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.