As the life sciences industry works to contain the COVID-19 outbreak, it is clear that the dynamics of the medical device and digital health industries are being disrupted. Going virtual is the new normal and executives of medtech and healthtech businesses, and their investors, need to develop their strategy for navigating their way through the evolving landscape.
In this 45-minute overview delivered by the MCRA All Star team, the panel of experts in their specialties dissected and discussed the ways which the regulatory, clinical and reimbursement pathways change and how you should be planning.
What we will cover:
- The impact of COVID-19 on clinical design and reimbursement
- The rise of telehealth and other digital health and how implementation of digital technologies could impact cardiovascular clinical studies
- The financial crunch and effect on clinical study design; thinking creatively with to reduce cost, timing, and burden
- Creating virtual clinical studies: limitations and advantages
- The impact of reimbursement on halting of elective procedures.
- Effect of quality of data on reimbursement
Glenn Stiegman, MS, Senior Vice President, Clinical and Regulatory Affairs, MCRA
Former FDA Chief of the Orthopedic Devices Branch
- 20+ years of regulatory experience
- Regulatory team has supported ~450 projects in the past year
- Additional prior roles at FDA include Team Leader for Spinal & Orthopedic Devices Branch and
- Team Leader for Carotid Stents, Peripheral Vascular Branch
- Overseen MCRA Regulatory Dept. with 13/13 unblemished PMA record.
Michael John, Vice President, Cardiovascular Regulatory Affairs, MCRA
Former FDA Chief, Interventional Cardiology Devices Branch
- 20+ years of cardiovascular experience
- Consults for >25 cardiovascular companies
- Oversaw the approval of all five -drug-eluting stents on the US market.
- Served as a Lead Animal Studies Reviewer across all 8 branches of DCD
- Additional prior roles at FDA include Animal testing Reviewer and Lead Reviewer in the Division of Cardiovascular Devices
Tonya Dowd, MPH, Vice President, Reimbursement, Health Economics & Market Access, MCRA
- 30+ years of reimbursement, health economics & market access experience
- Former Global Franchise Director of Healthcare Economics and Market Access within Johnson & Johnson's medical device division
- Healthcare company experience includes Biosense Webster, HeartFlow, & iRhythm
- Expert in upstream product plan development and downstream execution of reimbursement strategies
Iman Ahmad, Director of Clinical Affairs, MCRA
- 15 years of clinical research experience
- MCRA’s CRO is currently managing 18 clinical studies
- Extensive experience planning, managing, and monitoring clinical trials, from initiation through close-out, both in the U.S. and overseas
- Works closely with clients, as well as MCRA's integrated regulatory, reimbursement, and statistical experts, to develop strong protocols
Nikki Batista, Associate Director, Cardiovascular & Digital Health Regulatory Affairs, MCRA
Former FDA Assistant Director of External Heart Rhythm and Rate Device Team for the Division of Cardiac Electrophysiology, Diagnostics, & Monitoring Devices
- Extensive knowledge of cardiovascular and digital health medical device regulations
- Additional prior roles at FDA include Senior Lead Reviewer, Peripheral Intervention Devices Team and Lead Reviewer, Interventional Cardiology Devices Branch