A System Dynamics Method Applied to Risk Management in Medical Device Companies

摘要

New technologies and products arise in medical device industries with new risks it brings. That is one of the reason why competent authorities use a firm hand monitoring the risks and many design projects fail down. Manufacturers have trouble in controlling product development and product risk at the same time, and are especially out of confidence when making related decisions. To analyze how this problem works and seek for ways to solve it, the project turned to system dynamics and a qualitative method as QPID. Six medical device companies were interviewed and a model for medical device product development was completed. In the end, suggestions and a simulation phase for medical device businesses were given. And thus we can simulate and rely on the system dynamics analysis to improve our judgement and decisions. The best evidence to the benefits of the model is the quality and anticipation of the decisions that result from the modeling process.