The impact of Industry 4.0 on the medical device regulatory product life cycle compliance
McDermott, Olivia Foley, Ida Antony, Jiju Sony, Michael Butler, Mary
McDermott, Olivia
Foley, Ida
Antony, Jiju
Sony, Michael
Butler, Mary
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Publication Date
2022-11-07
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Article
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McDermott, Olivia, Foley, Ida, Antony, Jiju, Sony, Michael, & Butler, Mary. (2022). The Impact of Industry 4.0 on the Medical Device Regulatory Product Life Cycle Compliance. Sustainability, 14(21). doi:10.3390/su142114650
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.
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Publisher
MDPI
Publisher DOI
10.3390/su142114650
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CC BY-NC-ND 3.0 IE