So, welcome everyone to this Global Innovation Roundtable. My name is Prash Sanders from the University of Adelaide in Australia, and I'm joined by an esteemed panel that I'm going to get them to introduce themselves, clinicians, venture capitalists, industry, and also regulators, to provide us a neat insight into where the intersection between healthcare, innovation, and the global impact, and so we're going to have a discussion around this. We might go around, and I'll get each panelist to really present what they've done, and their lens through which they're seeing this problem, so that we can then have some discussion around that. So, Stephen, do you want to take it off? Yeah, so I'm Stephen Browning. I don't know if I can present on what I've done. I'm a federal regulator. I work for the FDA. My team regulates hemodynamic and heart failure diagnostics, so a lot of the sort of AI machine learning type stuff, trying to identify conditions earlier. I've been at the agency for about 12 years now. Okay, hello. I'm Lia Tzoref. I've been with Biosys WebSurf in the last five years. I should say J&J MedTech now. In my background, I'm a physicist. I hold a PhD in physics, and in my role, I'm responsible for AI and digital activities, as well as R&D collaborations. Hey, can you hear me? All right, Tom Osborne. I'm chief medical officer at Microsoft Federal, and before that, I was in government. Before that, I was in industry, and so how it relates to some of the things we're talking about, I think what's really exciting about the work that we do in the United States in all the different domains that we're in is when we innovate here and we're successful, that the tools, especially the digital tools that are scalable, can have profound impact around the world. Giovanni. Hi. Hi, I'm Giovanni Leo. I'm an engineer by education. I'm coming from Switzerland, Geneva, where I'm a partner in a fund for venture capital named Lake Geneva Ventures. Before that, I was an entrepreneur. I have created or co-founded a number of companies, among them Endosense and Abamed in the field of cardiology. I'm here, and thank you for inviting me. Deepak. Hi, I'm Deepak. I'm a cardiac electrophysiologist out of Bangalore. I'm also the mentor for the Indian Institute of Technology Biodesign program, and I trained at Mayo, and I'm back in India. Jeannie, would you like to introduce yourself? Hi, everybody. I'm Jeannie Poole, University of Washington electrophysiologist, and I guess that's all I need to say. It's great to be here. And Nasir, you're a lucky lass. Nasir Maroosh, Tulane University, electrophysiologist. I just trained with Jeannie, by the way, a little bit, a couple of months, and a good friend of Prash. So, we're talking about innovation on a global sense, and we've had a lot that's occurred in the electrophysiology space. And so, what I'm keen for people to do is to talk about what excites you the most about the innovation we've had, and what concerns you the most in terms of this. Nasir, do you want to start on this? Because, you know, you've been pushing the boundaries in terms of AI and the research and how to define new things. It may be a useful thing for you to have something. Yeah, for innovation in medicine, we are in a great time. In a great time and a great field, both of us, cardiac electrophysiology. We were the innovators back then, and now we continue to be leading the way, to be honest, in terms of everything we do. And you see the people sitting on this table. In EP, it's always computer, analytics. AI has been there for us a while without us knowing about it, so it's become handy for us to be. In the last 24 years, especially since we are doing EFL ablation, we start looking for the latest, making our procedure better and faster and safer. And you can tell in the last 24 years, and maybe hundreds of billions of dollars later, maybe it's too much, hundreds of billions, but you can tell what that means. But we are in a great place. So, the challenge we have today, since I spent the time with Jeannie Poole, and I talk about this all the time, not because she's sitting at a table, but in 1996 with Gus Barry and Jeannie. And you know Gus is in that room when he was building SCADHEFT and you. Innovation was, he was inventing the next ICDs and defibrillators and so on. You think, I was thinking, what's the next big thing? What can we make our research a product that can be scaled and moved on and be given to anybody else to make medicine easier and faster? The challenge we're facing today, everybody in medicine, every physician, every fellow, thinks they are innovators and want to do discovery, which is great. But the research that we're building and putting together, it's always people think about this as the first goal in their head. How can we make that a product? The mentality changed a lot in the last 24 years, or in the last 30 years, since I was a fellow, a student. If you ask me, that's my number one challenge. Number two challenge is to get this fear out of us as physicians to invent and discover. We tend to keep things for ourselves, our perspective. We hate to share, we're scared to share with people, to start a new big thing. That's something we have to work on in a new cosmos, like these rooms here. People talk to each other, interact with each other, but everybody wins. Not only one or two. There's a lot of challenges, but I can tell today and now, we went very far if you look at our fellows today and our research fellows and AI engineers and everybody thinking how to innovate and discover. There's no research centers anymore. There's discovery centers at universities, if you can say so. I would like to add to what Nasir said. I'm really excited of the field of electrophysiology. Usually in other fields you see innovation and it usually comes to a kind of a saturation. In this field, it's not happening. This is really exciting. Think of 30 years ago, how the field looked like. There were the beginning of navigation technologies, mapping technologies just started. Ten years later, new workflow entered the field, pulmonary vein isolation and more. Then catheters came in with more electrodes, more power. But it's not stopping. We see new innovation coming more and more into the field, like pulse field ablation. AI is starting to penetrate into this field. It's really exciting to see that innovation is coming with a non-stop pace. I also agree with Nasir that I think that physicians in the field of electrophysiology, and by the way, this is quite unique, are also technical. They have a lot of ideas. I'm coming again from Johnson & Johnson MedTech. We work very closely with physicians because we like being close to the ideas that are coming directly from the field. They come to us with really innovative ideas and we think that this is one of the best ways to innovate. So, encouraging you all to come and approach us if you have a good idea. Maybe I'll dive into Thomas. Thomas, you've lived through a bunch of innovations and now you're kind of in a different role. I'm interested to hear what you think in terms of what are the pitfalls that we're facing? What concerns you about the innovation that's going on? Wow, that's a great question. So, if I may, I'll give a double-edged sword a little bit. So, one of the things that concerns me, I mean, obviously, there's no shortage of problems to solve in healthcare, and we really have an opportunity and responsibility to do more. But a couple of things. The first thing is the current paradigm of how we deliver care is not adequate or sufficient to solve the problems that we have today. We have three titanic forces that are colliding together and they're all going in the wrong direction. Significant increase in cost that is only going up. We don't have enough providers, and that's also going in the wrong direction. And there's more patients that need care than ever before. So, all those things are working together in an unsynergistic way, in a negative loop. And that's happening at a national scale in the U.S. It's also happening at a global scale in every domain. But in particular, it's also happening in cardiology, where you have expensive care, not enough providers, and you don't have enough resources to take care of them all. And so, that's one aspect. The other aspect that I'm really thinking a lot about, and the people that I work with think a lot about, is the digital divide. And that's obviously a big deal in the U.S. It's a big deal for people that have and don't have. It's a big deal around the world, between different types of economies throughout the world. And the challenge that we are all going to face, and we have to be mindful of, is not only do these technologies have the opportunity to really democratize care and make it more equitable, but those who do have it are going to be better off than those that don't. And that's going to further divide not only people's health and wellness, but also economic opportunities. Because if you're sick, then you're not going to be able to get the jobs and the education that allow you to get the care that you need, and that's going to have generational effects. And so, the things that we do in health care, in any domain, has a significant impact not only on the health and wellness of someone, as an individual, but also on their family, their community, and society as a whole. And so, that's a huge responsibility for us all. So, you talk about some of the really advanced tools that everyone's excited about. AI, for example. There's huge potential where if we do something right, then it's scalable, and it can really be done in a cost-effective way if we do it correctly. We've got to be thoughtful with the right stakeholders involved. But if we do it in a way that's not thoughtful, obviously we can do harm, but also we can get to the point where some people will have those tools, and some people won't. And that's going to further pull people apart, and it's going to have a larger chasm in this divide. And so, when you think about that, that, I think, is one of the tremendous things. Okay, let's just throw an analogy. We all saw the Olympics recently, and, you know, a fraction of a percent difference in one athlete over another can make the difference between meddling and not meddling. You know, that's huge. It's the difference between endorsements and being forgotten. When you talk about the power of the tools that we have that we could potentially use, that's not a fraction of a percent difference. That's like, you know, could be a 20% or 80% difference in efficiencies. And if you have more efficient care, you have quicker diagnosis and better results for everybody involved, cheaper care, more effective care, more people get seen. So, that is certainly an issue, and if we are not mindful of that, we can also do harm with good intent. Important. I want to pick up on a couple of things you said and also bring Deepak into this. So, one of the things that we are faced with is that we may be innovating at a rate that suits a small group of people, and we may be missing a whole global community. And, Deepak, I'm keen to hear your story, coming from India and the background there. Thank you for some excellent points. You kind of touched upon a lot of what I believe in. I've been privileged enough to undergo training in the United States. I've been able to take that training back home. And I've also had the experience of people not trusting what you're saying, because they simply haven't been exposed to the amount of pathology that you may have been exposed to, or your thoughts are not really matching. So, what, as you said, is development, say, specific to the United States, or maybe Europe also, if it doesn't apply to people in, say, China and India too, you're actually missing out on a large chunk of pathology. What we may decide on, saying that this is disease, this is how disease progresses, or this is how disease evolves, if you don't have the natural history of disease in a population that's not treated on them, you really don't understand that disease in terms of its variations, in terms of its presentation. And now that AI has come to the picture, AI is probably one of those tools that requires more data to be even better. And so the more we exclude people out of AI algorithms that is created, the lesser the chance that we'll be able to even treat the people whom we are intending to treat. So, as a whole, as you rightly pointed out, AI has this opportunity to democratize healthcare, and healthcare is one of those unique situations, it's actually driven by the top. The ability to prescribe is still at the level of the physician. It's not at the level of the nurse who's sitting and watching over the patient every day or every minute, every six hours. It's still at the level of the physician. So, our duty in being able to empower that nurse, or the physician assistant, or the person who's on the bedside, to be able to provide meaningful input to make that decision-making is what AI should all be about. I'm pretty sure a lot of physicians on this table and people who are listening to us, have the ability to read an ECG very well. But reading an ECG is a difficult art. If you bring it down or break it down into its basics, not a lot of people understand that. So, the ability to even give something as simple as interpretation of an ECG correctly, reproducibly, might actually just improve the way we deliver healthcare to a lot of people. So, again, you touch upon a lot of important points. I really, really do think that now in this age where we have the technology, we have the global scale, and we have the computing power to actually cross continents very easily, this is something that we should really look into. Jeannie, I want to bring you into this discussion. Naseer raised the issue that everyone now wants to be an innovator and so there are the question of the studies that need to be done, the research that needs to be done. Deepak has raised the issue that we need to be doing things in different areas as well. I'm after your comment on what's the way forward in terms of this innovation. I think it depends on where you're talking about. So, if we're talking about global perspectives, I think that I want to take a little bit of a different approach to thinking about that because I agree that there's this risk for digital divide, but you have to step back and see the big picture, which is what I think you were getting at. And if you just look on the World Health Organization website or any of the bank lending websites, everything's about digital health and digital medicine because it is recognized that you can get to those patients because they're not going to necessarily have smartphones, although in India it seems like they all have smartphones, but that's not true in all health resource-constrained areas. But you can bring, you know, digital medicine is much more than an AI algorithm. It's much more than having a smartphone. It is a whole development of a way of delivering medical care because, yeah, it doesn't make any sense to just rely upon some fancy-dancy AI algorithm to do an ECG if the patient can't even get to the clinic to do it. So, when I think about digital medicine globally with a global perspective, I step back and think of it as a big picture and that it's really coming up with an entire plan, an entire structure by which you will approach the patients in whatever area of the world it is. And, you know, certainly it varies significantly in terms of whether you're talking about South America or you're talking about Africa, you're talking about India. So I just wanted to make that one comment. What was your other question to me? So the other one was about the research side of things. How much of this needs to be proven and how much does it need to be proven on a global scale as opposed to locally? Yeah, I mean, it's really, really critical. We have to have human involvement. We're not at the point for, I think, most algorithms. Maybe it's AI algorithms that run AFib, you know, kind of detection or something. But for most of what we're talking about where we are, considering and providing health care to patients, and we have to be able to trust that whatever algorithm has been developed or if you use large language models or whatever it is, you know, we are not at the point where we cannot have human involvement. I mean, we have to. We would not say that that's okay to not rigorously look at our scientific evidence using our old Cox models and, you know, whatever. We would demand, you know, that there's that high level evidence. So at this point in time, we have to have human engagement because depending on the kind of, you know, model or the kind of, you know, machine learning algorithm that you're using, some of them are static, some of them are going to retrain. Obviously, the whole issue of bias is really, really critical. We learned all that in class A clinical trials, you know, 101, when there's 10% African Americans and there's, you know, 17% women, et cetera. So bias is a huge issue. We cannot have models being developed that are only, you know, testing what's going on in, you know, rural America, which is populated mostly by, you know, white people, and then take that to India. It's not going to work, you know, and then we're going to lose trust. And the people that we're, you know, trying to encourage to use this great new approach to delivering care, you know, we're going to run into trouble. So I think human oversight is still really critical. I think the evidence is really critical. I think, you know, the global, the ability to provide much better medical care globally, I find particularly exciting, and I think it can be done to minimize that digital divide. Probably not get rid of it altogether, but minimize it. So I guess continuing on that theme, Giovanni and also Thomas, in terms of kind of venture capitalists influencing global innovation, where does the global component of that feature in your decision making and how do companies pitch that? Well, I run a small VC fund, and therefore even if we speak about worldwide problems, we have to incentivize and to push for innovation, and innovation comes from the places where it comes from. And we welcome that, and we are happy that that is happening. So then what do we see and what do we push for? So we push for innovation that can show some traction, that really is a need to have, and I'm talking this to all the potential entrepreneurs that are here today, and this is really what we are looking for. For example, we are talking about artificial intelligence, and we are talking about diagnostics, we are talking about therapeutics, but I would love also to speak about regulatory, and here we have a strong component, because now we are using, we hear a company using artificial intelligence to speed up the regulatory process and to get help. And this is extremely important, because instead of having 10 dossiers running, we can have 100 dossiers running, so we can have more drugs, we can have more drugs available, and so more possibilities of treating patients. That's awesome, I agree with what you're saying Giovanni, and you know, I think there's a couple of ways to look at this. One way is, anytime you want to design, deploy, implement, test, any healthcare system tool, there's all these critical dependencies in that chain. You know, you've got regulatory, compliance, biomed, security, privacy, and the list goes on and on, and financing is one of those things. And so, whether it's a VC, an angel, a venture studio, an accelerator, that is a critical part of innovation. It's the catalyst, it's the oil, the grease that makes things move forward. And so having VCs that understand healthcare, that are willing to get into this sometimes treacherous space is not easy. Most VCs, at least some of them are cautious because of the complication and the timeline being protracted. I mean, it's not typically a three-year timeline that most VCs are into. And so having VCs that are sensitive to that, that understanding and are willing to get into it regardless is huge. So thank you for doing that. That's a critical part of this whole equation. And so that's one side. The other side is like, what do VCs think about this global market? I'm not in a VC, but I suspect that they like the idea. You know, because if you put the time and effort and bandwidth and risk into solving a problem in one domain, in one location, and it's a technical solution that's ultimately scalable, then you have many Xs on your investment, which is a big deal. But to your point and other points, you want to make sure that it's relevant for the populations that you're treating and that you're solving the problem for because not only genetically and ethnically and socially, but economically, social determinants of health, so many different factors have a huge impact on the success of the tool and the deployment and the adoption and the usability. So it's not like you can just plug and play and repeat. You really have to be sensitive about adjusting to the new environments that you're working in. Stephen, I want to turn to you. So, you know, we already heard in the earlier session, you know, Kevin Thomas saying, I want to know where I should be ablating persistent AF. And I kind of want technology here now for me to be able to use. So you're kind of at the FDA and you're faced with new technology coming out. You want to kind of help the clinicians, but yet you kind of have to be safe. So how do you balance that equation? And then where's the consideration of the global component of that? I mean, to start with the second portion of the question, I mean, all of our laws are written for the US. You know, we are sort of regulating to the US. That's what we're putting on the market. You know, we're sort of aware that other countries use FDA clearance as their bar because they don't have as well developed as an FDA or of a food and drug regulatory scheme as we do. But yeah, I mean, that walking that sort of nice edge of patient safety and stifling invasion is kind of what I do every day. And we try to strike the right balance. It's hard to do, but we also are sort of regulating with a relatively limited set of laws. I mean, the law that was written in 1976 for substantial equivalence, like substantial equivalence was kind of the afterthought. And now it's sort of how most medical devices are reaching the market. So, you know, one of the things that I would think through, and I talk to companies that are sort of early stage every day, and they're sort of like, what do we need like the bare minimum to get on the market? Like, what's the data set we need? What do we need to drive through? How can we make the clinical study the cheapest? And, you know, we will answer them, we will tell you. But I think that one thing that I would say as far as making this a more global thing is for the companies to sort of challenge themselves and say, is there a little more money I could put in? Is there a little more data I could add to this study, make the study bigger, sort of double, maybe these records are not easy to get, but once you've started getting them, you can get a little more. But if you double the size of the study, you include some foreign sites, you might end up in a better space in one go than just aiming for the minimum that we set out for you, and then trying to build on that. Let me extend that. So is there any discussion between the FDA and other regulatory bodies globally in terms of setting up things to be globally distributed as opposed to just the US? Regulatory harmonization is like a huge topic of discussion at FDA. The FDA is a humongous organization. There's 18,000, 19,000 of us. So that's all being done, not with me. So my group runs the, the group I run is sort of doing the FDA approvals, denials, like for a particular device set for the US. As far as harmonizing that, it's sort of done at a different level. So yes, there are conversations. No, I can't really speak to them. Can I add to that? I agree with you that harmonization of regulatory requirements is really crucial for the success of the industry in general. Take, for example, the AI Act, which was recently legislated by the European regulators. That's a very important legislation. However, it's kind of a cross-sectional legislation. So it applies to many industries as well as to the medical device industry. And for example, for J&J, MedTech, it was extremely important to have a very close dialogue with the European legislators to make sure at least to advocate for harmonization so that they tailor the AI Act also to the MedTech industry so that there will be no too many overlaps or double requirements with the four different regulators. So that's very important, the harmonization part. Leo, I'm gonna extend what you're saying. So from an industry perspective, how does one navigate what's done in each country in terms of distributing new innovations to different countries? How do you navigate this? Okay, so I mean, that's a question I think that we ask ourselves almost on a daily basis. So when we try to even consider what are the new features or new products that we would like to bring to the market, and they, of course, we would wanna have global market access. I think that we consider a few things. So first, it would be what would be the impact on the market. So of course, we would prioritize innovation that have high market need that will eventually bring high impact, a significant impact to the market. But after that, we would consider the regulatory pathways, reimbursement pathways, and then we will prioritize those that have kind of a smoother, faster pathways to the market because we want our patients to get the innovation as soon as possible. And more than that, what we also usually do is that we create collaborations with the university academic centers worldwide. So using that, we can learn about their needs, we can learn about the healthcare system in that country so we can better later answer the needs there. And also, of course, keep a very, we're talking about regulators, keep a very close dialogue with them to understand what are the requirements and be ready to answer them. You are in a place where you see the whole world from different, being in the Middle East, you can see the whole world and innovate from there and distribute. But I want to say something. Being a Lebanese who went to med school in Germany, and I came to the States 24 years ago, when we talk about the session today, Global Innovation, it's really based on in the US, with all respect everywhere else. The thinking comes from you, from you. But without him and the VCs in this country, you see innovation has been coming from Europe or from Haifa or from whatever in the world and been implemented here. That's something you have to keep in mind. And that's why the FDA role is so crucial as well to close the loop on us. So when we innovate here, and that's something I'm seeing in the last five to 10 years, our center, for example, that we started at Tulane, is called Tulane Research, Innovation and Discoveries, to promote that, because Tulane put a lot of efforts in innovation in medicine, for example, and they want everybody to innovate. Every university is doing so. The missing, the connection between this academician, your center, the research you've been doing on weight loss and integration dysrhythmias and all the tools you put together and the quality of life models, this should have been grabbed by a VC in the States directly and put into action. That link was missing in your country. And that's something we need to talk about. People say global, global. It's actually US, US, US. Europe is behind. All the innovators in India are lost somewhere in translation. Here, there's a reason why I said at the beginning, everybody of my fellows here, which all of them, I think, IMGs or international medical graduates, all of them, out of 24, 23, and all of them have ideas. If he walks in, a VC walks into a room today, he will grab 24 ideas and start new companies tomorrow morning. And they're all poised for that. When they were back in Germany or in France or in Australia, they think to get the next grant and be invited to speak at HRS next year, while the people in the US, they think about how to build the next big thing with Jeanne Poole or Gaspardi and the next startup. But that's have to be discussed. That's an elephant in the room nobody talks about. I can because I live in three cultures. And I tell you, it's here. That's why we do things here and invent here. Well, the responsibility is great, right? I mean, I think bringing this to the forefront is really important because if the US is the place that can innovate and can start these discoveries, then we also have that responsibility to make sure that the data is vetted, that whatever that devices has been tested, or at least as your next step after your first IDE trial or whatever, that part of that process built into it is what is the use case for this device somewhere else in the world? And how are you going to go about then testing it? We have to have that global hat on, even though we accept that we are, the US fortunately can drive a lot of this. I would like to make a comment about what an idea is and what a product is. Because idea is fantastic to have ideas, but then you need execution. And to have a good execution, you have to need an ecosystem. And we have some of this in Europe. There is a lot in the US and we have to recognize that this is very well developed here. And so if we want to push to have products developed out of US, we have to create or to push or to somehow help creating ecosystems out of here and in other countries. Mike, remiss of me not to have given you a chance to introduce yourself. Mike from McKinsey. I'm really interested, given your background in the company, you would see a global perspective here. And I'm interested in what you think. I mean, what Naseer has just raised is an important issue, that we don't have this kind of venture capital going grabbing ideas from a lot of these countries. And it's really based here in the US. I'm interested in your view. So I apologize for being late. It was on my calendar at the wrong time. My perspective on this comes, over time I've worn a lot of different hats. I've actually been in consulting where I am now. I've been the CEO of a structural heart startup company in. That was based in Galway, Ireland. Turns out in Galway, Ireland, despite all of its medtech, there's not a single animal lab in the entire country of Ireland. We did all of our animal work on the continent. So the ecosystem comment resonates with me. I do still see most of my comments on this though, through the lens of larger cap medtech, right? The companies that are at scale and driving kind of broad therapy penetration adoption. The comment you made earlier resonates. If I can be crass about it, it's because the US is where the margin is. And the gross margin is the mother's milk of companies. It's what pays for everything below the cost of goods line and what feeds into your sales forces and all of your R&D efforts. And it is crucial for companies to be able to access that margin to then be able to push it forward. And so that's just been a little bit of an economic kind of hard fact of life for a lot of technologies that have come forward. If I think broadly about the state of medtech innovation, and we make efforts to try to assess this, it is quite difficult, but we still try. It's a mixed picture, honestly. If you look kind of glass half full and the good news story, if you look broadly across medtech, people are working on the right things. If you look at the flow of venture dollars and R&D funding as a function of daily's disability adjusted life years, it largely aligns, right? People are working on meaningful conditions where there are real problems and opportunity for there to be solutions. That is a different picture on the pharma biotech side, right, where you saw rare disease predominate and you saw huge funding chasing tiny, tiny indications. It's beginning to shift a little bit as you're going back to cardiometabolic conditions and obesity and things like that, but it is still not as balanced as medtech. You're also seeing the sourcing of technology being more balanced than it was before. You are seeing sources, Israel has been a hotbed of innovation for a long time. You're now starting to see some of that come out of India, Ireland, China. It still has to be developed because of where the market sits and where the margin sits. You still see it being accelerated in different markets in different ways, but it's being sourced kind of in interesting places now. The challenge that we see is, if you look at the number of de novo approvals per billion dollars of funding, it has reduced by over 60% over the last 15 years, right? It's one of the most punch to the gut charts that we've ever made. When you just look at this catastrophic fall off where it was largely flat through the early 2000s and then through the teens, it has significantly plummeted. There's a lot of reasons for that. I think the complexity of the devices and technologies that are coming forward is a factor. I think the regulatory and quality and clinical requirements is a factor. I think that you're seeing a little bit of an execution challenge from large cap companies as well. Many of them saying that they still don't feel their level of R&D productivity has come back from COVID, that they haven't really gelled the way that they have before. But there is a view here, which is at some level, we're in the golden age of innovation. You see tremendously cool technologies coming out and these super cool physical digital product combinations. At the same time, it is taking longer, costing more. And as a venture capitalist on the other side of the table, I'm sure you're looking at your IRR and sweating that as you're doing the go forward projections and explaining and answering questions to your LPs. So I think that the unlock is going to have to be that the technologies that we talk about, whether it's AI or Gen AI or things like that, actually have to start contributing to the problems and making things easier. Because right now, a lot of it's just adding to cost and timeline, as opposed to saying, we're shortening the cycles, we know how to take out time, we know how to take out costs from this. And our engineers have changed their ways of working to be able to capture it. Because what I see a lot of is companies still doing the same thing, just with cool tools in their hands. I also think that... Great, can I make one quick comment about the de novo? So, one thing that happened is in 2014, we wrote the Substantial Equivalence Guidance and sort of built our capacity to review de novos. Whereas before that, we were, I'll say, shoehorning a lot of devices into 510k when sort of stretching the regulations. The other thing I'll say is that de novo is like a temporal decision. So, you have three devices that are all de novo at one time. Once one of them's cleared, the other two are 510ks, if they're substantially equivalent. So, if we're reviewing three in parallel, we grant one and two get denied. And so, when we're in this sort of rich space where a lot of people are chasing a lot of the same conditions, we can sort of work against ourselves on those numbers or those numbers can look a little bad, but they're not as bad as they might seem. I'll just quickly clarify, I may have slightly misspoke. We tried to look at de novos and PMAs, right? Because what we're trying to do is create a category of real innovation versus follow-ons and specials and things like that. So, we were trying to look at, and it's imperfect, I get it, right? But try to look at, okay, what is a real indication of innovation coming to market and saying what is it costing to be able to get that to market? Yeah. That's interesting. Just one more, sorry. One more comment, because we're trying to write, I mean, again, we're in this 1976 law, trying to use it fit for purpose for this. We're trying some novel strategies and one of them is the Viz AI was talking earlier about their de novo. We sort of wrote a reg that we think we can fit a ton of innovation in through the 510k. So, it's machine learning-based cardiac notification. If you look at the devices that are cleared under there, they're not all hypertrophic cardiomyopathy. There's low ejection fraction, there's coronary artery disease. So, those are very novel products that we sort of wrote a big umbrella that we think is well controlling the space while still allowing innovation through 510k. Let me just direct all of that to a slightly different way. Sorry, let me just direct that to a slightly different way. So, we've talked about innovation funding. We talked about the cost to create something and we talked about approvals for the same. So, here is my confusion and it's a legit confusion. So, we create something that costs X amount of money. We add a profit share to it, which is Y, resulting in a healthcare cost, which is X plus Y. But there is no, and I mean, FDA fund, FDA approval certainly adds to the cost. Why haven't we figured out a way to reduce X in the first place so that healthcare costs across the board are low? At every point in time, all of us are saying, we've got this cool stuff that we are trying to use, but guess what? It only pushes up healthcare costs. Healthcare costs that are an all-time high and mostly the stuff that I get to hear at my level is that it's bringing back the cost of development of the product. So, why not decrease the cost of development of the product, especially in the field that all of us are in, by actually having VCs, maybe, even say, is developing it under a high-cost environment the right way to even develop it in the first place? So, why not insist on the fact that you actually give us a more cost-effective way to develop it before we actually fund the same amount of money? So, if you have $100,000, is doing everything at a particular site with an inflated cost regimen the best way to actually use those $100,000? Or could you have done it in a much cheaper way? Because eventually, the high cost results in the inaccessibility of those products or inventions to a different substrate of society. To use an example of, say, even Biosense or J&J MedTech, the transfer time for a product of J&J MedTech from the United States to India, I'm pretty sure she'd know the timeline for it. And not all of it is only regulatory. Not all of it is only the fact that, hey, I can't really take it there because I don't know if my product is really working. A lot of it is also the fact that, am I going to get in what I put in first before I take it to that particular geographical location? And what we are not considering is, in that timeline, for a product that has already been shown to have value in a set of population, there is actually the ability or the lack of availability for a set of population to even gain access to those benefits of those products. Another example in the pharma sector is tefamidazine. The rates of tefamidazine was subsequently reduced before it even entered India. But now that it's entered India, there is a reasonable level of acceptability to it. But for the time that it didn't enter, what about those people at that point in time? So if we are considering patients as a whole, as what we are here to do, why not optimize the finances that are required for it across, right from the beginning? This has been a really exciting session, and we could keep going for a lot longer. What do we have? We have that we're in an era of amazing innovation that's going on. But we are also in a global environment where we're not equitable in terms of what we've been able to innovate out. And so we've got quite a bit of work to do still. So thank you everyone who's been on the panel and for the excellent discussion. Bring the session to a close. Thank you.

Global Innovation Roundtable

healthcare innovation

AI in diagnostics

global healthcare challenges

regulatory harmonization

digital divide

equitable access

inclusive medical research