BioticsAI CEO on FDA approvals, fundraising, and why healthcare startups need thick skin

Robhy Bustami, the CEO of BioticsAI, recently sat down with Isabelle Johannessen on the Build Mode podcast. They talked about something a lot of AI founders in healthcare don’t want to admit: the regulatory grind is brutal, and it doesn’t stop once you get approval.

BioticsAI builds AI-powered tools for fetal ultrasound analysis. That means their software has to be accurate, but more importantly, it has to pass the FDA’s bar for safety and efficacy. That’s a fundamentally different challenge from building a consumer app where you can ship first and fix bugs later.

Bustami was refreshingly direct about the process. He didn’t sugarcoat the paperwork, the waiting, or the sheer amount of evidence you need to produce just to get a meeting. The FDA isn’t your enemy, he said, but it’s also not your friend. It’s a system you have to learn to work with, not against.

What struck me was how he talked about team motivation. When you’re building in healthcare, you don’t get the dopamine hits of rapid user growth or viral launches. You get long cycles of silence followed by regulatory feedback. Keeping engineers and product people engaged through that requires more than just stock options. Bustami emphasized transparency — sharing the real timelines, the risks, and the small wins along the way. It’s not glamorous, but it works.

He also touched on fundraising. Healthcare AI is hot right now, but investors who understand the regulatory landscape are rare. Bustami said he’s had to walk away from deals where the VC wanted hockey-stick growth in 18 months. That timeline doesn’t exist in this space. You need investors who get that FDA clearance is a milestone, not a finish line.

The conversation didn’t shy away from the downsides either. Bustami admitted that building in healthcare means you’re constantly fighting entropy. Regulations change, clinical workflows shift, and reimbursement models are a moving target. If you’re not prepared for that, you’ll burn out fast.

I’ve seen too many healthcare AI startups pitch their tech like it’s a magic wand. Bustami’s approach is the opposite. He’s pragmatic, a little weary, but still committed. That’s the kind of founder I’d bet on — someone who knows the system is broken but is willing to work inside it anyway.

If you’re building in healthcare, listen to the full episode. It’s a rare honest look at what the day-to-day actually looks like, not the polished version you see in press releases.