About this episode

The episode discusses maintaining team morale and momentum during the lengthy FDA approval process in the medtech industry with insights from Robhy Bustami of BioticsAI.

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. 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 (engineers, clinicians, researchers) is critical to success The role of advisors and why active industry experts matter more than big names…

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