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

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