplinary story. So again, I love the fact that Shawn said, go in and talk to these entities, get an understanding of value analysis committees, especially here a little newer to the space, or maybe you've been an academic, or you've been some doctors that decided that they had some great ideas, because these are important pieces of the supply chain and the buying process to ultimately get your product bought. 

Sean Cheng  28:36  
And, yeah, just one more thing that you know that triggered me was the in going through these vac committees, there's different types of products actually, right? So, you know, I used to assume that it's all about price, and it's like the lowest price you could get. But if you're playing an area where there's not been any innovation for a decade, these stockers are dying to have something to and you could actually get through them. And this particular product that went through 40 day average is one of those where there's been no innovation and the existing product is just terrible, which I think a lot of you guys probably have a narrative for. And in that way, you can actually command speed as well as pricing, which is another huge part that I think merges return on investment as well as the reimbursement side that we don't talk about as much as, how do you go out and price this? And thinking about pricing not to add another element to this is you don't want to train the market, obviously, to be some low price, and that you can't command those margins that then turn into revenue multiples, that then turn into big acquisitions by these strategics. And so you want to think about pricing much earlier, and think about how you want to communicate your value to the vac committees, to the KOLs, and command that pricing that you really deserve, right? And so start that early too. Right? And, you know, maintain that as you're going along. 

Omar M. Khateeb  30:03  
Yeah, Ivanny, just kind of hearing what everybody's saying. You know, I had a thought here. I wanted to share with it. I'm a little off script here, but, you know, when you think about, like, the valley death, there's multiple valleys of deaths in our industry, right? And I always think about, you know, being a startup guy, like every startup, it's like trekking over a mountain like Mount Everest, right? And so if you were to go and scale Mount Everest, you don't just go and do that alone, because you'll die, right? And what do you do? You get, you get a Sherpa, you get a guide. And I think in our industry, a great representation of that is the service providers. You know, you know, for myself. I have a marketing growth agency. We have NAMSA that is clinical. We have a lot of recruiters here. And you know, something that's very special about LSI. I've been coming LSI every year since 2019 I always tell people, unless my wife's giving birth, like I'm gonna be here every every spring, which we try and plan so that the babies are not boring here this time. That's another story. But the reason why I mentioned that, is that I feel like there are too many entrepreneurs that, whether it through ego or fear, they try and do everything themselves. They see this mountain. They're like, Okay, I'm gonna start going out the mountain after I get to, like, base one or two, then I have some money. I'll, you know, go and get some marketing, or I'll talk to NAMSA, or I'll get a recruiter. And that's the wrong thing. The reason why is that, the one thing that I've realized myself as an entrepreneur, the best thing that I did was to shortcut myself and talk to a service provider, even if I can't afford them. And I can guarantee you today, with all the service providers here, if you're an entrepreneur, you don't have the money come to talk to NAMSA, talk trigger, talk to me, and if you can't afford our services, we're not going to say, hey, you know, let me know when you've raised a bunch of money. If that happens, then you should just blacklist that person. But this ecosystem is all about helping each other, and I can guarantee I'm looking out in the crowd like I see Tyler, who's a good friend. He's a recruiter myself. My father was a surgeon, and every year my father taught me that as part of his practice, he was going to do literally free surgery. She would have somebody who comes in cannot afford it, he would take care of the whole story. You're just part of it. And so I can tell you that a lot of service providers here, we're used to that, and we want to help you come and just talk to us early. There's a founder here who could not afford any of the things that we do. We're not my firm is not expensive, but it is pricey. I will say that we found a way to say, hey, like, let's just coach you so that you can do some things for now, and when it's time to come back and you have some funds, then we can help you more as a service provider. Again, whether it's NAMSA recruit or anybody else, we'd rather provide some guidance from now, because I'll give you, I'll tell you, this, the 15 minutes of free guidance we can give you is going to be way more valuable, and, you know, helpful to you, than if you try and go and scale this mountain by yourself. NAMSA has done 1000s, maybe millions, of clinical studies and data points, et cetera. For me, we worked with, you know, not 1000s yet, but many different companies. And so for us to just think very quickly and say, Hey, do X, Y, Z, you'll be fine. It's just like a Sherpa. Maybe you can't afford a Sherpa, but they can. You can call them and say, Hey, like, just avoid this. Like, one area, you'll fall and then when you raise enough money, you can maybe afford to buy a Sherpa that'll just carry you on their back, and, you know, we'll get you to the very top of the mountain. 

Dawn Bitz  33:07  
And it goes beyond just service providers, right? I mean, I'm not a service provider, but, you know, there are people that have been in the industry a long time, and I think because the ecosystem that you mentioned, the fact of the matter is, is that people want to give back to the ecosystem. They want to share their experience. They want to give guidance. They want everybody to succeed. If the water rises with them, then let's rise the water together. And so for me, I love to talk to other entrepreneurs. I love to share insights and thoughts and my experiences. It's an n of one, but guess what? It's an n of one, and there's an n of 1000 out here that can help you and do it for free.

Omar M. Khateeb  33:45  
And I think probably the most important thing to remember is that the reason why we do all of this is that, no offense to some of my sponsors, but like, you know, we're not vertical SaaS industry. We're not selling like marketing software. If this stuff doesn't happen, patients get hurt, they die, you know? And so we'd rather find ways to help each other early on from now, versus for us to have these egos and say, you know, how have the money? Or I just it's not worth the time. I'll figure it out on my own.

Ivanny Franklin  34:10  
I want to make sure we have great feedback everybody. I want to make sure we have some time if there's any questions, otherwise I can keep going. So if anyone does have a question? Let me pause here. We have a microphone. I think we're recording. So, yeah, good. 

Omar M. Khateeb  34:27  
Who's got the first question?

Adam Saltman  34:31  
No questions. They're ready for the test.

Dawn Bitz  34:34  
What does medpar stand for?

Ivanny Franklin  34:37  
So maybe a question for Shawn, when you're doing diligence, how do you pressure test either codes that you see or data that you're reviewing? I know, you know Adam, and I have done some deals on the side and reviewing pitch decks. We'll see some codes, and I'll run it past him and they're inaccurate. I think once even some. On some made up codes. Adam, right? So

We weren't going to say that in public

answers, but how do you pressure test it in your diligence? And yeah,

Sean Cheng  35:09  
I think there's certainly a bit of poker being played there where, you know, you put in some complex codes and letters and numbers. At some point I'll get jolted and say, I don't know. I'll just trust you. ABC four, there's quite a bit of that as well, but to almost point, there's the GPT, LLM engines are there now, and I could type it in and fact check pretty quickly now, and it's certainly using that now in my memos as well as my diligence. So I think we're getting smarter on the whole. And so I think based on that, you know, evolve context, it's, it's really good to be able to show, you know, specific codes, and also evidence on that. And so I think we, you know, investors, we look at one area, and then, like, about half an hour later, we have to shift to something else. And so we never go deeper, but we look for patterns. You know, humans are pattern recognizers, and so we base the pattern recognition on something else. And so there is a, you know, a very familiar pathway, or a reimbursement, you know, call to that and say we're the next Heart flow or we're the next Nova cure. That's really easy for us to get. And I think that's a great path to a narrative that I can then again, take to my investment committee and say they're the next Heart flow or they're the next no cure, and that's a really easy conversation for everybody to get. I think the harder thing is, if you're in a completely new field, and you're trying to build this, you know, value creation proof, you know, it's a really, really complex thing to tell the story, and I have to tell a story, is the only thing I can probably say as a takeaway. So help me tell that story to my partners and Investment Committee.

Ivanny Franklin  37:04  
How about maybe Dawn and Adam? How about communicating with regulatory bodies and payers in CMS? You know, are Is it good advice to include any questions like that in the pre submission Do you are there avenues to communicate directly with CMS? Do you suggest going directly to payers? How you know, in terms of kind of communicating? What are some best practices? There go first.

Adam Saltman  37:37  
Yeah, I think that you know what FDA has in place right now in the pre submission program is kind of unique. It's not available in many other geographies, and so, so the idea that you can go to them with a proposal, say, this is where, how I plan to go to market, this is what I plan to claim, this is the evidence I'm going to generate. And then getting your feedback on that is invaluable. I think you know that program is available. It's a little bit slow. It takes about 70 days right to get your written feedback, and by the way, I'm not seeing any delay in that, considering what has recently happened to FDA staffing. So I just wanted to get that out, because I know a lot of people have questions about that. In terms of CMS and payers, it's a little more of a black box to be honest with you. They if you're doing a high risk study, and you need an investigational device exemption. You will have to get an IDE through CMS for them to take that data for payment. But there's a lot of other devices that are not significant risk, and they just ignore CMS at their pera. So if you can get in front of them and say, Look, this is the trial I'm going to run, will this provide you with the evidence you need? Getting their feedback will be also super helpful. So try to work with them. I think the harder ones are the last audience I'll finish up real quick, which is really the clinical audience. And what do I mean by that? It's going to be like if you're in the cardiology space, go to the HA, you know, go to the heart failure society, or whatever you're working in. They have innovation working groups, every single one of them, and talk to them, get in front of them, present to them, you know, and get their input on what they're going to want to see you do to get like in the guidelines of care, right? That's the Holy Grail. Get into the guidelines of care. So anyway, hope that answered your question, but I would definitely go for them. 

Dawn Bitz  39:10  
Just one question for you. For them, just one question for you. So investigational versus experimental, when you're filing that sort of CMS with your IDE, you want to speak to that. For these guys, show that one more time, investigational versus experimental. So if you're developing your clinical trial, you're working through your IDE, you know, ideally, there's a way for you to get reimbursement through Medicare and the payers and I, as you know, again, my, in my experience, the difference between experimental and investigational are very important distinctions, and whether or not you might get reimbursement for your procedure versus when versus not even in your IDE.

Adam Saltman  39:57  
So experimental, no payment. 

Dawn Bitz  39:59  
Correct. 

Adam Saltman  40:00  
That is just the way it is. And so that is the default go to.

Dawn Bitz  40:04  
So you're paying for all every single expense that you incur with that clinical trial, because there's no and the hospital is not going to pay for it, so CMS isn't going to pay for it. Then guess who pays for it? He does. He does. But you gotta raise the money and then invest investigational,

Adam Saltman  40:24  
yeah. So investigational, you have to have that designation as investigational. So you need to go to that whoever that audience is, the FDA, CMS, whatever, and get an investigational designation for your product. Then they have actual coverage pathways for you, and it depends on whether you're inpatient, outpatient, how much you cost, etc. But, and there's also coverage for evidence generation, there's a whole pathway to do that. They'll cover you for three years while you do your study, so you need to get investigational. Thank you for prompting that. 

Dawn Bitz  40:55  
I wanted to bring that up before we ran out. 

Ivanny Franklin  40:56  
Yeah. Well, thank you. Well, let's give these guys a round of applause, we're at time, but thank you all. Thank you.