Northwestern Events Calendar

Apr
14
2025

Navigating Regulatory Hurdles for Medical Device Innovators: Myths and Realities from Bench to Bedside

When: Monday, April 14, 2025
12:00 PM - 1:00 PM CT

Where: Online

Audience: Faculty/Staff - Student - Post Docs/Docs - Graduate Students

Contact: Sonia Kim   (847) 467-0446

Group: Innovation and New Ventures Office

Category: Academic

Description:

Join the Querrey InQbation Lab for a special seminar with Elyse Kemmerer White, Ph.D.

Bringing a medical device to market is a complex and highly regulated journey. This seminar aims to demystify the process by addressing common misconceptions and providing a realistic view of the regulatory pathway from concept to clinical use. Tailored for researchers, engineers, clinicians, and entrepreneurs, the session will offer actionable insights into FDA requirements, preclinical and clinical trial planning, and best practices for early-stage innovators.

Dr. Kremmerer White will touch on case studies and also provide real-world examples to help attendees gain a better understanding of how to anticipate and overcome regulatory barriers, align product development with compliance needs, and accelerate their device’s path to impact.

Whether you’re just starting out or beginning to prepare for a submission, this seminar will provide valuable guidance on how to think strategically about regulation from the very beginning.

About the Speaker
Elyse Kemmerer White, Ph.D., is a distinguished neuroscientist, entrepreneur, and innovator at the forefront of MedTech and HealthTech. With a robust academic foundation from the University of Michigan and Lehigh University, she has led pioneering efforts in medical device innovation and clinical research. Her career spans transformative roles, including Co-Founder of a Venture-backed medical device startup company and Program Director at the National Institute of Neurological Disorders and Stroke (NINDS), where she has successfully bridged scientific discovery and real-world impact. Her expertise spans strategic planning, new product development, clinical validation, and cross-sector collaboration—underscoring her commitment to translating innovation into improved health outcomes.

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