Navigating FDA Clearance and Launching a Medical Device with Dr. Heather Underwood of EvoEndo

Today we’re catching up with Dr. Heather Underwood, CEO of EvoEndo. EvoEndo recently completed an $8.4 million Series A financing round on the heels of 510(k) FDA clearance in early 2022. We first spoke with Dr. Underwood in June of 2021. In this episode, we chart a course through her accomplishments, lessons learned through the FDA clearance process, working with CROs, and hear firsthand about the challenges she’s tackled as Chief Executive of a medical device startup ready to revolutionize clinical endoscopy practice with a safer, faster, cost-effective alternative. 

About EvoEndo
EvoEndo, founded in 2017 by Dr. Joel Friedlander (Chief Medical Officer), is making unsedated transnasal endoscopy a reality. General anesthesia has been the standard of care for pediatric patients undergoing endoscopies. This can be a traumatic experience, especially for patients with chronic health conditions who may require the procedure several times a year. But EvoEndo’s single-use small-diameter device for unsedated transnasal endoscopy is ready to transform this medical necessity. The company received 510(K) clearance from the FDA in February of 2022 and is poised for a commercial launch of its innovative product. 

About Dr. Heather Underwood
Dr. Heather Underwood joined EvoEndo as CEO in 2019 after completing the Stanford Biodesign Innovation Fellowship for medical devices. 

Dr. Underwood completed her Ph.D. at the University of Colorado Boulder's ATLAS program where she developed and implemented clinical decision support systems for midwives and nurses in Kenya, receiving the NSF Graduate Research Fellowship grant and a Gates Grand Challenges grant to support her research. She has spent the last 10 years founding and leading medical device startups, non-profit life science organizations, and innovative academic initiatives. 

Links
Heather Underwood | LinkedIn:
https://www.linkedin.com/in/hmunderwood/

EvoEndo:
https://evoendo.com/

Titan100:
https://www.titan100.biz/2022coloradotitan100

Proxima CRO:
https://www.proximacro.com/

Qualio website:
https://www.qualio.com/

Previous episodes:
https://www.qualio.com/from-lab-to-launch-podcast

Apply to be on the show:
https://forms.gle/uUH2YtCFxJHrVGeL8

Music by keldez 

Qualio website:
https://www.qualio.com/

Previous episodes:
https://www.qualio.com/from-lab-to-launch-podcast

Apply to be on the show:
https://forms.gle/uUH2YtCFxJHrVGeL8

Music by keldez

Transcript

 [00:00:00] Kelly Stanton: Hey everyone. Thanks for joining us on from lab to lunch today. I'm Kelly from Qualio and it's my pleasure to be your host and introduce you to these innovators in life sciences. If you haven't already, please subscribe and give us a review on Apple or Spotify. We'd love that and it helps other people find the show. 

If you want to be on the show, please see the application linked in the show notes. We've had a lot of people reach out and it's been our pleasure to connect with you.  

Today, we're talking to Dr. Heather Underwood. Dr. Heather Underwood is the CEO of EvoEndo. EvoEndo was founded in 2017 and its mission is to make endoscopies safer for patients by eliminating the need for general anesthesia while reducing the complexity and cost of endoscopy for physicians and hospitals. 

She joined EvoEndo in 2019, after completing the Stanford Biodesign Fellowship for Medical Device Innovation. Dr. Underwood completed her PhD at the University of Colorado Boulder's Atlas program, where she developed and implemented clinical decision support systems for midwives and nurses in Kenya, receiving the NSF Graduate Research Fellowship grant, and a Gates Grand Challenges grant to support her research. 

She has spent the last 10 years founding and leading medical device startups, nonprofit life science organizations, and innovative academic initiatives.  

Let's bring her in. 

[00:01:33] Kelly Stanton: Hi, Heather. Thanks for joining us today.  

[00:01:35] Heather Underwood: Hey Kelly. 
 

Thanks. Happy to be here.  

[00:01:39] Kelly Stanton: We love hearing about folks' backgrounds. Can you tell us a little bit about yourself and your journey to where you are today?  

[00:01:45] Heather Underwood: Sure. I have had a very nonlinear background to get to where I am today. So I actually was a computer science major in undergrad. Worked at, lot of the big software technology companies for awhile and realized I really wanted to use those skills to be a little bit more directly involved in solving problems, particularly in healthcare. 

So I went and did my PhD at the University of Colorado in Boulder and the project that I was working on there was a clinical decision support software system for nurses and midwives in Kenya. So I was traveling to Kenya very often and working very directly with patients and providers to really apply these tools and technologies to unmet needs. 

And. It was exactly what I wanted to be doing. So following that I was a professor at CU Denver for awhile building innovative initiatives around entrepreneurship... innovation. And then decided I wanted to do it myself as opposed to just teach it, went back to Stanford to do a post-doc in the Stanford Biodesign Fellowship. 

And then after that I got hooked up with EvoEndo. I started as a consultant and then moved into that CEO role in January of 2020.  

[00:02:59] Kelly Stanton: Nice. That's a nice transition. Tell us a little bit more about EvoEndo and how and why it was founded.  

[00:03:05] Heather Underwood: Yeah. Great. So EvoEndo was founded in 2017 by a group of interdisciplinary physicians at the Children's Hospital of Colorado. 

So essentially they have the program there called the Aerodigestive Medicine Program and it's made up of ear, nose and throat physicians, pulmonologists and gastroenterologists. So our Chief Medical Officer and co-founder Dr. Joel Freedlander and his colleagues had recognized the need for an unsedated alternative to upper endoscopy in pediatric patients. 

 Prior to EvoEndo and trans nasal endoscopy, the standard of care and best practices for pediatrics was to put patients under general anesthesia. To do any sort of routine upper endoscopy. This is a fairly traumatic experience for children and their families, especially for children that have chronic conditions where they need to do this multiple times a year. 

 So what Joel and his group at Children's of Colorado cobbled together was taking their pulmonology colleagues bronchoscopes, which were small enough to go through a pediatric nose into their esophagus and an off-the-shelf virtual reality headset, so that the patient could wear that during the procedure. 

And they were able to do a trans nasal esophagoscopy without any type of conscious sedation or general anesthesia in patients as young as five. So since then they have done over a thousand of these procedures and the patient demand for unsedated endoscopy has just grown and really fueled the adoption of this procedure more widely across the U.S. 

So EvoEndo was founded really to address the needs in creating a turnkey system that physicians and hospitals could get started with quickly to start and scale an unsedated trans nasal endoscopy program within their practice.  

[00:04:56] Kelly Stanton: That's really exciting. And you guys obtained your US FDA 510 K clearance earlier this year, correct? 

[00:05:03] Heather Underwood: We did .We got it on Valentine's Day.  

[00:05:06] Kelly Stanton: Oh, how exciting 

[00:05:08] Heather Underwood: Yes it was. Don't tell my partner about it. It was the best Valentine's Day gift I think I've ever gotten.  

[00:05:14] Kelly Stanton: Tell us a little bit more about that journey and accomplishment. A lot of our listeners really love to hear from companies just like you-- how they got there. 

How'd you do it?  

[00:05:22] Heather Underwood: It was a long journey and a lot of work and a lot of learning. We had some really incredible partners. We worked with Proxima CRO, they are regulatory consulting group and they just helped us navigate the whole process, of submitting that 510 K and putting it all together. 

 We also submitted twice, so we got rejected on our first try of submitting the 510 K and it was actually a really good thing. When we look back at the timeline and how it all worked out, we learned a ton by going through that submission process. And then, the feedback that we got from the FDA. 

You know about how we needed to improve our submission was very helpful. And so we were able to do it better the second time and make sure that we were addressing all those concerns in the right way. And, from a company standpoint and a commercialization standpoint, to have those extra four months while we resubmitted and waited again it really allowed the team to better prepare from a quality management system perspective, but then also just from a training and, planning our launch perspective. 

So that way, when we got FDA clearance in February, we were really ready to go.  

[00:06:33] Kelly Stanton: That's exciting. Yeah. Not familiar with very many companies who clear that hurdle the first time. It's often a multi-step multi try process. But only twice. And in that timeframe, that's that's that's quite an accomplishment for you guys. 

Nicely done.  

[00:06:47] Heather Underwood: Yeah, I really have our partners to thank for that. A lot of the consultants at out manufacturer and Proxima was just great.  

[00:06:53] Kelly Stanton: That's awesome. So in more exciting news this year, you've also completed Series A fundraising. Congratulations there too. Tell us what about that.  

[00:07:02] Heather Underwood: It has been a busy year .We closed our Series A in at the end of March and this round so 8.4 million was really focused on getting us launched this year. So we're doing a phased launch. We just completed our first clinical cases through our physician preference testing. And now we're just getting to the point where we're launching to a limited number of accounts throughout the us. Both pediatric and adult GI sites. 

And it's just been very exciting, we're growing the company. We're hiring a lot of people to help us accomplish those goals. And the fundraising really was on the heels of that FDA clearance. There was definitely a shift. I think that's a huge hurdle for companies to overcome, and it mitigates a lot of risks for investors. And so I think once we had that FDA clearance in hand, the fundraising process was definitely a little bit easier this time.  

[00:07:55] Kelly Stanton: Definitely. So 5 years, 10 years, where do you see EvoEndo headed? 

[00:08:00] Heather Underwood: Yeah, so EvoEndo in five years, what I really hope for the company is that we have continued to create. Optimized high quality products that address really important clinical needs for both pediatric and adult patients. I think that's one of our key differentiators is our approach to addressing those clinical needs. We are not a me too product. We are really looking at how to use the tools at hand to address those clinical needs in the best possible way. 

And so I would love for the company to continue to grow and provide that value to physicians and patients around the world.  

[00:08:42] Kelly Stanton: Was your clearance pediatric only, or it was pediatric and adults.  

[00:08:45] Heather Underwood: It was both. So number five we are indicated for use and all upper endoscopy therapeutic and diagnostic. 

[00:08:54] Kelly Stanton: Oh, that's great. That's that covers a very broad variety. So that's a a great way to, to get into the market, for sure.  

[00:09:01] Heather Underwood: Yeah, it's definitely an opportunity for us. We are a single use endoscopy platform and we've started really positioning it more as a platform to be widely used across those those demographics and populations that were indicated for but for a variety of GI conditions, that just haven't had good diagnostics and because of the existing equipment and technology really haven't been accessible to a broader range of people. So Barrett's Esophagus is a great example. The screening for that is very underutilized because it's a cumbersome and uncomfortable procedure for patients right now. But with the Evo endo system, not only can we make that more portable and accessible at multiple sites, but you can be in and out in about an hour and back to work or school. So we're really trying to reach a broader section of the population for some of these under-screened and monitored for diseases.  

[00:09:54] Kelly Stanton: That's great. That's great. And pretty unlimited potential for expansion.  

[00:09:59] Heather Underwood: That's the goal, that's the hope,  

[00:10:00] Kelly Stanton: Awesome. So how can physicians and other medical personnel learn more about EvoEndo's T&E system? .  

[00:10:07] Heather Underwood: I would start at our website. So EvoEndo.com has a ton of information about our product and our training system. And there's a contact form where physicians can reach out directly about scheduling a training with us .Emails to info@EvoEndo also come directly to us. 

And right now, we are scheduling in-services and trainings for physicians with our training model and our demo scopes. But we're scheduling out quite a few months at this point, which is great. There's a lot of demand, but I would say that would be a good place to start.  

[00:10:41] Kelly Stanton: Great. Great. 

So in shifting gears back to you, what have been some lessons learned along the way as the CEO of a medical device company?  

[00:10:49] Heather Underwood: I think it's become a bit cliche, but it will always take longer and cost more than you think. I think when people were telling me that at the beginning of this journey, I was like yeah, but I'll make it happen faster and cheaper. 

And. It's always good to have the goal. But I think medical devices in particular and life sciences where you're under more regulations and you're working within the hospital constraints and the processes they've put in place to protect patients and physicians. 

It is a long process. I think lessons learned is that really just to be prepared for that, be ready for that journey and hire really talented team to help get you there.  

[00:11:28] Kelly Stanton: Definitely. What advice would you give to others in this field or career path?  

[00:11:35] Heather Underwood: Yeah. I would say... to be comfortable with being flexible and being dynamic and knowing how and when to pivot a strategy based on new data. 

I think that this is not for the type of person who likes and needs a lot of certainty. We are constantly re-evaluating, the direction based on the new data coming in, that we're getting and Yeah, I think you just have to be dynamic and you have to be, you have to really love what you're doing. 

I think, to stay committed through all of the ups and downs that this process entails. So if you don't love what you're doing and you're not really committed to the mission, it is going to be a slog. So definitely love what you're doing. And then again, hire a great team to support you through it. 

[00:12:20] Kelly Stanton: Definitely. Yeah. This this path is definitely not for the faint hearted and you guys doing it at, in 2017 to now. That's pretty short, honestly, So while maybe you didn't do it, faster or shorter than you thought you certainly, I would say are on that that shorter side of that curve of what it usually takes to get there. 

[00:12:39] Heather Underwood: Yeah, I think that might be where my, tech background comes in a little bit, the cycles on software and new technology and apps and all of this is just so fast. So I think it's all a matter of perspective and relative,  

[00:12:53] Kelly Stanton: Indeed. If you could go back and tell yourself something at the start of your career, what would that be? 

[00:12:59] Heather Underwood: I think I would tell myself to trust my intuition. I think as a younger CEO, there's a lot of opportunity to doubt yourself in the decisions that you're making. And leading a company, there's a lot of, there's a lot riding on your shoulders and, I think if I could go back and tell myself just to really trust my intuition And that would be what I would tell myself. 

And hopefully I would believe me.  

[00:13:26] Kelly Stanton: You were recently awarded a Titan 100 best CEO's. Yeah. Apparently that strategy's working for you.  

[00:13:33] Heather Underwood: I just am taking it one day at a time and really love working with the team that we've built. We had our team onsite a couple of weeks ago and, we've just built a really passionate group of people that are ,that are so excited about what we're doing and incredibly talented. 

So, They made me look good.  

[00:13:49] Kelly Stanton: Well, that's great. Those, I think I think that's very true though. The best leaders do surround themselves with good people and enable those good people to do their job well. So again, congratulations, nicely done.  

[00:14:00] Heather Underwood: Thank you. Yeah, so it was, it was a really neat event to be, and it was, it wasn't just healthcare you or life sciences. 

It was a hundred CEOs from across the Colorado business ecosystem. And it was really great to see, just to see what Colorado has to offer in terms of, world-class leadership. It was a great event.  

[00:14:19] Kelly Stanton: That's exciting. There's a lot here. It's a pretty amazing place to be.  

So where can people go to learn more follow along and connect with you.  

[00:14:26] Heather Underwood: Yeah. So our website again, is a great place to get in touch with us directly. LinhkedIn is where we do a lot of our social posts. And you can keep up to date with where we're headed. We're traveling a lot, going to a lot of different hospitals, sites and conferences, and, really looking ahead to our launch this year. 

So that would probably be the best. And then direct email info@evoendo.com. And we would love to get in touch with you and learn more.  

[00:14:52] Kelly Stanton: Awesome. Well, Thank you so much for your time today, Heather. Really appreciate it. It's good to good to hear from you.  

[00:14:57] Heather Underwood: Thank you, Kelly. It was great to catch up.