BioticsAI Founder on FDA Approvals, Funding, and the Reality of Building Healthcare

Founders building in healthcare can do more than just build fast and destroy. The timelines are longer and the stakes are higher. Success depends on a navigation system that emphasizes rigor over speed.

That’s exactly the reality that Robhy Bustami, co-founder and CEO of BioticsAI, has been building. His company is developing an AI co-pilot for ultrasound that can help detect fetal abnormalities. Misdiagnosis rates remain alarmingly high in this field. Bustami joined Isabel Johannessen on Build Mode to discuss how the company has navigated a highly regulated sector and kept the team motivated while cutting through all the red tape.

BioticsAI has launched Scrappy. The team built an early working version of the product for less than $100,000. This is an almost unprecedented milestone in the world of medical devices. This prototype helped us win the 2023 TechCrunch Startup Battlefield, giving us early visibility and credibility. In January, the company received FDA approval, which means it can begin deployment in hospitals and grow its business at a new rate.

From day one, the team approached product development with FDA approval in mind. Rather than build first and think about regulation later, we integrated clinical validation, regulatory strategy, and product development into one process. This means working closely with clinicians, collecting large datasets, and running structured clinical studies before reaching the submission stage.

While the FDA process itself is often seen as a black box, Bustami emphasizes that founders don’t have to navigate the process blindly. Engaging early with regulators through pre-submission meetings allowed the team to align on study design and expectations. Still, the risk is never completely eliminated. For many investors, the biggest question is simple. “What if the FDA says no?”

Internally, these long schedules create a different kind of challenge: keeping teams motivated when their biggest milestones are years away. For BioticsAI, that meant building a culture of collaboration between engineers, clinicians, and researchers to ensure everyone sees results.

“We make sure that everyone is fully aligned, even if it’s outside the technical scope,” Bustami said, noting that “we always see wins on the research and development side,” from clinical studies to new medical partnerships.

Now, with FDA clearance secured, BioticsAI is entering a new phase of deployment. The company has begun rolling out its technology in hospitals and plans to expand beyond obstetrics into the broader field of reproductive health.

Building healthcare is a long game. It requires patience, discipline, and a willingness to operate under uncertainty. For founders looking to walk that path, the reward is not just the success of the company, but the chance to build something that truly changes the way care is delivered.

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