FDA approval, fundraising, and the reality of building in healthcare according to BioticsAI founder

Healthcare AI is a brutal space to build in. The regulatory hurdles alone can kill a startup before it even gets to market. BioticsAI CEO Robhy Bustami knows this better than most.

He sat down with Isabelle Johannessen on Build Mode to talk about how his company navigated the FDA approval process, raised money in a tough environment, and kept the team from burning out while dealing with all the red tape.

BioticsAI is focused on using AI for fetal ultrasound analysis. That’s the kind of application where mistakes aren’t just costly—they can have real consequences for patients. So the FDA scrutiny is intense, and rightfully so.

Bustami didn’t sugarcoat the process. Getting FDA clearance took longer than expected, required more data than planned, and demanded a level of rigor that most software startups never have to think about. But he also made it clear that this isn’t something you can shortcut. If you’re building in healthcare, the regulatory path is part of the product, not an afterthought.

On the fundraising side, he acknowledged that healthcare AI doesn’t fit neatly into the VC playbook. Investors want fast growth and big exits, but healthcare moves slow and the margins are tight. Bustami’s advice was blunt: find investors who actually understand healthcare, not just AI hype. The ones who get it will stick with you through the long cycles.

Team motivation was another topic he touched on. When you’re building a product that has to pass FDA muster, the feedback loops are long. Engineers and clinicians working on the product might not see their work deployed for years. Bustami emphasized the importance of celebrating small wins along the way—internal milestones, data improvements, positive clinical feedback—to keep people engaged when the finish line feels distant.

What I appreciated about the conversation was the lack of fluff. Bustami didn’t pretend building in healthcare is glamorous. He laid out the grind honestly: the paperwork, the waiting, the rejections, the pivots. But he also made it clear that if you can survive it, you build something that actually matters.

There’s a lesson here for any founder looking at healthcare AI as a gold rush. It’s not. It’s a slog. But for the ones who can handle the pace, the moat is real.