Medsider: Learn from Medtech and Healthtech Founders and CEOs - The Biggest Mistakes to Avoid When Designing Medical Device Prototypes: Interview with Mike Wallace, CEO of DeVoro Medical

Episode Date: January 28, 2021

We recently caught up with medtech start-up extraordinaire, Mike Wallace, who shares his insights and experiences with the Medsider community. Mike is the co-founder and CEO of DeVoro Medical, an early-stage medical device company focused on developing innovative devices for peripheral thrombectomy.Mike says the initial idea or concept for a medtech company is just 5% of the journey. Medsider is all about shining light on that other 95%!In this conversation with Mike, he’ll give tips to newcomers, including some mistakes entrepreneurs often make in the early stages of their companies. Mike explains how you can pivot when an idea doesn’t pan out, and he’ll give his expertise on seed-stage fundraising as well as navigating the regulatory waters. Plus, more on his current work with DeVoro, including how he started working on problems related to peripheral thrombectomy.But first, a bit more on Mike’s medtech background:Prior to co-founding DeVoro Medical, Mike served as Chief Technical Officer and VP of Operations for Silk Road Medical. Mike has spent most of his professional career working for medical device start-ups, some of which include Target Therapeutics (acquired by Boston Scientific), BARRX Medical (acquired by Covidien), and Baxano (acquired by Trans1). In addition, Mike has co-founded and exited three other start-ups: TW Medical and GW Medical Neuro (both acquired by Stryker Corp) and CardioProlific (acquired by Philips). Mike graduated with a B.S. in Mechanical Engineering from the University of Delaware, holds a M.S. in Mechanical Engineering from the University of California, Davis, and is the co-inventor or primary inventor on over 130 issued U.S. patents.Before we jump into the conversation, I wanted to mention a few things:First, I’m trying something a little different with this next series of Medsider interviews, which will be focused entirely on stories from some of the most compelling medtech and healthtech startups across the globe. Here's the deal: I’ve asked these founders and CEOs to answer a series of questions, which I’ve converted to audio stories with the help of some professional voiceover artists. Think of these conversations almost like recorded fireside chats that you might find on Audible. They’re short and sweet, but packed with tons of great insights.I’ve never tried this before, so let me know what you think!Second, if you’re into learning from proven medtech and healthtech experts, and want to know when the next interview goes live, head over to Medsider.com. You can sign up for our totally free newsletter, which includes access to certain types of gated articles as well as regular content updates. Lastly, here's the link to the full interview if you'd rather read it instead.

You've been involved in several innovative early-stage med tech companies. When it comes to designing and prototyping the alpha and beta versions of a medical device, what do you think is the biggest mistake most startups make? Many first-time entrepreneurs simply don't work hard enough or smart enough. They don't understand their target disease well enough. They don't do enough research on competitive products. They don't talk to enough experts to hear brutal critiques, and they don't pivot at the right times because it often requires starting over again.

Lastly, they simply lose interest in their project because it can be hard, lonely, and sometimes soul-breaking work to get your project far enough along to be worthy of being funded. 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, and in this episode we catch up with MedTech startup extraordinaire Mike Wallace, who shares his insights and experiences with the MedSider community. Mike is the co-founder and CEO of DeVoro Medical and Early Stage Medical Device Company focused on developing innovative devices for peripheral thrombectomy. Mike says the initial idea or concept for a MedTech company is just 5% of the journey. Medsider is all about shining light on that other 95%, as you guys probably know.

So in today's talk with Mike, he'll give tips to newcomers, including some mistakes entrepreneurs often make in the early stages of their companies. Mike explains how you can pivot when an idea doesn't pan out, and he'll give his expertise on seed stage fundraising as well as navigating the regulatory waters. Plus, more on his current work with DeVoro, including how he started working on problems related to peripheral thrombectomy. But first, a bit on Mike's Medtech resume. Prior to co-founding DeVoro Medical, Mike served as the chief technical officer and VP of

operations for Silk Road Medical. Mike has spent most of his professional career working for medical device startup, some of which include Target Therapeutics, which was acquired by Boston Scientific, Barks Medical, which was acquired by Cavidian and Boxino. I'm not even sure if I'm pronouncing that right, which was required by Trans1. In addition, Mike has co-founded and exited three other startups, which include TW Medical and GW Medical Neuro, which were both acquired by Stryker, and then Cardio Prolific, which was acquired by Phillips. Mike graduated with a BS in mechanical engineering from the University of Delaware, holds an MS in mechanical engineering from the University of California,

Davis, and is the co-inventor or primary inventor on over 130. U.S. patents. Okay, so before we jump into the discussion, I wanted to mention a few things. First, I'm trying something a little different with this next series of MedSider interviews, which will be focused entirely on stories from some of the most compelling med tech and health tech startups across the globe. So here's what's different. I've asked these founders and CEOs to answer a series of questions, which I've converted

to audio stories with the help of some professional voiceover artists. Think of these conversations almost like recorded fireside chats that you might find on Audible. They're short and sweet but packed with a ton of great insights. I've never tried this before, so I'm really curious what you think. Leave a comment as a podcast review or hit me up via email by visiting Medsider.com. And if you end up leaving that review, just make sure it's five stars. Wink-wink, if you know what I mean. Okay, second, if you're into learning from proven med tech and health tech experts

and want to know when the next interview goes live, head over to medsider.com. You can sign up for our totally free newsletter, which includes access to certain types of gated articles, as well as regular content updates. You can also check out our premium Medsider memberships as well, which come with some super cool benefits, everything from clean, easy-to-read transcripts to exclusive Ask Me Anything interviews and masterclasses with some of the most experienced med tech experts in the world.

Since opening up these premium memberships, I've been pleasantly surprised at how many people have signed up, so if you're interested, visit Medsider.com to learn more. Lastly, we've got a lot of Medsider goodness in store for the near future. Not only will I continue to interview some of the best med tech and health tech leaders on the planet, I'm super excited to announce a new series here in the future. I don't have all the details ironed out just yet, but my goal is to give you a behind-the-scenes look at what it takes to get a startup off the ground, to go from zero to one, so to speak.

It should be a lot fun, so make sure to sign up for our free newsletter at medsider.com. All right, without further ado, let's get to the interview. Mike, please tell us a little about your personal background, as well as what you're working on at Duvoro Medical. I grew up half-time in Ireland and half-time in the Philly area, which was an interesting mix of cultures. My Irish father always espoused the great contributions of first-generation immigrants to this country, implying I better build on that reputation, and so that's one of my professional goals. After getting my undergraduate engineering degree, I moved to Northern

California as a young newlywed in 1993 to chase the excitement of the West Coast lifestyle and take advantage of a free master's degree program at UC Davis. After working with an energetic surgeon in graduate school, I got hooked on the thrill and pace of developing novel medical device products. The surgeon was passionate about his procedures and pushed me to develop new technology to support his vision. The net result, once completed, was beautiful. A new procedural solution that helped patients who were having ACL surgery.

I thought, what could be better than doing this for a living? Upon graduation, I immediately got a job. job at Target Therapeutics after cold calling Eric Engelson, who was the VP of R&D in operations. He invited me down to Fremont, California for an interview. And that's how I got my first medical device job in Silicon Valley. Fast forward 27 years and I'm now running DeVoreau medical, a disruptive peripheral thromectomy company that I co-founded with Scott Greenhawk in 2018. It's our third startup together and a fun privilege to lead the company. It took time and a lot of experience for me to be ready for this current CEO role, and I think we're poised to do some

special things at Duvoro. At Duvoro, how did the idea for your peripheral thromectomy device come about? Scott, and I were studying the limitations of commercial stroke thermectomy solutions, and sort of stumbled across our initial idea. For about nine months, Scott, a talented engineer, Roy, whose last name is hard to pronounce and myself work the quintessential nights and weekends while holding down other jobs. On our 19th try, we finally got our prototype to ingest clot like no other device we've come across. This accomplishment and some rapidly issued patents gave us the clear signal it was time to raise

some money, pull together a team, and drive the project aggressively forward for our first application, which was acute ischemic stroke. 18 months later, with the help of a super talented engineering team, we developed our wolf-vermectomy solution through successful human use in acute. stroke patients. The outcomes were impressive and we were thrilled with our progress. As part of our funding arrangement, we sold the rights of the wolf-hermectomy system for neurovascular applications to Stryker Corporation in late 2019. After that, we immediately redirected the team's efforts on the wolf-hermectomy's next application, which make up devoural medical's peripheral

phermectomy efforts. We were fortunate to be able to leverage all the knowledge we gained from the Wolf Stroke Project to accelerate the development of the wolf peripheral phermectomy solutions. Mike, you've been involved in several innovative, early-stage Med-Tech companies. When it comes to designing and prototyping the alpha and beta versions of a medical device, what do you think is the biggest mistake most startups make? Many first-time entrepreneurs simply don't work hard enough or smart enough. They don't understand their target disease well enough.

They don't do enough research on competitive products. They don't talk to enough experts to hear brutal critiques, and they don't pivot at the right times because it often requires starting over again. Lastly, they simply lose interest in their project because it can be hard, lonely, and sometimes soul-breaking work to get your project far enough along to be worthy of being funded. In my experience, the initial idea, all critical, is just 5% of the journey. Commercially successful products are the result of intense multidisciplinary efforts, and are most often led by stubborn, unrelenting founders. Many early start-ups and first-time entrepreneurs don't have enough

experience or staying power to bring their first ideas to fruition. Those who keep edit and master their trade will ultimately win and get rewarded. You'll get some yourself. When it comes to navigating the regulatory waters, what one to two pieces of advice would you give to other startup leaders? Get some wins with 510K products first. You learn more with multiple projects that are shorter in duration, then graduate to pre-market approval projects later in your career if you have the patience and the passion

to pursue longer duration efforts. Mike, tell us more about your approach to scientific evidence. What's your best counsel for other early stage companies that are building out their clinical research roadmap? First, learn the unmet needs of your market, understand product requirements, and know your competition inside and out. You must have a clear problem that needs fixing and a decent market size. Then with your idea in hand, pressure test your solution with those you can trust. If the solution passes all your business requirements, then build a small team with engineers, technicians and physicians who have deep domain expertise in the disease or the core technology.

All team members must be talented at early product development and resilient to failure. These types of people are much harder to find than you think. Lastly, you as the leader are key. You must recruit, sell, and inspire. Many, many times over. If that is not your thing, it will be a tough road. Once you have your team, then it's the due loop of ID8 prototype and test. Keep running this loop until the product meets your bench,

and animal testing requirements. Then go evaluate the product in humans, safely and ethically. And finally, if needed, iterate again. What are a few of the most important lessons you've learned over the years when it comes to insurance coverage and reimbursement? In other words, how much are you thinking about this topic when designing and developing device concepts? No or limited reimbursement is a major risk that you have to seriously weigh before starting

a company. If reimbursement is not in place, then you better have all the other risks almost retired in your mind, technical, clinical, and regulatory. Also, be prepared to raise plenty of money to ultimately influence the medical societies and insurance companies with the necessary clinical data and cost-saving justifications. All that being said, it can be extra rewarding if you can overcome reimbursement challenges that are often part of commercializing breakthrough solutions. One example I saw up close was when the CEO of Silk Road Medical, Erica Rogers, led the team through CMS reimbursement for the in-row procedure.

This was achieved about two years before Silk Road's enormously successful IPO. But it's important to note that it took over a decade of oversight, funding, and consternation by Silk Road medical's co-founders and board members before reimbursement risk was retired. Most startup companies don't have the lasting power that Silk Road needed to obtain new reimbursement hurdles. Mike, you've had the opportunity to work on several seed stage METEC projects. What's the most important piece of advice you'd give to other entrepreneurs that, that are trying to raise pre-seed or seed rounds of capital. The further you can develop your idea and to risk it, the easier it will be to raise the ever-critical seed round.

The most important thing to note is you can take your initial idea a lot further than you think with just sweat equity and a little cash. Maybe it's just the co-founder's cash for a while. You can do your own IP searches, file your own provisional patent applications, ask friends for some materials for prototypes, clean your garage, and set up a table with a microscope,

To build your early prototypes, recruit other like-minded people, and incentivize them with equity rather than cash to get started. You will need every friend in your network to ultimately make your company successful, especially if it's your first one. So yes, you need some friends and allies too, vet and double-vette your idea with physicians and business experts that you trust.

Do all this before you raise a serious seed round. Other entrepreneurs are comfortable raising money earlier in the vetting process, but raising money earlier, even if you can do it, may not be prudent if you can vet the project further with just founders and early team member sweat equity. Plus, you minimize your ultimate dilution when you raise that seed round after taking the project further. For smart and experienced investors to invest in your seed round, they need to fall in love with your idea and plan.

Trust that you can run the company successfully through the next phase and have an appetite for early investments. While it may take time to find these investors, they do. exist. Such great advice. Mike, what's next for Duvoro Medical? What are you most excited about over the next few years? We have Duvoro feel the thromectomy market has somewhat settled for existing technologies of suction tubes and dragnets to open thrombus occluded vessels. We believe limiting the solutions for thromectomy procedures limits patient outcomes, especially when it comes to the peripheral vascular. Duvoro thinks of problems differently, and we are partnering

with physicians who want to challenge the status quo in thromectomy. Significant improvements in patient outcomes require significantly different thinking and solutions. We believe the wolf thromectomy solution will meet those challenges. Duvoro products will help address gaps in the arterial thrombosis, DVT, and PE space. Our mission is to bring to market novel, best-in-class peripheral thromectomy and imbelectomy solutions to enable end-block removal of both hard and soft clot in a rapid and Lytic-free procedure. Our wolf technology has several technical and ease-of-use advantages over-the-market leaders such as Inari, Penumbra, and Boston Scientific.

We can't wait to commercialize these products and help our patients. Before we get to some rapid-fire questions, where can readers or listeners go to learn more about you in Duvoro Medical? We are currently in stealth mode but plan to come out in late 2021. Check our website then, which is www.duvorummedical.com. Okay, now for some fun questions. Mike, for someone that is starting their entrepreneurial journey in the med tech or health care arenas, what's the most critical thing they should know?

It is super exciting, but also hard. You don't see many 20-year-olds disrupting the medical device space because it takes time to learn all the operational and entrepreneurial skills needed to run a med tech company. But for those who like a challenge, want to help patients and are lifelong learners, it's a very rewarding, fun, and stimulating field to work in. What influential books, podcasts, or resources have been most helpful in your entrepreneurial adventures? One of my favorite books is Shoe Dog by Phil Knight. One of the themes revolves around the idea that Nike didn't always know where they were going. Kind of like, fake it until you make it. For a planner like myself, it's helpful for me to realize that at certain times, you're forced to take risks outside your preferred comfort zone.

In those moments, you have to believe that you and your team will get through it. You just have to ride the startup bull. Also, I'd recommend reading or listening to anything that describes the path of both successful and failed medical device companies. Many patterns can be gleaned from their experiences and stories. Are there any med tech or healthcare entrepreneurs that you find particularly inspiring? Entrepreneurs that I worked closely with over the years have inspired me the most and include Henry Nita, Eric and Jelsen, Erica Rogers, Bad Sada, Jeff Blight, Greg Barrett, Scott Greenhawk, and Tom Malls. This is an amazing, talented group of people that have all started early stage companies, and I have been lucky to work for or alongside them all.

If you had to teach a class on one thing, what would the topic be? How to be a medical device executive and entrepreneur in the San Francisco Bay Area, while being the primary breadwinner and co-raising four kids. In other words, how to effectively balance security, risk, and following your dreams. Lecture one starts with the most important piece of advice, marry the right person. I get very lucky with that one. Starting over in your mid-20s, knowing everything you know now, what would you do differently? Nothing. It has been far from a perfect run, but definitely a fun, exciting journey.

The best is yet to come, and I believe we can all change our path anytime we want, if we really, really want to.