Aims and Objectives: This research aims to suggest a concise framework to help in the better
conceptualisation and integration of users in the medical device development (MDD) process. The
current economic, political and social climate concerning the matter of healthcare delivery has
resulted in the emergence of numerous users and user groups for whom the healthcare system has not
previously catered for. These users have created ambiguity for the designers and manufacturers of
medical devices as the boundaries between their needs and requirements have blurred, outdating
current methods of MDD to meet consumer needs.
Research Design and Methodology: The research methodology begins primarily with conducting a
literature search on the theories relating to user requirements and medical device development. The
paper outlines these findings through initially describing users and user involvement and relating
them to medical devices. The cross-disciplinary nature of healthcare influenced the investigation into
multiple disciplines including; IT, Ergonomics – particularly participatory research, Psychology and
Design. These disciplines expose various methods and processes, which are useful to user
requirements research. These methods were analysed for their compatibility, and then used to
construct a conceptual framework for user involvement in MDD.
Results: The research insinuates the true significance of user involvement and hence resulted in the
formation of a conceptual framework to aid user involvement in the MDD process. The framework is
produced by the amalgamation of relevant methods examined across the disciplines, in a
complimentary fashion.
Conclusion: The originality of this research lies in its use of a multidisciplinary approach. Previous
research claiming multi-methods has dealt with combining two disciplines or methods at a time i.e.
Computer supported cooperative work (CSCW) with participatory research (Scandurra et al, 2008)
for the needs analysis of healthcare professionals only. Collaboration across disciplines has also been
investigated (Johnson et al, 2005), but this was for the purpose of redesign rather than initial designs.
This framework can help medical device designers to fully access all user requirements through more
extensive collaboration right at the start. It reduces the risk of high costs involved in device rejection,
usually associated with belated recognition of user needs in the design cycle
