Statistics and experimental design are essential for medical device development, powering everything from marketing approval to investor reviews to grant applications.

Join Drs. Isabel Allen and Julia Seaman from BayView Analytics as they share recent experiences from their work with the FDA. They’ll cover biostatistical strategies that led to success (and some that didn’t), along with practical advice for navigating analytics in product development.

In 2023 and 2024, BayView Analytics supported three FDA approvals: two in AI-aided diagnostics and one in an ophthalmology device using AI for measurement. They continue to work with diagnostic, device, and therapeutic startups, providing:

• Statistics and analytics consulting
• Proof-of-concept, data-driven approaches
• Phase 1–4 design and analysis
• Competitive intelligence research
• Development of FDA analysis plans and trials for approval

This session will help you use analytics to sharpen your competitive edge and position your product for regulatory and market success.