Background User engagement has become a central tenet of healthcare policy. This paper reports on a case study in progress that highlights user engagement in the research process in relation to medical device development.

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There are generalisations from the case study, and the model outlined. New products for managing EB wounds can logically benefit other groups. The model is transferable to other clinical problems, which can benefit from research and technological advances that are integral to clinical needs and care.

Epidermolysis bullosa (EB) is an inherited disorder causing extensive, painful skin blistering and wounds. Currently, there is no cure and the focus of care is on the clinical management of the skin and other affected body systems, together with supportive care to individuals and families. The wound care for Epidermolysis bullosa (WEB) project is a collaboration with adults with EB, carers, clinical nurse specialists, a designer and manufacturers to develop novel products for EB wound care. This article reports the findings from workshops with adults with EB, their carers and clinical nurse specialists, together with observations of dressing changes. A cluster of significant limitations were revealed in the performance of wound care products, designed to cover a single wound, when they are used to cover extensive and whole body wounds. A working hypothesis for EB wound care was developed from the findings, together with design concepts and new products for EB wound care. In addition, a model of user engagement in medical device development and evaluation has been tested.

This article reports on the structured literature survey methodology, which was used to identify how and at what stage users of medical devices are engaged in the medical device technology cycle, including methods and tools for evaluating device outcomes. This was not a conventional systematic review of the literature. The stated purpose of the survey is broader than synthesizing best evidence to inform an area of practice and policy, as undertaken in a conventional systematic review. The survey was systematic in the sense that an explicit search strategy was used with inclusion and exclusion criteria to minimize sampling bias. An established qualitative methodology, framework analysis, was used to organize and synthesize major fi ndings from a broad range of healthcare literature. The search strategy and thematic analysis are presented, to contribute to the literature on review strategies, together with the major fi ndings concerning users and medical devices.K E Y WO R D S : framework analysis; medical devices; survey methodology; user engagement Evaluation