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Past Event

The future of medical device safety and innovation

Past Event

Welcome and Opening Remarks

Tens of millions of medical devices are used on a daily basis in the U.S., including pacemakers, knee replacements, and glucose test strips. It is critical for providers, patients, manufacturers and others to have access to better information about the performance of these devices. Not only will this information enhance patient safety, but it will also inform the development of new and more effective products. However, in today’s current market there are limited resources and tools available to collect this information. Through a cooperative agreement with the U.S. Food and Drug Administration (FDA), the Engelberg Center for Health Care Reform formed the National Medical Device Postmarket Surveillance System Planning Board; a multi-stakeholder group tasked with building this capability and designing a system to gather this information.

On February 23, the Engelberg Center hosted a discussion that highlighted the planning board’s long-term vision, identified key considerations and implications for stakeholders, and evaluated potential opportunities to support and sustain this initiative. The event included the release of the planning board’s preliminary report.

Click here to download the National Medical Device Planning Board’s February 2015 report.

Agenda

Opening Remarks

J

Jeffrey Shuren

Director, Center for Devices and Radiological Health - U.S. Food and Drug Administration

Creating a Viable National Medical Device Postmarket Surveillance System

K

Kathleen Blake

Vice President, Performance Improvement - American Medical Association

O

Omar Ishrak

Chairman and Chief Executive Officer - Medtronic plc

B

Bill Murray

President and Chief Executive Officer - Medical Device Innovation Consortium

L

Lewis Sandy

Executive Vice President, Clinical Advancement - UnitedHealth Group

A

Alan Guttmacher

Director, Eunice Kennedy Shriver National Institute of Child Health and Human Development - National Institutes of Health

A

Alan Balch

Chief Executive Officer - Patient Advocate Foundation

J

Jodi G. Daniel

Director, Office of Policy, Office of the National Coordinator for Health Information Technology - U.S. Department of Health and Human Services

Supporting Medical Device Innovation

A

Aaron V. Kaplan

Professor of Medicine in Cardiology, Director, Dartmouth Device Development Symposia, and Director of Research, Cardiology Section - Geisel School of Medicine and Dartmouth-Hitchcock Medical Center

Closing Remarks

Welcome

Congressional Leadership in Innovation and Regulation

C

Clay Alspach

Chief Health Counsel - U.S. House of Representatives

E

Eric Flamm

Detailee, FDA - U.S. House of Representatives

Lunch

C

Clay Alspach

Chief Health Counsel - U.S. House of Representatives

E

Eric Flamm

Detailee, FDA - U.S. House of Representatives

Leveraging Current Efforts to Build a Long-Term System

M

Mitchell Krucoff

Professor of Medicine and Cardiology; Director, Cardiovascular Devices Unit and eECG Core Laboratory - Duke University Medical Center; Duke Clinical Research Institute

R

Richard Platt

Professor and Chair, Department of Population Medicine - Harvard Pilgrim Health Care Institute

C

Carmella Bocchino

Executive Vice President of Clinical Affairs and Strategic Planning - America's Health Insurance Plans

J

Joe Selby

Executive Director - Patient-Centered Outcomes Research Institute

S

Sally Okun

Vice President for Advocacy, Policy and Patient Safety - PatientsLikeMe

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