建構系統動態模式探討醫療器材產業FDA產品召回的結構性問題

The information of US FDA medical device recall database shows a risingtendency in product recalls year by year. Product recalls not only affect thequality of medical care, but also impact the financial performance of suppliers inthe medical device industry. It is a structural quality risk problem for the supplychain manufacturers in the medical device industry that is harder to be resolvedby the quality improvement of individual manufacturers. In order to respond thisproblem, the cooperation of suppliers in the supply chain, FDA’s reviewmechanism, and innovative R&D by the manufacturer should be explored by amethod with holistic and systematic perspectives, and understand the systemstructure and system behavior of the medical device industry. Further, aneffective solution is proposed. Therefore, this study uses system dynamicsmethodology to explore the structural problem of FDA product recalls in themedical device industry, and analyzes its system structure and system behavior.Related policies and management implications will be discussed in the expectedresearch results.