Challenges of Building a Startup in Regulated Industries

Starting a business in industries with strict regulations presents significant obstacles for entrepreneurs. In a recent episode of Build Mode, Isabelle Johannessen, the editor of Startup Battlefield, delved into the experiences of two founders who are navigating the complexities of regulated sectors to drive innovation and disrupt traditional practices.

In this insightful discussion, the focus is on the impact of regulatory clearance on the development and growth of startups. While regulatory hurdles can prolong timelines and require meticulous planning, they do not have to stifle innovation entirely.

The first guest on the show is Gabriel Sanchez, the CEO, and co-founder of Enspectra Health. Sanchez shares the journey of his company, which has created a device aimed at eliminating the need for dermatologist skin biopsies. He recounts the challenges of obtaining FDA clearance over a decade and provides practical advice for entrepreneurs navigating similar regulatory processes.

Following Sanchez, Isabelle talks to Tom Harries, the co-founder of Earth Funeral, a startup focused on transforming human remains into soil. While Earth Funeral did not face FDA approval due to its focus on end-of-life services, the company encountered legislative hurdles as it expanded into new territories. Harries discusses the challenges of introducing a novel approach to laying loved ones to rest and the importance of legislative support in such ventures.

Build Mode releases new episodes every Thursday, covering a range of startup-related topics. Stay updated by subscribing to the podcast or watching on YouTube. Isabelle Johannessen hosts the show, produced and edited by Maggie Nye, with audience development overseen by Morgan Little. Special thanks to the Foundry and Cheddar video teams for their contributions.