Zeitler Emily P, Al-Khatib Sana M, Slotwiner David, Kumar Uday N, Varosy Paul, Van Wagoner David R, Marcus Gregory M, Kusumoto Fred M, Blum Laura
Duke Clinical Research Institute; Duke University Hospital, Durham, North Carolina.
Duke Clinical Research Institute; Duke University Hospital, Durham, North Carolina.
Heart Rhythm. 2016 Feb;13(2):e39-49. doi: 10.1016/j.hrthm.2015.12.001.
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.
医生在推动医疗设备创新方面具有显著优势,但将一个想法转化为临床应用的过程却很复杂。为了开始应对这些明显的障碍,心律协会在2015年心律协会年度科学会议期间召集了一个医疗设备创新利益相关者论坛。该论坛促进了关于医疗设备创新的公开讨论,包括医生参与的障碍和可能的解决方案。本报告基于所出现的主题。首先,医生创新者必须采取有条理的方法来识别未满足的临床需求和潜在解决方案。其次,通常需要通过寻求投资来获得大量资金,才能取得有意义的进展,将一个想法转化为设备。第三,规划美国食品药品监督管理局和医疗保险与医疗补助服务中心的监管要求至关重要。除了这些问题,知识产权以及医疗保健的总体趋势,包括国际市场,对于医生创新者来说都是至关重要的相关考虑因素。重要的是,专业协会有多种方式可以帮助医生创新者应对复杂的医疗设备创新局面,更快地将具有临床意义的设备推向市场,并最终改善患者护理。这些努力包括通过科学会议和其他聚会促进潜在合作者之间的互动;收集、评估和传播最新的科学信息;以及在与监管机构和政策制定者的互动中代表成员的利益。