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

• How to build momentum and celebrate wins during long, uncertain timelines

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Chapters:

00:00 Building a $100K MedTech Startup

00:32 Intro: Biotics AI & the Problem with Ultrasound Misdiagnosis

02:16 What Biotics AI Actually Does (AI Copilot for Ultrasound)

02:54 Early Days: Startup Battlefield & First Product

07:10 Navigating FDA Approval (Without Guesswork)

09:22 What FDA Clearance Unlocks (Going to Market)

10:59 Selling into Hospitals & Early Customers

12:11 Keeping a Team Motivated During Long Timelines

18:54 The Hardest Parts of Building in MedTech

22:22 Fundraising, Advisors, and Building the Right Team

28:33 The Future of AI in Reproductive Healthcare

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.