Navigating the long and uncertain path to FDA approval requires more than just groundbreaking technology—it demands sustained team motivation, strategic investor relationships, and the ability to operate effectively when timelines are unpredictable. In this week's episode of Build Mode, host Isabelle Johannessen speaks with Robhy Bustami, co-founder and CEO of BioticsAI—a Startup Battlefield-winning company that develops an AI copilot for ultrasound to detect fetal abnormalities. Bustami shares the real journey from building a $100,000 prototype to achieving FDA clearance, offering insights into what it truly takes to create a product in one of the world's most heavily regulated industries.

During the conversation, they explore the realities of building a medtech startup, including areas where the "move fast and break things" mindset simply doesn't apply. Every milestone requires patience, careful coordination, and deep trust among stakeholders. The discussion covers several critical topics:

- How to maintain motivation and keep your team focused when FDA approval remains uncertain - Essential knowledge for founders about navigating the FDA process from the very beginning - Strategies for finding investors who truly understand the slower, high-risk nature of medtech - Why cross-functional collaboration—with engineers, clinicians, and researchers—is vital for success - The importance of advisors who are active industry experts rather than just big names - Ways to build momentum and celebrate wins during long, unpredictable timelines

Subscribe to Build Mode on Apple Podcasts, Spotify, or wherever you listen. Watch full videos on YouTube. New episodes 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.

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