Building venture-backable companies in heavily regulated spaces

Building in regulated industries adds a massive hurdle to the already challenging journey of building a startup. And this week on Build Mode, Startup Battlefield editor Isabelle Johannessen spoke to two founders who are working to make progress  in industries ripe for disruption, despite the regulatory headaches that might have deterred many other people.  

In this episode, we’re talking about life and death and how regulatory clearance doesn’t have to be a damper on innovation but it will elongate timelines and require careful planning from the jump.  

Isabelle is first joined by Gabriel Sanchez, the CEO and co-founder of Enspectra Health. The company has built a device that aims to do away with the need for dermatologist skin biopsies. Sanchez breaks down his decade-long journey to receiving FDA clearance. Throughout the interview, Sanchez offers tactical advice to anyone in the midst of a long regulatory process and explains how he’s kept his company afloat and his team motivated despite the uncertainties.  

Next, Isabelle speaks with Tom Harries, the co-founder of Earth Funeral, an end-of-life startup that has developed a new process that transforms human remains into soil. Harries didn’t have to lead his team through a long FDA approval process (because the FDA is primarily concerned with the living), but his company has faced its own legislative challenges. Earth Funeral launched at a time when its alternative process was only legal in one state. And though its path to expansion doesn’t hinge on accreditation or approval from a government agency, it does depend on legislative bodies and voters who may be discomforted by a new way to lay a loved one to rest. 

New episodes of Build Mode drop every Thursday. Subscribe to the podcast or watch on YouTube. Isabelle 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.