Analysis of barriers to medical device development in India: an interpretive structural modelling approach

Efficacious product development is a critical issue faced by medical device manufacturing industries. Indian medical device industry is in nascent stage constituting of 75 % imports indicating diminutive device development activities unlike other sectors of manufacturing which are vigorously making forays through indigenous product development. The objective of this paper is to identify barriers to medical device development (MDD) and develop a structural model of it. 11 most significant barriers are identified using opinions of MDD experts and the literature review. They are further ranked by 33 experts through questionnaire survey. The mutual relationships among the barriers are established based on opinions of one group of experts using interpretive structural modelling (ISM) approach. The barriers are quantified using reachability matrix and further categorised as: autonomous, dependent, linkage and driver barriers using MICMAC analysis based on the mutual influence and dependence. The model is further validated by another group of MDD experts. Combination of ISM and MICMAC analysis gives a high level contextual relationship among the barriers identified. The barriers have compounding effect. Dependent barriers have higher dependence and present resulting actions. The driver barriers have high driving power and low dependence indicating need for systematic plan of action. Identification of barriers to MDD and developing the contextual relationships among them is a unique effort. It will provide an aid to the top management, developers and policy makers to develop strategies for MDD. Moreover, it will assist to accelerate indigenous contribution towards MDD which will ultimately deepen the penetration of low cost and better quality medical care for larger part of the population. This paper develops a model of barriers to MDD in India; which can be customised for other sectors and contexts. © 2016, The Society for Reliability Engineering, Quality and Operations Management (SREQOM), India and The Division of Operation and Maintenance, Lulea University of Technology, Sweden.