Build Mode Making life (and death) better despite regulatory barriers
Dec 18, 2025
Gabriel Sanchez, CEO of Enspectra Health and a Stanford innovator, discusses his journey developing a groundbreaking FDA-approved skin imaging device, emphasizing the challenges of regulatory navigation. Tom Harries, co-founder of Earth Funeral, shares insights on building a human composting service while tackling the cultural taboos of death and regulatory hurdles. Both founders offer tactical advice on securing funding in regulated spaces and adapting their strategies through lengthy approval processes, highlighting the importance of education and advocacy in their industries.
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Noninvasive Virtual Biopsy Unlocks New Data
- InSpectra created the first new skin imaging physics FDA-cleared in ~28 years, enabling noninvasive "virtual biopsy" data.
- That new data gives access to cellular and molecular features normally only seen via histology, powering diagnostic advances.
From Stanford Lab To Fast 510(k) Clearance
- Gabriel traced InSpectra from a Stanford lab invention through licensing, prototyping, and a Series A that shifted focus to regulatory work.
- After four years of trials and documentation they submitted a 510(k) and received clearance in just over three months.
Design For Reimbursement From Day One
- Align regulatory pathway with reimbursement strategy early to avoid post-clearance commercial dead-ends.
- Consider hybrid approaches to leverage predicates and existing CPT codes to accelerate payment pathways.