Proceedings from Heart Rhythm Society’s Emerging Technologies Forum, Boston, MA, May 12, 2015
February 1, 2016—The Heart Rhythm Society convened a forum of stakeholders in medical device innovation in conjunction with the 2015 Heart Rhythm Society Annual Scientific Sessions. The forum facilitated open discussion on medical device innovation, including obstacles to physician involvement and possible solutions. This report is based on the themes that emerged.
It outlines the major elements of introducing an innovative idea to the bedside, including managing intellectual property; securing financial investment for research, development, and commercialization; a discussion of applicable regulations by the FDA; the pathway to coverage by the CMS and other payers; and other considerations.