A model of user engagement in medical device development

Abstract

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.

Close to the bench as well as at the bedside: involving service users in all phases of translational research

“…The search for biomarkers lies, as we have already noted, at the heart of translational 19 Gagnon et al 45 Grocott et al 22 …”

“…As regards later phases within drug development, there are grounds for optimism: empirical research on medical technological innovation is increasingly indicating the key role that users can play in ensuring functionality and usability. [19][20][21][22] Indeed, there is a small but growing body of evidence regarding the scientific benefits of involving service users and other stakeholders throughout the translational conduit. Table 2 documents indicative research (from systematic reviews to theoretical research) on the reasons for embedding involvement, as well as some of the mechanisms through which one might do so, as regards: The potential benefits of embedding such involvement range from improving recruitment rates within clinical trials, to identifying new and important research questions and ⁄ or potential hypotheses, to developing interventions that are more likely to be taken up in the clinic and by communities.…”

Medical device design in context: A model of user–device interaction and consequences

“…Many authors have stated the value of a user centred design approach in medical devices, and provided guidance on the theory behind this approach (Grocott, Weir, & Ram, 2007;Sawyer, 1996)how and when to conduct the work (Martin, et al, 2007) and with what groups of people (Shah, Robinson, & AlShawi, 2009). …”

Designing Industrial Design in the Highly Regulated Medical Device Development Process. Defining our valuable contribution towards usability

“…Only one article provides a description of industrial design activities and contribution to the practice of medical device design and includes the following areas: aesthetic design, form giving, human factors application and testing, along with contextual inquiry/ethnography methods (Petrie & Copeland, 2011). Further, in instances where team disciplines or members are defined, such as the study by Martin, Clark et al whereby team members included: engineering, nursing, medical physics, and clinical physiology, design or industrial design is missing (Martin, Clark et al 2012, Grocott, Weir et al 2007). This paper aims at describing the role of industrial designers within the agency mandated processes using a multiple case study methodology to identify contemporary approaches in device development.…”