Open Innovation and Involvement of End-Users in the Medical Device Technologies’ Design & Development Process: End-Users’ Perspectives

Abstract

Literature and Regulatory bodies growing interest in End-Users' implication in Medical Device Technologies (MDTs) development processes are a clear proof of the importance of this involvement and the positive impacts it can have on the development, implementation and use of MDTs, thus subsequent improvements in healthcare services' delivery. However, existing research has mainly been focused on the theoretical importance of this involvement, and the manufacturers' views and attitudes, with little attention focused on End-Users' concerns and thoughts concerning this process. The aim of this paper is to identify the perspectives of Nurses and Doctors as the best representatives of MDT End-Users, regarding their own involvement in MDT development processes. The results of 49 semi-structured interviews conducted with End-Users, helped identify a number of high-level themes: 1) End-Users' conflicting perspective with that of manufacturers regarding the impact of their involvement in MDT development; 2) End-Users' concerns regarding the nature of their contribution, its level and their suggestions for a potential amelioration. These results reveal the importance End-Users attach to their involvement in MDT development processes, and the added value they perceive for the proper development as well as upgrade of MDTs. It also underlines many concerns they have regarding the current patterns of involvement, and suggests their recommendations for a standardization of this process, with input on forms and levels of involvement .