The use of early economic evaluation to inform medical device decisions: an evaluation of the headroom method

摘要

The headroom method proposes to offer medical device developers a simple way to integrate health economics into the decision of whether or not to develop a device, so that only commercially viable innovations are pursued. The aim of this PhD research is to evaluate the headroom method on this basis. A mixed-methods approach is used to assess both its prognostic ability and its usability by developers.udTwo prospective case studies demonstrate the method’s early application, whilst efficacy is assessed by twenty further case studies where the headroom method is applied retrospectively. The headroom method predicted NHS uptake with a sensitivity of 92% and a negative predictive value of 67%; however, results reflect the close-to-market context of the study sample. When numerical headroom assessments were considered alongside qualitative factors identified (relating to the clinical and market context), the method generally offered a good indication of future market potential. Interviews with twelve potential users of the method identified practical issues around time, expertise and objectivity, which varied according to the participant’s involvement in the innovation process. The headroom method is demonstrated to be a flexible approach, which could ground development choices in the value that a device might offer the health service.ud