Building in a regulated industry adds a huge hurdle to the already difficult journey of building a startup. And this week on Build Mode, Startup Battlefield editor Isabel Johannessen spoke to two founders who are trying to make progress in an industry ripe for disruption, despite regulatory issues that may have deterred many others.
In this episode, we talk about life and death and how regulatory approvals don’t have to stifle innovation, but they do extend timelines and require careful planning from the beginning.
Isabelle was initially joined by Gabriel Sanchez, CEO and co-founder of Enspectra Health. The company has developed a device aimed at eliminating the need for dermatologists to perform skin biopsies. Sanchez details his 10-year journey to obtaining FDA clearance. Throughout the interview, Sanchez offered tactical advice for those in the middle of a long regulatory process and explained how he has kept his company and team motivated despite the uncertainty.
Next, Isabel speaks to Tom Harries, co-founder of Earth Funeral, an end-of-life startup that has developed a new process for turning human remains into soil. Although Harries didn’t have to lead a team through the FDA’s lengthy approval process (because the FDA is primarily concerned with consumers), his company faced unique legal challenges. Earth Funeral was started when that alternative process was only legal in one state. And the path to expansion depends not on certification or approval by government agencies, but on legislators and voters uncomfortable with new ways to put loved ones to sleep.
New episodes of Build Mode drop every Thursday. Subscribe to our podcast or watch on YouTube. Isabel Johannessen is our host. Build Mode is produced and edited by Maggie Nye. Audience development is led by Morgan Little. And a special thanks to the Foundry and Cheddar video teams.
