BioticsAI’s Founder on FDA Wins and Building in Healthcare

Building a startup in healthcare isn’t about moving fast and breaking things—it’s about patience, precision, and navigating complex systems. That’s the path Robhy Bustami, co-founder of BioticsAI, has taken while developing an AI-powered ultrasound assistant designed to detect fetal abnormalities.

Speaking on the Build Mode podcast with host Isabelle Johannessen, Bustami shared insights into what it really takes to build in one of the most regulated industries.

From Scrappy Start to FDA Approval

BioticsAI began with a lean approach. The team managed to build an early working prototype for under $100,000—something rarely seen in the medical device world. That early momentum helped them win TechCrunch Startup Battlefield in 2023, giving the company valuable exposure.

The big breakthrough came in January, when the company received approval from the U.S. Food and Drug Administration. This milestone allows BioticsAI to begin deploying its technology in hospitals and scaling its operations.

Building With Regulation in Mind

Unlike many startups that focus on speed first, BioticsAI integrated regulatory strategy into its product development from day one.

The team worked closely with clinicians, gathered extensive datasets, and conducted structured clinical studies early in the process. This approach helped them avoid costly delays later and ensured they were aligned with FDA expectations before submission.

Bustami emphasized that the FDA process doesn’t have to be a mystery. Early communication—such as pre-submission meetings—can help founders understand requirements and reduce uncertainty.

Managing Risk and Investor Concerns

Despite careful planning, risk is always part of the equation. One of the biggest concerns for investors is simple: what happens if FDA approval doesn’t come through?

This uncertainty can make fundraising more challenging, especially in the early stages when regulatory outcomes are still unknown.

Keeping the Team Motivated

Long timelines are another major challenge in healthcare startups. With years between key milestones, maintaining team morale can be difficult.

At BioticsAI, the solution has been strong internal alignment. Engineers, clinicians, and researchers are kept closely connected, ensuring everyone understands progress—even outside their specific roles.

Bustami highlighted the importance of celebrating smaller wins, from research breakthroughs to new partnerships, to keep momentum going.

Entering the Next Phase

With FDA clearance secured, BioticsAI is now shifting its focus to deployment. The company has started rolling out its technology in hospitals and plans to expand beyond obstetrics into broader areas of reproductive health.

The Bigger Picture

Healthcare innovation is a long game. It demands discipline, collaboration, and the ability to operate under uncertainty. But for founders who succeed, the impact goes far beyond business metrics.

As BioticsAI moves forward, its journey shows that combining AI with rigorous healthcare standards can lead to meaningful improvements in patient care—and potentially save lives along the way.

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