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Founders Gabriel Sanchez (Enspectra Health) and Tom Harries (Earth Funeral) share what it takes to build in heavily regulated industries where "move fast and break things" simply won't work. In this episode of Build Mode, they reveal the realities of navigating FDA approval processes, state-by-state regulations, and cultural taboos while building products that are literally matters of life and death. Gabriel walks through Enspectra's nearly decade-long journey to FDA clearance for their skin imaging device, while Tom discusses building a human composting service as an alternative to cremation and burial. They offer tactical advice on iterating while waiting for regulatory approval, planning your runway when success is largely out of your hands, and raising venture capital in spaces that many investors consider too taboo to touch.
Chapters:
00:00 Intro
00:30 Meet Gabriel Sanchez - Enspectra Health
02:34 The First FDA-Approved Skin Imaging Physics in 28 Years
04:24 From Stanford Lab to Clinical Device
06:43 Navigating FDA Clearance and Reimbursement Strategy
43:33 Scaling While Managing Regulatory Barriers
46:55 Where Earth is Today and Future Growth
48:00 Outro
New episodes of Build Mode drop every Thursday. 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.
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