Health Technology Assessment of medical devices. Overcoming the critical issues of current assessment

AbstractMedical devices are introduced in the market with an ever‐increasing rate, with important benefits for the whole society's health. In the greatest majority of cases, although representing the entry point for devices, healthcare local institutions/hospitals do not receive any macro‐level guidance from (inter)national authorities for their assessment. Hence, in the absence of a methodological support, local institutions/hospitals started to assess devices autonomously, building on Health Technology Assessment (HTA) tools based on Multi‐Criteria Decision Analysis (MCDA), in order to take into‐account the multifaceted aspects connected with devices. However, the strategies described so far in the scientific literature for implementing MCDA in local‐based HTA of medical devices suffer from a harsh methodological weaknesses – that is, the use of bespoke criteria for the specific device to be assessed ‐ that severely affect the evaluation of medical devices. Within this scenario, this work proposes a new tool based on peer‐to‐peer IF‐TOPSIS, intended for micro‐level assessment of medical devices with the main objective of overcoming the above‐mentioned critical issues and provide local institutions/hospitals with a general tool. An example of application of this tool in the choice between three neurological devices is shown. Contributions are both theoretical and practical. Theoretically, while proposing a general MCDA tool for micro‐level HTA, we answer the call for the identification of key methodological principles for the local assessment of medical devices. At the practical level, this tool is readily implementable and can be adapted to consider the local idiosyncratic characteristics of the context where decisions have to be made