Adam Lewin, "Medical device innovation in America: The tensions between food and drug law and patent law" (April 2012).
Medical devices are an extraordinarily large and important component of the delivery of healthcare services. This Paper examines the manner in which they are introduced into commerce and the ways in which legal privileges and encumbrances upon medical devices affect their dynamics in the market. The usual way of regulating introduction of new products to promote innovation is through the patent system. With medical devices, a complex regulatory framework also governs their market introduction. These two independent bodies of law are occasionally in tension, producing a number of distortions and unusual incentives for manufacturers of medical devices. This Paper aims to understand the medical device regulatory context in detail and to survey these pressure points, with an emphasis on how the interaction between food and drug law and patent law relates to innovation policy.