Prog Cardiovasc Dis. 2012 Nov-Dec;55(3):307-15. doi: 10.1016/j.pcad.2012.08.004.
Medical devices have emerged as an important clinical option to treat certain serious diseases for which there are no equivalently effective surgical or pharmaceutical alternatives. Although all clinical activities impose high ethical standards of comportment to protect patients, medical device R&D and product application have a number of relatively unique aspects that distinguish them from other technologies such as pharmaceuticals. These include the following: R&D project selection; regulatory requirements, and their intended and unintended effects; when is a new product design sufficiently safe and effective for routine use in patients; and, physician-industry relationships in the innovation process in the context of real or perceived conflict of interest (COI). Each of these factors has implications for the delivery of care, health care leadership, and patient well-being.
医疗器械已成为治疗某些严重疾病的重要临床选择，而这些疾病尚无同等有效手术或药物治疗方法。尽管所有临床活动都要求高标准的行为准则，以保护患者，但医疗器械研发和产品应用有一些相对独特的方面，使其有别于其他技术，如药品。这些方面包括：研发项目选择；监管要求及其预期和非预期影响；新产品设计在何种情况下足够安全有效，可常规用于患者；以及在实际或感知的利益冲突（COI）背景下，创新过程中医生与行业的关系。这些因素都对医疗服务的提供、医疗保健领导力和患者福祉产生影响。
