The Future of Medical Devices: How COVID-19 and the Rise of Digital Health has changed Regulatory, Clinical, and Reimbursement Dynamics in the Medical Device Industry

Life Sciences, Clinical Trials, Medical Device, Healthcare, Digital Health, Healthcare Finance,
  • Thursday, July 09, 2020

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 med-tech and health-tech businesses and their investors need to develop a strategy for navigating their way through the evolving landscape.

In this 45-minute overview delivered by MCRA, the panel of experts in their specialties will dissect and discuss the ways which the regulatory, clinical and reimbursement pathways are changing and how you can plan to keep up with these changes.

Keywords:
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Speakers

Glenn Stiegman,MCRA

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
  • Team Leader for Carotid Stents, Peripheral Vascular Branch
  • Overseen MCRA Regulatory Dept. with 13/13 unblemished PMA record
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Michael John, MCRA

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
Message Presenter
Lauren Craig, MCRA

Lauren Craig, CPC-H, Director, Reimbursement, Health Economics & Market Access, MCRA

  • 15+ years reimbursement experience including positions at Shire Regenerative Medicine, Boston Scientific and most recently Intersect ENT
  • Executed national and regional sales and reimbursement strategies for multiple product launches consistently achieving top 20% rankings
  • Experience spans multiple therapeutic categories with focus in gastroenterology, pulmonology, ENT, surgical oncology and skin substitutes
Message Presenter
Iman Ahmad, MCRA

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 US and overseas
  • Works closely with clients, as well as MCRA’s integrated regulatory, reimbursement and statistical experts, to develop strong protocols
Message Presenter
Nikki Batista, MCRA

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
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Who Should Attend?

  • Medical device product manufacturers and investors

What You Will Learn

  • The impact of COVID-19 on clinical design and reimbursement
  • The rise of telehealth and other digital health and how the implementation of digital technologies could impact cardiovascular clinical studies
  • The financial crunch and its effect on clinical study design: thinking creatively to reduce cost, timing and burden
  • Creating virtual clinical studies: limitations and advantages
  • The impact of reimbursement on the halting of elective procedures
  • The effect of quality of data on reimbursement

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MCRA

Founded in 2004, MCRA is a leading medical device advisory firm and clinical research organization (CRO). MCRA’s value contribution rests within its industry experience at integrating five business value creators—regulatory, reimbursement, clinical research, healthcare compliance, and quality assurance—to provide a dynamic, market-leading effort from concept to commercialization. MCRA’s integrated application of these key value-creating functions provides unparalleled expertise for its clients. MCRA has offices in Washington, DC, Manchester, CT, and New York, NY, and serves more than 600 clients globally. Its core focus areas of therapeutic experience include orthopedics, spine, cardiovascular, diagnostic imaging, wound care, dental, general healthcare, digital health, neurology, robotics, in vitro diagnostic (IVD) devices, personal protective equipment, test kits for clinic and at home uses, ventilators, cardiopulmonary monitoring systems, and respiratory treatment devices

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