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

From Lab to Launch by Qualio

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