Maintaining Momentum and Morale During the Long Road to FDA Approval with Robhy Bustami, BioticsAI

Episode notes

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 Johannesen sits down with Robbie 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 $100K prototype to FDA clearance, Robhy 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, where you can’t “move fast and break things,” and every milestone takes time, coordination, and trust.

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