Surviving the long road to FDA approval requires more than just building great technology. It’s important to keep your team motivated, find the right investors, and learn how to operate when schedules are uncertain.
In this week’s Build Mode, Isabelle Johannessen speaks with Robhy Bustami, co-founder and CEO of BioticsAI, a Startup Battlefield winning company developing an AI co-pilot for ultrasound to help detect abnormalities in fetuses. From $100,000 prototypes to FDA clearance, Bustami shares what it really takes to build in one of the world’s most regulated industries.
This episode details what it’s really like to build a medical technology startup, including how you can’t “move fast and break things” and that every milestone requires time, coordination, and trust.
This conversation includes:
How to stay motivated and keep your team aligned even when FDA approval isn’t guaranteed. What founders need to know to navigate the FDA process from day one. How to find investors who understand the slow and risky nature of medical technology. Why cross-functional collaboration (engineers, clinicians, researchers, etc.) is critical to success. The role of advisors and why working industry experts are more important than celebrities. How to build momentum and celebrate victories during long and uncertain timelines.
Subscribe to Build Mode on Apple Podcasts, Spotify, or wherever you like. Watch the complete video on YouTube. New episodes of Build Mode drop every Thursday. Hosted by Isabel Johannessen. Produced and edited by Maggie Nye. Audience Development led by Morgan Little. A big thank you to Foundry and the Cheddar video team.
Apply to Startup Battlefield: We’re looking for early-stage companies that have won an MVP. So, nominate a founder (or yourself). Be sure to mention you heard about Startup Battlefield on the Build Mode podcast. Please apply here.
TechCrunch Disrupt 2026: We’ll be back at TechCrunch Disrupt in San Francisco from October 13th to 15th. There, the Startup Battlefield 200 will take place. So if you want to support them, or network with thousands of founders, venture capitalists, and technology enthusiasts, grab a ticket.
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