De innovatione: The concept of innovation for medical technologies and its implications for healthcare policy-making

Abstract Innovation is constantly evoked as an imperative to drive growth, however identifying an actionable and agreed upon definition that applies to different settings and purposes is not trivial. In healthcare, innovation has often been described in relation to pharmaceuticals. Defining innovation allows for proper recognition and rewarding, thus fostering present and future innovativeness in the system. Current definitions adopted by payers are focused on therapeutic added value and more specifically include clinically significant benefit, large health gains, and favorable risk-benefit balance at an acceptable cost. However, they may not be fully adequate to assess medical devices. Based on a systematic review of the academic literature in the field, we aim at summarizing acceptable definitions of innovation in relation to medical devices. Based on the innovation management and economics theory, proposed definitions have been classified according to the source of innovation, to the degree of discontinuity introduced and to the impact associated to the technology. They have also been compared with definitions adopted for drugs by main healthcare reimbursement agencies. Decision-making in healthcare often favors static allocative efficiency at the expense of incentives to innovate and obtaining valuable innovation, that is dynamic allocative efficiency. In the long run, this attitude may artificially shrink net returns from innovation and rebound on the sustainability of the healthcare systems, an undesirable consequence that a farsighted shared notion of innovation should try to prevent.