Unseen Risks, Unlocked Value: Quantifying Regulatory and Reimbursement Barriers in Medtech Investment | LSI Europe '25

Timothy Still  0:05  
All right, welcome. It is my pleasure to be the moderator here for unseen risks and unlocked value some of the regulatory and reimbursement barriers and med tech investment, and for those of you that might have been part of the morning session. I was actually on the panel for commercialization across continents, and what you're probably going to hear in the next few minutes is that one of my main focal points in giving advice to folks is to not disregard the importance of regulatory and reimbursement in your commercialization strategy. So by means of background, I'm Tim Still I'm an operating advisor with revival healthcare. I have been in med tech for over 35 years now. I have been an operator and a CEO a handful of times. I've had a few exits along the way, and now I have been more of an investor. I'm wearing an investor hat with revival, and I'm sitting on a couple boards. So I'm hoping to give you some some good questions from the standpoint of an operator and how this is important. So I'll turn it over to James for an introduction. We'll go from there.

James Pink  1:15  
Hi, I'm James pink, 27 years in regulatory and product safety. I'm a technical expert with RegNav and now a managing partner at James Pink Advisory Services. I advise on regulatory strategy across all jurisdictions, so global jurisdictions like you've just mentioned that in with the commercial side, and we founded regulatory navigation tools. So reg nav is short for regulatory navigation, hopefully sort of helping organizations understand what sort of pathway they have into the market. So thank you.

Tonya Dowd  1:56  
Thank you. Hi everyone. Tonya Dowd, Executive Vice President of reimbursement health economics and market access at PRIA healthcare. I have been in the reimbursement health policy space for about 30 years. So I started when I was five. We always kind of joke about that, but I have really focused on helping innovators early on, ideally bringing their technologies to market, understanding the stakeholders, the value proposition for the product, developing the reimbursement strategy, but I think most importantly, taking clients through the process of establishing the reimbursement and market access plans and market adoption. I spent about 12 and a half years at Johnson and Johnson in two different capacities, one of them being a part of the reimbursement team representing the acquisition and due diligence team for potential acquisitions and products. And also have consulted for over 15 years for two other consulting companies that were both acquired. And I went PRIA healthcare as the executive and we really provide that full service market access and reimbursement planning, early planning, and then again, that strategic execution throughout the product life cycle. PRIA is a 13 year old company, and we do, again, the full services of everything from early ideation, understanding the market, developing the reimbursement strategy and executing it through commercialization. That's really great to be here on this panel.

Timothy Still  3:26  
Great. So what we're going to try to do in the next few minutes is to try to focus on really strategic readiness and how to prioritize market and based on on that from a regulatory and reimbursement standpoint, how does that tie into the investment side of things? And so please ask ask questions along the way. So I'd like to start off with a question that often gets gets asked, What regulatory and reimbursement readiness is truly required before market entry? Where does a company really need to be as far as what stage before they're ready to go into a market? And we could maybe start actually going to start with Tonya, yeah,

Tonya Dowd  4:10  
you never, it's new. Never too early to start the reimbursement and market access strategy and think about that. And I always tell clients and advise clients to start even in the R and D phase, because that impacts your downstream market access and reimbursement plan and your regulatory strategy can impact that and vice versa. So starting early, understanding what the challenges are and the risks are is critical, and I kind of use the analogy of a marathon. I don't know if anybody is a marathon runner in here. I used to run half marathons. But would it be? Would you advise training, starting to train for a marathon the day before or early on? And I think we would all agree that early on is important, because it is really a marathon to get your product to market, to establish the reimbursement and really, ultimately, the market adoption. So the sooner, the better. Sure, just kind of giving one very specific example of how the regulatory strategy can impact the reimbursement strategy and considerations thereof, is if you have breakthrough designation in the US with FDA, you have reimbursement benefits actually. So really making sure that you understand those and what that means for your product are important. And then looking at again, just kind of the perspective of FDA and payers and stakeholders who are going to be using the product, the FDA, from their perspective, they're looking at the device. How does the device? Is the device safe and effective for a very broad patient population, typically, whereas the payers and other stakeholders who are going to be using the product are looking at, how does that device impact clinical and economic outcomes for a very specific patient population? And those are two very, very different perspectives that require different planning and evidence generation strategies.

Timothy Still  5:59  
So Tonya, with that, before we turn it over to you, talk to us a little bit about how important it is to get the right data up front. What have you seen with with companies that have maybe done it the wrong way, and companies that have done a very good job of getting the right data, the right clinical data right up front?

Tonya Dowd  6:18  
Yeah, and there's a great question. And I think the the, you know, the thought is, from a lot of companies, is the data stops. The data acquisition and evidence generation stops after FDA. And if we think about the FDA, the different FDA regulatory pathways, a, 510, K requires no data, essentially right with a predicate requires no data. DeNova requires some. PMA requires data. But with respect to the payers, again, going back to those different perspectives, the payers and the users of the product, the data, the evidence bar is much, much higher because they don't want the promise. They want the proof of whether or not the technology is impacting, again, patient outcomes. So I think starting early and understanding what that market access strategy is, again, very early on, that's going to help you with your evidence generation plan. And I think most importantly, really provide a realistic expectation in terms of the raise that you need, the money you need, the capital you need, and you're going to need to really execute on that evidence plan. I've worked just kind of looking at best practices, and we, I think everybody was here maybe for the hartflow example A few days ago. I worked with HART flow many years ago, and their motto was, we are going to really conquer and we're going to establish the right evidence, and really, you know, go to the market with with a substantial amount of evidence, and they have been quite successful because that's exactly what they did. I also worked for a company, glaucos. They're in the ophthalmology space. They created their own benefit category. Essentially, we started working with them on reimbursement strategy when they were developing the product very early on. They are successful in the market. They've been in the market for many, many years. But again, understanding that evidence plan and the capital you're going to need to execute it is so critical for the market adoption.

Timothy Still  8:17  
James, some from your your vantage point, what readiness does a company need to be at before they could really start, start down this path,

James Pink  8:25  
I think, basically just being aware of the regulatory environment that they're going to face. I mean, ultimately, that can be completely different just by changing where you're going to go in terms of a clinical pathway. So with what Tonya was saying, you know, I would always say, do the reimbursement thoughts and how you're going to commercialize a product first, because then that aligns you to a clinical pathway, a diagnostic pathway. It aligns you with a payer. Ultimately, the end goal that everybody wants is for these products to be adopted and used as often as they can be in an optimized way. So I guess the awareness is right, okay, if you now know where you want to go, and it's not necessarily in the US market, it could be various other markets as well. Most people now are beginning to think that the US is, that's the panacea, that's where all the money, that's, you know, that's so the traction is a little less, sort of, you know, ruthless as it used to be, for example. And so everything becomes a little bit too easy. So you get hubris. You get, like a regulatory hubris. There might be many of you in here who've invented products. You're very clever people. You all know what you're talking about. And strangely enough, regulations I can read. And in fact, I think you know, ultimately, everyone can chat GPT the hell out of it now as well and say, Oh, that's the that's the pathway. So first off is become aware of exactly what your target is. Unfortunately, many you. Startups, if you wish, or organizations who are going through different rounds of funding ultimately want to end up in a different some might want to be acquired by big organizations. Does that mean that you've got to have a huge amount of reimbursement commercialization that might be taken over by the big cos? But that therefore means that the 510, K pathway is okay, for example. But I think for me, awareness first, do you really know where you're going, what the target is, and very, very small, like a racing car, very small sort of variations can completely crash the whole thing. And that's the same with your intended purpose. It's the same with the clinical sort of groups that you wish, you wish to go for, and then the next is knowledge, because we need you to become aware that there are some bumps in the road. It's not easy. Regulation is not easy. Saying 510, k is not easy. It's about understanding what will be the things that trip my strategy very, very quickly, and I think on the knowledge side, then it's sort of engaging an ecosystem of people who understand the regulatory implications for that clinical intended purpose, right?

Tonya Dowd  11:16  
And even just to add on to that, understanding the strategic intent of your product, what is, what is your product really going to do? Is it changing care pathways? Is it going to make the process harder for physicians? Is are they going to be reluctant to adopt it? Because they might have to have they might have to change their behavior. What are their incentives and dis incentives to use the product don't make assumptions, and don't rely, unfortunately, on your friends and family, the sab that you might that you know we're paying a consulting fee for you want to get devil's advocate perspective, and you want to really do that primary research and understand the behavior change of the stakeholders who are going to be using your product. And take a take time to do that. And in the US, we have a very, very fragmented system. You've seen one hospital system and how it runs, and you've pretty much seen one hospital system and how it runs, but understanding how those physicians are incentivized, how the hospitals are incentivized, or your end stakeholder, and do that research. Take the time to do it, spend the resources, hire the right people to actually help you with that effort.

Timothy Still  12:26  
So it's, it's very interesting to hear them talk through these these points. And the perspective that I like to offer you is that from an operator standpoint, I've, I've been doing this for a handful of years, and the level of sophistication that you have to have for reimbursement and regulatory and the strategy is light years farther down the path than where it used to be. Long gone are the days where you could go out there to try to raise capital and say, This is the market I'm going to first because it has the most people, and that means is the biggest market opportunity. So what investors are now looking for is a strategy. What is the strategy of the management team? Where do they want to go when I put that investment dollar in, because you can't go to every market equally at the same time. So what I'd like to now ask the panel is, how do you identify the first international market to go after? Give a perspective on what you have seen from your your expertise, because, from an operator standpoint, I have seen companies change their plan based on how easy it is to get regulatory approval or reimbursement. Maybe we could start with you.

Tonya Dowd  13:42  
Yeah, and I'll just focus on the US market. And one thing you said about the total addressable market versus the serviceable addressable market, that's what you need to really understand. So really start peeling back the onion. What is the indication I mentioned before, who is the specific patient population that's going to benefit from your technology? Start peeling back then. I mean, understand the payer mix. And again, this is us focused. Are we talking about Medicare, Medicaid, commercial payers? What is the patient demographic again? What are the current care pathways that exist for these patients? So really, getting down to this isn't a you know, this not just looking at the holistic, you know, total addressable market, which is a great sound bite, but investors want to know really, where, what service, what is the serviceable addressable market? And how are you really going to bring that product to market? What is your plan and strategy and and they want a detailed plan. They don't want kind of pie in the sky. And we work with a lot of investors as well at PRIA who come to us to validate the market access and reimbursement plan for their potential investments.

James Pink  14:51  
Yeah, I agree. I think, I think that on the US market, what I've seen a number of times is companies almost just check the box and say, Oh, it's subset. To the equivalent the route. So, you know, we've got a consultancy involved. They're going to build, as a file, a submission. We, we did a Q sub. You know, there's a bit of due diligence. But the realities are is, how can you say that your device is substantially equivalent to another one in the market, and then expect to think you're going to get product market fit? It's, it's, it doesn't make any sense. Because why would a clinician, why would a health care system change what they're doing with an with just another technology that's not as well established? So you already got this dichotomy of, it's a contradiction in terms. It's substantially equivalent, but it's really different. And that's that that you can't have that, that you can't have that dichotomy. It doesn't it's a really precise calculus of what is the reimbursement, what is the clinical strategy, and then how does the regulatory strategy fit around it,

Tonya Dowd  15:54  
and then just kind of tagging on to that, the features and benefits, and taking those features and benefits and identifying, again, how that's impacting patient care. But to say that you want to be substantially equivalent, use a predicate, but then you want a premium price. So if you're saying you're the same on one side of your mouth, but you're kind of coming out of the other that I want a premium price, well, why? You know? Why is that? What is, what makes you work? What is the value proposition and proof that your technology is bet as as good as or better for the market.

James Pink  16:26  
Yeah, it's a calculus, not an arithmetic. Reimbursement strategy tick. Now, regulatory strategy tick. It doesn't work like that. You know. It doesn't work like that. You know, successful companies that get adopted and get market traction, it's because they've thought about the very, very precise sort of levers that they have to move in order to get this product into the market.

Timothy Still  16:49  
So as as an operator, and you're trying to figure out that best path forward, how do you prioritize markets? Is it? Do you start with regulatory approval, or do you start with reimbursement approval? Because if you look at the landscape for payers just in the US, it is a hornet's nest, and the process takes a long period of time, and if you do that versus the regulatory path, they might not line up. So if you're going to an operator and give him advice, from what you have seen in your vantage point, do you start with regulatory, or do you start with reimbursement?

James Pink  17:30  
Both, I'm not if I was a consultant and I wanted to make a lot of money out of somebody, I'd say, let's do the regulatory, because if you find out what you really need to do reimbursement, you'll be shit scared, and you'll not you'll not want to come near the regulatory pathway. So for me, it's more like get your stuff together in terms of how you want to get this into clinical hands and get the clinical benefit and the positive impact on patient management, and then we'll work out what the strategy is and the optimal regions to do that, whether it's you know, you've got to, if it's a novel claim, you need really good clinical data. If you need clinical data, you need recruitment. If you need recruitment, you need to look at which areas, which geographies are going to enable that. You might have in the UK, for example, we have the idap pathway you might have in Germany, you've got for digital health products that might be, you might be going into those markets, because you're getting a richer source of information data, and then that's where we can go with the reg strategy. But if I'm a transactional consultancy that's delivering regulatory strategies, I'm going to say, no, no, come here first because, and then we'll say it's a 510 k, and if you keep your claims really, really, really, really, you know, bound and generic, then you're going to get that 510, K, yeah, and then Tonya, you're going to sit there and think, What the hell has just happened?

Tonya Dowd  18:47  
Well, I think this is we had a conversation yesterday about, you know, who are the right what criteria do you use to hire the right consultants or personnel to actually do your regulatory and reimbursement strategy? And I would say that it's not an it should not be an academic exercise. It is a it is a pragmatic you need to find somebody that has a pragmatic approach that can actually take you through the process after the strategy is developed. And that's really, really, really hard to do, but having an individual who has experience, who can draw from that experience, and who can provide the practical, you know, the practical consultation and what you need to do, and then take you through that process, because it is iterative. It is choppy. It is like this. It is not linear. We have a lot of clients that come to us and and want to know, and this is their exact question, after I go to fda, what do I need to submit to CMS to then get reimbursement? Well, CMS might not even be part of the equation, to be honest. So you know, it's not a it's not a stagnant, one step or two step process. It is an iterative process, and reimbursement is all about your commercialization. Plan. That's what it is. It's your commercialization plan. So if you, you know you don't have a cogent commercialization plan, I don't think Tim is going to invest in you, right, right? Wouldn't that be that's important. So, so having, having and on the regulatory side, having an individual regulatory consultant who understands that, ran that reimbursements, at least Ben understands it, maybe to the level I do, but he has an appreciation for how that strategy impacts the regulatory plan is it's so important. And at my previous organization, we had, we worked very closely with our regulatory team. And even at PRIA, we have great outside counsel that we work with on the regulatory front, and we are collaborating for our clients together and and it is, it's a partnership approach, but really finding individuals who are experienced and can appreciate kind of, both sides and everything that really the holistically that goes into bringing a product to market.

James Pink  20:54  
And it is, I mean, everyone's you're looking at milestones. Where do you want to go? You know, I'd love to climb Mount Everest. It's be amazing. And I'm sure, you know, I could go online right now, and I could find somebody who can actually probably fly a helicopter up there, if it's allowed, and it'll cost me goodness knows how much money to get there, but they can get me there by hook or by club. But you know, if I've only got a certain amount of cash, a certain amount of investment, and I've got these priorities and milestones. I want to know people who've walked those paths, who understand what the trail looks like, understands what sort of you know, crocodiles, alligators, bears, or whatever's in the in the woods, you know, and ultimately, the navigation and the awareness of this calculus of clinical reimbursement, regulatory, safety, and then, of course, just the business structure, and understanding that that calculus of all those weird and wonderful makeup is is what we need to see whole team,

Tonya Dowd  21:55  
and understanding the why of what you're why you're doing something. We have clients that come to us. And, you know, ask, well, go, we need to go get a code. Go get us a code. No, we need to first understand the why and align on what that means. And I would say, don't use chat GPT as your consultants.

James Pink  22:13  
Well, like I said in that, they were in the corridor, we were talking about this earlier, and there's people in the corridor pitching and just going, Yeah, I reimbursement code for that. I've got the 510, K for that. It's tick, tick. And you're going, Oh, you're nuts. You know, ultimately, tell us about what your concerns are. Tell us what you don't know, and the things that you're trying to discover, what you know that's showing awareness. And that means that you're commercially ready, because you're prepared. You know, it's a long haul. It's a marathon. I've started the training. I didn't realize how hard it was. And it's, you know that those type of things move from awareness to knowledge, and then you start to create plans that are synthesized, that are going to be successful.

Timothy Still  22:57  
And I have to say that that this is just further evidence that you have to have this level of sophistication in your commercialization strategy if you want to be successful in raising capital. Medtech investment today is much different than it was 1015, years ago, and many of the people that are now on the investor side are ex operators, and we've lived the life of regulatory challenges, reimbursement denials. We know what it takes. We also know that both of these things can stop your business. It can put you out of business if it's not planned for so as companies come to LSI, and they come and they look at raising capital, one of the questions that that does come up quite a number of times is, do we go deep, or do we go broad? Do we try to go deep with reimbursement, regulatory in one particular market, or do we go broad and we go Europe wide? Do we go into Asia? And that's that's one that gets asked at every LSI meeting that I had been at and asked, from my perspective, we all had different opinions. But what I'd like to do is hear from both Tonya and James their their vantage point on all the people that they talk to, and which you would recommend, is it better to go deeper or better to go a little broad,

James Pink  24:22  
Oh, good grief, it's an ethics dilemma, then, isn't it? Because there's utilitarianism going on and people saying, I want to make as much money as I possibly can, and that means that I achieve these sort of outcomes, and therefore I get my, what they call it, earn out, or what do you exit? I get my exit, right? You know? And it's like, okay, well, if you're utilitarian, I'm not going to deal with you, you're done, you know, because you haven't got a why you're not in there to change healthcare. If you're in medical devices, you're here to impact positively humans and their health and their lives. So the broad is. Seems a bit nuts to me. It seems utilitarian from a deontology perspective, you know, a universal set of doing the right thing, having the right values, knowing that if you know, really believing in your product, really believing in the patient, that is going to get that positive impact, you know, now we're into something that we can deal with, you know, and we'll work with you. We'll work just as hard side by side to get you where you want to be. And that is, that's, I mean, Michael, who was going to be on this panel, that's exactly what he's about. It's, it's ultimately believable you want to impact that. And I think that has a marked effect on knowledgeable, Sage investors, rather than those that just think this guy or this girl's here for the earn out, you know, just for the exit, right?

Timothy Still  25:48  
And before we get Tonya, I can offer that I've literally been in a presentation where a founder was pitching about how they were going to bring a product to Germany, and it just so happened to be in an area that I was very familiar with, and I asked them what their plans were for regulatory and reimbursement, and they gave a very canned answer. And the truth of the matter was that product was not reimbursed in Germany. It had never been reimbursed in Germany, and it was going to be years of effort before it was reimbursed in Germany. So instantly, the credibility of that founder who was looking to raise, raise capital. It took a shot. So, so let's go to Tonya now to hear some more.

Tonya Dowd  26:30  
I couldn't agree more. Go, go focused and deep. It goes back to that TAM versus Sam right principle, going focused and understanding, you're gonna learn a lot. And, you know, as you launch, and take those learnings and then apply them to other markets, and I would say, in the US, even just regionally and geographically, every state runs, runs a little bit differently. And so really going deep, doing a limited launch when you first commercialize, because you can, you know, you there's a lot of learnings that are going to happen, and then continue to take it broader. That would be my recommended approach from my perspective. So go deep.

Timothy Still  27:10  
Okay, and can, can you maybe also offer group some of the key differences in between the US and Europe and Asia, because those, those tend to be kind of the big three buckets that people look at. And what are some of the different challenges there? One that I found out through through years of trying to get it done in Europe is, obviously, every country is different, and you need to have clinical evidence in that particular locale, but, but maybe spend a little bit of time with some some thoughts around that, yeah, and US, Europe and Asia.

Tonya Dowd  27:46  
Yeah, I've done some work in Europe when I was at J and J, and I would say the different a reimbursement perspective, specifically in market access, really understanding the system, right? And we have a lot, we have a lot of innovators who come to PRIA, and their value proposition is, I'm going to save the system money. Well, there is no system in the US. There's no, there's no system to be honest, right? There are multiple systems. And this is going to sound probably insane when I say this, but please bear with me, different than in let's say the NHS, or even the Franz Haas system, Haas, where that's the health technology assessment group. It's all about economic value, right? Economic Value Proposition in the US, if, in fact, you have a technology that you are is applies to a new technology, add on payment, let's say, and I'm not going to get into too much detail, the reason that CMS, the Centers for Medicare and Medicaid Services, has established alternative pathways, like an N tap, is based on cost additive. So your technology needs to be more costly than the DRG. This the payment system. It's it would fit a payment category it would fit into. And that is a way that's their way to incentivize hospitals to adopt your technology for a certain period of time until they know what payment category it should be in. So, so there's that's significant difference. Now CMS doesn't look at cost effectiveness when they make coverage decisions. However, the Medicare Advantage plans, which are commercial payers, do care about that. So that's where I'm talking about. The fragmentation. There is no system the only closed there are two closed systems, I would say, in the US Kaiser and the VA and that's it. But it is not. It is a potpourri of varied incentives and disincentives across, you know, across every state. And again, it goes back to, not to go deep, but it goes back to, as I'm talking, right? You can see looking at the patient population, if you have a technology that's. Specific for women or children. You're going to really need to understand Medicaid. Medicaid is the insurer for the indigent patient population. Okay, and every state runs their Medicaid program differently. So, so this is where you again, peeling back the onion, understanding details of your strategy, your patient population, your evidence generation needs, your your stakeholders, your physicians, who's going to use it? It all of these things really matter. So hopefully that's, I think, helpful, just from a broad perspective. But the way things you know, and every country in the in in Europe, is different. Every single country runs it different. And in Asia, Japan has a very, very difficult system to, you know, to get a product into from a reimbursement standpoint, definitely, right. So every system, every every country, is different, I would say again, going back to the experts, find the experts, especially in the US. Find the experts that know us. We at PRIA work with it with with a partner group. They do market access in the in Europe, yeah, and they have experts in every country. I don't claim to be an expert. I wouldn't want to do your reimbursement and market access strategy, but I know who we can. We can help you,

Timothy Still  31:14  
James, maybe little bit more from a Europe step standpoint that you could offer

James Pink  31:19  
that just blew my mind. We're putting Asia pack in there, and yes, and Europe, the old cogs are ticking now, I think it depends on how many ceremonies you want. So if you like champagne, sort of celebrations when you've got your 510 k, or you want another celebration when you've got your reimbursement code, or celebrate that someone's chucked in another 10 million or whatever, then ultimately you'll just pick whichever path of least resistance you think it is, which, of course, in regulatory systems, you've got what we call proportionality systems and precautionary ones. So in the US, it's not even proportionate anymore. It's pretty much open. If you want an AI system out in the market. It's there. What's great about the US, though, is that they'll sue the hell out of you if it's if it fails, and that's a really lucid understanding about what's going to happen to you. So they're giving you a lot of rope, basically, so you can keep that rope. And if you've not got a good reimbursement strategy, if you've not got a good product safety strategy. If you've not got a good business structure, then it will unfold at some point. So you'll have the champagne celebrations and then the massive hangover afterwards. The issue with the European system is it's highly precautionary at this moment in all in all contexts. So it's harder to get to but it's probably not as hard when you then start to think about how to commercialize and actually get the products adopted, because if you've got your calculus worked out, then you're probably going to arrive at a market that will adopt and pay for that adoption, probably faster in some instances. So you're in this situation now where you think, Okay, well, let's weigh those options up. That's not in all therapies, by the way, because it depends on whether or not there is, you know, an incumbent that quite simply won't be shifted in Asia Park, and in particular China, it's really fascinating at the moment with everything that's been done, because I kind of sometimes think that China just watches what's going on? And goes, holy crap. You guys are nuts. You've gone highly precautionary. Oh my God, you've guys have given a lot of rope to hang yourselves with. Let's just try and create an innovation environment that is balanced, and so you start to see this balance. But it's in my experience with working with companies that want to go into sort of Asia Park, the partnerships and collaborations and the business know how, and corporate know how, becomes a much higher demand. So it sort of moves then into, let's now work out how we can get institutional investment in those areas. We're going to have to build within, you know, geographically, build things there. We're going to have to do that. But I think the incentives at the moment on innovation in China, for example, is fascinating because and in Southeast Asia, because they're wanting to say, let's not rely on us products. Let's not rely on European products. Let's actually have, I think they met, they put a target in 2030 So correct me. If I'm wrong, don't anyone Google this. But I think it's something like 85 to 90% of all products in the market will be innovated from within China itself. And that still creates an opportunity, because the innovation doesn't necessarily mean the idea and the IP was established there. It just means that the company is now operating with Chinese labeled approved products, and therefore you've got this wonderful sweet shop sort of environment where you can go, do you know what I'm going to do this? It just depends on how deep your pockets are and what. Taste Buds alike,

Timothy Still  35:01  
right, right. So we're down to a couple minutes left, and what we want to do is is answer any questions that a few of you might might have. If you have any particular question that would like to ask the panel, we'd be more than happy to answer that. And if, if not, then I'm going to put the panelists on the spot and ask them for their last words of advice, any questions that folk folks have that we haven't covered, don't be shy. So I'll start off with my closing comments, just just from the standpoint of the operator slash investor. It's never too early to get regulatory and reimbursement involved, and an effective leader is someone who realizes the skill set that they don't have and they don't know, and is able to bring in the talent around them, and boy, I wish that I had the services that are available now outside of the company, that you could draw upon and get that expertise. So my advice to the group, as far as you know, really knocking down the barriers to getting that investment, it's get the right expertise in and get market access figured out early. Maybe we'll go to you next, and then we'll figure on,

James Pink  36:14  
yeah, I think that. I completely concur. I think it's, it's working with people who've trodden that path, and literally just listening to the bumps and the bruises and just avoid the arithmetic and the hubris that that creates when you sat there saying, Oh, I've got all these ticks in the box over the regulatory, you know, reimbursement stuff, and recognize it's a calculus, because if it's too good to be true, it's probably not, etc, so ultimately, just work on that basis. Don't have hubris in bringing a medical device to this market, any to any market. You can't do it. Despite being so smart, don't don't have it.

Tonya Dowd  36:56  
I have a Gosh, a lot of things to say, but I'll just sum it up really quickly, and I would say, again, understand your market. Understand the landscape. One of the, one of the key points I do want to make is we didn't talk much about it, but don't, don't go on chat, GPT or Google and identify a code, and then that's your reimbursement. And make that your reimbursement strategy. I call it code shopping. I actually coined that, that term. I have a webinar on it. So if you look, if you do Google it, you'll find it. But a code is simply an identifier that may or may not identify your technology and if, if it's going to be payable, right? So if it's going to be payable, you can have a code all day long and identifies a payment amount, but it might not be considered to be medically necessary and backed by evidence. So that's one thing I'll say, is the investors, the sophisticated investors like Tim and that cohort, see right through that if you throw up a code on a slide, and that's my reimbursements, that my reimbursement strategy, that's my commercialization plan, that's not gonna fly, not gonna work. Not gonna fly, no. And, you know, again, not underestimating, really, the the this, the early planning that needs to happen. And this is not a multi million dollar engagement, but really, you know, it's it. We start when and when work with companies like prio, who can be flexible. We understand, you know, we understand that funding is limited, oftentimes with early, especially early stage companies, but working with credible consultants who, again, are taking a pragmatic approach, not just going to do something because they can, and you don't understand the why. So really, really working with somebody who's going to be a partner with you in the for the long haul. And again, it's never too early. I always say this never too early to start.

Timothy Still  38:46  
So thank you for your time. We've got 25 seconds to spare, if there's no further questions, we wish you a good afternoon. Thank you so much. 

Tonya Dowd  38:46  
Thanks everyone.