Webinar: Regulatory Meets Reimbursement June 17 2026

Webinar: Regulatory Meets Reimbursement - What MedTech Innovators Need to Know About FDA Breakthrough and Beyond

FDA Breakthrough Device Designation can create meaningful opportunities for MedTech innovators, including earlier and more interactive engagement with the FDA, increased visibility during development, and potential connection points to emerging coverage and payment programs. 

But Breakthrough designation is often misunderstood. It is not a shortcut to clearance or approval, and it is certainly not a guarantee of coverage, payment, adoption, or commercial success. 

Learn more in this informative webinar presented live on June 17, 2026, featuring special guest speaker Dr. Brian Solow, former Chief Medical Officer of Optum Life Sciences and OptumRX (segments of UnitedHealth Group), along with PRIA’s Tonya Dowd, Sam Murray, and Suzy Engwall.

Panelists took a practical, balanced look at Breakthrough designation as well as TAP, RAPID, and TEMPO, from both the regulatory and payer perspectives.

Panelists:

• Brian Solow, MD, former Chief Medical Officer of Optum Life Sciences and OptumRX (segments of UnitedHealth Group)
• Tonya Dowd, MPH, EVP, Reimbursement, Health Economics, Market Access (RHEMA) and Corporate Development, PRIA
• Sam Murray, Head of Regulatory & Quality, PRIA
• Suzy Engwall, Sr. Director, Global Business Development and Strategic Growth, PRIA