Iterative technology assessment of medical devices

Summary form only given. Technology assessment and outcomes research play an increasingly important role in determining the potential cost effectiveness of new medical technology. While historically these methodologies have been applied after a technology has been accepted into clinical use, their use is occurring earlier in the technology development cycle. Applied at the outset of a project, technology assessment can be used to define the clinical specifications of a new medical device. It can be updated or iterated repeatedly during the development process to reassess the potential technology benefit as more data is obtained during clinical trials. Appropriately designed clinical trials can also generate preliminary outcomes data which help with regulatory submission and initial clinical acceptance of the new technology. This paper reviews the fundamental aspects of technology assessment and outcomes research important for biomedical engineers to consider before embarking on the development of a new technology