Can the fastest path to FDA approval end up being the slowest path to market adoption? Holley Proctor Miller, Founder and President of Grey Matter Marketing, has spent more than two decades helping medtech companies get new products adopted, starting with the early days of surgical robotics.
She and Nick Capman get into the adoption assumptions built into every regulatory pathway decision, why approval evidence and adoption evidence aren’t the same thing, and what regulatory, quality, and commercial leaders should decide together before a pathway is locked in.
A few topics they get into:
Why clearance gives you the right to enter a market but not a reason for the market to change
The questions a substantial equivalence claim raises with buyers
Why “for everyone” usually means “for no one”
Validating behavior instead of interest in market research
Why a narrow initial indication can be the stronger commercial position
The “magic triangle” of product design, regulatory design, and adoption design
A spinal fusion case where changing one variable transformed a launch
About Holley Proctor Miller
Holley Proctor Miller is Founder and President of Grey Matter Marketing. She previously worked at Computer Motion (now part of Intuitive Surgical) in corporate communications and product management, led marketing and global brand management roles at Allergan including for the LAP-BAND system, and served as CMO of NewHope Bariatrics. She holds a BA from Washington and Lee University.
About The FDA Group
The FDA Group helps life science organizations rapidly access the industry’s best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations. Learn more: https://www.thefdagroup.com/
