Background: Medical devices are continuously being improved in routine clinical practice. As necessary, new or\r\nadditional clinical data for an investigational medical device is collected through clinical research and/or registered clinical\r\ninvestigations. We conducted a questionnaire survey to determine the current environment for clinical research with medical\r\ndevices, particularly focusing on infrastructure and human resources in hospitals.\r\nMethods: The questionnaire for this study included 6 main topics: experience of clinical research, in-hospital manuals,\r\nissues on clinical research, related regulations, and effectiveness of a guidance published by the Medical Engineering\r\nTechnology Industrial Strategy Consortium. The questionnaire was mailed to all 10 core clinical research centers and 30\r\nmajor clinical trial institutions at the time of survey in Japan.\r\nResults: Eighteen hospitals (45%) provided responses. Relatively few clinical research activities with medical devices\r\nhad been conducted in each hospital, and two-thirds of respondents thought low number of clinical research activities was\r\nproblematic. A shortage of experts in medical devices was also raised as an important challenge. Most of the hospitals\r\n \r\n \r\n \r\n \r\n\r\n \r\n \r\n \Z \r\nevaluation of medical devices might not be included in the manuals. Many hospitals had too few clinical research coordinators\r\n(CRCs) for support of clinical research with medical devices, but half of the hospitals could not afford to increase the number\r\nof CRCs.\r\nConclusion: Our study revealed that the current environment for clinical research with medical devices in hospitals has\r\nbeen partly organized, but it was suggested that a shortage of experts, the complexity of the regulatory system, and a need\r\n \r\n
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