Medsider: Learn from Medtech and Healthtech Founders and CEOs - Don’t Build A Unicorn, Build A Useful Zebra: Interview with DeepLook CEO Marissa Fayer

Episode Date: April 10, 2024

In this episode of Medsider Radio, we had an engaging conversation with Marissa Fayer, CEO of DeepLook Medical. This startup is developing AI-powered diagnostic tools that help radiologists detect cancerous lesions in dense tissue.   Marissa has over two decades of experience as a medtech executive, entrepreneur, investor, and philanthropist, spanning companies like Hologic and Olympus. She’s the founder of HERhealthEQ, a non-profit focused on advancing global women's health, and an entrepreneur-in-residence at Graybella Capital and Goddess Gaia Ventures. She’s a TEDx Speaker, a UCSC Miller Center Social Entrepreneur Fellow, and winner of the 2022 First in FemTech award. In this interview, Marissa talks about the basics of product development, how to build iteratively, tips on identifying ideal regulatory pathways, and how she picks her advisors and board members.Before we dive into the discussion, I wanted to mention a few things:First, if you’re into learning from medical device and health technology founders and CEOs, and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.Second, if you want to peek behind the curtain of the world's most successful startups, you should consider a Medsider premium membership. You’ll learn the strategies and tactics that founders and CEOs use to build and grow companies like Silk Road Medical, AliveCor, Shockwave Medical, and hundreds more!We recently introduced some fantastic additions exclusively for Medsider premium members, including playbooks, which are curated collections of our top Medsider interviews on key topics like capital fundraising and risk mitigation, and a curated investor database to help you discover your next medical device or health technology investor!In addition to the entire back catalog of Medsider interviews over the past decade, premium members also get a copy of every volume of Medsider Mentors at no additional cost, including the latest Medsider Mentors Volume V. If you’re interested, go to medsider.com/subscribe to learn more.Lastly, if you'd rather read than listen, here's a link to the full interview with Marissa Fayer.

Yeah, everyone wants that unicorn. How about you take a zebra? Not everything has to be a unicorn, and it shouldn't be. Because I have to tell you, 99% of companies are not unicorns, and they're the ones that are propping up the economy. They're the ones that are coming out with the invasions. They're still profitable. They're still making multiples.

They're returning to their investors. They're improving patients' lives, and they're improving, you know, the physician's lives, and their day-to-day and, you know, their workflow. Welcome to Medsider, where you can learn from the brightest founders and CEOs in medical devices and health technology. Join tens of thousands of ambitious doers as we unpack the insights, tactics, and secrets behind the most successful life science startups in the world. Now, here's your host, Scott Nelson. Hey, everyone, it's Scott. In this episode of Medsider, I sat down with Marissa Fayer, CEO of Deep Look Medical.

Merce has over two decades of experience as a MedTech executive, entrepreneur, investor, and philanthropist spanning companies like Helogic and Olympus. She's the founder of the Her Health EQ, a nonprofit focused on advancing global women's health and an entrepreneur in residence at Greybella Capital and Goddess Guy Ventures. Here for you the key things that we discussed in this conversation. First, make sure that you're solving a real problem rather than creating solutions in search of a gap. Identify genuine need and develop a product that enhances efficiency and outcomes while fitting seamlessly into existing work. Second, when engaging with FDA, explain your technology in layman's terms. Leverage predicates if they're available, design trials primarily for regulatory purposes, but ensure they're equitable for broader credibility.

And third, accelerators are valuable for startups at any stage. They can offer networks, new perspectives, publicity, and even potential funding opportunities. However, they are also time-consuming, so assess the benefits and choose wisely. All right, before we jump into this episode, I wanted to let you know that the latest edition of MedSider Mentors is now live. We just published Volume 5, which summarizes the key learnings from the most popular medsider interviews over the last several months with incredible entrepreneurs like Gabriel Jones, CEO of Proprio, Kirsten Carroll, CEO of Can Do Health, Dr. David Alpert, founder of a Live

Corps, Greg Bolington, CEO of Magnolia Medical, and other leaders of some of the hottest startups in our space. Look, it's tough to listen or read every interview that comes out, even the best ones. But there are so many valuable lessons you can pick up from the founders and CEOs that join our program. So that's why we decided to create MedSider Mentor. It's the easiest way for you to learn from the world's best medical device and health technology entrepreneurs in one central place. To check out the latest volume, head over to MedsiderRadio.com forward slash mentors. Premium members get free access to all past and future volumes.

If you're not a premium member yet, you should definitely consider signing up. In addition to every volume of Medsider mentors, you'll get full access to the entire library of interviews dating back to 2010. You'll also be able to see all of our playbooks, which are handpicked collections of the most insightful interviews with the brightest founders and CEOs that join a program. Whether you're looking to master capital fundraising, navigate early stage development, tackle regulatory challenges, understand reimbursement or positioning your venture for a meaningful exit, Medsider Playbooks have you covered. And last, considering that fundraising can be one of

the most daunting tasks for any startup, we created a meticulous database of investors right at your fingertips. Explore a wealth of VC funds, private equity firms, angel groups, and more, all eager to invest in medical device and health technology startups. Access to this database is a premium member exclusive, so don't miss out. Learn more about MedSider mentors and our premium memberships by visiting Medsider Radio.com forward slash mentors. All right, without further ado, let's jump into the interview. All right, Marissa, welcome to Medsider.

Appreciate you coming on. Thanks so much for having me. Yeah, I am looking forward to this conversation, learning a little bit more about Deep Look. But before we get there, let's spend maybe five, ten, ten, inch-ish talking a little bit more high level. So before stepping into the CEO role, give us a sense kind of for your background, maybe an elevator-style pitch leading up to your current role. Yeah, for sure. So Met TechExec got into engineering while I was engineer, so got recruited out of school, went straight into healthcare. I thought I was going to aerospace.

I came into healthcare and never left. So I was in corporate for about 15 years doing new product development, manufacturing engineering work. I took on more and more roles. I was in mergers and acquisitions and integration, moved out of country, moved around on special products and projects. I developed a 3D mammography system, which ties into what we'll be talking about. And after 15 years, before it was popular, I think I burnt out. And before it was popular being an entrepreneur, I think that I figured out I was one. And so I started to, I started. my own consulting firm when everyone said I should go into consulting. Hi, I started a firm instead. So hence the entrepreneurship started a global nonprofit and started advising and helping companies

grow and doing a lot of, you know, that kind of work, sitting on boards, seeing advisory boards. And, you know, here I am today doing what I'm doing. Yeah. No, that's great. We'll definitely link to Marissa's LinkedIn profile in the full write-up on MedSiter for this particular interview. You can get a sense for sort of the colorful background, right? the number of experiences. But it's interesting that, and we won't go too deep on this topic, but I recently did a presentation for a small med tech group. And I showed this, are you familiar with like the midwit meme, right?

And I was like, well, early on in my career, I was like, you know, just got to do a lot of things, you know. And then you get to this, like the top of the bell curve where it's like, well, I need to make this move. And if I just do this, it's going to be the perfect move. And it's like, then the ninja on the far right is like, no, just do a lot of things. Right. Yeah.

Just need a lot of things and figure out what you might. like to do and you actually have no idea how it's all going to come together. I mean, listen, you know, now you look back and you're like, oh, that's how it all came together or you knit the story together. But in reality, no, when you're doing it, especially in your early career, no idea. I mean, there's a lot of smart people out there and I think I just probably wasn't as intentional as I probably should have been. No, no, I think you're dead on as probably the real scenario behind most people's journeys, right? It's like you're just, you very much figure it out as you go.

But like that, not to sound cliche, but like that famous Steve Job quotes of like you can only connect the dots, like looking backwards. I think that, I mean, the more I think upon that quote, I think it's very, very true, at least for me and probably a lot of others. It sounds like, yeah, you're the same way. So with that said, most of your time is being spent on deep look. Give us a sense for like the technology, like what it is and maybe frame that up as if I was a freshman in high school and I didn't know anything about the space.

and maybe weave in, like, you know, why you're even interested in the space? Yeah, so Deepak has a great technology that's our flagship product. It's called DL Precise. It's based on shape recognition. It's very deterministic fixed software. So, you know, what we were learning to code with a million years ago. And so it's the basics of AI. And we are able to measure, segment, and visualize lesions in existing images.

So everyone eventually will have. mammograms, ultrasounds, CT images, or MRIs, we're able to one-click measure segment and visualize those. It's a help for radiologists to better get to diagnosis, to better get to better information, better, you know, decisions and have information for them so that it helps their workflow. And so that's our first product. We have secondary products that we're working on now and that will be developed and released in the next few months.

and then obviously continuing on from there. Additional tools that help radiologists. For us, we're FDA cleared, which is a really big milestone for sure. And we're at the commercial stage. So we have four commercial contracts. And so it's really exciting to kind of get this technology into people's hands. And for us, we're FDA cleared across all imaging modalities and all health conditions, which is the broadest designation that you possibly could have.

And so really, we help to visualize. cancer or non-cancer, you know, suspicious lesions in existing imaging. And first and foremost, we can do that in breast cancer. We're very good in dense breasts. So what we do is it's based on shape recognition and reading the technicalities of the pixels in imaging. And so that's what we do, which is exciting. And so, you know, my background in breast cancer and in imaging, especially at WholeLogic. I spent nine years out of my career, my corporate career there,

developed a 3D mammography system, did a lot of work in imaging. And honestly, as a woman who has dense breasts, which affects 45% of all women in the world, disproportionately affecting black women, Asian women, and Jewish women. Honestly, this is personal. This is personal to me, to my family and to my friends

and people that, you know, I know. And that the problem is when you have dense breast tissue or any dense tissue, you have a two to three times higher likelihood of having cancer and also having the imaging miss your cancer. And so we are a tool that can help visualize for the radiologists. Got it. I had no idea. I guess the prevalence of breast cancer was that much higher with dense tissue, I guess. That's interesting. No idea. Got it. And Deeplook Medical is the website. Deeplookmedical.com is the website, just as it sounds. We'll link to it in the full write-up on

Medsider, but definitely encourage everyone if you're interested in this, if you're like, your ears have been perked, right? Or you're kind of leaning into like this technology. Definitely encourage you everyone to check that out. So, Marissa, just a couple follow-up questions. So it sounds like radiologists are primarily using the technology. So if I'm a deep look rep, right, am I selling into the radiology department? Like, where does this, where does this fit within that kind of the healthcare ecosystem? Yeah, it fits into the radiology department, fits also into clinical trials. The interesting part of our business model, is that we don't have any reps for sales.

We actually partner with channel with other distribution and channel partners. Because, listen, a small technology company is not going to make inroads into a hospital. But Bayer Healthcare is going to. Or Tipis, which is a billion dollar company, or Barco, $2 billion, owns 90% of the medical monitor business. They have the ability to make those calls and to get in more efficiently as an additional product. And so that's how we get into radiologist's hands. Eventually, we'd love to get into patients' hands as information that the radiologist provides.

So, yeah, but really, this is radiology, oncology, some clinical trials. That's where anybody would find us. Got it. And you mentioned the technology is FDA cleared. I think maybe your first clearance was back in 2021, if I remember correctly. And so you're actively commercializing this now. actively commercializing. I mean, COVID didn't help to be clear, nobody to care about cancer for several years. And yeah, so we're commercializing now. We have four commercial contracts with some very

large companies. And so they've integrated our technology into their technology as additional offerings and just additional products that they have. And so, yeah, commercializing now, which is which is the exciting part. Yeah, yeah, no doubt. Yeah, seeing your baby kind of be, be, worn into the universe. But you know, it's interesting that you mentioned this being used for clinical trials. That's one of the things that I, in conversations with other entrepreneurs that are kind of thinking about their, you know, how do they go to market? How do they get through kind of the ebbs and flows of the development life cycle? And one of the things that I always encourage them is if there's a creative way at all to demonstrate revenue early in the process, like the better, right?

It's going to be that much easier to raise capital to your next milestone, et cetera. And I'm glad that you mentioned that, right? Because that's come up with other entrepreneurs that have been on the program. It's like, they've found. interesting ways, you know, and some of it's actually through, through trials, right? Stratos Labs is an example. I think their wearable broncoscope, I believe, if I remember correctly, they actually, I think they had maybe some inbound interest from pharma companies or companies that were wanted to use their technology for clinical trials. It was like, well, that's a perfect, that's a perfect way to, right, opens up some, some revenue, right, that helps, you know,

the company, or is positioned to the company in a much better light for future, future investment. So that's cool. Yeah. And for us, I mean, listen, it's a different revenue stream. You know, it's still like a software partnership and things like that. But, you know, instead of being part of just the regular screening and diagnostic pathway, it's completely different pathway. We're relying on our partners. They're a very large company.

They're enrolling people into their trials and using their software. We're, you know, we're a utility there. And, you know, every time we get used, we get paid. And it's kind of, you know, some of it's kind of passive income. but it works. Why not? Yep, yep, no doubt. Well, cool. Let's step inside the old Medsider time machines I like to call it and kind of go back and learn a little bit more about your personal journey and really kind of what you've been through at Deep Look, right, over the past three to four years now. And I think if my, I'm looking at your LinkedIn profile now, you got involved with the company in 2020. Is that right?

So I joined as an advisor in 2020. Got it. So I was speaking in 2019, I was speaking at a conference to the founders said, you know, they came up to me after I spoke and we had a good conversation. They're like, you're going to be our CEO. I'm like, we've just met. So how about I wait a little bit? And so, and obviously I was pre-FDA and, you know, that was in COVID and all of these things. So I joined as an advisor for several years. And in August of 2022, I took over at the behest and blessing of. the founders as CEO. And yeah, yeah, here I am. So I've been leading to company for about a year and a quarter. Okay, got it, got it. And you're obviously involved. You've been taking a lot of

swings, you know, at the plate over your career, been involved in a lot of, a lot of startup, kind of this entrepreneurial ecosystem. And I often think, not often think, I still fundamentally believe that like the moving through like the early stages of development, right, when you've got, you know, not a lot of resources, very limited to capital, you're trying to hit that. that kind of that next iteration, right, of your product, whether it's software, whether it's hard work, et cetera. It's really, really challenging, right? Because you've got to make hard decisions. You've got to do things typically pretty lean. And so anyway, with all of that said, what's your, you know, what are like maybe one to two pieces of advice that you have for other, you know,

founders, entrepreneurs that are kind of early on in their venture, but are trying to try to deal with this, you know, this, try to cross a lot of hurdles with not a lot of resources. I mean, listen, it's pretty basic. Find an actual problem and just don't invent one. Like, find a problem that you can solve and that has either a market, an existing market, or a market that you can create and to grow. I mean, listen, you know, not everything's going to be the Uber of X, Y, and Z. Sometimes you're just something else in an existing market or something better or something different. So like, but find problem. Don't just like create something that has actually no value to anybody and figure out how it fits.

And especially in healthcare, you have to figure out how it fits into their day to day and how it fits into their workflow, their life, you know, their, their daily practice. Because physicians and nurses and anybody in health care does not have any time. There's no time. And so you have to be in augment. to either drastically change their outcomes or reduce the amount of time that they're spending on something. And especially, this is a trend for the next five, ten years. But like, be a help.

I only know health care, really. So, I mean, you know, that's what I talk about only. But I would say, like, find a problem, figure it out, figure out how you can get it into the workflow. Like, for us, we figure it out. we're never going to have a sales team that's going to get into a hospital. Well, how do you get your product out then? You go with channel partners. That was the better way of doing business for us personally.

So, you know, I think it's just figuring out what makes the most sense and taking like just a little bit of time to think that through. Like don't shove it down everybody's throat thinking that you know everything. Like that's a problem. Like you have to ask physicians, you have to ask hospital administrators, you have to ask, you know, anybody doing the work. Like, how can you make their day better? Right, right. And I'm sure that that's probably the key for your particular solution, right, at Deeplook is like really understanding.

Yeah, at its core, like it does this thing, right? But actually, like truly understanding how a radiologist, like how it fits into their workflow, right? I think has probably been especially important. And that this topic kind of surfaces quite a bit in these conversations. with other medtech founders and CEOs that I have on the program is this idea of like, yes, you have your device, your software, whatever, is like solving this pain point, right? The solution. But really truly understanding, like, how it actually fits into, to your point, into the actual

clinical workflow is huge and oftentimes underappreciated. Yeah. Well, there's so many incredible innovations that are out there. Let's be clear. So many of them. And the problem that most of them have is that they can't figure out how to get adoption because they can't get into the workflow. You can have the best invention, the best technology.

If you can't get it into people's hands because they can't, it doesn't help them or you can't get it into the system, it doesn't matter how great it is. Right. There's also a lot of companies and technology that have been acquired to be shelved because it's just, it's like it's noise. Yeah. It's too painful. It's too painful.

Yeah. So you just need to like figure out how it works. Yeah. Yeah. I still, like I'm not going to name the product. name, but like there's a particular device in kind of the cardiovascular space that comes to mind that, you know, was started by a legendary entrepreneur, really, really cool actually technology, but I think ultimately failed because of this very thing, just too cumbersome to set up and to use.

And it's just like, great idea, just never really truly fit within a normal workflow, right? So it's like huge, hugely important. And you also have to start at a certain place. You can't start at the end point. You have to start where people can understand it and where you can work. Like your MVP, but make it easy. Make it, you know, make it something, yes, that's helpful. It's not your end product.

I mean, for us, deal precise. MVP, get in the door. Our next product, that's the one everyone probably really wants. The ones after that, those are the ones that they really want. This is an incredible technology and it leverages and allows us to get to the next step, gets to the next product, gets to, you know, the next innovation. that's important. This is the first step of many. And I'm not saying we haven't figured out, certainly, because no company actually does. But like that's, that's what you need to do in order

to get it in. Get their adoption. Make sure it's understandable. Don't speak in technical speak. Don't. Like nobody understands. Like you're going to have to start like what we do. We start with deterministic software. It's not learning. It's not taking any images. Not, you know, we don't have to worry about HIPAA. You don't have to worry about all these things because it's just, it's software. It's already fixed. Lauren. You're like, it's done. And then, then you start to layer on AI and machine learning and all of these other things, you know, in the future. But like, understand where people are at right now. You might be in super deep tech, but I got to tell you in health care, not there yet. No. Like, like, figure out where everybody is and figure out how you can get there eventually.

Yeah, that's a good point. And so, so on that, on that note, so you, you, you, you, you, mention this idea of just getting into market, right, with like a first-gen type of technology. And I'm sure you probably heard this, maybe even some from investors, maybe specifically that said, well, Marissa, I like what you're working on, but I want this game-changing thing, right? That's what I really want to invest in, right? It has to, it can't be like a slightly better version. It has to be, like, dramatically different. What's your, what's your take on that? Those are the dreamers, and those are, listen, there needs to be a ton of dreamers going for the moonshots, going for the big ideas.

I got to tell you, one in, you know, one out of 100 of them are successful. When you go with actual incremental improvements, I mean, these are not real hard and fast stats, I would imagine six out of 10 of them are successful. That's a dramatic difference. So, I mean, yeah, everyone wants that unicorn. How about you take a zebra? Yeah. How much you take a gazelle, whatever, you know, whatever analogy you want to use, you know,

you can take the horse, you know, whatever you want. and not everything has to be a unicorn and it shouldn't be because I have to tell you, 99% of companies are not unicorns and they're the ones that are propping up the economy. They're the ones that are coming out with the invasions. They're still profitable. They're still making multiples. They're returning to their investors. They're improving patients' lives and they're improving, you know, the physician's lives and

their day-to-day and, you know, their workflow. Like not everything is this pie in the sky. And yeah, of course, like you need to see the potential. But like, you know, I don't necessarily believe in like an 100x multiple. I mean, that's just not realistic. And if any, if all investors are looking for that, I mean, then nothing else gets invested in. Right. Nothing.

Nothing. And we're at the status quo. So like there needs to be a lot of people who are happy with a 5, 7, 10x, which is incredible. It's incredible. That alone is incredible. And you add all of those up, well, then you get to 100x. Right, right. And I think a lot of times that I hear, I hear this pushback around, like, you know,

working on something truly differentiated, truly, you know, truly game-changing. A lot of, like, if I had a point to a trend, it's usually, it's usually coming from people that don't have, like, that great of commercial chops, right? Because they just don't understand, like, if you, you could be working on the most amazing thing, right? And it's maybe it solves a real painkiller, like a real, but it's, but it's like massively different from what someone's used to using. That's going to, that's going to equate to a ton of friction. You know what I mean? And 20 years. In 20 years. You're lucky. Yeah. So if you have a time in the and the capital to spend for those 20 years until the market actually gets to where you need it to be,

wonderful. Yeah. Yeah. It's funny. I wish you look. You know, like I'm happy for that. And that's an interesting to invest in for the future. But there's about 27 middle steps that have to get there for that one game changer. And by the time it actually happens, it's no longer a game changer because everything else has incremented up to that. Yeah, yeah, no doubt. It's, it's, we'll get to the next topic here in a second, but I was having the same conversation with someone recently. And we were talking about like this pitch deck. He was like, I'm so glad I didn't see that this thing was like incorporated AI and it's going to do all. this weird stuff that this audience that uses this product has no idea how to use.

You know what I mean? And that's, you know, anyway, we're kind of laughing about that. But let's shift gears a little bit. You've been involved in healthcare really throughout your entire career. I always like to kind of use the phrase that it's like, you know, if you're doing a healthcare startup, it's like playing the game on hard mode, you know? And largely because of the regulatory and clinical, you know, sort of constraints that are typically involved with most of the products that we build in the space. So with that said, like thinking of maybe, and maybe frame this up just specific to Deep Look, like what, like what has been your approach to kind of mapping out the, the regular, you know, that regulatory process because it can

sometimes, you know, be overwhelming for a lot of, a lot of entrepreneurs. It is quite overwhelming. And I've had three conversations just today about it. So, you know, it's very time consuming and confusing. And, you know, it's really hard to understand. And thankfully, I was involved in regulatory and quality a lot when I was in corporate. So I learned a lot of that experience, too. But listen, you know, we were, you know, I inherited a company more or less at head of day clearance, which is great. The way we were able to obtain it was to make it just very like understandable, code, deterministic, not learning. Because, you know, even years ago and increasingly today, the regulators are not that familiar with AI while they think they might be.

They're not. and it's still hard for general people to understand unless you're the tech developers. And so, you know, it's hard. It's, you know, from us, we're taking it very like methodical, doing exactly what we should be doing, planning it out months and months in advance, making sure that the testings there. And really, it's about showing what you're saying you're doing and proving it. And also, it's, you know, if you can use a predicate, obviously. Somebody else has done it, done the really, really hard work for you in the past.

I mean, use it. Capitalize on it. There's no reason not to show how you're similar, show how you're better, show how you're different, but show how you can, you know, utilize that. It's a really big benefit. There's a lot of companies that want to go to Novo, which is incredible. And especially in this new, you know, tech AI space, great, wonderful to do. but it's very hard.

And honestly, sometimes the first one's not the best. So I think like, you know, if you can, the easier route is always, you know, a predicate with a 510K. That's just typically easier. That was the route that we were lucky to have taken. That is the route we will continue to probably take. You know, we potentially will be going after a breakthrough designation because we can do something different.

But that's a designation in addition to a 510K. It's also a proven methodology. It's a proven way of doing business. But like go for your pre-sub meetings. Have those, like, they're free. Like, have them. Have those meetings. They're available to you so that you know how to do it correctly.

And honestly, like, hire regulatory consultants, you know, or a regulatory team internal. I mean, that's the way to do it. These people are experts. If you're a business person, you're probably not also a regulatory expert. You might know it. But first of all, do you want to fill out all that paperwork? Probably not. And second of all, it's also nice to have somebody else to bounce ideas off of and to have,

you know, to almost not have a safety net, but to have the backup for some other eyes looking at it. So it's hard. Regulatory and healthcare is hard. I mean, there's nothing else to say about it. It is. And I think you just have to also speak in English, like in the, in a language. like in a language and not tech speak because the FDA is very good at what they do for certain things, but they're not designers.

They're not, you know, developers. That's not their background. They don't claim to be that. We need to put it in English. Yeah. Yeah. That's something that's come up quite a bit with other folks that have been on the program is this idea of when you're approaching, you know, FDA in this case, right,

approaching it very much from an educational standpoint, right? Like you would be teaching anyone else for that matter, it's just a little bit of a different audience. And focusing on that sort of that educational element is really, really crucial. But you brought a good point about predicates too, because I'm sure you've seen it too, but you've been around entrepreneurs that are like, if we're going to use this predicate,

but I think we need to do this different clinical trial design or something like that in order to somehow demonstrate, you know, superior performance to FDA when they don't even need it, right? They're not asking for it. And so it's like, yeah, I think, I think it's really, really important kind of like point of delineation is like there's a regulatory process, right? But unless you think it's necessary to do some novel clinical trial design, right, as an example, don't do it. Just follow the path, right?

That's been that's been blazed before you with a predicate device, you know? Yeah, I would say that, yes, you can, as an add-on, there's two things. First and foremost, make sure your clinical trials are equitable. So make sure that they include all different types of people from all different backgrounds because most of them done before have not been. So, you know, you could be using a predicate and it could be a 20-year-old trunicate, whatever it happens to be. I can guarantee you probably not tested on women, probably not tested on people of color,

probably not tested of, you know, of people who are not East Coast urban basis. So tested on different people. include those people, everybody, in your clinical trials. It's actually not required by, you know, by FDA. So do that. So that's the first thing. And second of all, you can run really fancy, completely novel trials, and not trials, studies in parallel or afterwards.

So that you can show the differential to the customers. Yeah. But, you know, there's no reason to do it just if you're trying just to get your. FDA clearance. Mm-hmm. There's no reason. Hey there, it's Scott, and thanks for listening in so far. The rest of this conversation is only available via our private podcast for MedSider

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