Convergence technology in cancer medicine.

The field of convergence technology may be defined as an area of technologic innovation in which multiple devices or functionalities are combined within a single platform in a way that adds functional, operational or economic synergies. Within the field of medical devices, this concept embodies many different types of novel combinations representing syntheses of therapeutic, diagnostic and digital information technologies. In the current era of healthcare reform, such combinatorial technologies will be pressed to demonstrate improvements in comparative effectiveness compared with the use of separate independent components. Moreover, the new more stringent regulatory environment will require much greater levels of pre- and post-market safety reviews conducted under the auspices and authority of the US FDA Office of Combination Products. This branch of the FDA scrutinizes submissions and divides them into drugs, devices and biological products and includes many submissions previously regulated by disparate centers, such as the Center for Devices and Radiologic Health and the Center for Drug Evaluation and Research. The field of convergence technologies already amounts to a worldwide market extending to tens of billions of dollars and this article will attempt to summarize some of the key elements of this continued push for added value and more personalized medicine.