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Safety and effectiveness evaluation of flexible electronic materials for next generation wearable and implantable medical devices
Nano Today ( IF 17.4 ) Pub Date : 2020-12-01 , DOI: 10.1016/j.nantod.2020.100939
Kuan Chen , Jiayu Ren , Chunying Chen , Wei Xu , Song Zhang

Abstract 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.

中文翻译:

用于下一代可穿戴和可植入医疗设备的柔性电子材料的安全性和有效性评估

摘要 随着人口老龄化和经济环境的加剧,人们对健康的需求已经从病后求医转变为保持积极健康到晚年。灵活的电子技术进步现在使我们有可能开发可穿戴的下一代植入式医疗设备。然而,在预期柔性电子技术在医疗设备中普及之前,必须首先证明其预期临床用途的安全性和有效性。本文总结了医疗保健领域柔性电子技术的最新发展,重点从监管科学的角度对此类创新医疗器械的安全性和有效性评估要求。在此处,
更新日期:2020-12-01
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