Robhy Bustami, the CEO of BioticsAI, sat down with Isabelle Johannessen on TechCrunch’s Build Mode recently. The conversation wasn’t your typical founder fluff piece. It was a grounded look at what it actually takes to build a healthcare AI company when the FDA is breathing down your neck.
BioticsAI operates in a space where the margin for error is essentially zero. That’s not hyperbole. When your software is helping clinicians make decisions, you can’t ship a half-baked model and patch it later. Bustami was refreshingly direct about how the company has navigated that reality.
The regulatory grind is real, and it’s expensive.
A lot of founders in AI talk about “moving fast and breaking things.” In healthcare, breaking things means people get hurt. Bustami didn’t shy away from the fact that FDA approval is a slog. It’s not just about the paperwork. It’s about designing your entire product roadmap around the timeline of a regulatory body that doesn’t care about your startup’s burn rate.
He mentioned how the team has had to stay motivated through what he called “cutting through all the red tape.” That’s a nice way of saying they’ve spent months on documentation, validation studies, and back-and-forth with regulators instead of building features users can touch. I’ve seen similar stories from other healthtech founders. The ones who survive are the ones who accept this upfront rather than fighting it.
Fundraising in a regulated market is a different game.
Bustami didn’t get into specific numbers, but the subtext was clear: VCs who don’t understand healthcare regulation are a liability. BioticsAI has had to find investors who get that the timeline to revenue is longer, the risk profile is different, and the exit might not come in a standard 5-year window.
This is something I’ve noticed across the industry. The AI hype cycle has produced a lot of founders who think they can slap a chatbot on a medical record system and call it a day. The ones who actually get funding and traction are the ones who treat compliance as a feature, not an obstacle.
Keeping the team motivated through the slog.
This part of the conversation stood out to me. Bustami talked about maintaining morale when the product isn’t launching for months because of regulatory hurdles. Engineers want to ship. Clinicians want to see results. The CEO has to be the buffer.
He didn’t pretend there’s a magic formula. It’s about transparency, setting realistic expectations, and celebrating the small wins — like passing an audit or getting a positive comment from a reviewer. That’s harder than it sounds when you’re burning cash and the finish line keeps moving.
What I took away from this.
BioticsAI is a case study in why healthcare AI is not for the faint of heart. The technology has to work, the regulations have to be satisfied, and the business has to survive long enough to see both happen. Bustami’s approach seems to be: acknowledge the suck, plan for it, and don’t lie to your team or your investors.
If you’re building in this space, the takeaway is simple. Get comfortable with slow progress. Find investors who understand the regulatory landscape. And make peace with the fact that your product might be in development for years before it touches a patient.
That’s not pessimism. That’s realism. And in healthcare AI, realism is the only sustainable strategy.
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