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.
Agenda
Session 2: Clinical Development, Product Approval, and Reimbursement
Lunch and Breakout Sessions
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
Michael Mussallem
Chairman and Chief Executive Officer - Edwards Lifesciences
Session 1: Research and Pre-Clinical Development Challenges in the Current Environment
More Information
To subscribe or manage your subscriptions to our top event topic lists, please visit our event topics page.