ABSTRACT
This chapter aims to introduce the routes and requirements for realizing medical devices, enabling the pervasive healthcare engineer to enter the minds of the regulators and assessors and to better understand the industrial processes. In the first section, the concept of health technology assessment is introduced, which is the framework that judges the effectiveness and value of a device. The second section presents the regulations pertaining to medical devices in some detail including definitions and classifications, standards and quality systems, and the key aspects of conformity processes in Europe and North America. A brief overview of clinical studies includes ethics approval and some recent advances in clinical trials that are particularly suited to medical devices. Also covered in this section are deployment and data issues, the former to ensure continued monitoring of the device and the latter arising from the link between the predominantly independent worlds of devices and computer networks that are coming together in pervasive healthcare. The third section examines the product design process for medical devices that is being developed by the Multidisciplinary Assessment of Technology Centre for Healthcare (MATCH) research program. The concluding section reiterates the multidisciplinary environment of the pervasive healthcare innovator and points to sources of information and advice.
