Bridging the Gap: Overcoming Regulatory Pathways & Advancing Medtech Policy

July 15, 12-1PM EDT

In this webinar, we’ll explore how pediatric clinical trials differ from adult device studies, what developers need to know about working with IRBs and families, and how regulatory pathways such as PMA and 510(k) apply in pediatric settings. We’ll also discuss the FDA’s growing acceptance of real-world data and real-world evidence, including recent policy developments that may create new opportunities for pediatric innovators.

Register here: https://www.eventbrite.com/e/bridging-the-gap-overcoming-regulatory-pathways-advancing-medtech-policy-tickets-1990889184143

The purpose of our 2026 webinar series, Founders’ Stories in Pediatric Innovation, is to shine light on the complex lifecycle of pediatric medical device development by bridging the gap between clinical need and commercial viability. The series is designed to deliver actionable insights on the regulatory, design, and funding challenges unique to the pediatric “orphan market,” while connecting the MPDC ecosystem with prospective founders, clinicians, and investors. Through real-world stories, it aims to inspire and demonstrate that while the pediatric path is challenging, it is both achievable and deeply impactful.

Episode 3: Clinical & Regulatory Reality: Real World Evidence with Dr. Dionna Green will cover:

  • How pediatric clinical trials differ from adult device studies, including enrollment and ethical considerations
  • Navigating FDA pathways and requirements, including PMA vs. 510(k) in pediatric contexts
  • Working with IRBs, families, and other key stakeholders in pediatric research
  • The growing role of real-world data and real-world evidence in regulatory decision-making
  • Common timing challenges and strategies for advancing pediatric devices toward approval

Why Attend?

If you’re building or supporting pediatric medical devices, this session will provide practical insights into clinical trials, FDA expectations, and the growing role of real-world evidence to move innovations forward.