Interpretive structural modelling of risk sources in medical device development process

Development of new devices is known to bring substantial amount of revenues to medical device manufacturing companies, but is often a risky endeavour. The risks are stemmed from number of sources which have catastrophic effects on medical device development (MDD) process. This paper explores risk sources in MDD process. A model of interaction among these sources is developed based on contextual mutual relationships among them. The risk sources which can jeopardize the MDD processes in terms of cost, time of development and quality of device are identified primarily through experts’ opinions and literature review. The mutual relationship among them is established using interpretive structural modelling methodology. They are further classified based on the mutual influence and dependence using MICMAC analysis. The results show that the risk sources have mainly two groups; one has high dependence and low driving power representing the resulting actions. Another group has high driving power and low dependence indicating the need for systematic attention. Third group is of autonomous risk sources which are relatively disconnected from the system but are important when considered separately. This research is a unique effort and will be a lighthouse for the developers, decision makers and researchers to focus and deal with the risk sources which can impede the processes and may even result in harmful events related to devices. This study is focused on risk sources in MDD process but can be applied to product development in other areas to improve the development processes. © 2015, The Society for Reliability Engineering, Quality and Operations Management (SREQOM), India and The Division of Operation and Maintenance, Lulea University of Technology, Sweden.