Keeping your team motivated when FDA approval isn’t guaranteed
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.
TL;DR
- Building a medtech startup requires managing team motivation and investor relations alongside technology development.
- Navigating the FDA process demands a different approach than typical tech startups, emphasizing careful planning and execution.
- Finding investors familiar with the slower, high-risk nature of medtech is crucial.
- Cross-functional collaboration with engineers, clinicians, and researchers is essential for success.
- Active industry experts and advisors are more valuable than those with just big names.
- Maintaining momentum and celebrating wins are important during long, uncertain approval timelines.