Medsider: Learn from Medtech and Healthtech Founders and CEOs - Why Design Thinking is Crucial for Medical Device Innovation: Interview with Madorra CEO Holly Rockweiler

Episode Date: March 15, 2022

In this episode of Medsider Radio, we’re sitting down with Holly Rockweiler, co-founder and CEO of Madorra.Holly spent the early part of her career working as a research scientist for Boston Scientific. In 2013, she took a fellowship at Stanford University’s Byers Center for Biodesign, where she met her future business partner, Ryan Krone. Through the fellowship, Holly and Ryan developed Madorra, a non-hormonal medical device that treats vaginal dryness. As co-founder and CEO of Madorra, Holly’s on a mission to improve women’s health. In this episode of Medsider, Holly discusses the importance of listening to your patients when developing medtech solutions, and why having a cause can be a valuable motivator. She also shares her most valuable learnings from participating in Stanford's Biodesign program.  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. If you’re interested, go to medsider.com/subscribe to learn more.Lastly, here's the link to the full interview with Holly if you'd rather read it instead.

So we had actually kind of way overshot on trying to solve all these problems in a form factor that nobody was really going to adopt because it was too different from what they were using. So that was an interesting learning for me and just kind of having to walk that back, you know, to still address the problems. But give them something that they're used to, you know, the departure from what they're used to to what they're going to use now can't be so vast. Welcome to MedSider Radio, where you can learn from proven medtech and healthcare thought leaders through uncut and unedited interviews. Now, here's your host, Scott Nelson. Hey, everyone, it's Scott. In this episode of MedSider, I sat down with Evo-Indo CEO, Dr. Heather Underwood. She's a medical device and health technology entrepreneur with a highly diversified background at the intersection of computer science, global health, human-centered design, education, and international development.

Heather is passionate about the healthcare space and innovative ideas that lower costs, empower patients and physicians, and improve health outcomes. Here view the key learnings that we discussed in this conversation. First, you don't need to come up with something new, and you're most likely not going to. But you can examine the problem you're trying to solve, take key learnings from others, and create something unique that's a mashup of different concepts that ultimately meet your patient's needs. Second, stay open and be creative when it comes to fundraising. It doesn't all have to come from venture capital.

For example, angel investors can provide more than money. Their care and emotional investment means they're in it for more than financial returns. Third, the FDA is definitely a hurdle and 510K clearance is something we're celebrating. But it is not the end of the race. Figuring out reimbursement can make or break a company. The earlier you start to think about it, the better. Okay, so before we jump into the discussion, I wanted to let you know that we just released the first volume of Medsider mentors. A print-based book that summarizes the key learnings from my favorite Medsider interviews over the past six months.

Look, I fully realize it's tough to listen or read every Medsider interview that comes out, even the best ones. But there are so many valuable lessons you can glean from the founders and CEOs that join our program. So that's why we decided to create Medsider mentors. It's a way for you to learn from the best thought leaders in our space in one central place. Here's a teaser of what you'll see in this first volume. Gar Hong Kong, founder of HealthQuest Capital, teaches you how to successfully pitch your startup. Patricia Ziliak, CEO of Ivinsons, discusses what you really need to know about clinical trials.

Jared Bauer, CEO of Ionic Sciences, shares best practices for avoiding obstacles in your startup journey. That only scratches the surface, so if you're interested in learning more, head over to Medsider Radio.com forward slash mentors. If you're a premium Medsider member, you'll get free digital access and a print version sent straight to your door. 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. This includes conversations with experts like Erica Rogers, CEO of Silkrow and Medical, Dr. David Albert, founder of LiveCore, and so many others. Learn more by visiting Medsiderradio.com forward slash mentors.

Again, that's Medsider Radio.com forward slash mentors. All right, without further ado, let's get to the interview. All right, Heather, welcome to Medsider Radio. Appreciate you coming on. Thank you. Nice to be. Yeah, I'm glad we were finally able to make this happen after a few rescheduling kind of incidences. But I know you're knee-deep with Evo-Indo in the midst of commercializing your technology. So really, I think it's going to be a fun conversation to go a little bit deeper about what you've built and what the team is doing currently. But before we go there, could you give us a high-level overview of your professional

background before taking on the CEO role at Evo? Yeah. And thanks again for having me on the podcast. So before Evo Epo Eendo, it's a pretty non-linear path. I have done a lot of different things leading up to where I'm at now. Immediately prior to this, I was at the Stanford Biodesign Fellowship Program, so 10 and a half months of intense training on how to become a medical device entrepreneur. So that was really what opened the door and got me involved with Eboendo.

But prior to that, I was actually a professor at the University of Colorado building interdisciplinary initiative focused on innovation, prototyping, entrepreneurship, with really that passion of working at the intersection of healthcare and technology. That was really, you know, what I did for my PhD work. I was doing a lot of work in obstetrics and nursing and writing software programs for them. And that was mostly done in Nairobi in Kenya, actually. So yeah, I seem to find interesting things to do and just go where that takes. me. That's great. And your undergrad you did at University of Washington. Is that right? I did. Yeah, in computer science. I started getting into the international development angle there

as well. I was actually doing a lot of work in Bangalore in India. In public schools, developing interdisciplinary collaborative game systems for kids in public schools. That's great for your time. Hopefully we can talk a little bit more about that because I was reading on your LinkedIn profile, kind of reference to like a pectograph. Am I, is that right? Am I saying that right? Part of graph. Part of graph. What is that, I guess, for those like me that have no idea what that is? Yeah, it's a paper-based clinical decision support system. So it tracks maternal labor over time. So essentially there's a number of graphs on the form. And you measure fetal heart rate, maternal heart rate, cervical dilation, and a number of other vital signs

during labor. And the idea is that if you're tracking them regularly, you can actually anticipate if a woman is going to have obstructed labor, which puts her at higher risk for postpartum hemorrhage. And so my PhD work was really focused on enhancing that form with some digital pen technology. Okay, cool. That's awesome. That's awesome. All right. So you went through the biodesign program, right? And I know we were going to have Joel on the program, but the schedules didn't align, who's your chief medical officer and co-founder of Evo Indo. But let's talk to us a little bit more about that transition from the biodesign program into Evo Indo and how this technology kind of came to be.

Yeah, so the company was founded out of the Children's Hospital of Colorado. So Joel and the other three co-founders, two pulmonologists and an E&T physician, and then Joel, who's a pediatric GI, we're all working together at the Aerodigestive Medicine Program, at Children's Hospital of Colorado. And really, it came out of this need. They were putting kids under general anesthesia for these endoscopic procedures. And so the Aerodigestive Medicine Program

had kind of tried to solve the problem by only putting the kids under general anesthesia once and doing what they called a triple scope. So for these complex airway conditions, you know, all three specialties could actually do their exam once. So you're not putting the kid under general anesthesia multiple times, which has a bunch of risks and cost, obviously. And so Joel, our chief medical officer, was looking at his E&T colleagues, and they do unsidated transnasal laryngoscopy all the time.

And then his pulmonology colleagues had these really, really thin broncoscopes that were small enough to go through the nose and long enough to get into the esophagus. and he was like, I wonder if I could just do the whole procedure unsidated, you know, for this upper GI procedure. And so he kind of cobbled together these off-the-shelf pieces and realized that he could do a complete, well, not a complete esophagoscopy. So just into the esophagus GI exam, completely unsidated on patients, you know, as young as five. And so that was really when the feasibility of doing the procedure was proved out. And then they needed a system, you know, obviously cobbling the these pieces together is not ideal and very challenging for other hospitals to do. And so that was the Evoendo was born, so to speak. Yeah. And so it was founded in 2017 and I came on board in late

2019. And at that point, you know, they had really gotten a long way on developing a prototype, but didn't really have a lot of the regulatory strategy in place, you know, kind of where we were going as a business, what our core value proposition was. And so that's really where I picked it up. Got it. I love those ideas that where you're kind of you're stealing from other spaces, so to speak, and then sort of like combining them into a new innovative solution. It's like those are the best, it's where typically a lot of the best ideas come from, right? I'm a big fan of Austin Cleon's book, Steal Like an Artist, right? Which is, you know, kind of covers this concept, right?

Whereas it's like, it's not, typically there's not like a lot of, like, world-renowned creativity. It's like an insight from like, in Joel's perspective of like, oh, they're doing it that way over here. and oh, my colleagues over here are doing it this way, can we combine them in, in order to create a better solution. So yeah, most new ideas are not new. Right. Oftentimes they're just mashups of other ideas. Totally.

Totally. Yeah. That's great. So before we kind of talk about where you're at now, current, like if I'm a, if I'm a patient, I've got some GI disorder, maybe it's upper GI disorder. Currently, I go to a gastroenterologist and I have to, I go under general sedation, correct? That's kind of like in a standard of care right now? So in pediatrics, it's full on general anesthesia.

So for adults, it's typically conscious sedation, similar to what you would get for a colonoscopy, for example. So it still takes a whole day your time. Got it. Got it. And you're because of the innovation in your system is being able to deliver these instruments through the nose and transnasal, which would, in, in order to avoid, you know, anesthesia altogether then. exactly yeah so just a couple of squirts of lytocane you know in your nose and the back of the throat and then you know they our scope is so small and optimized for a full trans nasal eGD so our scope is actually much longer than the broncoscopes so a GI could actually get into the stomach and

small intestine it opens up a lot more diagnostics that you can do um without sedation or anesthesia okay so yeah you'd come in with symptoms essentially and you could have your trans nasal endoscopy done in clinic that day. You wouldn't have to reschedule another visit six weeks out, you know, with all the sedation anesthesia. Right. Cool. That's great. My mom actually spent her and most of her career as a GI nurse. And so when I was looking at your site and trying to better understand the technology, I was like, oh yeah, kind of, you know, I sort of know enough to be dangerous here to kind of see what, see what you guys are doing. So that's, I'd love to hear her. Yeah, that's really cool. Yeah, yeah, yeah. I'll definitely send her, send her the, the,

the interview once we go live, I think she'll probably probably find it fascinating. So before we kind of step in inside the sort of the Medsider time machine, right, and learn a little bit more about kind of the story leading up to this point. Give us a sense for where Evoendo is currently at. I know when I go to your website at evoendo.com, there's a little banner, right, that, you know, where you're calling out the 510K clearance. So congratulations on that. I think that happened earlier earlier this year in 2022. But give us a sense kind of where the company's at right now. Yeah, we actually got FDA clearance on Valentine's Day this year. So that was a nice gift from the FDA. And then we had really done a lot of laid a lot of the groundwork to start our clinical cases pretty much right away. So we had five KOL sites, you know, physicians that, you know, know, no Joel and had tried to start transnasal endoscopy programs. And we've been talking with them over the last few years. And so they were the first. wants to use our system in patients. All of those cases went really well. We were very happy with

how the system performed. And, you know, one of the examples that I love is at one of the hospitals, they essentially put us in a closet that had a bunch of other like, you know, equipment in it. And, you know, it's just stuff they needed out of the way. And we turned that room into an endoscopy suite in about 20 minutes. Our system is just very portable and it was great. So, And I mean, we have a lot of stories now from clinical cases, you know, young kids who haven't previously been able to get scoped because they were too medically fragile, for example. And so our system allowed them to get the diagnosis and the look that they needed. And so it's really just been great.

You know, I think this is what we've been working towards the whole last five years, essentially, to actually get this technology to patients and provide the value and the benefit of an unsidated alternative to these upper endoscopies. So we got through our first 25 clinical cases, which was really sort of our physician preference testing phase, our evaluation. And now we're in commercial soft launch. We have about 50 sites that were going out, the majority of them pediatric, but we also have adult sites in that list as well. Obviously, smaller scope. Pediatric noses are much smaller. If I'm an adult, I'm going to want the smaller scope in my nose as well. So huge adult.

value proposition there as well. So that's, that's where we're at. We're full on looking at sales and training, doing a lot of the market development efforts with our clinical team. And building out the team overall. Exciting, exciting time. I mean, five years ago, the company was sort of like founded, right? You come on, what, three years ago, is something like that. We're recording this in August of 2022 and you're in the midst of a soft commercial launch, you know, getting to see this technology right in the hands of physicians and impacting patients' lives. That's pretty, that's pretty cool time for sure. So with that, with that said, let's jump, let's jump into, let's, let's rewind the clock here a little bit and jump into kind of some of the early days of Evo ando. And you

mentioned earlier, Heather, that you, you came on board and there was some semblances of a working prototype. Maybe you'd cross sort of like the technical feasibility kind of phase, but it sounds like for my, these are my own words, right? You came into kind of sort of shore up things, right? Build a better foundation, set the strategy, you know, the go forward strategy. Let's talk about some of those early, those early devices, right? Maybe you had your alpha. Like, what are, what are some of the key lessons that you learn kind of going through that at Evo, Indo? And maybe kind of frame that around just your thoughts on this in general, right? You spent almost a year at the biodesign program. You sort of taught, you know, taught this, right, at the, you know, as a professor.

So, you know, give us an idea of kind of your thoughts around where most MedTAC entrepreneurs kind of make mistakes kind of in this early concepting iteration phase. Yeah. And, you know, I think this is one of the areas where maybe med device differs a little bit from, you know, other, industries, other sectors. What we found was that, you know, we tried to be really innovative. Like, we tried to solve all the problems and make, we made, or some of our early prototypes were just these, it didn't even look like a scope. You know, we were trying to be so creative and so innovative and different from what, you know, physicians were used to using to address all these problems that we had saw, you know. And so we started doing some user feedback, you know,

like getting people to evaluate the prototypes and, you know, just kind of have them in their hand and play with them. And it was not intuitive to them at all. So we had actually kind of way overshot on trying to solve all these problems in a form factor that nobody was really going to adopt because it was too different from what they were using. So that was an interesting learning for me and just kind of having to have to walk that. back, you know, to still address the problems, but give them something that they're used to using, you know, the departure from what they're used to to what they're going to use now can't be so vast, right? You know, and I think, I think my PhD work demonstrated that as well, you know,

like we didn't come in with a cell phone technology or a new partograph on an iPad. We came in with the digital pen, so they're still using the same paper form. So the departure from what they're using now, closing that gap while still solving the problem, I think is where real innovation plus usability and adoption later meet. Yeah, that's such a good point. We're, one of the companies I'm involved with Crossfire Medical, which is developing devices for chronic weakness insufficiency, so little, little catheters that go inside a vein, the goal is to close them down. We experienced something very similar, right, where you've got an incredibly talented group of engineers that can come up with almost like everything possible, right? I mean, within reason. And tons of great ideas,

tons of potential features. But one of the things that, you know, as we kind of tried to try to narrow the focus down is thinking about usability, right? Like when we, you know, to kind of achieve commercial adoption, it can't be that different, right? You know, and if it is, if it is significantly different, you've got to like bake in a bunch of training, right? And a lot of, a lot of resources and work around around changing some behavior there. So I think that's a really phenomenal point around. Yeah. Correct.

Oh, no, I was just going to say, just around, like, you know, some people would think they naturally gravitate towards like, you know, the most innovative, creative, like, thing, right? But thinking through kind of some logistics and like what that sort of roadmap looks like is crucial, you know, so. Yeah, and I was just going to say, I think it dovetails into how we think about regulatory strategy also. You know, our device is a 510K, you know, class.

two device, which relies on having a predicate, obviously. And so, you know, we shifted our strategy a little bit when we were thinking about how to submit our 510K application to not look that different, right? You know, we wanted to stay in that 510K realm for our application with the FDA. And so we actually had to kind of think through that in that early prototyping phase, you know, And it really impacted our strategy, you know. And I think that we were successful getting FDA clearance in the timeline that we did because of the way we were thinking about that early on. Right.

Yeah, that's so, that's so smart. It sounds like you, yeah, whether you were driving that or you had kind of a team, a team around you to kind of think through that. That's super smart because it's like those are, from my perspective, those sometimes are like healthy constraints, right? Like you want to establish substantial equivalence. So on paper, they kind of have, you know, the more similar the better, right? But at the same time, you're kind of thinking around, you know, how to solve, like, clear pain points.

And that couldn't have been easy with a system like yours because it is really innovative, right? I mean, you're delivering, you know, a lot. You're delivering, you know, these, you know, these, you know, scopes, you know, an entirely different way, right? So it sounds straightforward on paper, but, you know, like from a practical standpoint, probably not the easiest, easiest feed, I'd imagine. No. And I, you know, it sounds, it's always easy to talk about things happening. in hindsight and being like, oh, yeah, we thought of that. We did that right. But we made a lot of

mistakes. We tried a lot of things and kind of realized soon enough, you know, where we could pivot our strategy to take those things into account. So, you know, our system also has a virtual reality patient distraction component, right? So this helps the patient feel more comfortable. It helps the position feel more comfortable because the patient is essentially blindfolded during the procedure. And, you know, at first we were trying to build this into our overall system as a, you know, a medical device when really that's not what it is. You know, it's essentially like a happy meal that comes with our system. You know, the kid can use it. They can take it home.

It's it wasn't part, it wasn't necessary as part of our 510K submission. And so thinking through that, you know, I think really led us on a much more streamlined and cost effective path when we were thinking through regular. Yeah, yeah, that's super, that's very well thought out approach. And if you're new to this kind of thing and listening to this interview, like, rewind this and listen to Heather's comments. I mean, because it's very, like, it's a very, very, very intelligent approach to not only does, you know, device design, but also thinking through the inputs needed to kind of cross those, those regulatory hurdles, right? And so those have to be in line. There's no doubt. Otherwise, you're going to be looking at a very, a very long roadmap with, with a lot of, a lot of capital burnt along along the way, so to speak. I want to, towards the tail end of this kind of segment in the interview, I want to circle back around to kind of some of the, that your transition kind of away from sort of, you know, the professor life, so to speak, into the end of the biode design program.

But we'll wait to get there because we're talking about regulatory, right? And you mentioned earlier as part of this, you know, this initial kind of limited market release and then soft launch, you've identified a few, a few facilities to kind of kind of laid the groundwork, so to speak, establish some key centers of excellence, so for lack of a better description. Talk to us about your approach just to clinical evidence in general and what that looks like, whether it's, you know, from a trial perspective or even just like post-market kind of registries and laying the proper foundation with innovative tech like you're building at Evoendo. Yeah. So again, with our 15K application, we didn't have to do any

you know, large clinical studies in order to get FDA clearance. And so we're really focused on, like you said, kind of that post-market study and thinking about what we actually need to show in order to help improve the adoption of the system and also this unsidated transnasal endoscopy procedure, you know, which I, which I think has some obstacles of its own, right? So when you are changing workflow in a hospital system, adding a new procedure that was previously done, the OR, or the GI suite, moving that into a hospital-op patient clinic, for example, there's a lot that goes into that shift and adopting the procedure and ultimately our system. So when we're thinking about our clinical evidence generation strategy,

we're really thinking about what the pain points are to adoption. So on the patient side, you know, if we're thinking about us being patients, going in to get an endoscopy, if your doctor positions it as well, we could put you under general anesthesia or, you know, we could sedate you. you know, you won't even know what's happening, or you can be completely awake, well, you shove a scope down your nose. You know, it's like there's a lot of patient awareness about the actual procedure, what it entails, the time that it gives you back in your day and, you know, reduced side effects. Obviously, sedation, depending on some of the contraindications,

can have severe implications for some patients. So huge patient awareness and advocacy push, thinking about showing studies that demonstrate feasibility. There's already quite a few of those about the unsidated T&E procedure. And in kids, our chief medical officer has published a lot of those. So, you know, adults, if kids can do it, we can do it too. So thinking about patient feasibility, patient tolerance, patient acceptance. Then on the physician side, you know, I think it's really showing that they can do as good of an exam, you know, and it actually helps them increase screening or, you know, decrease timed treatment, you know,

if they are able to do more procedures more often because they're not doing sedation or general anesthesia. So, you know, we're really just thinking about the biggest hurdles to adoption, physicians, hospital systems, and payers, actually, if we're thinking about all our stakeholders and then patients as well and addressing those with our good love to. 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.

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