Building venture-supportable companies in highly regulated spaces

Building in regulated industries adds a huge hurdle to the already difficult journey of building a startup. And this week on Build Mode, Startup Battlefield editor Isabel Johansen spoke with two founders who are working to make headway in industries ripe for disruption, despite regulatory issues that may be deterring many others.

In this episode, we talk about life and death and how regulatory clearance doesn’t have to be a barrier to innovation but will lengthen timelines and require careful planning from the jump.

Isabel is joined first by Gabriel Sanchez, CEO and Co-Founder of Enspectra Health. The company has built a device that aims to eliminate the need for skin biopsies from a dermatologist. Sanchez is on his decade-long journey to obtain FDA approval. Throughout the interview, Sanchez offers tactical advice for anyone in the midst of a long organizational process and explains how he kept his company afloat and motivated his team despite doubts.

Next, Isabelle speaks with Tom Harris, co-founder of Earth Funeral, an end-of-life startup that has developed a new process that turns human remains into soil. Harris did not have to lead his team through a lengthy FDA approval process (because the FDA is primarily concerned with biology), but his company faced legislative challenges of its own. Earth Funeral was launched at a time when the alternative process was legal in only one state. Although its path to expansion does not depend on accreditation or approval from a government agency, it does depend on legislatures and voters who may be upset by the new way of burying loved ones.

New episodes of Build Mode are released every Thursday. Subscribe to the podcast Or watch YouTube. Isabel Johansson is our host. Build Mode was produced and edited by Maggie Nye. Audience development is led by Morgan Little. And special thanks to the Foundry and Cheddar video teams.