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Interpretive structural modelling of risk sources in medical device development process

Author

Listed:
  • Santosh B. Rane

    (Sardar Patel College of Engineering (University of Mumbai))

  • Milind Shrikant Kirkire

    (Sardar Patel College of Engineering (University of Mumbai))

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.

Suggested Citation

  • Santosh B. Rane & Milind Shrikant Kirkire, 2017. "Interpretive structural modelling of risk sources in medical device development process," International Journal of System Assurance Engineering and Management, Springer;The Society for Reliability, Engineering Quality and Operations Management (SREQOM),India, and Division of Operation and Maintenance, Lulea University of Technology, Sweden, vol. 8(1), pages 451-464, January.
    • Handle: RePEc:spr:ijsaem:v:8:y:2017:i:1:d:10.1007_s13198-015-0399-6
    DOI: 10.1007/s13198-015-0399-6
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    References listed on IDEAS

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    1. Swagatika Mishra & Saurav Datta & S.S. Mahapatra, 2012. "Interrelationship of drivers for agile manufacturing: an Indian experience," International Journal of Services and Operations Management, Inderscience Enterprises Ltd, vol. 11(1), pages 35-48.
    2. Bastian A. de Mol, 2014. "Regulation of risk management of medical devices and the role of litigation," Journal of Risk Research, Taylor & Francis Journals, vol. 17(6), pages 735-748, June.
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    Cited by:

    1. Lanndon Ocampo & Joerabell Lourdes Aro & Samantha Shane Evangelista & Fatima Maturan & Kafferine Yamagishi & Dave Mamhot & Dina Fe Mamhot & Dawn Iris Calibo-Senit & Edgar Tibay & Joseph Pepito & Renis, 2022. "Research Productivity for Augmenting the Innovation Potential of Higher Education Institutions: An Interpretive Structural Modeling Approach and MICMAC Analysis," JOItmC, MDPI, vol. 8(3), pages 1-25, August.
    2. M. Suresh & G. Mahadevan & R. Dev Abhishek, 2019. "Modelling the factors influencing the service quality in supermarkets," International Journal of System Assurance Engineering and Management, Springer;The Society for Reliability, Engineering Quality and Operations Management (SREQOM),India, and Division of Operation and Maintenance, Lulea University of Technology, Sweden, vol. 10(6), pages 1474-1486, December.
    3. Sainath G. Bidikar & Santosh B. Rane & Prathamesh R. Potdar, 2022. "Product development using Design for Six Sigma approach: case study in switchgear industry," International Journal of System Assurance Engineering and Management, Springer;The Society for Reliability, Engineering Quality and Operations Management (SREQOM),India, and Division of Operation and Maintenance, Lulea University of Technology, Sweden, vol. 13(1), pages 203-230, February.
    4. Santosh B. Rane & Sandesh Wavhal & Prathamesh R. Potdar, 2023. "Integration of Lean Six Sigma with Internet of Things (IoT) for productivity improvement: a case study of contactor manufacturing industry," International Journal of System Assurance Engineering and Management, Springer;The Society for Reliability, Engineering Quality and Operations Management (SREQOM),India, and Division of Operation and Maintenance, Lulea University of Technology, Sweden, vol. 14(5), pages 1990-2018, October.
    5. Santosh B. Rane & Yahya A. M. Narvel, 2021. "Leveraging the industry 4.0 technologies for improving agility of project procurement management processes," International Journal of System Assurance Engineering and Management, Springer;The Society for Reliability, Engineering Quality and Operations Management (SREQOM),India, and Division of Operation and Maintenance, Lulea University of Technology, Sweden, vol. 12(6), pages 1146-1172, December.
    6. Santosh B. Rane & Prathamesh R. Potdar & Suraj Rane, 2019. "Accelerated life testing for reliability improvement: a case study on Moulded Case Circuit Breaker (MCCB) mechanism," International Journal of System Assurance Engineering and Management, Springer;The Society for Reliability, Engineering Quality and Operations Management (SREQOM),India, and Division of Operation and Maintenance, Lulea University of Technology, Sweden, vol. 10(6), pages 1668-1690, December.
    7. Rajiv Kumar Sharma, 2022. "Examining interaction among supplier selection strategies in an outsourcing environment using ISM and fuzzy logic approach," International Journal of System Assurance Engineering and Management, Springer;The Society for Reliability, Engineering Quality and Operations Management (SREQOM),India, and Division of Operation and Maintenance, Lulea University of Technology, Sweden, vol. 13(5), pages 2175-2194, October.

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