Mar 5

Past Event

Biomedical Innovation: Identifying Challenges and Prioritizing Needs

Summary

Rapidly evolving technology, emerging markets, an increasingly globalized development process, and evolving health policy reforms are presenting device manufacturers with unprecedented opportunities for valuable innovation. However, these trends are also creating significant challenges to current biomedical development frameworks. In response, the U.S. must sustain the industry's entrepreneurial spirit, and maintain an environment that encourages innovation and access to novel devices.

On Wednesday, March 5, 2014, the Engelberg Center for Health Care Reform and the National Institutes of Health (NIH) held an all-day forum to discuss emerging issues in biomedical innovation. The panel sessions explored a number of challenges for developing novel medical devices that benefit patients, and for prioritizing medical device research that accommodates unmet medical need.

Over the course of the day, manufacturers, regulators, payers, investors, patient representatives, and other stakeholders engaged in a thoughtful discussion on a number of topics. These topics included developing incentives to support investment in research and development; providing adequate infrastructure to support medical device development; and creating more efficient and transparent regulatory and reimbursement pathways. Attendees also discussed the need to actively engage patients in the decision-making process throughout the development pipeline.

 

 

Event Agenda

  • 8:30 - 9:30

    Welcome and Opening Discussion: Medical Device Innovation Grand Challenges

  • 9:30 - 11:00

    Session 1: Research and Pre-Clinical Development Challenges in the Current Environment

    • Bill Murray

      Medical Device Innovation Consortium

    • Megan Moynahan

      Case Western Reserve University

    • Michael Minogue

      Abiomed

    • Paul LaViolette

      SV Life Sciences Advisors

  • 11:00 - 12:30

    Session 2: Clinical Development, Product Approval, and Reimbursement

    • Murray Sheldon

      U.S. Food and Drug Administration

    • Mark Deem

      The Foundry

    • Pamela Tenaerts

      Clinical Trials Transformation Initiative

    • David Nexon

      Advanced Medical Technology Association

    • Jo Carol Hiatt

      Kaiser Permanente

    • Sean Tunis

      Center for Medical Technology Policy

  • 12:30 - 1:30

    Lunch and Breakout Sessions

  • 1:30 - 2:45

    Session 3: Identifying Unmet Needs and Prioritizing Device Research

    • Imran Babar

      Rare Genomics Institute

    • Robin Barr

      National Institutes of Health

    • Bryan Luce

      Patient-Centered Outcomes Research Institute

    • Diane Dorman

      National Organization for Rare Disorders

  • 2:45 - 3:30

    Closing Summary and Next Steps

Details

March 5, 2014

8:30 AM - 3:30 PM EST

Brookings Institution

Falk Auditorium

1775 Massachusetts Avenue, N.W.

Map

For More Information

Brookings Office of Communications

202.797.6105