Quality 4.0 derived from Industry 4.0, also known as the fourth industrial revolution. Prior to the fourth revolution, the first revolution started with machine manufacturing, steam power, and the move to cities by agriculturalists. In the second industrial revolution, production was automated and mass manufacturing cut the cost of consumer and industrial products. The third revolution involved the use of electronics and control systems in manufacturing, which helped drive down costs and resulted in increased product complexity and lower product costs. Today’s fourth industrial revolutionary change is driving new quality paradigms, processes, and technologies (https://blog.lnsresearch.com/quality40).
In the medical device manufacturing market, in particular, there are numerous challenges to design and produce safer devices. Regulatory requirements are just one component—but incorporating emerging and continually evolving technologies requires device companies to raise their game if they want to stay ahead of the competition and leverage cutting edge technologies—from the Internet of Things (IoT) to artificial intelligence and machine learning to augmented reality and even robotics. Quality 4.0 is the convergence of these new technologies that make up the manufacturing landscape.