Exploring the role of clinical research in technology assessment and approval

Well-designed and well-managed clinical trials are the cornerstones for the integration of innovative medical technologies into accepted and reimbursable medical practice. With the advent of more highly sophisticated medical imaging devices has come a significant increase in the demand for rigor in clinical research. Increased focus on consumer safety, long-term medical outcomes and overall clinical utility of newer and often more expensive imaging modalities has been instrumental in driving changes in not only device approval processes, but consumer and third party perceptions of new medical technologies. Integrating clinical research specialists into the product development team allows the manufacturer to employ a planned and systematic strategy for moving their product from "investigational" to approved and reimbursable technology.