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The Impact of Industry 4.0 on the Medical Device Regulatory Product Life Cycle Compliance

Author

Listed:
  • Olivia McDermott

    (College of Science and Engineering, University of Galway, H91 TK33 Galway, Ireland)

  • Ida Foley

    (College of Science and Engineering, University of Galway, H91 TK33 Galway, Ireland)

  • Jiju Antony

    (Department of Industrial and Systems Engineering, Khalifa University, Abu Dhabi P.O. Box 127788, United Arab Emirates)

  • Michael Sony

    (Wits Business School, University of the Witwatersrand, Johannesburg 2000, South Africa)

  • Mary Butler

    (College of Science, Atlantic Technological University, F91 YW50 Sligo, Ireland)

Abstract

The fourth industrial revolution, also referred to as Industry 4.0, has resulted in many changes within the MedTech Industry. The MedTech industry is changing from interconnected manufacturing systems using cyber-physical systems to digital health technologies. The purpose of the study is to establish how Industry 4.0 can understand the impact Industry 4.0 is having on product lifecycle regulatory compliance and determine the effect Industry 4.0 is having on product lifecycle regulatory compliance. A qualitative research approach was utilised to gather data from the MedTech industry by conducting interviews with Medtech industry leaders. This research demonstrates that Industry 4.0 is easing product lifecycle regulatory compliance and that the impact is more positive than negative. Industry 4.0 offers many benefits to the MedTech Industry. This research will support organisations in demonstrating how digital technologies can positively impact product lifecycle regulatory compliance and support the industry in building a business case for future implementation of Industry 4.0 technologies.

Suggested Citation

  • Olivia McDermott & Ida Foley & Jiju Antony & Michael Sony & Mary Butler, 2022. "The Impact of Industry 4.0 on the Medical Device Regulatory Product Life Cycle Compliance," Sustainability, MDPI, vol. 14(21), pages 1-22, November.
    • Handle: RePEc:gam:jsusta:v:14:y:2022:i:21:p:14650-:d:965746
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    References listed on IDEAS

    as
    1. Bhamra, Ran & Hicks, Christian & Small, Adrian & García-Villarreal, Enrique, 2022. "Value, product delivery strategies and operational performance in the medical technology industry," International Journal of Production Economics, Elsevier, vol. 245(C).
    2. Sony, Michael & Antony, Jiju & Mc Dermott, Olivia & Garza-Reyes, Jose Arturo, 2021. "An empirical examination of benefits, challenges, and critical success factors of industry 4.0 in manufacturing and service sector," Technology in Society, Elsevier, vol. 67(C).
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    Cited by:

    1. Cubillas-Para, Clara & Cegarra-Navarro, Juan Gabriel & Vătămănescu, Elena-Mădălina, 2024. "Gliding from regenerative unlearning toward digital transformation via collaboration with customers and organisational agility," Journal of Business Research, Elsevier, vol. 177(C).
    2. António Cardoso & Manuel Sousa Pereira & José Carlos Sá & Daryl John Powell & Silvia Faria & Miguel Magalhães, 2023. "Digital Culture, Knowledge, and Commitment to Digital Transformation and Its Impact on the Competitiveness of Portuguese Organizations," Administrative Sciences, MDPI, vol. 14(1), pages 1-25, December.

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