Medical Devices and Digital Health After
COVID-19: Implications for the Industry
and Your Business
Sponsored by MCRA
Tuesday, June 9, 2020 · 11:00 a.m. - 12:00 p.m. EDT
Location: Your office or conference room (no need to travel!)
With COVID-19 disrupting every aspect of life as we know it, it may seem impossible to know what medical device clinical trials will look like after the pandemic. While there’s not a crystal ball, a better understanding of what you can expect after COVID-19 will allow you to make plans now.
During this free webinar, MCRA’s panel of five experts — Glenn Stiegman, Michael John, Tonya Dowd, Iman Ahmad and Nikki Batista — will explain how you can develop a strategy for navigating your way through the evolving landscape. They’ll discuss ways that the regulatory, clinical and reimbursement pathways will change. And they’ll reveal how you should be planning for the post-COVID-19 world.
- Impact of COVID-19 on clinical design and reimbursement
- Rise of telehealth and other digital health technologies and how implementation could impact cardiovascular clinical studies
- Effect of the financial crunch on clinical study design and how to reduce cost, timing and burden
- Advantages and limitations in creating virtual clinical studies
- Impact of reimbursement on the halting of elective procedures
- Effect of data quality on reimbursement
Prepare for future success in the medical device and digital health trials with this panel’s roadmap for a post-COVID-19 plan. Join us by registering today.
Who Will Benefit:
Medical device product manufacturers and investors.
Meet Your PresenterS:
Senior Vice President, Clinical and Regulatory Affairs
Glenn Stiegman is MCRA’s senior vice president, clinical and regulatory affairs, and is the FDA’s former chief of the orthopedic devices branch. With more than 20 years of regulatory experience, he oversees MCRA’s regulatory department, where he and his team have supported approximately 450 projects in the past year and a 13/13 unblemished PMA record. Mr. Stiegman also served in the FDA as team leader for spinal and orthopedic devices branch and team leader for carotid stents, peripheral vascular branch.
Vice President, Cardiovascular Regulatory Affairs
Michael John is vice president, cardiovascular regulatory affairs for MCRA. He previously served as FDA chief, interventional cardiology devices branch. With over 20 years of cardiovascular experience, Mr. John consults for more than 25 cardiovascular companies. He oversaw the approval of all five drug-eluting stents on the U.S. market and served as a lead animal studies reviewer across all eight branches of DCD. Mr. John’s other prior FDA roles included animal testing reviewer and lead reviewer in the division of cardiovascular devices.
Vice President, Reimbursement, Health Economics and Market Access
Tonya Dowd is MCRA’s vice president, reimbursement, health economics and market access. She has more than 30 years of reimbursement, health economics and market access experience. Ms. Dowd was also global franchise director of healthcare economics and market access within Johnson & Johnson’s medical device division. Other healthcare company experience includes Biosense Webster, HeartFlow and iRhythm. In addition, she is an expert in upstream product plan development and downstream execution of reimbursement strategies.
Director of Clinical Affairs
Iman Ahmad, who has 15 years of clinical research experience, is MCRA’s director of clinical affairs. She has extensive experience planning, managing and monitoring clinical trials, from initiation through close-out, both in the U.S. and abroad. Ms. Ahmad works closely with clients, as well as MCRA’s integrated regulatory, reimbursement and statistical experts, to develop strong protocols. MCRA’s CRO is currently managing 18 clinical studies.
Associate Director, Cardiovascular and Digital Health Regulatory Affairs
Nikki Batista, MCRA’s associate director, cardiovascular and digital health regulatory affairs, has extensive knowledge of cardiovascular and digital health medical device regulations. She was previously the FDA’s assistant director of external heart rhythm and rate device team for the division of cardiac electrophysiology, diagnostics and monitoring devices. Other prior FDA roles include senior lead reviewer, peripheral intervention devices team and lead reviewer, interventional cardiology devices branch.