Abstract

The introduction of new healthcare technologies requires an appropriate discourse between clinicians who identify problems to be overcome and industrial partners that provide potential solutions. New products go through a tight regulatory process before they can be widely used. Although this process is somewhat different for medical devices compared with drugs, the principles are the same: demonstration of proof of principle and safety, and identification of patients most likely to benefit. However, their use nowadays depends as much on a demonstration of cost-effectiveness as on clinical effectiveness. Cost-effectiveness analysis requires quantification of both clinical effect and overall costs of different treatments.