Building in regulated industries adds a massive hurdle to the already challenging journey of creating a startup. This week on the Build Mode podcast, Startup Battlefield editor Isabelle Johannessen spoke with two founders who are making progress in industries ripe for disruption, despite the regulatory headaches that deter many others.
This episode explores themes of life and death, discussing how regulatory clearance does not have to stifle innovation, though it will elongate timelines and requires careful planning from the very beginning.
Isabelle is first joined by Gabriel Sanchez, the CEO and co-founder of Enspectra Health. The company has built a device designed to eliminate the need for dermatologist skin biopsies. Sanchez details his decade-long journey to receiving FDA clearance. Throughout the interview, he offers tactical advice for anyone navigating a long regulatory process and explains how he has 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 to transform human remains into soil. Harries did not have to lead his team through a long FDA approval process, as the FDA is primarily concerned with the living, but his company has faced its own legislative challenges. Earth Funeral launched when its alternative process was legal in only one state. While its path to expansion does not hinge on accreditation from a government agency, it does depend on legislative bodies and voters who may be discomforted by this new way to lay a loved one to rest.
New episodes of Build Mode are released every Thursday.