"Robhy Bustami emphasizes that founders don't have to navigate the FDA process blindly. Early engagement with regulators through pre-submission meetings helped the team align on study design and expectations."
"The team built an early, functioning version of the product for under $100,000, an almost unheard-of milestone in the medical device world, which helped them win TechCrunch Startup Battlefield in 2023."
"Instead of building first and figuring out regulation later, BioticsAI integrated clinical validation, regulatory strategy, and product development into a single process, working closely with clinicians and collecting large-scale datasets."
"Internally, long timelines create challenges in keeping a team motivated when the biggest milestone is years away, necessitating a strong culture of engagement and support."
Building in the healthcare sector requires a focus on regulatory compliance and team motivation. Robhy Bustami, CEO of BioticsAI, is developing an AI copilot for ultrasound to detect fetal abnormalities. The company built a prototype for under $100,000 and won TechCrunch Startup Battlefield in 2023. They gained FDA approval in January, allowing them to launch in hospitals. The team integrated clinical validation and regulatory strategy into product development, engaging with regulators early to align on expectations and study design.
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