FDA approval, fundraising, and the reality of building in healthcare according to BioticsAI founder
Source: TechCrunch
Founders building in the healthcare space can’t just “build fast and break things.”
Timelines stretch longer, stakes are higher, and success depends on navigating systems that reward rigor over speed.
That’s exactly the reality Robhy Bustami, co‑founder and CEO of BioticsAI, has been building in. His company is developing an AI copilot 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 has navigated a highly regulated space, kept the team motivated, and cut through the red tape.
From Scrappy Beginnings to FDA Approval
- Early prototype: Built for under $100,000—an almost unheard‑of milestone in the medical‑device world.
- TechCrunch Startup Battlefield 2023: The prototype helped BioticsAI win the competition, bringing early visibility and credibility.
- FDA clearance: In January 2026 the company gained FDA approval, allowing it to launch in hospitals and accelerate growth.
From day one, the team approached product development with FDA approval in mind. Instead of building first and figuring out regulation later, they integrated clinical validation, regulatory strategy, and product development into a single process. This meant:
- Working closely with clinicians.
- Collecting large‑scale datasets.
- Running structured clinical studies before ever reaching the submission stage.
Demystifying the FDA Process
The FDA process is often viewed as a black box, but Bustami emphasizes that founders don’t have to navigate it blindly:
- Early regulator engagement: Pre‑submission meetings helped align study design and expectations.
- Risk remains: For many investors, the biggest question is simple—“What if the FDA says no?”
Keeping the Team Motivated
Long timelines create a different kind of challenge: keeping a team motivated when the biggest milestone is years away. At BioticsAI this meant:
“Making sure everyone is completely aligned, even if it’s outside of their technical scope, and constantly seeing wins on the R&D side—from clinical studies to new healthcare partnerships.”
— Robhy Bustami
Upcoming Event
| TechCrunch Event | Location | Date |
|---|---|---|
| TechCrunch Disrupt 2026 | San Francisco, CA | October 13‑15, 2026 |
The Next Phase: Deployment
With FDA clearance secured, BioticsAI is now rolling out its technology in hospitals and planning to expand beyond obstetrics into broader areas of reproductive health.
Building in healthcare is a long game. It requires patience, discipline, and a willingness to operate in uncertainty. For founders willing to take that path, the reward isn’t just a successful company—it’s the chance to genuinely change how care is delivered.
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About the Contributors
Maggie Nye – Podcast Producer for TechCrunch, based in Denver, Colorado. Former Brand and Content Manager for BUILT BY GIRLS. Holds a B.A. in Journalism (minor in English) from Hofstra University.
Contact: maggie@techcrunch.com | View Bio
Isabelle Johannessen – Leads Startup Battlefield, TechCrunch’s iconic launchpad and competition for the world’s most promising early‑stage startups.
Contact: isabelle.johannessen@techcrunch.com
e TechCrunch, she designed and led international startup acceleration programs across Japan, Korea, Italy, and Spain—connecting global founders with VCs and helping them successfully enter the U.S. market. With a Master’s in Entrepreneurship & Disruptive Innovation—and a past life as a professional singer—she brings a blend of strategic rigor and stage presence to help founders craft compelling stories and stand out in crowded markets.
[View Bio](https://techcrunch.com/author/isabelle-johannessen/)