Medsider: Learn from Medtech and Healthtech Founders and CEOs - From FDA Reviewer to Medtech CEO: Interview with Zenflow CEO Shreya Mehta

Episode Date: May 29, 2025

In this episode of Medsider Radio, we sat down with Shreya Mehta, co-founder and CEO of Zenflow.Zenflow is a medical device company focused on treating benign prostatic hyperplasia (BPH). A biomedical engineer, Shreya brings over 15 years of experience in medtech, including serving as a lead reviewer at the FDA, where she specialized in cardiovascular devices. Shreya co-founded Zenflow in 2014 out of the Stanford Biodesign Innovation Fellowship. The company was one of the first medical device startups backed by Y Combinator and also received early support from StartX and the UCSF Rosenman Institute at QB3.Shreya's experience at Zenflow reveals strategies for grounding innovation in patient needs, building productive FDA relationships, and leveraging accelerator programs to transform academic concepts into viable businesses.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 3 packages that will help you make use of our database of 750+ life science investors more efficiently for your fundraise and 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 VII. 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 Shreya Mehta.

You have to make sure that you're building a relationship with your reviewer. I was often with my best companies on a text basis, and it's just like, that doesn't mean it's not formal, but building that relationship and being able to back questions quickly, that's going to be to your company's benefit. And so take time, build that relationship, build a trust with your reviewer, and that'll get you a long way. Welcome to Medsider, where you can learn from the brightestrower, where you can learn from the bright 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 Shreya Mettech, co-founder and CEO Zenflow, a medical device company focused on treating BPH. A biomedical engineer, she brings over 15 years of experience in MedTech, including serving as a lead reviewer at FDA where she specialized in cardiovascular devices. Sharia co-founded Zenflow in 2014 out of the Stanford Bio Design Innovation Fellowship.

And interesting enough, the company is one of the first medical device startups backed by Y Combinator. Here for you the key things that we discussed in this conversation. First, design your product to address unmet clinical needs. The tech should follow from there. Once Zinflow identified gaps in BPH treatment, the team focused on developing a solution that met patients' desire for flexible and a reversible system, even in the face of of technical challenges. This patient-centric approach informed engineering decisions and ultimately

defined the spring system's value proposition in the market. Second, treat FDA relationships as strategic business partnerships. With experience on both sides of the regulatory process, Shrea emphasizes building rapport with reviewers, noting it can lead to more productive outcomes, but just as important as the value of strong clinical evidence. Even if it means pursuing a more rigorous path like a PMA, solid data doesn't just support approval. It drives adoption, reimbursement, and exit potential. Third, leverage accelerator programs like Y Combinator and Star Dex to support the transition of academia to business, not just for fundraising, but to build essential business fundamentals and community support. For Zinflow, these accelerators help transform its concept

from just an idea with prototypes into a structured company with clear business parameters. All right, before we dive into this episode, I'm pumped to share that volume seven of Medsider mentors is now live. This latest edition highlights key takeaways from recent Medsider interviews with incredible entrepreneurs like Bill Hunter, CEO of Canary Medical, Brian Lord, CEO of Pristine Surgical, Don Crawford, co-founder of Safian, and current CEO of Corvista Health, and other proven med tech founders and CEOs. Look, we get it. Keeping up with every MedSider interview isn't easy. That's why we created Medsider mentors. These e-book volumes distill the best practices and insider secrets from top founders and CEOs, all in a downloadable,

easy-to-digest format. To check the latest volume out, head over to medsiderradio.com forward slash mentors. Premium members get free access to all past and future volumes, plus a treasure trove of other resources. If you're not a premium member yet, you should definitely consider signing up. We recently revamped Medsider with swanky new features, especially for our premium members. In addition to every volume of MedSider mentors, you'll get full access to our entire interview library dating back to 2010. You'll also get Medsider playbooks, curated guides, path with actionable insights and topics like fundraising, regulatory challenges, reimbursement strategies and more. And if you're fundraising, don't miss our exclusive investor database,

featuring over 750 life science VCs, family offices, and angels. We've even created three custom packages to help you with your next fundraise. Learn more about Medsider mentors and our premium memberships by visiting MedsiderRadio.com forward slash mentors. All right, without further ado, let's dive into the interview. All right, Sharia, welcome to Medsider Radio. Appreciate you coming on. Thank you for having me, Scott. I'm looking forward to it. I know. This has been like a long time in the making it feels like. So it's good to finally have you have you on the program. Really looking forward to to learning about like the past 10 years as Inflow, right? As a co-founder now CEO of the company and I think it'll be fun to chat about kind of the journey, right? Going from engineer to entrepreneur.

But with that with that said, I reported a very short bio at the outset of this this interview. But let's start there. You know, give us maybe a couple minute overview, right, of your of your background leading up to co-founding the company now leading it as a CEO. So I'm a biomedical engineer by training. I'm an engineering nerd. You know, I worked in R&D in my early career in manufacturing, R&D at St. Jude Medical. And then from there, I went into graduate school and I transitioned actually more into a regulatory career. So I worked at FDA for a number of years, worked on class two, class three devices. I did probably hundreds of 510Ks, IDEs, PMAs, ran a panel meeting, you know, all of those were in the cardivasia space. But nonetheless, you know, I think having

the background of having been on the other side of the table at FDA has been really educational and happy to have had that experience. That being said, you know, I kind of wanted to, I didn't want to pigeonhole myself into being just on the regulatory. career path. I found out about a program at Stanford called the Biodesign Innovation Fellowship and, you know, honestly wanted to move out to the West Coast, I love California. So applied to that fellowship program and what I was really seeking to do was to gain a little bit more of a holistic perspective on how medical technology becomes successful, right? So it's not just the regulatory aspect of things, but also how does reimbursement work? How do you, you know, raise financing? How do you

think about IP and strategy and how do you actually build a successful product and business. And so applied to that fellowship program and got in in 2013 and then Spun Zenflow, the company that we'll talk about today out from the Stanford Buy Design Innovation Fellowship. And as you touched on, it's been about 10 years now since starting that company. And it's been quite the ride. Yeah, I can imagine. And there's, you know, there's been, I guess we've been probably close to 300 now interviews with founders and MedTech CEOs. I think you might be the first one that said on the other side of that particular table, right, the reg table, right?

Sometimes we'll have investors, right, that are now operating a company and can sit on both sides, but it's a definitely unique experience. I bet it's paid off, right, in spades, especially with the novel technology, right, that you're developing at Zenflow. So, yeah, that's cool. Well, on that note, tell us about the spring system, right? give us a sense for kind of like what the disease or major problem like you're trying to solve, maybe what standard of care versus, you know, how this device is different?

Yeah. So standard care is a right place to start, right? So biode design, I've drunk the Kool-Aid for biode design. They tell you you start with the unmet need. And when we were there at Stanford, we met so many urologists. We met so many patients who were suffering from enlarged prostate or benign prostateic hyperplasia. So what happens is the prostate grows, it creates obstruction. patients have a terrible quality of life issue based on that growth. And so what we developed was a

gentle spring-like device that props open the prostateic urethra and allows men to urinate more freely. So our approach in particular is really unique in that we deliver not just with a gentle implant, but also a flexible system. It doesn't require any catheterization after the procedure. And then most importantly, the implant is totally removable, making the procedure totally reversible. And what this means is that, you know, we get to open up the BPH market. There are technologies out there for BPAH. And what our particular approach means is that we open the market to first-line therapy. So by virtue of it being a much more patient-friendly procedure and approach, we think that we can open up the market to many.

millions of more patients, obviously billions of larger market opportunity. So our, you know, it really started with the unmet need and by virtue of the technology is where is where the market really opens up to a new category. Got it. And I'm on the website now, which is zenflow.com. We'll link to it in the full write-up on MedSider. But for those listening, it's ZEN flow, just as it sounds. Cool name, by the way. I love the name. I've always, always liked it when I first heard about Zenflow. But just to kind of drill down in the technology itself, let's say I'm a patient may be eligible for this as a frontline therapy. I presume because it's so minimally invasive. This is done in the clinic, right? In the neurologist's clinic. I don't have to go to probably

a hospital for this. Okay, got it. It's implanted. How long is the implant left behind before it's removed? It's a permanent implant. And so it's reversible. You said it's reversible. Okay, got it. It's intended to be permanent, but it can be removed. And yeah, it's similar to, you know, we kind of make the analogy similar to drugs. It's like you, you start taking drugs. If it's not working for you, if you're having side effect, that's not worth the benefit, you can stop taking the drug. Similarly, you can have the implant removed. Oh, that's interesting. Okay.

Okay, got it. And then the likelihood of someone wanting it to be removed? Is it like, is it, are we talking to like it's a pretty low percentile? I would imagine. It is. Yeah. No, we don't, you know, our removal data is on par with other BP, or I should say, our reintervention data is on par with other BPH therapies out there.

But, you know, at the end of the day, I think what we're doing is we're really, driving the patient decision, right? And again, by virtue of that and ability to fully reverse, we think patients will elect to undergo a procedure like this perhaps earlier than they might have otherwise. That's really where we see a huge, yeah, huge opportunity. Yeah, I can only imagine, right, to overcome some of that maybe inherent skepticism of having, you know, an implant, right, and rather a kind of sensitive area and having that optionality, right, to have it, you know, hey, if this doesn't go as planned or I don't like the results, it can be removed. And we start, you know, from scratch almost. And that's one thing I'd like to highlight, too, is when men

have BPH issues, it's kind of the first time that something's happening below the belt that isn't, you know, police or pleasure. Right. And for women, it's a very different experience. But for men, it's such a, it's a very private decision, right? And it's something that's really meaningful to them. And so that was another reason why it just, we wanted to make sure that it was a truly patient-friendly approach. Yeah. Yeah. I can see why one of my, one of my friends, um, had, I'm not even sure if you had BPH, maybe it was like early onset of BPH. I can't remember, but he's not, he's not that old, but he's in Dubai, had a procedure done, not, not was Zinflow at all. It was like some other device. And it didn't go very well, put it that way. And so I can,

I can imagine, like, I'm not overly familiar with like, yourology space and in great detail, but I can imagine, right, just if he, if he's presented with an option, right, where it's like, hey, this doesn't, this, you know, this can always be removed, right, down the road. That's, that's especially important. So why not? Yeah, exactly, exactly. Why not give it a shot? So that's cool. With that said, we're recording this in early Q2, 25 for those listening kind of down the road or maybe re-listening to this down the road. Where's the company at in terms of kind of its life cycle? Yeah, so we've treated about 300 patients now in the context of several pilot studies and then our pivotal study most recently. And we're preparing at this point for PMA approval and commercialization.

So we're kind of right at the precipice of that sort of, you know, clinical validation and transferring the design to commercialization, which we're really excited about. So we expect the product to be on the market in 26, which is going to be here before we know it. Yeah, no doubt. Yeah. I mean, we're like almost almost mid-year, right? You know, not too far away, mid-25. So, yeah, what a cool time, though. I mean, not too many med tech startups kind of make it, make it this far, right? So to be to be on the precipice of commercialization, that's pretty cool, especially with the PMA device. So, yeah, no doubt. With that said, let's spend the next 20 or 30 minutes kind of going back in time. and I'd love to learn a little bit more about the journey getting here, right, over the past,

you know, decade or so. But again, for everyone listening, it's zenflow.com, zenflow, zenflow.com, just as it sounds, and highly encourage everyone to check out the device and the company in more detail. But first question on the docket is, especially considering your co-founder, engineering background, I'm sure the current system, right, or the current device that you expect to commercialize didn't look the same way, right, when you were first developing it, you know, 10 years ago coming out of the bio-design program. when you think about as a startup, right, having to do a lot with typically a small amount of resources

and trying to iterate quickly, you know, for other, you know, newer med tech entrepreneurs, right, that don't have, you know, that haven't had the experience or, you know, been at the plate to take some swings. How do you, you know, typically encourage them to kind of work through those early stages, right, while trying to conserve as much cash, but also be able to kind of show progress at the same time? One of the things I like to say is always, always, start with the unmet clinical need, right? Ground yourself in that. It's actually really tempting as an engineer, especially. We like toys. We like, you know, complex systems. I think at the end of the day, if your technology is not addressing the big picture unmet need, you know, you already have a, it's already difficult in the startup world to survive. And I think if you're going technology first, that makes it even harder.

So always start with the unmet clinical need. One example of this is we had our approach is through a flexible system, which is a huge game changer in this space. And it was technologically difficult, you know, from an engineering standpoint to advance a flexible system through all these trials and whatnot. And so I was challenged very early on. I started off as CTO at the company. And it's like, can we just do this through a rigid? Can we just? And at the end of the day, the patient, you know, friendliness of this approach is what's going to drive the market and adoption. And so we were persistent. Some might call it stubborn with a flexible approach. And we stayed grounded in that need and how we are vision for developing this market. And I think that was that was to our advantage,

certainly. I kind of think there's times like along the road, right, where you getting pressure to like, you know, to go to go to that rigid system, right? Or to just, you know, pivot or flex on that kind of mandate, right, that technological mandate. For others that maybe are going through that, like I can try to make that decision. Do we stick to our guns or pivot? Any new words of wisdom? I think if that piece of your technology is what you think is going to, is that the game changer?

Is that the difference maker in this space? Then lean into it. And, you know, there's always shortcuts and easy ways out. But I think if you're grounded and that, which is most important, which is at the end of the day, the patient's decision, then I think you got to stick to your guns. Yeah, that's good, good stuff. The benefit that we that we touched on earlier, the optionality, right, of having, you know, kind of being able to kind of reverse this, right, or remove the implant. Was that, was that another kind of big, unmet need that you identified quite early on to? Absolutely, yeah. Removability, which means reversibility of the procedure was critical. So the implant design in particular was, it was designed to allow for removability. And it was always intended to be permanent, but ease of removability is something that is, is, is, important for physicians and patients.

Got it, got it. Thinking back to either your time at biodesign or even early at Zenflow and you're trying to identify like what are the big, the big unmet needs here, are there some things that kind of like help you kind of narrow in on what, what you should develop or maybe sort of tips to really kind of like, I guess, focus a little bit. Because, you know, I'm always reminded, we talk about kind of the unmet need. I'm always reminded me that, that, or reminded of that Henry Ford quote, right? Like I would have listened to people, you know, I would have just built a faster horse or whatever

I can't remember exact phrase you used. But you can see how people would gravitate towards that, right? If I listen too much to people and they don't really know what's possible, you know, I could get stuck kind of building the wrong thing. So any thoughts kind of on navigating that during kind of early stage development? Yeah, I think one thing that we did is you obviously should listen to your customers, right? But you also have to just, there's a benefit to firsthand observation and design drives at home. I think early entrepreneurs, you should, you know, any opportunity that you have to be alongside some of the KOLs in the space or physicians who are working in the field or even nurses who are working in the field or in the operating room,

go and observe firsthand because with that observation, I think you learn, you know, more than you might just what's conveyed verbally. Yeah, that never sees it amaze me, right? Like how much, how many little things you pick on by just being so close to the, to the end user, right? And it could be, could be a physician, could be patient, could be, you know, a different type of stakeholder, they're kind of in that workflow, but like just, the more intimately involved you are, like, it just, it always, there's always, there's always learnings, right, that are, that are picked up. So, yeah, that's good stuff. Let's talk a little bit about the, the clinical roadmap, right? You started, based on our research, it looks like you started the pivotal trial

in 2021 and are now kind of, you know, close to submitting for PMA approval, you know, kind of, again, almost to the commercialization stage. When you think back to your times at FDA, right, sitting on that side of the table now, you know, developing a novel system that gets to the stage of, you know, of a full, you know, PMA pivotal trial. As you've kind of thought, you know, been, you know, knee deep in that that, that, that, that, what are a couple of key things that you've, that you've kind of learned now being on the, on the industry side over the past decade? Yeah. One thing I'll say is that don't necessarily shy away from a PMA path, right? So it's sometimes conventional wisdom sort of dictates the easier the regulatory path, the better off.

you are. And I think, I think, you know, there is a balance there. I think one of the things that we've seen, you might know John Norris. He was at SVB. Now he's at HSBC. He always presents on, you know, the annual health care report. And one thing that I think I've seen very consistently from him in the last like 10 years is when it comes to exits, we actually see even if you have a class two device, oftentimes you don't see the level of adoption that you really expect until you gather clinical data on that device. And so in any case, you're, you know, your look at your medical device is hard. And it takes many years to develop the level of rigor that's required for, let's say, a larger company to consider acquisition. And so don't shy away from the PMA because by virtue of

that you're going to have to do, let's say you have to do an RCT. That's building value. It's building really important value. And you might feel, you know, a little burdened by the regulatory path. But I think it's okay to pursue that because you're, you're building value in the company. And at the end of the day, hopefully that means, you know, greater acquisition potential to. Yeah. Yeah. There's an inherent moat in overcoming, you know, much, much taller hurdles, right, i.e. more rigorous regulatory pathways. So that's really good feedback. When you even take a step back and think about, you know, what companies are truly venture backable. And a lot of cases that, you know, It's not a class two.

In some regards, it could be a class two device. But typically, even if it's a class two device, it's something that's going to require clinical data or a little bit more rigorous, rigorous kind of a reg, rig pathway. So yeah. Yeah, that clinical evidence is everything, even from a reimbursement standpoint, too. Yeah. I'd be remiss if I didn't, if I didn't mention or asked this to kind of on the same topic. But when you think back to your time, right, at FDA and now, you know, now going, I'm sure

engaging with FDA quite a bit, right, over the. the past decade. Any other tips that come to mind, right, on how, you know, industry can do a better job of engaging with, with FDA? You know, one thing that always surprised me on the other side of the regulator table is that businesses often consider, companies like ours consider business relationships with, let's say, supply chain vendors, right? And it's, or even the bank that you work with. And I always, I think that on the other side of the table, it felt like oftentimes companies weren't considering that with the same level of business relationship, as they might with other parties that they're working with.

And yes, they're a regulator and yes, you have to be formal and careful about what you say, et cetera. But I think at the end of the day, it comes down to relationships too. And you have to make sure that you're building a relationship with your reviewer. You know, I was often with my best companies on a text basis, right? And it's just like it's not, that doesn't mean it's not formal, but building that relationship and being, you know, being able to back questions quickly, that's going to be to your company's benefit.

And so take time, build that relationship, build a trust with your reviewer, and that that'll get you a long way. Yeah, that's a good way to frame it, right? Like if you're, maybe if you're not that close to your reviewers where you could maybe fire off a text, maybe you need to take a step back and kind of rethink how you're, you just set a new bar, for how should we be engaging with, text bases. folks at FDA, yeah, TechSpace, invite to Slack or teams, I guess, your choice. Yeah, but joking aside, her name is escaping me, but she brought up something similar. It's been a couple

years to say her on the program, but she's developing a concussion device. And that was one of her takeaways is that she viewed when she went to, I mean, this is back when FDA was doing more in-person meetings, that was maybe like kind of the standard. That, you know, it was always surprising to her, like, other people were just like, you have this pretty important, right, Q-Sub meeting or something like that or whatever meeting it is, right? Let's take a use of an example. And it was very transactional, right? There was no sense of like, hey, my name is Scott. I have X number of kids. I live in so-and-so. Like, there was no like getting to know you kind of, right, or very little of that. And it was like, you know, I actually, she took a little bit of a different

path, tried to get to another reviewers a little bit more. And she said that was one of the things, Oculogica. That was the name of the company. What's her name? I can't remember. I'd have to go back and look it up. But that was really good. It's really good feedback, you know, to know that, like, look, it's, yes, it's transactional to a certain extent. But at the end of the day, it's, you know, you're transacting with people, right? It's people on the other side of the table, right? You know, trying to, in most cases, trying to march towards a similar goal.

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 Premium Members. If you're not a premium member yet, you should definitely consider signing up. Here's why. First, MedSider Premium Members get access

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