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

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.

Public governance in the context of Construction 4.0: a systematic and comprehensive literature review

“…4.3.2 Reduced non-value add waste. Furthermore, technological advancements can facilitate compliance by integrating regulatory requirements into the design and development of products and services (Mcdermott et al, 2022). Through technologies like digital platforms, IoT and blockchain, compliance measures can be embedded into organizational processes and supply chains.…”

“…Furthermore, technological advancements can facilitate compliance by integrating regulatory requirements into the design and development of products and services (Mcdermott et al. , 2022).…”

Digital Culture, Knowledge, and Commitment to Digital Transformation and Its Impact on the Competitiveness of Portuguese Organizations

“…The system presented can be integrated with other 4.0 tools, such as sensors, and consequent analysis of real-time data on the quality of the soil and the climate is then included in the model developed. McDermott et al (2022) considered Industry 4.0 as the revolution of process digitalization in companies that completely changed the way products, processes, and services were delivered to customers. According to McDermott et al (2022), who developed their research in the "MedTech Industry", Industry 4.0 is the transformation of digital technologies, such as cloud computing, big data, big data analytics, cyber-physical systems, systems integration, cybersecurity, 3D printing, and the IoT, to change the way this industry does business.…”

“…McDermott et al (2022) considered Industry 4.0 as the revolution of process digitalization in companies that completely changed the way products, processes, and services were delivered to customers. According to McDermott et al (2022), who developed their research in the "MedTech Industry", Industry 4.0 is the transformation of digital technologies, such as cloud computing, big data, big data analytics, cyber-physical systems, systems integration, cybersecurity, 3D printing, and the IoT, to change the way this industry does business. Digital technologies help organizations deliver processes, products, and services efficiently and effectively to their customers and, for now, have a positive impact on regulatory compliance.…”