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

Author

Listed:
  • Santosh B. Rane

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

  • Milind Shrikant Kirkire

    (Sardar Patel College of Engineering (University of Mumbai)
    Finolex Academy of Management and Technology (University of Mumbai))

Abstract

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.

Suggested Citation

  • Santosh B. Rane & Milind Shrikant Kirkire, 2016. "Analysis of barriers to medical device development in India: an interpretive structural modelling 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. 7(3), pages 356-369, September.
    • Handle: RePEc:spr:ijsaem:v:7:y:2016:i:3:d:10.1007_s13198-016-0497-0
    DOI: 10.1007/s13198-016-0497-0
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    References listed on IDEAS

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    1. 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. 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.
    2. Lucian Ispas & Costel Mironeasa & Alessandro Silvestri, 2023. "Risk-Based Approach in the Implementation of Integrated Management Systems: A Systematic Literature Review," Sustainability, MDPI, vol. 15(13), pages 1-22, June.
    3. 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.
    4. Sajid Ullah & Farman Ullah Khan & Vanina Adoriana Trifan & Adina Eleonora Spinu & Grigorie Sanda, 2022. "Modeling Key Strategies for Reducing Socio-Economic and Health Crisis: Perspective from COVID-19 Pandemic," IJERPH, MDPI, vol. 19(21), pages 1-21, October.
    5. 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.

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