Sakuma Ichiro
Annu Int Conf IEEE Eng Med Biol Soc. 2015 Aug;2015:1729-32. doi: 10.1109/EMBC.2015.7318711.
For development rational evaluation method for medical devices' safety and efficacy, regulatory science studies are important. Studies on regulatory affairs related to a medical device under development should be conducted as well as its technological development. Clinical performance of a medical device is influenced by performance of the device, medical doctors' skill, pathological condition of a patient, and so on. Thus it is sometimes difficult to demonstrate superiority of the device in terms of clinical outcome although its efficacy as a medical device is accepted. Setting of appropriate end points is required to evaluate a medical device appropriately. Risk assessment and risk management are the basis of medical device safety assurance. In case of medical device software, there are difficulties in identifying the risk due to its complexity of user environment and different design and manufacturing procedure compared with conventional hardware based medical devices. Recent technological advancement such as information and communication technologies (ICT) for medical devices and wireless network has raised new issue on risk management: cybersecurity. We have to watch closely the progress of safety standard development.
对于开发医疗器械安全性和有效性的合理评估方法而言，监管科学研究至关重要。在进行医疗器械技术研发的同时，还应开展与其相关的监管事务研究。医疗器械的临床性能受设备性能、医生技术、患者病理状况等因素影响。因此，尽管该医疗器械的有效性已得到认可，但有时仍难以在临床结果方面证明其优越性。为了恰当地评估医疗器械，需要设定合适的终点指标。风险评估和风险管理是医疗器械安全保证的基础。对于医疗器械软件而言，由于其用户环境复杂，且与传统基于硬件的医疗器械相比设计和制造流程不同，因此识别风险存在困难。诸如用于医疗器械的信息和通信技术（ICT）以及无线网络等最新技术进步，给风险管理带来了新问题：网络安全。我们必须密切关注安全标准制定的进展情况。
