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date: 17 August 2017

Economic Evaluation of Medical Devices

This is an advance summary of a forthcoming article in the Oxford Research Encyclopedia of Economics and Finance. Please check back later for the full article.

The economic evaluation of medical devices (MDs) is challenging. They are typically less regulated than pharmaceuticals, and the clinical evidence requirements for market authorization is generally lower. The specific characteristics of MDs, such as the device-user interaction (learning curve), the incremental nature of innovation, the dynamic nature of pricing and the broader organizational impact, complicate their analysis. This article addresses three related topics. First, how can regulatory processes for MDs be strengthened and more closely aligned to the needs of economic evaluation? Second, how can methods of economic evaluation be enhanced—by improving the analysis of the available clinical data, by establishing high-quality clinical registries, and by better recognizing MDs’ specific characteristics? Third, how can the market entry and diffusion of MDs be better managed by understanding better the key influences on MD diffusion and by linking diffusion with cost-effectiveness evidence through the use of performance-based risk-sharing arrangements.