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

Olivia McDermott (), Ida Foley, Jiju Antony, Michael Sony and Mary Butler
Additional contact information
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

Sustainability, 2022, vol. 14, issue 21, 1-22

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.

Keywords: medical device; medtech; Industry 4.0; regulations (search for similar items in EconPapers)
JEL-codes: O13 Q Q0 Q2 Q3 Q5 Q56 (search for similar items in EconPapers)
Date: 2022
References: View references in EconPapers View complete reference list from CitEc
Citations: View citations in EconPapers (3)

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