Healthcare founders can't simply move fast and break things. Development timelines are longer, the stakes are much higher, and success depends on navigating systems that value rigor over speed. That's the reality Robhy Bustami, co-founder and CEO of BioticsAI, has been living. His company is creating an AI-powered ultrasound copilot designed to detect fetal abnormalities—an area where misdiagnosis rates remain surprisingly high. Bustami joined Isabelle Johannessen on Build Mode to talk about steering through a heavily regulated industry, keeping the team motivated, and cutting through bureaucratic red tape.

BioticsAI started lean. The team built an early, working version of the product for under $100,000—a nearly unheard-of achievement in the medical device field. In January, they received FDA approval, allowing them to launch in hospitals and scale the business at a faster pace. From the start, the team approached product development with FDA approval as the end goal. Rather than building first and worrying about regulations later, they combined clinical validation, regulatory strategy, and product development into one process. This meant working closely with clinicians, gathering large-scale datasets, and running structured clinical studies before even reaching the submission stage. The FDA process is often seen as a black box, but Bustami stresses that founders don't have to navigate it blindly. Early engagement with regulators through pre-submission meetings helped the team align on study design and expectations. Still, risk never fully disappears. For many investors, the biggest question is simple: What if the FDA says no? Internally, those long timelines create a different challenge: keeping a team motivated when the biggest milestone is years away. At BioticsAI, that meant building a culture of alignment across engineers, clinicians, and researchers, ensuring everyone saw the wins happening along the way. "Making sure everyone is completely aligned, even if it's outside of their technical scope," Bustami said, "constantly seeing wins on the R&D side," from clinical studies to new healthcare partnerships. Now, with FDA clearance secured, BioticsAI is entering a new phase: deployment. The company is beginning to roll out its technology in hospitals, with plans 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 build something that genuinely changes how care is delivered. Subscribe to Build Mode on Apple Podcasts, Spotify, or wherever you like to listen. Watch the full videos on YouTube. Isabelle Johannessen is our host. Build Mode is produced and edited by Maggie Nye. Audience Development is led by 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 nominate a founder (or yourself). Be sure to say you heard about Startup Battlefield from the Build Mode podcast. Apply here. So if you want to cheer them on, or just network with thousands of founders, VCs, and tech enthusiasts, then grab your tickets. Use code buildmode15 for 15% off any ticket type.