The FDA's New Human Factors Guidance: What Every Founder and Investor Should Know

​The FDA's new Human Factors & Usability Engineering guidance signals evolving expectations that can influence product design, regulatory timelines, product adoption, and investment risk.

​Join an invite-only roundtable of medical device founders and investors for a practical discussion on what the new guidance means for product development, regulatory strategy, due diligence, and commercialization. Together we'll exchange real-world experiences, challenges, and practical strategies in a confidential, peer-to-peer setting.

​Agenda quick FDA Briefing: Rose Huang, Founder & CEO of Accelidea, will present the key updates from the FDA's new guidance and discuss the practical implications for medical device companies.

​Founder & Investor Roundtable: An interactive discussion with invited founders, investors, and industry leaders to share insights, lessons learned, and practical perspectives.

​Why attend? Founders: Stay ahead of evolving FDA expectations and reduce regulatory and execution risk. Investors: Sharpen diligence on regulatory execution risk and identify stronger investment opportunities.

​Attendance is limited to 15 participants to encourage candid discussion and meaningful interaction.