Evaluation of success factors for medical device development using grey DEMATEL approach

Abstract

PurposeSuccessful device development brings substantial revenues to medical device manufacturing industries. This paper aims to evaluate factors contributing to the success of medical device development (MDD) using grey DEMATEL (decision-making trial and evaluation laboratory) methodology through an empirical case study.Design/methodology/approachThe factors are identified through literature review and industry experts’ opinions. Grey-based DEMATEL methodology is used to establish the cause-effect relationship among the factors and develop a structured model. Most significant factors contributing to the success of MDD are identified. An empirical case study of an MDD and manufacturing organisation is presented to demonstrate the use of the grey DEMATEL method. Sensitivity analysis is carried out to check robustness of results.FindingsThe results of applying the grey DEMATEL methodology to evaluate success factors of MDD show that availability of experts and their experience (SF4) is the most prominent cause factor, and active involvement of stakeholders during all stages of MDD (SF3) and complete elicitation of end-user requirements (SF1) are the most prominent effect factors for successful MDD. A sensitivity analysis confirms the reliability of the initial solution.Practical implicationsThe findings will greatly help medical device manufacturers to understand the success factors and develop strategies to conduct successful MDD processes.Originality/valueIn the past, few success factors to MDD have been identified by some researchers, but complex inter-relationships among factors are not analysed. Finding direct and indirect effects of these factors on the success of MDD can be a good future research proposition.