Conceptualizing data-driven closed loop  production systems for lean manufacturing  of complex biomedical devices—a  cyber-physical system approach

A model is presented for shifting the manual intensive manufacturing process of complex biomedical devices towards more lean and efcient production process via application of concepts of cyber physical systems in combination with big data and analytics in a closed loop manner. The concept model is capable of handling high product volumes and variety, has ability for self-adaptation and correction in various operating conditions, and ofers real-time quality control. The approach acknowledges the challenge of these industries operating in a strict regulated environment and the higher standards of built-in quality required by developing a closed loop process, proposed to be built in accordance to the requirements of regulatory bodies and current Industry 4.0 practices. The proposed model illustrates that modern manufacturing methodologies and concepts can be integrated and adopted in such highly regulated manufacturing environments and that the model can be deployed to diferent production scenarios.