Medical Device Development

Abstract

The medical device industry in the United States and worldwide is immense in its economic impact (sales in 2009 were $260 billion worldwide, $120 billion in the United States alone, $64 billion in the European Community, and $45 billion in Japan; in 1998 the US medical equipment trade surplus was $18.2 billion. Between 87,000 and 140,000 different devices are produced in the United States annually by approximately 8200 different manufacturers employing some 311,000 people. Furthermore, it is believed that more than 1000 of these manufacturers are development-stage only companies without products yet on the market. Medical devices are or extreme importance to the health of the citizens of the world (Nugent 1994; The Wilkerson Group 1999) (see Table 4.1). While it is true that the large companies dominate the market in terms of sales and revenue, just as with pharmaceuticals, it is the small companies that dominate innovation. The assessment of the safety to patients using the multitude of items produced by this industry is dependent on schemes and methods that are largely peculiar to these kinds of products; are not as rigorous as those employed for foods, drugs, and pesticides; and are in a persistent state of flux. Regulation of such devices is, in fact, relatively new. It is only with the Medical Device Amendments (to the Food, Drug, and Cosmetic Act of 1976) that devices have come to be explicitly regulated at all and with the Safe Medical Devices Act of 1990, the Medical Device Amendments Act of 1992, and subsequent laws that the regulation of devices for biocompatibility became rigorous (see Table 4.2). According to section 201(h) of the Food, Drug, and Cosmetic Act, a medical device is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component, part, or accessory, that is: