The Japanese medical device industry's stagnation over the years can be attributed to the uncertainty related to device development. The purpose of this study is to identify the major factors that impact development. We studied the ventricular assist device EVAHEART through interviews with the persons involved and created a development model using system dynamics. There are at least six stages in the device development process, including interactions with academia and the government. Through a simulation and comparison to Novacor, it was determined that the satisfaction of academia leads to government action in the subsequent measures. Our trial simulation of EVAHEART suggests that it has the potential to clarify unclear relationships in the development of devices.
ASJC Scopus subject areas