Safety and effectiveness evaluation of flexible electronic materials for next generation wearable and implantable medical devices

Abstract

• Flexible electronic technology provides opportunities for next generation wearable and implantable medical devices. • Safety and effectiveness of flexible electronic technology must be proved in intended clinical use. • Flexible electronic materials should balance their properties and biocompatibility. • Biocompatibility assays should be carried out according to contact tissue and duration time. • Conductivity, mechanical compliance and robustness, long-term stability and chemical resistance are key properties. 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.