ABSTRACT

Medical Devices The medical device industry has been undergoing rapid growth, diversification, and increasing technical sophistication. Its unique products and services already have gained a fairly good reputation and have demonstrated substantial proven value to society as a whole. The future certainly promises even more creative diagnostic and treatment systems that should result in significant public health benefits. However, the industry also has unique risks and vulnerabilities, as described in this chapter, that can and should be appropriately managed. It is not a fully mature industry, and special precautions should be taken in the selection of such devices. This chapter emphasizes the role of the medical device manufacturer and how that impacts other medical services.