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Heart Rhythm. 2016 Feb;13(2):e39-49. doi: 10.1016/j.hrthm.2015.12.001.

Proceedings from Heart Rhythm Society's emerging technologies forum, Boston, MA, May 12, 2015.

Author information

1
Duke Clinical Research Institute; Duke University Hospital, Durham, North Carolina. Electronic address: emily.zeitler@duke.edu.
2
Duke Clinical Research Institute; Duke University Hospital, Durham, North Carolina.
3
Weill Cornell Medical College, New York, New York.
4
Biodesign Program, Stanford University, Stanford, California.
5
University of Colorado Anschutz Medical Campus, Aurora, Colorado.
6
Cleveland Clinic Lerner College of Medicine, Case Western Research University, Cleveland, Ohio.
7
University of California, San Francisco, San Francisco, California.
8
Mayo Clinic, Jacksonville, Florida.
9
Heart Rhythm Society, Washington, District of Columbia.

Abstract

Physicians are in an excellent position to significantly contribute to medical device innovation, but the process of bringing an idea to the bedside is complex. To begin to address these perceived barriers, 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. First, physician innovators must take an organized approach to identifying unmet clinical needs and potential solutions. Second, extensive funds, usually secured through solicitation for investment, are often required to achieve meaningful progress, developing an idea into a device. Third, planning for regulatory requirements of the US Food and Drug Administration and Centers for Medicare & Medicaid Services is essential. In addition to these issues, intellectual property and overall trends in health care, including international markets, are critically relevant considerations for the physician innovator. Importantly, there are a number of ways in which professional societies can assist physician innovators to navigate the complex medical device innovation landscape, bring clinically meaningful devices to market more quickly, and ultimately improve patient care. These efforts include facilitating interaction between potential collaborators through scientific meetings and other gatherings; collecting, evaluating, and disseminating state-of-the-art scientific information; and representing the interests of members in interactions with regulators and policymakers.

KEYWORDS:

Innovation; Medical device; Professional societies

PMID:
26801401
PMCID:
PMC4724379
DOI:
10.1016/j.hrthm.2015.12.001
[Indexed for MEDLINE]
Free PMC Article

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