Building a medical AI startup: BioticsAI’s founder on FDA approval, fundraising, and why healthcare is a grind

Robhy Bustami, CEO of BioticsAI, sat down with Isabelle Johannessen on the Build Mode podcast to talk about what it’s actually like building an AI company in healthcare. Not the glamorous version. The one where you spend more time with regulators than with users.

If you’ve never dealt with the FDA, you might think it’s just a box to check. Bustami makes it clear: it’s a whole different way of building. You can’t ship fast and break things. Every feature, every data point, every model update has to be justified, documented, and often re-validated. It’s slow, expensive, and honestly, kind of soul-crushing if you’re used to the pace of consumer software.

What stood out to me is how he talked about team motivation. It’s one thing to grind through regulatory hurdles when you’re a founder with equity and vision. It’s another to keep engineers and product people fired up when their work gets stuck in review cycles for months. Bustami didn’t pretend there’s a magic trick. He emphasized transparency — being honest about timelines, celebrating small wins (like a successful audit, not just a product launch), and making sure people understand why the red tape exists. That last part is easy to overlook. If your team sees regulation as pointless bureaucracy, they’ll burn out. If they see it as protecting patients, they’ll buy in.

On fundraising, he didn’t sugarcoat it either. Healthcare AI is a tough sell to VCs who want hockey-stick growth. The sales cycles are long, the customers (hospitals, clinics) are slow to adopt, and the regulatory uncertainty spooks a lot of investors. Bustami’s advice: find investors who actually understand healthcare, not just AI. They’ll ask harder questions but they won’t panic when things move slowly.

I’ve heard similar stories from other founders in this space, but Bustami’s honesty about the emotional toll was refreshing. He admitted there were moments where he questioned if it was worth it. That’s rare for a CEO to say publicly, and I respect it.

One thing that didn’t come up much but I think matters: the cost of compliance. Smaller startups often get squeezed because they can’t afford the regulatory experts or the legal fees. BioticsAI seems to have managed, but I wonder how many good ideas die not because the tech doesn’t work, but because the path to market is too expensive.

If you’re building in healthcare AI, Bustami’s conversation is worth your time. Not for tactical tips, but for the reassurance that the grind is normal. And that if you can survive the regulatory slog, the moat you build is real.