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Interpretive structural modelling of risk sources in medical device development process

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Abstract

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.

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Acknowledgments

This work was supported by All India Council for Technical Education (AICTE) under Grant Ref No. 20/AICTE/RIFD/RPS (POLICY-1) 61/2013-14. The authors are grateful to the concerned authorities and the MDD experts who contributed to this study. The authors express sincere thanks to the anonymous reviewers for their valuable suggestions to improve quality of this paper. The authors also express thanks to the editor and his team for the continuous guidance and support for this work.

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  1. Department of Mechanical Engineering, Sardar Patel College of Engineering (University of Mumbai), Bhavan’s Campus, Andheri (W), Mumbai, Maharashtra, 400058, India

    Santosh B. Rane & Milind Shrikant Kirkire

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  1. Santosh B. Rane
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  2. Milind Shrikant Kirkire
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Correspondence to Milind Shrikant Kirkire.

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Rane, S.B., Kirkire, M.S. Interpretive structural modelling of risk sources in medical device development process. Int J Syst Assur Eng Manag 8 (Suppl 1), 451–464 (2017). https://doi.org/10.1007/s13198-015-0399-6

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