Keeping Your Team Motivated When FDA Approval Isn’t Guaranteed l Build Mode

Early FDA Engagement Prevents Retrofitting

Bustami utilized FDA pre-submission meetings before conducting clinical studies to align on expectations and avoid retroactively rebuilding the product to meet regulatory standards.

De-Risking Through Integrated Development

The team embedded regulatory, clinical, and product development together from day one to ensure safety and efficacy were intrinsic to the AI models rather than afterthoughts.

Managing Regulatory Uncertainty

While FDA rejection remains the primary investor concern—compounded by evolving AI regulations—continuous monitoring of regulatory changes allows for strategic pivots during the approval process.

Real-Time AI Co-Pilot for Ultrasound

Biotics AI's tablet-based software integrates with existing ultrasound machines to provide instant feedback to operators, directly addressing the 50% misdiagnosis rate of fetal abnormalities caused by operator error.

Comprehensive Data Collection Strategy

The company gathered tens of thousands of ultrasound images across diverse patient demographics through partnerships with 15 maternal fetal medicine specialists to support FDA submission.

Expansion Beyond Initial Clearance

Following FDA clearance for standard fetal anatomy screening, the company is now expanding its AI to detect specific fetal abnormalities and maternal/gynecologic conditions.

Converting Clinical Partners to Customers

Biotics AI strategically merged its FDA clinical validation process with its go-to-market strategy, transforming research partners like Mymonities Medical Center into inaugural customers.

Bi-Coastal Deployment Strategy

While maintaining co-founders in the Bay Area, Bustami relocated to New York to leverage proximity to major hospital hubs including Mount Sinai and Northwell for initial commercial deployment.

Maintaining Momentum Pre-Approval

To sustain team motivation during the lengthy FDA process, Bustami emphasizes cross-functional alignment between engineers and clinicians while celebrating interim milestones such as publications and new healthcare partnerships.