Medical Sensors - Defining a Pathway to Commercialization

Abstract

Novel sensor technologies are under development in a variety of medical industries, to detect specific biological, chemical, or physical processes that transmit or report valuable patient data. In parallel, there is also a growing global regulatory requirement to improve the external identification of implantable medical devices, e.g., manufacturer, device, and procedure-related information. Sensor developers and manufacturers need to define a concise regulatory and commercialization plan that identifies the challenges, risks, costs, and timelines of bringing such technologies to the market, well in advance of finalizing initial design requirements.