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Past Event

Biomedical innovation: Identifying challenges and prioritizing needs in medical device research and development

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.




Session 2: Clinical Development, Product Approval, and Reimbursement


Pamela Tenaerts

Executive Director - Clinical Trials Transformation Initiative

Lunch and Breakout Sessions


Pamela Tenaerts

Executive Director - Clinical Trials Transformation Initiative

Session 3: Identifying Unmet Needs and Prioritizing Device Research

Closing Summary and Next Steps

Welcome and Opening Discussion: Medical Device Innovation Grand Challenges


Alan Guttmacher

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


Omar Ishrak

Chairman and Chief Executive Officer - Medtronic plc

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


Bill Murray

President and Chief Executive Officer - Medical Device Innovation Consortium

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