Diagnostic Innovation and the Business of Regulation

This presentation is based on an exploration of the growing field of molecular diagnostics, heralded as the next frontier for medical innovation. In the last few decades the regulatory regime for medicines has shifted in numerous ways to accommodate the interests of the pharmaceutical industry (Davis and Abraham 2013). We investigate medical devices in this context, where manufacturers have learned from pharmaceutical companies in terms of how to produce, market and protect their commercial innovations, but also in the way that they interact with, respond to and shape the regulatory regime. Laboratories that produce diagnostic innovations at the molecular level can build on the promise of personalized or ‘precision’ medicine, where medical products are tailored to the individual patient. We explore how these molecular diagnostic manufacturers interface with the regulatory regime to most effectively deliver their products to patients. Our work is based on an evaluation of the regulation of in vitro diagnostics in the US, EU and Canada, ethnographic work at events for commercial laboratories and regulators, and interviews with manufacturers, scientists and regulators. Through this work we explore the relationship between the laboratories producing molecular diagnostic tests and the regulators approving the tests. Ultimately we present a complex picture of the intersection between markets and medical regulation.