Evidence requirements for innovative imaging devices: from concept to adoption.

Changes in the regulatory and reimbursement environment for advances in imaging in the United States are leading to increasing requirements for formal clinical evidence of efficacy, effectiveness, and safety. The authors describe 5 phases of an imaging product's lifecycle: design, regulatory clearance and approval, early adoption, reimbursement, and full adoption. Each phase has distinct needs for clinical evidence. With increasing costs of clinical evidence generation, the question of ownership of the responsibility to gather clinical evidence at each successive phase becomes important. Mismatch between the pace of advances in imaging technologies and the time required to do formal clinical trials to clear regulatory and reimbursement evidence requirements threatens patient access to the benefits of innovation such as reduction in exposure to radiation. Public and payer requirements for clinical evidence must also be evaluated for their impact on incremental design improvements, which have historically characterized advances in diagnostic imaging.