Building a Healthcare AI Startup: FDA, Fundraising, and the Long Grind

Robhy Bustami, the CEO of BioticsAI, sat down with Isabelle Johannessen on Build Mode recently. They talked about the kind of stuff that doesn’t make it into press releases. The grind. The red tape. The weird, slow slog of building a medical AI company.

If you’ve never worked in healthcare tech, you might think the hard part is the science. Nope. The hard part is the FDA. The hard part is convincing investors you’ll survive the approval process. The hard part is keeping your engineers from quitting when they realize they’re writing documentation for the third time instead of shipping features.

Bustami was pretty candid about all of it. He didn’t sugarcoat the regulatory side. The FDA process isn’t just slow — it’s unpredictable. You think you know what they’ll ask for, and then they ask for something else. And you can’t argue. You just do it.

What I found interesting was how he talked about team motivation. In a normal startup, you can show users growing, revenue climbing, something tangible. In healthcare AI, you might spend two years getting approval before a single patient uses your product. That’s brutal for morale. Bustami said they focused on the mission, but also on small wins — internal milestones, celebrating when a document got accepted, stuff like that. It sounds cheesy, but I’ve seen teams fall apart without it.

Fundraising is its own beast. Healthcare AI is capital intensive, and VCs are skittish. They want to see a path to revenue that doesn’t depend on “we’ll figure out reimbursement later.” Bustami mentioned that being transparent about timelines — even ugly ones — helped build trust with investors. No one likes surprises, especially not when they’re writing million-dollar checks.

The conversation also touched on something I think about a lot: the gap between what AI can do in a lab and what it can do in a hospital. BioticsAI’s tech is solid, but deployment is a whole different problem. Integration with existing systems, training staff, dealing with liability questions — none of that shows up in a demo.

Bustami didn’t pretend to have all the answers. That’s refreshing. Most founder interviews are polished to the point of uselessness. This one felt real. He acknowledged that building in healthcare is harder than he expected, and that some days it feels like you’re moving backward. But he also said the team is still there, still pushing, because they believe the end result matters.

I don’t know if BioticsAI will be a massive success. Nobody does. But I respect the honesty. Healthcare needs more founders willing to say “this is harder than I thought” instead of pretending everything is under control.