How Flexibility and Curiosity Can Influence a Successful Medtech Startup

Interview with EvoEndo CEO Heather Underwood

EvoEndo CEO Dr. Heather Underwood thinks about things a little differently than your average CEO. Her flexible and curious approach to running a medtech start up has certainly proved successful: recently EvoEndo was able to fundraise millions and get 510(k) clearance for their single-use endoscopy system they call the “EvoEndo System.”

So where did Heather’s unique approach to running a company come from? Her interdisciplinary past can shed some light on the subject.

Starting with her Bachelor of Science, cum laude, in computer science and engineering from the University of Washington, Heather’s analytical mind was at work: her undergraduate research focused on developing multiplayer educational game platforms for primary schools in India.

Continuing onward, Heather 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.

Heather then cofounded Inworks—an interdisciplinary initiative offering courses and certificate programs in innovation, prototyping, and design as a professor at the University of Colorado Denver. Her last stint in academia occurred when she was selected for the 2018-2019 Stanford Biodesign Fellowship Class. Upon completion, she entered the medtech space and has been leading EvoEndo ever since.

As Heather’s roles have changed, she’s never left behind her distinct skill sets, but instead honed them to positively influence her role leading EvoEndo.

In this episode of Mediser, Heather elaborates on her unique approach to innovation in the medtech arena, how fundraising isn’t one-size-fits-all, and why regulatory clearance isn’t the end of the road.

Guest
Heather Underwood
CEO of EvoEndo

Dr. Heather Underwood is a medical device and health technology entrepreneur with a highly interdisciplinary 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, improve health outcomes, and make a meaningful impact on people’s lives.

Key Learnings from Heather’s Experiences

  • You don’t need to come up with something completely new to solve a difficult clinical problem. Starting with a deep understanding of the challenge you’re trying to solve and staying solution-agnostic allowed EvoEndo to use key learnings from other fields of medicine to create something unique that ultimately meets patients’ needs.
  • Stay open and be creative when it comes to fundraising. It doesn't have to all come from venture capital. Angel investors can provide more than money: their care and emotional investment means they’re in it for more than financial returns.
  • The FDA is definitely a hurdle, and 510(k) clearance is something worth 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.

Don’t Bother Reinventing the Wheel

It’s easy to get caught up and overwhelmed by the urge to create something brand new that solves all the problems in your given field, but it’s rarely doable. This was the case for EvoEndo early on when they were first trying to nail down prototypes around solving endoscopic challenges.

As Heather puts it, they overshot the initial design and created something that was too different from what physicians were used to. This wasn’t a complete failure though, thanks to early user feedback and consistent input from our co-founders.. Heather explains that “[after] getting people to evaluate the prototypes and just kind of have them in their hand and play with them, [we learned] it was not intuitive to them at all.”

This setback, while difficult, didn’t stop EvoEndo. It simply forced them to reevaluate their approach. One bit of insight Heather shares is simple: “The departure from what they're used to, to what they're going to use now can't be so vast if you want them to adopt it quickly and incorporate it into their day-to-day practice.”

It seems obvious when she says it, but it’s easy to fall into the trap of creating something so new and impressive that you forget that the actual people using your product have to want to use it, and that the jump from one technology to the next can’t be monumental.

Looking at the big picture, Heather explains, “new ideas are not new….oftentimes they're just mashups of other ideas.” This concept was central to what eventually became the “EvoEndo System.”

By using and combining ideas from other fields, and taking to heart valuable feedback from their clinical partners, Heather and the team at EvoEndo were able to come up with a physician-friendly system that allows endoscopic procedures to be performed without the need for general anesthesia or conscious sedation.

While the initial innovation was sparked by a need identified in the pediatric field, the application also has value for adults: a smaller, less intrusive scope is a win for people of any age.

“Stay curious and stay flexible. Things are going to change,” Heather says.

Keep Your Investment Options Open

Fundraising is a crucial part of every company’s path, which is hardly arguable. The journeys raising capital vary wildly from one company to the next, though. Rolling with the punches and adapting your strategy to different investment opportunities is crucial, especially when it comes to innovative medical technology.

Heather and EvoEndo ran into a series of particular situations. Early on, they approached traditional venture capitalists and were met with a surprising response: the investors wanted to put more into EvoEndo; they wanted to write bigger checks for ultimately bigger returns.

However, VCs were skeptical of the possibility for larger returns based on what they viewed as a small market opportunity in pediatrics, and wanted the company to demonstrate commercial traction before considering an investment.

So EvoEndo shifted their approach to something that felt more applicable to their journey: angels. From the beginning, there had been a core group of angel investors, but after getting feedback from traditional venture capitalists, EvoEndo decided to double down.

Heather explains, “[Angels] are some of the most passionate, committed, involved people. They care on multiple levels. They're not in it for just a return. I'll say if you're looking for other angels and you've already got angels interested, just leverage their enthusiasm to put the word out to their networks. And that was kind of how we saw our angel group, our investor group, grow.”

Aside from angel investors and traditional venture capitalists, Heather says there are other routes to funding as well. “I would recommend that [you] don't limit yourself. There are a lot of opportunities for non-dilutive funding through grants or Department of Defense or whatever it is, where your solution or your device really resonates with the population. There might be some funding there.”

Regulation, Commercial Adoption, and Reimbursement: All Things to Consider

No two aspects of an innovative medical technology journey are the same.

One company’s successful path does not guarantee future wins. Just because you raised millions doesn’t mean your device will pass regulatory standards, and just because you pass regulatory standards doesn’t mean that commercial adoption will be easy. On top of those layers, and often overlooked, is reimbursement.

EvoEndo was fortunate to receive 510(k) clearance relatively quickly. The news came on Valentine’s day, like a nice gift from the FDA. But it wasn’t good luck that carried them through clearance: diligent planning and knowing what to include in their submission is what propelled them over the FDA regulatory hurdle.

This sort of future planning is integral to EvoEndo’s success. By considering the common challenges that face medtech companies, and anticipating future hurdles, Heather and her team have been able to cross the chasm to commercialization.

One of the largest obstacles Heather thinks is deserving of time and effort is reimbursement. She says EvoEndo spent a lot of time on this topic, and that she’s glad they did.

“We did a reimbursement landscape [analysis], and I would highly recommend it. It may not seem worthwhile early on and it may seem like a very expensive endeavor for an early-stage startup, but that was absolutely crucial to our success and why we're commercializing now.”

Staying ahead of the game is always important, and it can’t be stressed enough in the startup world. “Maybe the biggest takeaway is if you're developing a device and you've got a working prototype and hopefully a little bit of funding: it's never too early to address the reimbursement topic.”

Download a copy of the interview transcript right here.
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EvoEndo CEO Dr. Heather Underwood thinks about things a little differently than your average CEO. Her flexible and curious approach to running a medtech start up has certainly proved successful: recently EvoEndo was able to fundraise millions and get 510(k) clearance for their single-use endoscopy system they call the “EvoEndo System.”

So where did Heather’s unique approach to running a company come from? Her interdisciplinary past can shed some light on the subject.

Starting with her Bachelor of Science, cum laude, in computer science and engineering from the University of Washington, Heather’s analytical mind was at work: her undergraduate research focused on developing multiplayer educational game platforms for primary schools in India.

Continuing onward, Heather 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.

Heather then cofounded Inworks—an interdisciplinary initiative offering courses and certificate programs in innovation, prototyping, and design as a professor at the University of Colorado Denver. Her last stint in academia occurred when she was selected for the 2018-2019 Stanford Biodesign Fellowship Class. Upon completion, she entered the medtech space and has been leading EvoEndo ever since.

As Heather’s roles have changed, she’s never left behind her distinct skill sets, but instead honed them to positively influence her role leading EvoEndo.

In this episode of Mediser, Heather elaborates on her unique approach to innovation in the medtech arena, how fundraising isn’t one-size-fits-all, and why regulatory clearance isn’t the end of the road.

Guest
Heather Underwood
CEO of EvoEndo

Dr. Heather Underwood is a medical device and health technology entrepreneur with a highly interdisciplinary 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, improve health outcomes, and make a meaningful impact on people’s lives.

Key Learnings from Heather’s Experiences

  • You don’t need to come up with something completely new to solve a difficult clinical problem. Starting with a deep understanding of the challenge you’re trying to solve and staying solution-agnostic allowed EvoEndo to use key learnings from other fields of medicine to create something unique that ultimately meets patients’ needs.
  • Stay open and be creative when it comes to fundraising. It doesn't have to all come from venture capital. Angel investors can provide more than money: their care and emotional investment means they’re in it for more than financial returns.
  • The FDA is definitely a hurdle, and 510(k) clearance is something worth 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.

Don’t Bother Reinventing the Wheel

It’s easy to get caught up and overwhelmed by the urge to create something brand new that solves all the problems in your given field, but it’s rarely doable. This was the case for EvoEndo early on when they were first trying to nail down prototypes around solving endoscopic challenges.

As Heather puts it, they overshot the initial design and created something that was too different from what physicians were used to. This wasn’t a complete failure though, thanks to early user feedback and consistent input from our co-founders.. Heather explains that “[after] getting people to evaluate the prototypes and just kind of have them in their hand and play with them, [we learned] it was not intuitive to them at all.”

This setback, while difficult, didn’t stop EvoEndo. It simply forced them to reevaluate their approach. One bit of insight Heather shares is simple: “The departure from what they're used to, to what they're going to use now can't be so vast if you want them to adopt it quickly and incorporate it into their day-to-day practice.”

It seems obvious when she says it, but it’s easy to fall into the trap of creating something so new and impressive that you forget that the actual people using your product have to want to use it, and that the jump from one technology to the next can’t be monumental.

Looking at the big picture, Heather explains, “new ideas are not new….oftentimes they're just mashups of other ideas.” This concept was central to what eventually became the “EvoEndo System.”

By using and combining ideas from other fields, and taking to heart valuable feedback from their clinical partners, Heather and the team at EvoEndo were able to come up with a physician-friendly system that allows endoscopic procedures to be performed without the need for general anesthesia or conscious sedation.

While the initial innovation was sparked by a need identified in the pediatric field, the application also has value for adults: a smaller, less intrusive scope is a win for people of any age.

“Stay curious and stay flexible. Things are going to change,” Heather says.

Keep Your Investment Options Open

Fundraising is a crucial part of every company’s path, which is hardly arguable. The journeys raising capital vary wildly from one company to the next, though. Rolling with the punches and adapting your strategy to different investment opportunities is crucial, especially when it comes to innovative medical technology.

Heather and EvoEndo ran into a series of particular situations. Early on, they approached traditional venture capitalists and were met with a surprising response: the investors wanted to put more into EvoEndo; they wanted to write bigger checks for ultimately bigger returns.

However, VCs were skeptical of the possibility for larger returns based on what they viewed as a small market opportunity in pediatrics, and wanted the company to demonstrate commercial traction before considering an investment.

So EvoEndo shifted their approach to something that felt more applicable to their journey: angels. From the beginning, there had been a core group of angel investors, but after getting feedback from traditional venture capitalists, EvoEndo decided to double down.

Heather explains, “[Angels] are some of the most passionate, committed, involved people. They care on multiple levels. They're not in it for just a return. I'll say if you're looking for other angels and you've already got angels interested, just leverage their enthusiasm to put the word out to their networks. And that was kind of how we saw our angel group, our investor group, grow.”

Aside from angel investors and traditional venture capitalists, Heather says there are other routes to funding as well. “I would recommend that [you] don't limit yourself. There are a lot of opportunities for non-dilutive funding through grants or Department of Defense or whatever it is, where your solution or your device really resonates with the population. There might be some funding there.”

Regulation, Commercial Adoption, and Reimbursement: All Things to Consider

No two aspects of an innovative medical technology journey are the same.

One company’s successful path does not guarantee future wins. Just because you raised millions doesn’t mean your device will pass regulatory standards, and just because you pass regulatory standards doesn’t mean that commercial adoption will be easy. On top of those layers, and often overlooked, is reimbursement.

EvoEndo was fortunate to receive 510(k) clearance relatively quickly. The news came on Valentine’s day, like a nice gift from the FDA. But it wasn’t good luck that carried them through clearance: diligent planning and knowing what to include in their submission is what propelled them over the FDA regulatory hurdle.

This sort of future planning is integral to EvoEndo’s success. By considering the common challenges that face medtech companies, and anticipating future hurdles, Heather and her team have been able to cross the chasm to commercialization.

One of the largest obstacles Heather thinks is deserving of time and effort is reimbursement. She says EvoEndo spent a lot of time on this topic, and that she’s glad they did.

“We did a reimbursement landscape [analysis], and I would highly recommend it. It may not seem worthwhile early on and it may seem like a very expensive endeavor for an early-stage startup, but that was absolutely crucial to our success and why we're commercializing now.”

Staying ahead of the game is always important, and it can’t be stressed enough in the startup world. “Maybe the biggest takeaway is if you're developing a device and you've got a working prototype and hopefully a little bit of funding: it's never too early to address the reimbursement topic.”

Download a copy of the interview transcript right here.
Share:
Twitter
Facebook
LinkedIn
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