Surviving the long road to FDA approval isn’t just about building great technology — it’s about keeping your team motivated, finding the right investors, and learning how to operate when timelines are uncertain.
This week on Build Mode, Isabelle Johannessen sits down with Robhy Bustami, co-founder and CEO of BioticsAI, a Startup Battlefield-winning company building an AI copilot for ultrasound to help detect fetal abnormalities. From a $100,000 prototype to FDA clearance, Bustami shares what it actually takes to build in one of the most regulated industries in the world.
In this episode, they break down what it really looks like to build a medtech startup, including where you can’t “move fast and break things” and that every milestone takes time, coordination, and trust.
This conversation covers:
How to stay motivated and keep your team aligned when FDA approval isn’t guaranteed.
What founders need to know about navigating the FDA process from day one.
How to find investors who understand the slower, high-risk nature of medtech.
Why cross-functional collaboration (e.g., with engineers, clinicians, researchers) is critical to success.
The role of advisors and why active industry experts matter more than big names.
How to build momentum and celebrate wins during long, uncertain timelines.
Subscribe to Build Mode on Apple Podcasts, Spotify, or wherever you like to listen. Watch the full videos on YouTube. New episodes of Build Mode drop every Thursday. Hosted by Isabelle Johannessen. Produced and edited by Maggie Nye. Audience development led by Morgan Little. Special thanks to the Foundry and Cheddar video teams.
Apply to Startup Battlefield: We are looking for early-stage companies that have an MVP. So nominate a founder (or yourself). Be sure to say you heard about Startup Battlefield from the Build Mode podcast. Apply here.
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