Risk Management Of Development Of A Medical Devices "Biological Patch" Of M Company

Since reform and opening-up, China has to face population aging problem. Medical Industry of China developed rapidly and it has became important part of China’s economy. Medical devices,especially Class-III Medical Device, is a kind of special commodity, which is closely-related with public health, is important way for prevention, diagnosis, treatment of disease. It is also important for health care and recovery of patients. There is many similarity between medical devices R&D and drugs R&D, such as High investment, high risk, long period, low success rate. Medical devices R&D is an integrated and complicate system engineering, the setback of any process in R&D will result to failure of project. Accordingly, risk management of medical devices R&D will contribute to smooth development of products.Compare to the risk management of development of drugs, there is less study in medical devices. Especially there is less case study in risk management of implantable medical devices. In this paper, to the cause and problem in the development of “BIOLOGICAL PATCH”, a serial of study was done with method including risk management assay, risk identification, risk evaluation and real-time risk monitor in R&D.In study of this paper, to the the development of “BIOLOGICAL PATCH”, a serial of risk, including risk of project decision making、technique risk、management risk、environmental risk 、 financial risk and production risk, was confirmed by Brainstorm method. In the qualitativeanalysis of project risk, the whole risk level of this project was evaluated by Subjective Probability Method and was confirmed in control. According to the influence of risk, the order from high to low is technology risk、management risk、decision making risk、production risk、financial risk. In thequantitative analysis of project risk, judgment matrix was configure by analytic hierarchy process( AHP). All levels of risk was analyzed systematically. Among them, product development and it’s Pilot scale test should be draw more attention on. In addition, risk response measures and risk monitoring was configured according to various risk.The result of this paper contributed to the smooth development of “BIOLOGICAL PATCH” and access to medical device markets in the past. It may also supply some reference to other company in their risk management in development of medical devices.