In this episode of Build Mode, founders Gabriel Sanchez of Enspectra Health and Tom Harries of Earth Funeral share what it takes to build in heavily regulated industries. In these fields, the common startup mantra of “move fast and break things” simply does not apply. They reveal the realities of navigating complex FDA approval processes, state-by-state regulations, and cultural taboos while building products that are literally matters of life and death.
Gabriel Sanchez walks through Enspectra’s nearly decade-long journey to secure FDA clearance for its non-invasive skin imaging device. Meanwhile, Tom Harries discusses the process of building a human composting service as a sustainable alternative to traditional cremation and burial.
Together, they offer tactical advice for entrepreneurs in similar spaces. This includes strategies for iterating on a product while waiting for regulatory approval, planning your financial runway when success is largely out of your hands, and raising venture capital in industries many investors consider too taboo to touch.
New episodes of Build Mode are released every Thursday. The host is Isabelle Johannessen. The podcast is produced and edited by Maggie Nye, with Audience Development led by Morgan Little. Special thanks are given to the Foundry and Cheddar video teams.