FDA approval, fundraising, and building reality in healthcare according to the founder of BioticAI

Innovators building in the healthcare space can’t just quickly build and break things. The timelines are long, the stakes are high, and success depends on navigation systems that reward persistence with speed.

That’s exactly what Roby Bustami, founder and CEO of BioticsAI, has been building on. His company is developing an AI assistant for ultrasound that helps detect fetal abnormalities, an area where misdiagnosis rates remain surprisingly high. Bustami joined Isabelle Johannessen on Build Mode to discuss how the company navigated the highly regulated environment and kept the team motivated while cutting through all the red tape.

BioticsAI got off to a scrappy start. The team built the first, working version of the product for under $100,000, a milestone almost unheard of in the world of medical devices. That example helped them win the TechCrunch Startup Battlefield in 2023, bringing early visibility and credibility. In January, they received FDA approval, which means they can start launching in hospitals and grow the business at a new rate.

From day one, the team approached product development with FDA approval in mind. Instead of building first and getting legal later, they combined clinical validation, regulatory strategy, and product development into one process. That meant working closely with clinicians, collecting large data sets, and conducting systematic clinical studies before reaching the submission stage.

The FDA process itself is often considered a black box, but Bustami insists that innovators don’t have to navigate blindly. Early communication with regulators, through pre-posting meetings, helped the team align the research structure and expectations. However, the danger is never completely gone. For many investors, the big question is simple: What if the FDA says no?

Internally, those long timelines create a different kind of challenge: keeping a team motivated when a milestone is years away. At BioticsAI, that meant building a culture of alignment across engineers, clinicians, and researchers, to ensure that everyone sees the wins that are happening.

“Making sure that everyone is completely aligned, even if it’s outside of their technical field,” says Bustami, “he always sees success on the R&D side,” from clinical studies to new healthcare partnerships.

Now, with FDA approval secured, BioticsAI is entering a new phase: deployment. The company is beginning to introduce its technology to hospitals, with plans to expand beyond obstetrics into broader areas of reproductive health.

Building in health care is a long game. It takes patience, discipline, and a willingness to work with uncertainty. For innovators willing to take that path, the reward isn’t just a successful company — it’s the opportunity to build something that truly changes the way care is delivered.

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