2020 Annual Public Forum (Virtual)

Visit apf.mdic.org to see the full agenda and register for future sessions. Catch up on past sessions below.

Fireside Chat

Thursday, June 18, 2020

FDA Commissioner, Dr. Stephen Hahn sits down with MDIC’s President and CEO, Pamela Goldberg to discuss his role as Commissioner, key priorities for the Agency, and how COVID-19 has impacted the device industry.

Speakers:

  • Stephen Hahn, MD | Commissioner, FDA
  • Pamela Goldberg, MBA | President and CEO, Medical Device Innovation Consortium (MDIC)

CDRH Town Hall

Thursday, June 25, 2020

Hear from FDA’s CDRH leaders as they discuss the important work and partnership between the Agency and MDIC, and how it relates to FDA’s strategic priorities.

Speakers:

  • Nadim Yared | President and CEO, CVRx and MDIC Board Chairman (Moderator)
  • Jeff Shuren, MD, JD | FDA Center for Devices and Radiological Health (CDRH), Center Director
  • Michelle Tarver, MD, PhD | FDA CDRH, Office of Strategic Partnerships & Technology Innovation (OST), Director for Patient Science Engagement
  • Andrew Farb, MD | FDA CDRH, Office of Product Evaluation and Quality, Office of Health Technology 2, Chief Medical Officer
  • Daniel Caños, PhD, MPH | FDA CDRH, Office of Clinical Evidence and Analysis, Director
  • Jessica Wilkerson | FDA CDRH, Office of Strategic Partnerships & Technology Innovation (OST), All Hazards Readiness Response & Cybersecurity, Cyber Policy Advisor
  • Francisco “Cisco” Vicenty | FDA CDRH, Office of Product Evaluation and Quality, Compliance and Quality Staff, Program Manager – Case for Quality
  • Sara Brenner, MD, MPH | FDA CDRH, Office of Product Evaluation and Quality, Office of Health Technology 7, Associate Director for Medical Affairs
  • Anindita “Annie” Saha | FDA CDRH, Office of Strategic Partnerships & Technology Innovation (OST), Director for Partnerships to Advance Innovation Regulatory Science

Includes exclusive extended Q&A not shown in the live session!

How can RWE advance diagnostics in the COVID-19 era?

Thursday, July 9, 2020

The COVID-19 pandemic has illustrated the value of in vitro diagnostics like never before.  At the same time, it has challenged the healthcare ecosystem to determine how these important, innovative IVDs perform in the real world, and how we might use the data generated in regulatory decision-making.  Join this expert panel in exploring the barriers and opportunities to timely access to RWE, and the new Medical Device Innovation Consortium Framework for addressing quality issues and potential clinical study designs to support submission for clearance or approval of IVDs currently under EUA.

Speakers:

  • Danelle Miller, JD | Roche Diagnostics, VP, Global Regulatory Policy and Intelligence (moderator)
  • Wendy Rubinstein, MD, PhD | Director, Personalized Medicine, FDA:CDRH:OHT7-OIR
  • Tyler O’Neill, DVM, PhD| Roche Diagnostics, Clinical Science Leader, Acute Care, Infectious Diseases, Clinical Science, Medical & Scientific Affairs
  • Ed Heierman, PhD | Abbott, Sr Product Cybersecurity Architect | IVD Industry Connectivity Consortium (IICC), Chief Technology Officer
  • William G. Morice II, MD, PhD| Mayo Clinic Laboratories, Professor and Chair, Department of Laboratory Medicine & Pathology, President

Patient preference and RWE strategies to develop a patient-centered regulatory strategy

Thursday, July 16, 2020

FDA’s CDRH has issued several guidance documents in consideration of using patient preference data in regulatory benefit-risk assessments and real-world evidence to support regulatory decision-making for medical devices. But rather than considering these as two separate topics, device manufacturers should consider these guidance documents together in the development of a cohesive regulatory strategy that maximizes patient input and the potential for regulatory success. Patient preference information can help manufacturers, providers, and regulators understand the level and type of risks patients with a given condition would be willing to endure and the level and type of benefit that would be most meaningful. Real-world evidence has the potential to give a more comprehensive view of how a technology performs and enables manufacturers and regulators to understand the long-term outcomes of medical technology without delaying initial approval. Patient experience and preference information can help inform effective real-world evidence strategies by capturing insight into how patients interact with health technology, their preferences for how their data is used, and their perspectives on risks. A real-world evidence strategy ultimately means working with patients’ real-time and long-term health data and provides an opportunity to capture longitudinal experience and preference information. As such, researchers should seek patient consent to use the data and patient input on how their data are used. Combining the objectives of using patient preference and real-world evidence data in a comprehensive regulatory strategy will ensure sponsors are maximizing the potential for patient input in their regulatory submissions. FDA guidance can be leveraged to ensure this strategy will meet FDA expectations. This panel will discuss the value of patient preference and real-world data and how FDA guidance can be used to ensure a device sponsor’s regulatory strategy meets the needs of both the patient and the regulators.

Speakers:

  • Stephanie Christopher, MA, CCRC | Senior Program Manager, Health Insights, Providence St. Joseph Health
  • Carrie M. Kuehn, MA, MPH, LPD, RAC | Evidation Health

Perspectives on RWE: Assessing Its Use, Impact, and Role in the U.S. and EU

Thursday, July 23, 2020

The adoption of real-world evidence (RWE) can help ensure the availability of safe, effective and innovative technologies for patients. Demand for RWE continues to grow, with global regulatory bodies looking to Real-World Data (RWD) for pre- and post-market decisions and payers requiring more evidence to make their coverage decisions.

In this virtual session, attendees will learn about the types of RWE, explore the role of technology in advancing device evaluation, understand barriers and facilitators for RWE, and hear how RWE can be used to support patients, as well as regulatory and coverage decisions.

Speakers:

  • Robbert Zusterzeel, MD, PhD, MPH | NESTcc Research Network Director, MDIC (Moderator)
  • Daniel Caños, PhD, MPH | FDA CDRH, Office of Clinical Evidence and Analysis, Director
  • Martin Gibson | CEO, NorthWest EHealth Limited
  • Bray Patrick-Lake, MFS | Director of Strategic Partnerships, Evidation Health
  • Justin W. Timbie, PhD | Senior Health Policy Researcher, RAND

New Frontiers in Access with RWE Development

Thursday, July 30, 2020

Market access is a critical step in achieving widespread adoption of cutting-edge medical technologies. Insurers consider a variety of factors when formulating medical coverage policies for medical devices, including the overall strength of evidence and availability of clinical guidelines and health technology assessments by independent organizations.

Join access and reimbursement experts throughout the device industry as we explore and evaluate new frontiers in market access with RWE development.

Speakers:

  • Jeff Farkas | Vice President, Global Health Economics, Reimbursement, and Government Affairs, Medtronic | Chair, MDIC Health Economics and Patient Access Steering Committee (Moderator)
  • Tamara Syrek Jensen, JD | Director, Coverage and Analysis Group, Centers for Clinical Standards and Quality, CMS
  • Gregory Daniel, PhD, MPH | Head, U.S. Healthcare Policy, Edwards Lifesciences
  • Naomi Aronson, PhD | Executive Director Clinical Evaluation, Innovation and Policy, Office of Clinical Affairs, Blue Cross Blue Shield Association
  • Eleanor M. Perfetto, PhD, MS, Executive Vice President, Strategic Initiatives, National Health Council

NESTcc 2020: Progress, Priorities, and the Path Ahead

Thursday, August 6, 2020

The National Evaluation System for health Technology Coordinating Center (NESTcc) seeks to support the sustainable generation and use of timely, reliable, and cost-effective Real-World Evidence (RWE) throughout the medical device lifecycle. By joining this session, attendees will hear an overview of NESTcc initiatives to drive RWE forward, including the status ofNESTcc’sTest-Cases, the publication of the Data Quality and Methods Frameworks, the creation of a roadmap and infrastructure for active surveillance, Data Network expansion, Collaborative Community efforts, and commercialization activities.

Speakers:

  • Sandra Siami, MPH | NESTcc Senior Vice President, MDIC (Moderator)
  • Adrian Hernandez, MD, MHS | Professor of Medicine at Duke School of Medicine; Vice Dean and Executive Director, Duke Clinical Research Institute
  • Diane Wurzburger, JD | Executive of Regulatory Affairs, Developed Markets & Global Strategic Policy, GE Healthcare
  • Kathleen Blake, MD, MPH | Vice President of Healthcare Quality, American Medical Association

Recordings will be posted here within one week of the original session date. Please contact apf@mdic.org with any questions.