Literature DB >> 26801401

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

Emily P Zeitler1, Sana M Al-Khatib2, David Slotwiner3, Uday N Kumar4, Paul Varosy5, David R Van Wagoner6, Gregory M Marcus7, Fred M Kusumoto8, Laura Blum9.   

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.
Copyright © 2016 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

Entities:  

Keywords:  Innovation; Medical device; Professional societies

Mesh:

Year:  2016        PMID: 26801401      PMCID: PMC4724379          DOI: 10.1016/j.hrthm.2015.12.001

Source DB:  PubMed          Journal:  Heart Rhythm        ISSN: 1547-5271            Impact factor:   6.343


  38 in total

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Authors:  Lisa Schilling; Alide Chase; Sommer Kehrli; Amy Y Liu; Matt Stiefel; Ruth Brentari
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Review 2.  The role of human factors in the design and development of an insulin pump.

Authors:  Noel E Schaeffer
Journal:  J Diabetes Sci Technol       Date:  2012-03-01

Review 3.  Diffusion of medical technology: medical devices in India.

Authors:  Ajay Mahal; Anup K Karan
Journal:  Expert Rev Med Devices       Date:  2009-03       Impact factor: 3.166

4.  A historical perspective on clinical trials innovation and leadership: where have the academics gone?

Authors:  David L DeMets; Robert M Califf
Journal:  JAMA       Date:  2011-02-16       Impact factor: 56.272

5.  How much do physician-entrepreneurs contribute to new medical devices?

Authors:  Sheryl Winston Smith; Andrew Sfekas
Journal:  Med Care       Date:  2013-05       Impact factor: 2.983

6.  Innovation at the Food and Drug Administration's Device Center.

Authors:  William H Maisel
Journal:  JACC Cardiovasc Interv       Date:  2012-07       Impact factor: 11.195

7.  Medical device innovation: prospective solutions for an ecosystem in crisis. Adding a professional society perspective.

Authors:  Mitchell W Krucoff; Ralph G Brindis; Patricia K Hodgson; Michael J Mack; David R Holmes
Journal:  JACC Cardiovasc Interv       Date:  2012-07       Impact factor: 11.195

8.  Improving cardiovascular health: a balance between discovery and delivery.

Authors:  William A Zoghbi; David R Holmes
Journal:  JAMA       Date:  2013-03-20       Impact factor: 56.272

9.  Evolving reimbursement and pricing policies for devices in Europe and the United States should encourage greater value.

Authors:  Corinna Sorenson; Michael Drummond; Lawton R Burns
Journal:  Health Aff (Millwood)       Date:  2013-04       Impact factor: 6.301

10.  Response to the Center for Medicare & Medicaid Services coverage with evidence development request for primary prevention implantable cardioverter-defibrillators: data from the OMNI study.

Authors:  Michael O Sweeney; Scott Sakaguchi; Grant Simons; Christian Machado; John E Connett; Fang Yang
Journal:  Heart Rhythm       Date:  2012-03-01       Impact factor: 6.343

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