FROM CONCEPT TO CLINIC: The Realities of Planning and Running Medical Device Clinical Studies In the U.S.
An Exclusive Webinar
APRIL 28, 2026
2:00-3:00 PM ET
THE CHALLENGE: Planning and running a medical device clinical study in the U.S. today can feel overwhelming—especially when you’re balancing timelines, budgets, investor expectations, and navigating complex and evolving U.S. Food and Drug Administration (FDA) regulatory compliance obligations. How do you prioritize and order what needs to be done? Are you up to speed on U.S. enforcement priorities?
WHAT WE’LL COVER: This no-cost event will address key considerations for planning and running a medical device clinical study in the U.S. Neil O’Flaherty, Partner, Amin Wasserman Gurnani, and Robin McIntosh, Founder, McIntosh Clinical Consulting, will walk you through the most important clinical, regulatory, and operational considerations, explain common misconceptions, and highlight decisions that are difficult—or impossible—to fix later. Their goals are to orient sponsors, set expectations, highlight risks and how to avoid or minimize them, and show why early clinical + regulatory alignment matters.
WHO SHOULD ATTEND: This program is designed specifically for small and mid-sized medical device companies seeking a clear, practical overview of how U.S. medical device clinical studies really work. Whether you are considering running your first U.S. device clinical study, expanding from non-U.S. clinical trials, or want to pressure-test your current strategy, this session will provide the actionable guidance you need to approach the U.S. market with clarity and confidence.
ABOUT THE PRESENTERS
Robin McIntosh, Founder
McIntosh Clinical Consulting
Robin McIntosh is an independent clinical development consultant with 30 years of experience designing and executing clinical programs in the pharmaceutical, medical device, and biotech sectors. She partners with early- and growth-stage companies to turn innovation into practical, global clinical development strategies, with deep expertise in therapeutic and aesthetic dermatology.
Neil O’Flaherty, Partner
Amin Wasserman Gurnani
Neil is a seasoned veteran with over 35 years of legal experience representing medical device companies, assisting clients with Class I, II, or III medical devices at any stage in their product’s premarket and commercial lifecycle. Companies, from multinational firms to start-ups, look to Neil for his strong substantive knowledge of complex FDA requirements and policies, and his ability to help them succeed in a highly regulated industry.
Secure Your Spot Today!
Register here.
If you have any questions, please contact [email protected].
We hope to see you there!
