Founders building in the healthcare space can’t just build fast and break things. Timelines stretch longer, the stakes are higher, and success depends on navigational systems that reward rigor over speed.
This is exactly the reality that Robhy Bustami, co-founder and CEO of BioticsAI, has created. 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 navigated a highly regulated space and kept the team motivated while cutting out all the red tape.
BioticsAI started to disappear. The team built an early, working version of the product for under $100,000, an almost unheard of milestone in the medical device world. This prototype helped them win the TechCrunch Startup Battlefield in 2023, bringing early visibility and credibility. In January, they won FDA approval, which means they can begin rolling out to hospitals and grow the business at a new pace.
From day one, the team approached product development with FDA approval in mind. Instead of building first and calculating 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, and conducting structured clinical studies before we ever got to the submission stage.
The FDA process itself is often seen as a black box, but Bustami stresses that founders don’t need to navigate it blindly. Early engagement with regulatory authorities through pre-submission meetings helped align the team with study design and expectations. However, the risk never completely disappears. 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 a team motivated when the biggest milestone is years away. At BioticsAI, that meant building a culture of alignment between engineers, clinicians, and researchers, making sure everyone could see the wins that were happening.
“Making sure everyone is fully aligned, even if it’s outside of their technical field,” Bustami said, “continually seeing wins on the R&D side,” from clinical studies to new healthcare partnerships.
Techcrunch event
San Francisco, California
|
13-15 October 2026
Now, with FDA clearance secured, BioticsAI is entering a new phase: development. The company is beginning to develop its technology in hospitals, with plans to expand beyond obstetrics into broader areas of reproductive health.
Building health care is a long game. It requires patience, discipline and a willingness to operate under conditions of uncertainty. For founders who want to follow this path, the reward isn’t just a successful company – it’s the opportunity to build something that truly changes the way care is delivered.
Join the Build on feature Apple Podcasts, Spotifyor where you want to listen. Watch the full videos at YouTube. Isabelle Johannessen is our host. Construction mode Produced and edited by Maggie Nye. Head of Audience Development is Morgan Little. And a special thanks to the Foundry and Cheddar video teams.
Apply to Startup Battlefield: We are looking for early stage companies that have an MVP. So name a founder (or yourself). Make sure you’ve heard about Startup Battlefield from the Build Mode podcast. Apply here.
TechCrunch Disrupt 2026: We’re back for TechCrunch Disrupt on October 13-15 in San Francisco, where Startup Battlefield 200 takes the stage. So if you want to cheer them on or just network with thousands of founders, VCs and tech enthusiasts, then get your tickets.
Use a password buildmode15 with a 15% discount on all ticket types.
When you purchase through links in our articles, we may earn a small commission. This does not affect our editorial independence.
