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 and kept the team motivated while cutting through all the red tape. BioticsAI started scrappy. The team built an early, functioning version of the product for under $100,000, an almost unheard-of milestone in the medical device world. That prototype helped them win TechCrunch Startup Battlefield in 2023, bringing early visibility and credibility. In January, they gained FDA approval, which means they can begin launching in hospitals and growing the business at a new rate.
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. That meant working closely with clinicians, collecting large-scale datasets, and running structured clinical studies before ever reaching the submission stage. The FDA process itself is often viewed as a black box, but Bustami emphasizes 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 kind of challenge: keeping a team motivated when the biggest milestone is years away.
A experiência da BioticsAI mostra que é possível conciliar inovação com regulação, desde que a estratégia regulatória seja incorporada desde o início. Para startups de healthtech, o caminho não é mais fazer primeiro e depois se preocupar com aprovações, mas sim construir um produto que já nasça pensando nas exigências dos órgãos reguladores. O resultado é um processo mais longo, mas com muito mais chances de sucesso.
