medical devices will attract many levels of scrutiny because of the great social costs and benefits associated with health care.
This diversity and complexity of policies can be frustrating to innovators, particularly if they do not appreciate the intricate history of health policy in the United States. It must not be forgotten that multiple sources of public policy may be beneficial as well. The system permits experimentation and flexibility and prevents the likelihood that one institution or individual could unilaterally ban or promote a technology. Nevertheless, polyintervention is particularly acute for the medical device industry and can have an adverse impact on innovation. While innovation is important, other values, including safety, universal access, and cost controls, cannot be overlooked. Some of these values may compete with innovation. Our ultimate goal should be to reconcile the competing societal values wherever possible. When it is not possible, we must be explicit about the conflicts and make the hard policy choices fairly and rationally. Innovators and patients deserve no less.
1. The medical device industry is not the only one subject to polyinterventionary effects. Others include the oil industry, the automobile industry, and the nuclear power industry. For each, the configuration of public policies varies according to the history of the industry, the values of the public, and the perceived importance of the issues at stake.
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