Medsider: Learn from Medtech and Healthtech Founders and CEOs - How to Transition from a Consumer Product to a Medical Device: Interview with Rohan Dixit, CEO of Lief Therapeutics

Episode Date: March 24, 2021

In this episode of Medsider Radio, we’re talking with Rohan Dixit, the Founder and CEO of Lief Therapeutics, which makes consumer- and clinical-grade wearable devices for mental health. Rohan is a neuroscientist who started his career as a researcher with Stanford and Harvard. Rohan founded BrainBot, his first company, at age 23. He’s been the CEO of Lief since 2015.Today, Rohan’s going to break down how Lief started, and we’ll get into product development, how he approaches clinical research, why they initially launched their device as an over-the-counter consumer product, and many other topics related to medtech startups. Before we jump into the conversation, I wanted to mention a few things:If you’re into learning from proven medtech and healthtech leaders, and want to know when new content and interviews go live, head over to Medsider.com and sign up for our free newsletter. You’ll get access to gated articles, and lots of other interesting healthcare content. Second, if you want even more inside info from proven experts, think about a Medsider premium membership. We talk to experienced healthcare leaders about the nuts and bolts of running a business and bringing products to market. This is your place for valuable knowledge on specific topics like seed funding, prototyping, insurance reimbursement, and positioning a medtech startup for an exit.In addition to the entire back catalog of Medsider interviews over the past decade, Premium members get exclusive Ask Me Anything interviews and masterclasses with some of the world’s most successful medtech founders and executives. Since making the premium memberships available, I’ve been pleasantly surprised at how many people have signed up. If you’re interested, go to medsider.com/subscribe to learn more.Lastly, here's the link to the full interview with Rohan Dixit if you'd rather read it instead.

I think the trap that a lot of people get into with thinking about clinical products is that because there's such a high regulatory burden right off the bat, you often need to either raise a ton of capital and give up a lot of equity ownership, or if you're not able to do that, oftentimes the idea just dies. And that's a shame. So we were lucky in that we were able to take advantage of releasing a product that was really geared around wellness and stress where we could learn a lot about, well, how could we manufacture this medical law at scale? how can we iterate on the user interface of the app of the device itself when it gives you feedback, what allows us to build a good habit with our patients and our users to ensure compliance and efficacy. And so we were able to kind of bootstrapped into a medical device by releasing and selling a consumer product initially. And then we were, again, I think the theme of our company's journey really is just being lucky to find the right people at the right time to help us guide to the next days.

And so we were connected with great regulatory teams that were able to then take what we had and guide us down the path once we had more data and more funding to be able to release a medical device product, which we released at the beginning of last year under the market. And that's called the LEAF RX, and that's focused on clinical populations. The indications for use are different. But again, we were able to use a lot of the learnings from our consumer device to kind of bootstrap into that. Welcome to Medsider Radio, where you can learn from proven med tech and healthcare thought leaders through uncut and unedited interviews. Now, here's your host, Scott Nelson.

Hey there, it's Scott, and in this episode of Medsider Radio, we're talking with Rohan Dixit, the founder and CEO of Leaf Therapeutics, which makes consumer and clinical grade wearable devices for mental health. Rohan is a neuroscientist who started his career as a researcher with Stanford and Harvard and then founded BrainBot, his first company at age 23. He's been the CEO of Leaf since 2015. Today, Rohan's going to break down how Leaf Therapeutics got started and we'll get into product development, how he approaches clinical research, why they initially launched their device as an over-the-counter consumer product, and many other topics related to MedTech startups. Okay, so before we jump into the company,

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You'll get access to gated articles and lots of other interesting healthcare content. If you want even more inside info from MedTech experts, think about a Medsider premium membership. We talked to experienced healthcare leaders about the nuts and bolts of running a business and bringing products to market. This is your place for valuable knowledge on specific topics like seed funding, prototyping, insurance reimbursement, and positioning a MedTech startup for an exit. In addition to the entire back catalog of MedSiter interviews over the past decade, premium members get exclusive Ask Me Anything interviews and masterclasses with some of the world's most successful MedTech founders and executives. Since making the premium memberships available,

I've been pleasantly surprised at how many people have signed up. So if you're interested, go to Medsider.com to learn more. All right, without further ado, let's get to the interview. Rohan, thanks for joining Medsider Radio, really looking forward to this conversation. Glad to be here, Scott. Thanks for having me. Awesome. So let's dive right in. I told the listeners a little bit about your bio at the beginning of this podcast, but I want to hear it kind of from you. So if you don't mind, give us maybe a high level overview of your personal background as maybe just a slight, sort of summary of LEAF therapeutics before we actually kind of fully dig into your story.

Yeah. So I'm the CEO of LEAF Therapeutics, which is a medical device company that makes wearable patches, smart ECG patches for mental health. So we're a medical device wearable for mental health. And that actually kind of ties into my background. Myself struggled with anxiety and depression as a young adult. And that sort of led me into the field of neuroscience. I was a neuroscientists at Harvard and Stanford studying mental health, as well as mindfulness and how the kind of interplay between those two things seems to occur in the brain. And that was sort of the epitist for leaf therapeutics, what we ended up finding in the laboratory through neuroimaging work and structural imaging work of the brain during a mindfulness meditation was to find sort of

the basis for how self-regulation tends to work in ameliorating mental health conditions. And that was kind of the inception point for our company. Got it, very good. That's super helpful. Always loved starting out with like a high level overview. Hopefully everyone can kind of, you know, that's listening can sort of understand kind of where we may go with this conversation knowing a little bit about you. So on that note, you mentioned that you're at Sanford and Harvard. This idea sounds like it sort of spun out of some research. Can you tell us a little bit more about like how your actual wearable device, how that idea really came to life, you know, take us back in time. And I'm as a follow up and we'll maybe get

to this after the fact. I'd love to better understand your HRV diagnostic technology, because I know that's something that's being implemented in a lot of wearables today, whether it's more consumer devices like Woop or ORA or other kind of more, you know, med tech oriented wearables. So I'd love to learn a little bit more about that technology too. But first take us back in time and help us understand a little bit more about like how this idea went from napkin to an actual thing. Yeah, absolutely. So I think, like you mentioned, a lot of this started in the laboratory looking at mindfulness techniques. And, you know, as a neuroscientist, I think we have a bias as a field to assume that everything interesting about the mind is happening between your errors, right? It's happening in the brain.

But you mentioned heart rate variability, HRV, which obviously is a biosignal associated with the heart. And it turns out that there's actually a lot of emotional information that is represented. by the millisecond time scale differences from one heartbeat to the next. It's interesting because anecdotally, right, we always talk about, you know, emotional states and having a broken heart and having a heavy heart, et cetera. And this is kind of like how we speak about mental health and emotional state. But there is actually some physiological basis for some of these ideas. And the heart and the brain are actually connected in kind of a feedback loop,

whereby a lot of your emotional state is actually your brain recognizing the state of your body, primarily and in large part, your heart. And so what we kind of, what we jumped into with leaf, and by measuring this biosignal, HRV, heart rate variability is, well, one, how do we measure this as accurately as possible in a clinically meaningful way? So you mentioned tools like Apple Watch, the aura, the whoop-in, those are all generally wrist-worn wearables, they're consumer products, and they're designed to measure biosignals with a degree of accuracy that sometimes comes second to ease of use and ease of

manufacturability. But what we've been at Leith has really taken a clinical approach where we have a single-lead ambulatory ECG, actually an FDA-class-2 medical device, where we're measuring HRV at a super-high degree of accuracy, which allows us to make some interesting clinical inferences and perhaps some diagnostics down the line as well. But it also allows this to do because we have such good data coming in is we can get people real-time with feedback, biofeedback on their HRV, this biomarker of mental health in real time. So you can imagine with mental health, right, for example, take anxiety. You may go into a situation where there's a lot of pressure, perhaps you're giving a big presentation,

right? And as you're gearing up for that, you notice or you may not perhaps notice when you first start to kind of build a stress response. And what the leaf device is able to do by tracking HRV is to detect that at a very early phase and give you immediate biofeedback through haptics through a vibrotactile interface built into the patch. It reflects back your biomarker in real time to you. And it teaches you how to breathe and relax

to actually self-regulate that biomarker back into a healthier space and then go about your day. And so what we've done at least kind of innovate on measuring a mental health biomarker at high accuracy, but then primarily giving people real-time feedback so they can actually make little microcorrections throughout their day and improve their mental health and thereby how they interact in their day-to-day lives. That's great. And I want to, if you don't mind, I want to unpack your answer a little bit before we kind of progress with the Lee's story. But let's start out with HRV. And I probably should

have started it out here anyway if I was a better interviewer. But But heart rate variability, for those that are listening that have no idea what this is, or maybe they've heard like loosely described it really don't have any in-depth knowledge about it. Can you give us kind of an elevator sort of pitch, if you will, around HRV, like what it is and why it's so important? Yeah, absolutely. So heart rate variability, HRV is, like I mentioned, technically the little variations from one heartbeat to the next. And, you know, people often think of your heart rate, right, as being, what, 60 beats a minute, 65 beats, minutes and a constant kind of metronome. But what is actually the case is that if your heartbeat is

really a true metronome beating at, say, 60 beats for a minute, consistently one beat after the next, that's actually a very bad sign. You're at high risk for heart attack and all kinds of unpleasant stuff. You actually want variability in your heart rate. And so heart rate variability is a signal of both physical and mental health. It's kind of like this amazing biomarker that's at the intersection of the mind-body connection, which is something that we've been looking for in medicine and psychology, frankly, for 100 years. So what we've done with HRV and what the field is doing just in general is understanding, okay, well, what are the mental health states that correlate with this biomarker and how can we start to tease apart the specific parts of the biosignal

that correspond to different conditions? So, for example, with Leif, we've focused on anxiety, which is the largest mental health condition as our first kind of target. And so what we've been able to do using machine learning and artificial intelligence is actually take this biomarker HRV, which is a great index for a variety of mental health states, and find out what the exact kind of levers are to understand what's happening in a user, both acutely and chronically. For example, their kind of chronic level of anxiety, as well as real time when they're having acute stress response.

And those two things in parallel can allow you to create a digital care plan for a behavioral health patient where you're really understanding where they're coming from, how they're tracking over time, as well as being able to intervene in real time in the moment. So that's kind of the promise of HRV, this ability to understand somebody's wellness, their mental health, and to allow them to improve it over time. And Scott, just really briefly, I think the other thing that is of interest is this concept of biofeedback. I'm not sure if your listens are familiar with biofeedback, but I can give an example if that would be helpful. Yeah, yeah, go ahead. Go ahead. Biofeedback is an interesting technology. I guess it was developed initially in the 70s, you know, as a former researcher myself, I think a general new technologies often get tested on college students because they're cheap guinea pigs for research. So yeah, this was initially studied, I believe, using fingertips temperature gauges. It's one of the earliest biofeedback experiments.

Biofeedback is this incredible skill that allows you to control things about your body that you previously thought were completely unconscious. So, for example, their fingertip temperature, they split these two groups of students into an up-regulation group and a down-regulation group. They said, well, this group number A, you're going to raise the temperature of fingertip. And group B, you're going to lower the temperature of the fingertip, which is impossible, right? We have no conscious control over our fingertip temperature, or so you would think, but it turns out that if you have an accurate, and that's the key word, an accurate measurement of your fingertip temperature, and you're feeding it back to the user or to the patient of clinical subjects in real time, the digital thermometer say,

they can actually learn to up or downregulate something like their fingertip temperature in real time through biofeedback. And that's kind of what the skill of biofeedback is, which is really fascinating, right, and it has all kinds of possibilities. Fingertip temperatures is not that useful. I don't know what you would do with that. Maybe you could kind of like slowly cool down your drink or heat it up. But you can imagine right with a mental health biomarker, which, is what HRV seems to be. If you could learn to be aware of and control that,

it might be really useful as a behavioral health intervention. And so that's kind of the second piece of what LEAF does. We measure HRV at a clinical creative accuracy so that we can give people the ability to do biofeedback and learn how to control it in real time through the patch itself. Got it. Yeah, that's super helpful. And I know just to speak to HRV personally,

Like I wear an oaring cool technology, and I'm actually looking at my data now. And I look at HRV as one of the key kind of metrics that comes from the ore device. And just to kind of put this in perspective for people that aren't familiar with it, like if I drink alcohol as an example, like I have a couple glasses of wine, even just like one or two, like, you know, otherwise, you know, pretty, pretty healthy biodynamic wine in the evening, my HRV will be noticeably inferior to when I don't drink alcohol. an example. And so it is it's certainly a very interesting signal, HRV, not just for kind of like consumer health, but to your point, you're using like a very like high quality diagnostic measurement of HRV and using that as a signal for mental health. And one of the reasons I even reached out to you, Rahan, in the first place is like I'm so intrigued because you're, I'm so intrigued with kind of like what you're doing around like mental and emotional health and using HRV as like a signal

for that because it's something that I personally have always underappreciated, right? And has really kind of like come to fruition or sort of surfaced in a much greater degree in like my life over the past four to five years leading juve, you know, the stresses, the challenges, etc. in running a startup, you know, some of these things that maybe I am, and more me, have, you know, kind of not paid attention to historically, you know, they can kind of bubble up. And, you know, emotional health, mental health is one of those things. And I love the idea how you're trying to quantify that, right, through HRV, but also allowing users of your product to not just like see it and measure it, but also to improve upon it, right, is what it sounds like. And you're using kind of a

sophisticated algorithm to help people actually sort of get control over some of those, some of those issues that may have otherwise been kind of hard, hard to quantify. Is that kind of making sense? my kind of, my personal take on Leaf kind of, does it resonate with you? Yeah, that's absolutely right. And I am nodding along with you, actually, because I can, I can empathize with stress. And I think a lot of people can now, especially, especially in the situation we're in with the pandemic and economic dislocation, it's a time when I think a lot of people are becoming more and more aware of the effect that stress can have on how you do your work, how you interact with your family, friends.

And so it's such an important thing. And it's surprising to me, just as a society that really haven't made understanding stress and regulating stress a core part of how we educate ourselves and learn how to live our lives because it does have such a huge impact on not only our personal lives, but at aggregate societal level, I mean, healthcare costs are probably $300 billion per year and estimated productivity losses due to stress and all of the comorbid self-conditions of stress that come along with it. So I can definitely empathize.

Yeah. Yeah, it reminds me of a, I think a tweet that I saw recently from Julian Shapiro with demand curve and Dell curve, kind of a pretty well-known, you know, digital marketer. but he mentioned like some of the things like like why are these very obvious things that everyone needs not taught in school they they're not no one learns about these things and I think one of them if I remember seriously right was was about around this very topic like how do you actually how do you actually deal with anxiety and stress in in relationships and you know normal sort of everyday experiences you know what I mean it's not something that's never taught you know for most people kind of hard to kind of hard to sort of like understand because it hasn't today been overly quantifiable. It's kind of one of these softer sort of things, emotional and mental health, because it's somewhat difficult to measure. So anyway, I appreciate the background. That's super helpful. Let's use this as a transition to actually dive into kind of maybe some more business lessons that you've learned in your experiences with LEAF, especially considering you came out of like a research lab, right? So, you know, I'm sure you've learned a lot along the ways. One of the first questions I have with you is, is with respect to the first kind of alpha and beta versions, of the leath device. If you can, tell us maybe a little bit more about, like, the signal that

you were finding in research and how you actually began to develop an actual product around it. And maybe frame that around, maybe, you know, keep in mind or frame that around, like, what are maybe some of the one or two things that you would, you want other entrepreneurs that may be in the similar stage to really understand, you know, how to do that right, how to do that the correct way, you know, going from an idea on the back of an Apean to, you know, the alpha, beta version of an actual physical product. I don't know if I know the right way. I can tell you how.

Yeah, so yeah, like I mentioned, and you just alluded to, you know, a lot of this work around biomarkers of mental health started in my time in research labs looking at different neurological conditions and also looking at things like mindfulness and how they affect the body. And initially, the approach that I was taking was looking at. EEG, the kind of electroactivity of the brain. And so all of our initial prototypes and actually released the first product around this was a consumer EEG device that we used to teach people with chronic pain to self-regulate their pain response by wearing this headset. And ended up selling that technology. But what we learned through that process was that if you're looking for a biomarker mental health, like I mentioned, I think, or a little earlier in our conversation, you tend to only look at the brain, but there are a lot of disadvantages to trying to measure

from the brain as a practical matter, right? So one of them, for example, with fMRI machines, you're looking at millions and millions of dollar machines that require super cool magnets and big spaces and technicians, and so that's not something that everyone can do and certainly not real time. And if you're thinking about EEG, which is another way of measuring brain wave activity, well, you know, you can't really move around, you can't even blink without totally corrupting the signal. And so you really limit the ability for a user to interact with the technology and to be in their real life.

Like you think about mental health, right? Your issues with stress, anxiety, depression aren't happening when you're sitting still, like, in a closet somewhere. It's happening in your real life, when you're cut off at work, when you're, sad about a relationship or, I mean, there's so many interactions that happen in an environment where you would want real-time feedback to be able to guide you in the moment, because that's how real learning happens, self-awareness learning happens in the moment by making iterative steps to understand yourself and to understand how to change yourself in different ways. And so,

so all of that being said, it kind of led to initially stumbling upon heart rate variability. And this was five, six years ago, kind of before people were in the way. had really started thinking about heart rate variability as a as a biomarker that might be really interesting. And we started digging into the research around, oh, gosh, well, this biomarker seems to correspond with a bunch of different mental states. You can analyze it in different ways. And so the initial prototypes that we built were in my garage and as this typical Silicon Valley story. So I basically invited a bunch of, a bunch of our hacker friends over to my garage in San Francisco, we started putting together a bunch of different prototypes. We tried to measure heart rate

from the bottom of your soul, inside of your ear, clip to your wrist, all kinds of different places. And the prototype and process, I have some pictures that I'll have to share with you at some point, Scott, but some of them looked pretty funny. One of the initial prototypes was I was dating a nurse at the time that we were kind of going through this process, and she had left her stethoscope on the desk before she went into the hospital. And so I was kind of looking at the stethoscope and thinking like, wow, okay, real-time feedback. How could we give that to a user? And so I took the stethoscope, put it on, held it to my heart. And I was listening to my heart. And I was like, I need to go into the world and just to experience this. And so I couldn't figure out how to attach the sethoscope to me.

And her bra was lying on the ground. So I actually just grabbed this pink frilly bra, strapped it on, strapped the setthoscope on, and started walking around the streets of San Francisco. And that was the first leave. And so San Francisco is a cool city, so didn't get too many weird looks. But your point about unusual prototypes, I think we went through just about every type of iteration until we finally settled on a form factor of a sleek medical grade patch that you wear under your clothing. Got it, got it. And thinking about that, those early kind of origin stories to where you're at now, is there any other feedback that you might give to other folks that are in a similar spot

in terms of how to rapidly prototype an idea? So you can, you know, can I continue on down the development path in the most efficient way possible? Yeah. I mean, I think you said it. The key words rapid. So it's not about making a perfect prototype. It's, I think, about tiny iterations that do. you something that allow you to get to the next iteration as quickly as possible. And so, you know, I just mentioned, you know, literally hacking together's stethoscopes and just random devices we use duct tape. We really focused on, I think, decreasing this cycle time in order to have clearly defined learning

objectives where we're trying to understand in an iterative way, what are the goals that the device needs to fulfill, and how are we best able to do that, given the material design, given the electronics, and given the software and the firmware that we have available to us to do calculations in real time. And so I think you need to think about things in a holistic kind of way. You need to think about speed and rapid cycles, but it helps, I think, in that process to be creative, but also to have people involved that have a deep expertise in one or all of these different areas, whether that's hardware, software, sensors, et cetera, because without that kind of that baseline, I think it's very difficult to be able to quickly make kind of adjustments in real time.

Got it. And at the time, like, you know, going back to, you know, what would have, it's probably been four or five years ago. Now we're recording this conversation early 2021. So that's probably a semi-accurate time frame. Like, let's call it maybe like 2014, 15, 16. Like, you're, obviously this is a startup. I'm not entirely sure, like, if you've raised capital at that point. But how are you effectively able to kind of, you know,

curate, if, you know, for lack of better description, a group of those kind of experts, right? Those hardware experts or maybe even some software experts to help you kind of dial in on those, on the early versions of the leaf device. Yeah. And I think that is my, be a challenge for a lot of people. You know, you're looking around thinking you have a great idea,

some ideas for how you could turn that into a commercial product, but maybe not all the, all the pieces, all the skill sets quite yet. And part of our approach was actually just sort of lucky. You know, I myself have a software background. A lot of my friends are hardware engineers, biomedical engineers. So I think being part of communities like you find in San Francisco in the Bay Area where there is a high density of technical talent can be helpful, of course. But I think in general, you know, passion goes a long way. And so what people really respond to, especially at that earliest prototype stage, right, is you as a human being, your passion, your integrity and why you're doing this. The why is, I think, a big reason in medical devices in general, right? And the nice thing

about the field that we're in is that, you know, ideally when you're making a product to bring to market, you're actually helping patients real lives, it's not saving lives. And so that can be, I think, a really strong motivating factor and can allow you to bring that team together, even if you don't have all the elements of it right off the back. Got it. So what I'm hearing from you is, like, what was instrumental for you at the time is obviously it helps being in a dense sort of ecosystem like the Bay Area. And I think most people think of software, but, you know, there's a lot of, like, hardware, especially med tech hardware expertise, engineering expertise in that part of the country. What I'm hearing from you, Rohan, if I can kind of summarize, is like being able to

curate kind of that community around what you're trying to do has a lot to do with the why. You know, if it's something that is like you can, you can effectively tell people about the purpose, division, why you're so interested in this topic and be passionate about that, you know, that, that, you know, can lead to, you know, people that may otherwise not be overly interested in your thing, you know, begin to help you out, you know, throw you a bone in those early days. Am I hearing that right? That's absolutely right. And, you know, Scott, that led for us to, you know, eventually taking our prototype to a hardware venture capital group called HACS, which is great.

I highly recommend them. They basically were able to invest the first seed capital into the company. We actually went with them to Shenzhen, China, where they have a whole ecosystem that they built. They're based in San Francisco and in Shenzhen and China and back and kind of at that interface of learning how to take a prototype and manufacture it. scale. And so I think that what we were able to do was, which is really lucky, I think, is connect with people at the right stage to help us get to that next milestone, even if we couldn't quite see exactly how we would get there. We were lucky to be introduced to people that could help us along the way. Got it. Got it. Super helpful. Let's begin to kind of talk a little bit more about

maybe the next phases of leaf. And where my head is going is largely kind of around the regulatory and maybe clinical aspect of your hardware, considering it's a, you know, it's a full-on medical device. And I know Leif, and feel for you to correct me if I'm wrong, but I think Leif is is available over-the-counter to consumers, you know, direct-to-consumer, someone could buy it from your site. But it's also, it appears to be kind of a device that's positioned for, you know, kind of clinical monitoring with healthcare practitioners as well. So can you tell us a little bit more about how you've navigated those two kind of size at the table, so to speak, right?

the direct-to-consumer kind of over-the-counter aspect, as well as kind of the more, you know, clinical sort of more regulated aspect of working with practitioners. Yeah, absolutely. So we launched our initial product as a consumer device, and we actually crowdfunded it on Kickstarter. And so that was really good. Oh, did you really? Okay. We did.

Yeah, yeah. And that's a stress and anxiety product, really. And I think the trap that a lot of people get into with thinking about clinical products is that because there's such a high regulatory burden right off the bat, you often need to either raise a ton of capital and give up a lot of equity ownership, or if you're not able to do that, oftentimes the idea just dies. And that's a shame. And so we were lucky in that we were able to take advantage of releasing a product

that was really geared around wellness of stress, where we could learn a lot about, well, how could we manufacture this medical device at scale? How can we iterate on the user interface? So the app of the device itself, when it gives you feedback, what allows us to build a good habit with our patients and our users to ensure compliance and efficacy. And so we were able to kind of bootstrapped into a medical device by releasing and selling a consumer product initially. And then we were, again, I think the theme of our company's journey, really, is just being lucky to find the right people at the right time to help us guide us to the next

phase. And so we were connected with great regulatory teams that were able to then take what we had and guide us down the path once we had more data and more funding to be able to release a medical device product, which we released at the beginning of last year under the market. And that's called the LEAF RX, and that's focused on clinical populations. The indications for use are different. But again, we were able to use a lot of the learnings from our consumer device to kind of bootstrap into them. I absolutely love that.

And I think so many traditional med tech companies, and again, I'm not speaking from my own personal objective. So for those listening, take it with a grain of salt, right? But I've seen this firsthand, even with how we initially rolled out our first devices with Juve, is that anyone who's ever been in a startup understand the idea that you need to, it's ideal to ship product, right? To get product in the hands of consumers as early as possible, right? Everything else kind of pales in comparison to that feedback. And I love the fact that you initially line. I'm not sure if that was strategic or if you kind of in retrospect sort of thought that you guys kind of stumbled upon the right path forward. But I love the fact that you kind of shift early, so to speak, right, with a consumer, more of a consumer grade wellness product, learned a ton.

And that allowed you to maybe, you know, raise additional funds or to kind of pivot into, you know, a more capital-intensive, you know, med tech play. So I love that. I love that fact. So I'm not sure if there's anything else you want to add to that real on. But I just don't, I understand it now. You still have two products, one that's positioned, one. more as a consumer product than one one that's the leaf RX, or do you just have the leaf RX now? We do have those two products still available.

That may be something that we try to bring closer together over time. But, yeah, I mean, I think that it's worked out well for us so far. And, yeah, I know that this may not be a path that necessarily everybody could take. You're building an implantable cardiac defibrillator. You know, you probably can't release out of a wellness product. but it has worked really with for us, and I do recommend it if you're able to. Yeah, and just on this note, because I think it's an interesting topic, and it's one that I maybe am maybe a little bit more nerd, I get nerdy about, because I think there, even if you have,

right, a, let's take a class three device, right, whether there's a planable or something that would maybe even require a PMA pathway or a Genova pathway, like, that doesn't mean that you necessarily have to, like, sell a product to a consumer to get feedback, right? I think it's just so valuable to get something in the hands of consumers as early as possible. Right. So as an example, let's say you do, let's say you have some sort of innovative orthopedic implant as an example. Like what is the lowest cost way to actually get something tangible in the hands of a consumer to allow them to just get you feedback, right? Maybe it's a 3D printed model of some type, right?

To a group of, you know, 55, 60 year olds that are considering, you know, a hip replace that are knee replacement. I'm kind of just talking out loud here, but I just love this concept of like thinking creatively about how to ship early in essence, right? Maybe there's not an economical transaction there, right? But just getting your idea and making it tangible, right, for your perspective audience. So I think it's awesome that you guys were actually able to do it early. I mean, your product lends itself in a way that may be a way that's not otherwise attainable for other METTEC companies. But I love this idea and you're a great example of how, how,

all can be done for sure. Absolutely. Absolutely. And there's always, like you mentioned, things that you can test. You can use the, if your product has an app, like how do users engage with that. If you're selling primarily to doctors and to physicians, then you know, you can talk about the value proposition. You can get them through pre-de printing models. I mean, you're absolutely right. Any ways you can kind of move the ball forward and keep learning quickly is I think the name of the game at this early phase, right? Because the truth is 90% of startups are going to fail. And so the faster you can go through that process, I think the better off you are. Yep, 100%.

And I know, like, this is like, it's not rocket science, but I think so many people get stuck, like advancing the development process sort of a bit in a closed door, you know, and then they come out every now and then and get, you know, voice of customer feedback. But in reality, they could be kind of building in public and maybe not entirely in public, but they couldn't be building in public, if you know what I mean. And a lot, that would probably improve them a lot, especially in the early stages, for sure. But yeah, let's, I know, I know we're running a bit up against the clock. So I want to kind of fast forward to some of these other other questions because I think

the audience is really going to be interested to hear your take on it. So let's talk a little bit more about, I want to ask you a little bit more about your approach to insurance coverage and reimbursement with your kind of with more of your, the Leaf RX device. But before we go there, you've got some, I think, some clinical data on your device. Can you walk us through kind of like how you've approached gathering, you know, clinical evidence? And, you know, are there any kind of interesting learnings that other folks can gather about how you've done that in a cost-effective or efficient way? Yeah, happy to share what we did.

It's helpful. So, you know, we're a technology, heart rate variability biofeedback that has been around in general for 30 years. And so we've been lucky to work with some of the original inventors of that technology throughout the development process to help us take some learnings from, you know, decades of clinical. research on our type of technology and apply to the novel form factor and some of the newer and kind of more updated things that we're bringing to the table. So that was, I think, initially very helpful because we're able to, whereas a lot of people who are, I think, creating very, very new types of technologies where there's just not a lot of clinical evidence, you're kind of throwing a Hail Mary. There's a lot of, there's a lot of guests work that you need to do at an early stage

to bet on the technology up front in order to hopefully on the tail-end clinical trials come out with good data. And so to the degree that you're able to leverage existing clinical research, even if it's just to build confidence yourself that you have something that's going to bring value to patients and to clinicians, and I think that's ultimately very helpful. In terms of our approach to clinical trials, we have been barely nimble, I think, compared to maybe some other ways that you could go about collecting clinical trial data. And so we chose to do distributed clinical testing of our product. And so we're publishing now our first kind of pilot data around using the leaf device

with our full kind of leaf program, which also optionally includes coaching from health coaches. And so the way that we ended up kind of bringing that to market was actually similar in a lot of ways that to the process everyone goes through, IRB, etc. But we were able to leverage some of our consumer learnings in terms of how do you get in touch with a large number of people, how can you kind of open up the funnel of potential patients that would be interested in enrolling in a clinical trial to lots of folks instead of, you know, the traditional approaches, which sometimes that are hard, end up kind of a little bit slower to recruit patients. And because we are a totally remote

device. We were able to very quickly, I think within 48 hours, recruit all the patients that we needed online, and then immediately send them devices through the mail being a fully remote product and collect an asynchronous and fully remote data set, which really brought down the costs. You don't have to necessarily have an in-person location to run a trial. So that was basically our approach. Great. I love that. Did you do that when I say that, the work, right? this kind of decentralized kind of virtual clinical trial study increment and management. Did you do that all internally or did you work with kind of an outside partner? We had consultants, but we did a lot of it internally as well.

Our team had a great academic background and training and my background in academic research as well, I think was helpful. And we were able to do it on a shoestering budget. Well, maybe not quite shoestering, but I think less than you might think it costs. on a clinical trial. That's awesome. That's awesome. I love it. And for those that are more interested in this topic of like how do you, how do you potentially maybe even turn a clinical study from a cost center into potentially maybe even a break-even or profit center, highly recommend the interview I did with Matthew with proof pilot, which is kind of an innovative kind of hybrid slash virtual

clinical study SaaS product. And we talked a lot about this very topic. So I highly encourage you to listen to that interview. I know, Ron, we're, we've only got about 10 minutes left. So two other questions before we get to kind of the rapid fire round. The first question is around insurance coverage and reimbursement. So I know we talked a little bit about your, kind of your consumer play, which is probably clearly a cash pay, kind of, you know, consumers pay are paying cash for this product. But with your RX product, the LEAF product, that is kind of more of a health, a health care, you know, it's meant to be used in conjunction with health care providers, is that reimbabre? burst and how have you approached kind of that landscape? It is. And so we've designed the product to,

as a biomarker and monitoring tool to fit into the remote patient monitoring codes that have been released by a center for Medicare, by CMS, and now followed by a lot of private insurers as well. And so that's been the approach that we've taken in the short term. I mentioned just a few moments ago that we also have ancillary services like coaching. We have a partnership with, a large telepsychiatry provider where we're able to, if needed, bring in higher liberal care, coaches, psychiatrists, et cetera, and those are all additional codes that we kind of bundle and stack on top of each other. So that's been our approach. Got it. And is there anything kind of that you, as you went from kind of consumer to this

healthcare play, is there anything about kind of insurance coverage of reimbursement that sort of, you know, was unexpected or, you know, you were, you know, somewhat surprised to learn? You know, this is my second medical device startup, I think, but if I think back to the first, there was a lot that I was impressed to learn. Yes. We don't have enough time. It's got to go into all the surprises that they lay in store for someone just kind of learning about how reimbursement is done in the United States. But it's a complex process. And, you know, insurers are different in how they treat different codes and different regions differ from one another. And so it just takes some time, I think. But all, Ultimately, if you're providing value to the payer to the insurance company, you're helping decrease costs, right? If you're helping the patient with their outcomes, if you're helping the healthcare provider themselves deliver better care to people and maybe even save some time, then ultimately people are going to, the process is going to be smooth for you, or at least smoother.

And so I think those are kind of the North Stars for any medical device company, just trying to make sure that you're providing value people. Yeah, and I would completely echo that sentiment. And maybe one of the things that stands out to me right away is like with the LeBRX product specifically, before even going probably down that path too far, you already sort of understood that it fell under this remote monitoring kind of coverage and reimbursement umbrella. And there's so many other MedTech startups that I think don't make that a crucial kind of variable up front, right, before they go down, you know, the development pathway is really understanding what coverage and reimbursement looks like.

you know, because the reality is if a device or product isn't covered or reimbursed, I mean, access in most cases is going to be really, really challenging. So, yeah, tons of lessons to learn there, but for the sake of time, we won't go too deep. But the last question I had kind of around really kind of the overarching kind of narrative around Leaf and your story here is funding. I know you mentioned you participated in early on, I think, in some type of incubator program. But can you help us understand a little bit more about the lessons you've learned raising capital for Leaf therapeutics?

Sure. Yeah. I think I can share I guess the learnings that we've had and we're just one startup amongst many and one company amongst many so I don't know how Apple these will be across the wide audience but one of the things that I've learned

is just having an extremely high degree of integrity and honesty and transparency I think in talking with investors and everyone really in life but particularly in the investment space I think is really important. Oftentimes you're meeting someone or you're meeting a group of people who need to rapidly develop trust with you as an entrepreneur and as a company. And just the basis, the kind of context of any new venture is that there's a lot of unknowns, right? And so being able to be

very upfront about what you don't know and where your failings are, I think is maybe counterintuitably an extremely helpful thing to bring to the table. And so that's one learning that might be helpful I love that. It reminds me of a comment that Bruce Shook made in a recent interview I did with him. He exited his most recent startup to intact vascular to Phillips, and is now with running Vesper medical. But he mentioned something along those same lines, but within the context of FDA. He was like, everyone understands that if you're pursuing a PMA, that PMA pathway, there's going to be some warts along the way. And if you're proactive in addressing those up front and not waiting until maybe some of these wars are discovered on the back end, you're going to be

so much better off. And you're going to garner so much more respect and support from, whether it's from regulatory bodies like FDA or from investors like you called out. So certainly appreciate the sentiment. And then let's actually, let's use this time. I know because we're up against the clock here, Rohan, but before we get to these rapid fire questions, is it best just for, and I'll link to this in the show notes for this interview, but best to, yeah, if folks want to learn more about what you're doing with Leaf, go to the website, which is getleaf.com. That's G-E-T-L-I-E-F.

So Leif is not how you maybe normally spell it. It's get-leaf. G-E-T-L-I-E-F.com. Is that the best place where people should learn more about what you guys are up to? Yeah, anyone that has questions. I would be happy to connect to answer them.

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You can feel free to provide rapid fire answers, or if you want to expound a little bit, that's totally fine as well. So the first one is for someone that is starting kind of their entrepreneurial journey, right? They've made the, they're going to make the lead to the world of startups, kind of in the med tech or healthcare space. what's probably the single most important thing that they should know? Interesting. So as someone that's just kind of starting into the med tech space, yeah, what would be the most important thing to know?

I think understanding the patient pain and the provider pain is, I think, a really helpful question to assess before you get started. And looking at those folks and understanding are you really solving a critical need for them? Got it. Got it. The key part of that being critical, you know, it's not just a Band-Aid fix, but something they, you know, they need a doctor for, you know, pain they need a doctor for, punful intended. So, next question. Are there any influential, you know, books, podcasts or other resources that have been, you know, very, very helpful in your kind of entrepreneurial adventures, anything that comes to mind right away? You know, I would love to, I would love to plug some books and podcasts here. Your podcast is. it was a great one amongst them. I think I've been lucky that I've just been introduced to people that have been incredible mentors and guides throughout the process. And it's really, you know, I've learned a ton from them. And I don't think we would have come this far without,

without really great people around us who were able to guide us. Got it. On that note, Rohan, is there anyone that stands out from your opinion? Any folks that have been particularly helpful or inspiring? Gosh, yeah. There's a long list. You know, we've had, investors, former entrepreneurs who have helped guide us through all kinds of tricky situations that we had no experience with at the time. And great regulatory people, too. So I couldn't take just one person, Scott, I don't think, but I would echo that this is a long journey and it's a complex space and having the right people around you is really important. So in whatever ways that you can bring those people into your network, even if it means giving up a little equity

or finding a way to make it work, I'd just highly recommend that. Got it. I love it. And it's certainly a marathon. There's no doubt about if you're operating kind of in the healthcare, you know, whether it's med tech or health tech or what have you. Certainly a long journey, as you put it, well said. Two last questions. If you could teach a class on one thing, you know, whether it's a semester long class or maybe it's just a small workshop, is there a topic that stands out that you'd love to teach others on? Yeah, I would love to teach folks about deep learning artificial intelligence in general as it applies to predicting patient outcomes from biomarkers and data.

I think that that's such an underutilized kind of part of medicine at this current time. But I do see over the next 10, 20 years, us being able to make a lot more inferences in a semi-autominated way based on slapping a sensor on somebody. And so I think that is something I would love to share with more people. Got it. Awesome. All right. Last question. Starting over in your, you know, maybe your mid to late 20s.

Well, I know you're a younger guy, Rohan. So maybe let's call it mid-20s. Knowing everything that you know now, right? Is there anything that you would do differently? Gosh, yeah, I started my first company at 23. So I, but I think, what would I do differently? Oh, it's the last question. And there's not much time left.

So I don't know if I can. into the case that I've made. But one thing that I would do differently is seek out mentors earlier in the process. I think I learned late. When we first kind of started this entrepreneurial journey, I thought that I had all the answers and that I could figure it out. And, you know, hey, you may be able to as a really smart entrepreneur. I mean, I know there must be dozens or hundreds of them listening to this podcast.

You can figure out a lot of stuff. The time that it's going to take you to learn things. on your own is just time that you don't have. And so if there's anything that I could turn back the clock and change, it would be seeking out people who had done the process before, who had taken a company from the initial phases all the way to exit, and just learn from them right off the bat that I think it would have saved a lot of time. Yeah, that's one of the themes that I'm gathering in this interview is like,

you know, finding the right people to kind of to work alongside is crucial. And that's not rocket science. I think most people that are listening to this have some sort of startup experience. or like are in kind of the startup world kind of understand that. But, you know, as, you know, as a follow-up comment, like I think it's, and you mentioned this kind of subtly earlier, is find ways to get those people around you. Find ways to get them involved. You know, maybe it's, maybe it's giving up a little bit of equity if you don't have,

if you don't have the capital. But find, you know, find creative ways to keep those, to incentivize those folks and keep, you know, make sure they're aligned with what you're doing. It seems like that's kind of a theme of the conversation so far. Rohan, I think we're up against the clock here a little bit, a little bit over time. So I can't think enough for coming on the program. For those listening, I'll have you hold on the line, Rohan. But for those listening, if you want to learn more about Leaf and what Rohan's team is doing,

go to getleaf.com, G-E-T-L-I-E-F dot com. If you're digging these types of interviews with startup folks like Rohan, go to MedSider.com. Don't forget about that. If you're new to MedSider, go to MedSider. Go to MedS-I-D-R-M-Sider.com and subscribe to the free newsletter. or we'll let you know every time a new discussion like this goes live. So go to the MedCenter.com and enter your best email there.

Rahan, was there something else you wanted to say? No, I just wanted to thank you, Scott. It's a pleasure speaking to you. And, yeah, I hope that this was helpful for some of the flooding entrepreneurs out there, our folks that are further along in their journey. It's important, I guess the last thing to say is just to have fun. I think, you know, that often gets lost in the shuffle. And so, yeah, it's great speaking about some.

with us and thanks for all the wonderful questions. I appreciate.