FDA Approval, Fundraising, and the Reality of Building in Healthcare According to the Founder of BioticsAI

Founders who work in healthcare can’t build quickly and break things. Timelines stretch longer, stakes are higher, and success depends on navigating systems that reward accuracy over speed.

This is exactly the reality that Robbie Postami, co-founder and CEO of BioticsAI, has been building. His company is developing an AI co-pilot 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 a company navigates a highly regulated space and keeps the team motivated while cutting through all the red tape.

BioticsAI got off to a rocky start. The team built an early, effective version of the product for less than $100,000, a feat almost unheard of in the world of medical devices. This prototype helped them win the TechCrunch Startup Battlefield in 2023, creating early exposure and credibility. In January, they received FDA approval, which means they can start launching their products in hospitals and grow their business at a new rate.

From day one, the team began developing the product with FDA approval in mind. Instead of building first and discovering the regulation later, they integrated clinical validation, regulatory strategy, and product development into a single process. This means working closely with clinicians, collecting large-scale data sets, and conducting structured clinical studies before reaching the application stage.

The FDA process itself is often viewed as a black box, but Bustami stresses that founders don’t have to approach it blindly. Early engagement with regulatory agencies, through pre-submission meetings, helped the team align the study design with its expectations. However, the risks never completely go away. For many investors, the bigger question is simple: What if the FDA says no?

Internally, these long timelines create a different kind of challenge: keeping the team motivated when the biggest accomplishment is years away. At BioticsAI, that meant building a culture of alignment between engineers, clinicians, and researchers, ensuring everyone had visibility into the gains that were happening.

“Making sure everyone is fully committed, even if it’s outside their technical scope, and we’re constantly seeing wins on the R&D side,” from clinical studies to new health care partnerships, Bastami said.

Now, after receiving FDA approval, BioticsAI is entering a new phase: deployment. The company has begun rolling out its technology in hospitals, with plans to expand beyond obstetrics into broader areas of reproductive health.

Construction in healthcare is a long game. It requires patience, discipline, and a willingness to work under uncertainty. For founders willing to follow this path, the reward isn’t just a successful company — it’s the opportunity to build something that truly changes how care is delivered.

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