BioticsAI CEO on FDA approvals, fundraising, and why healthcare is a grind

Robhy Bustami, CEO of BioticsAI, sat down with Isabelle Johannessen on the Build Mode podcast and didn’t sugarcoat a thing. If you’ve ever wondered what it’s actually like building a company in healthcare — not the glossy version, but the one where you’re drowning in red tape and regulatory paperwork — this conversation is worth your time.

BioticsAI is doing the kind of work that sounds straightforward until you try it: using AI to analyze medical imaging. But as Bustami laid out, the hard part isn’t the model accuracy or the data pipeline. It’s the FDA. It’s the endless compliance checks. It’s the fact that one misstep can set you back months, not days.

“The reality is that healthcare moves at a different pace,” Bustami said, and you could almost hear the exhaustion in that statement. He’s been at this long enough to know that the startup playbook — move fast, break things — just doesn’t apply when you’re dealing with patient data and regulatory bodies. You move slow, you document everything, and you learn to live with the fact that your timeline will always be longer than you want.

On the fundraising side, Bustami was blunt: healthcare investors are a different breed. They want to see traction, but they also want to see that you understand the regulatory maze. It’s not enough to have a great demo. You need to show that you’ve navigated the FDA before, or at least that you have a plan that doesn’t rely on wishful thinking. He mentioned that BioticsAI raised capital by being transparent about the challenges, which is refreshing in an ecosystem where everyone pretends everything is going perfectly.

What I found most interesting was how he talked about team motivation. When your product takes years to ship and every release feels like a slog, keeping people excited is hard. Bustami said he focuses on the mission — the actual impact on patients — rather than the milestones. It’s a cliché, but he made it sound genuine. He also emphasized giving the team autonomy, which is probably the only way to survive the grind without burning out.

The conversation didn’t shy away from the boring stuff either: compliance, documentation, working with hospital IT departments that move at a glacial pace. Bustami’s takeaway was that you can’t outrun the system. You have to work within it, and that means hiring people who are comfortable with process, not just product.

I’ve seen too many healthcare AI startups crash because they underestimated the regulatory burden. Bustami’s approach — acknowledge it, plan for it, and don’t pretend it doesn’t exist — is the only one that has a shot. If you’re building in healthcare, listen to this episode. It might save you a few years of pain.