Safety and effectiveness evaluation of flexible electronic materials for next generation wearable and implantable medical devices
Safety and effectiveness evaluation of flexible electronic materials for next generation wearable and implantable medical devices
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DOI：
10.1016/j.nantod.2020.100939
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发表时间：
2020-12-01
期刊：
影响因子：
17.4
通讯作者：
Zhang, Song
中科院分区：
文献类型：
--
作者：
Chen, Kuan;Ren, Jiayu;Zhang, Song
随着人口老龄化和经济气候的加剧，人们对医疗保健的需求已经从病后就医转变为晚年保持积极健康。柔性电子技术的进步现在给了我们开发可穿戴的下一代植入式医疗设备的潜力。然而，在柔性电子技术有望普遍用于医疗设备之前，必须首先证明其预期临床用途的安全性和有效性。本文综述了柔性电子技术在医药卫生领域的最新发展，重点从监管科学的角度阐述了柔性电子技术创新对医疗器械安全性和有效性评价的要求。在此，我们试图建立一个适合柔性电子技术特点的标准化评价体系，以帮助基于柔性电子技术的创新医疗器械从实验室发展到临床批准产品。(C) 2020 Elsevier Ltd.版权所有。
With the increased aging population and economic climate, people's demand for healthcare has changed from seeking medical treatment after illness to maintaining active health into later years. Flexible electronic technological advancements have now given us the potential to develop wearable, next-generation implantable medical devices. However, before flexible electronic technology is expected to be commonplace for medical devices, safety and effectiveness in their intended clinical uses must first be proven. This paper summarizes the latest developments in flexible electronic technology in the context of medicine and healthcare, with emphasis on the requirements for safety and effectiveness evaluation of such innovations for medical devices from the perspective of regulatory science. Herein, we attempt to establish a standardized evaluation system suitable for the characteristics of flexible electronic technology, with the goal to help expedite the development of innovative medical devices based on flexible electronic technology from the laboratory to clinically approved products. (C) 2020 Elsevier Ltd. All rights reserved.