Studies On The Project Risk Management Of The R&D Of Medical Apparatus

R&D project of medical apparatus develops with the characteristics of interdisciplinary, relative low feasibility, long period and restricted by strict regulation, which determines the high risk of the project. How to effectively avoid the high risk of medical appratus’R&D is the burning problem and arduous task faced by the research and development workers. Therefore, to analyze the risk factors during the R&D of medical apparatus and to take effective risk management lead to theoretical and practical significance for the sustainable development of medical apparatus. This thesis is on the basis of the theoretical research on the combination of medical apparatus’R&D project cases. With the usage of the knowledge and methods of project risk management, the author explored the risk management of medical apparatus’R&D project including the following aspects:1. To introduce the background and purpose of the article briefly; on the basis of referring to the relevant literature, to comprehensively describe the status and development of the risk management of medical apparatus.2. To give detailed explanation to the organization and R&D process of corporations that get involved in the R&D of medical apparatus. To coordinate experts with relevant background and build risk management team, through the way of interviews and brain storms to identify the potential risk factors and developed the risk factors list with16kinds of risk factors in5categories, to conduct the empirical study of the risk factors list through the questionnaires to ensure the accuracy and objectivity.3.According to the importance to sort the risk factors through using AHP to generate judgment matrix and develop the risk factors list in different stages during R&D process, to take reasonable measurements to tackle different types of risks with the methods of mitigation, avoidance, share and acceptance and supervise these measurements.4. To implement the risk management by taking High intensity focused ultrasound therapy system R&D project as a case study, analyze and control the risk factor in accordance with the methods described in the article, to verify the feasibility and operability of the theory.Through taking the risk management theoretical knowledge and methods, the exploratory study in the thesis provides reference to the medical appartus’R&D project and benefits the further study of the project risk management theory.