M公司医疗器械产品“生物膜片”研发的风险管理
发布时间：2018-07-13 10:22
【摘要】：随着改革开放的发展和人口老龄化的到来,我国的医药产业发展迅速,医药行业成为我国国民经济的重要组成部分。医疗器械,特别是三类植入医疗器械,它的安全性和有效性是与大众医疗健康和生命安全密切相关的,是一种特殊的商品,是现代医学用于疾病预防、诊断、治疗、保健和康复的重要手段。但是医疗器械产品研发与药品研发具有相类似的特点,如高投入、高风险、周期长、成功率低等。它的研发是一项复杂的系统工程,任何一个环节出现问题即可能导致项目的失败。因此,对医疗器械产品研发过程进行风险管理将有利于保证产品的顺利研发。目前国内有很多学者进行了医药产品研发管理的理论研究,但是主要集中于新药的研发;对于医疗器械研发特别是植入医疗器械的项目管理的实际案例研究较少。基于以上现实情况的基础上,本文以M公司的“生物膜片”研发产品为风险管理模型,运用风险管理的理论基础,对研发的风险进行了规划、识别、评估、控制等。本文在风险识别过程中,通过头脑风暴法识别出“生物膜片”研发风险主要有决策风险、技术风险、管理风险、环境风险、财务风险和生产风险;在风险定性分析中,根据主观评分法计算出风险整体水平小于预设项目整体评价基准,判断“生物膜片”研发项目的整体风险水平可以接受,按风险大小顺序依次为技术、管理、决策、生产、财务风险;在风险定量分析中,采用层次分析法构造判断矩阵,得到各层级风险的风险度,在风险控制时要特别重视能否开发成功风险和中试放大风险;根据不同的风险类型制订了合理的风险应对措施,并进行监控。本文是对医疗器械研发过程从项目风险管理理论和实际应用的探索研究,其成果将为同行进行产品的项目风险管理提供借鉴和参考。
[Abstract]:With the development of reform and opening up and the coming of population aging, the pharmaceutical industry in our country has developed rapidly, and the pharmaceutical industry has become an important part of our national economy. Medical instruments, especially the three types of medical devices, are closely related to the health and safety of the public, and it is a special kind of business. Product is an important means of modern medicine for disease prevention, diagnosis, treatment, health care and rehabilitation. However, research and development of medical equipment products are similar to drug research and development, such as high investment, high risk, long cycle and low success rate. Therefore, the risk management of the research and development process of medical devices will help ensure the smooth development of the product. At present, many scholars in China have carried out the theoretical research on the research and development management of medical products, but mainly focus on the research and development of new drugs, and the actual cases of medical device research and development, especially the project management of medical instruments implanted. Based on the above realities, this paper takes the "biological diaphragm" of M company as a risk management model and uses the theoretical basis of risk management to plan, identify, evaluate, control and control the risk of R & D. In the process of risk identification, the "biological diaphragm" is identified by the brainstorming method. Risk mainly includes decision risk, technical risk, management risk, environmental risk, financial risk and production risk. In the qualitative analysis of risk, the overall risk level of the project is calculated according to the subjective scoring method. The overall risk level of the "biological diaphragm" R & D project is acceptable, according to the order of risk. The second is technology, management, decision making, production and financial risk. In the quantitative analysis of risk, the analytic hierarchy process (AHP) is used to construct the judgement matrix, and the risk degree of each level of risk is obtained. In the risk control, we should pay special attention to the success risk and the pilot magnification risk. This article is a research on the theory and practical application of the project risk management in the process of medical device research and development. The results will provide reference and reference for the risk management of the product.
【学位授予单位】：华南理工大学
【学位级别】：硕士
【学位授予年份】：2015
【分类号】：F426.4;F272.3
本文编号：2119025
[Abstract]:With the development of reform and opening up and the coming of population aging, the pharmaceutical industry in our country has developed rapidly, and the pharmaceutical industry has become an important part of our national economy. Medical instruments, especially the three types of medical devices, are closely related to the health and safety of the public, and it is a special kind of business. Product is an important means of modern medicine for disease prevention, diagnosis, treatment, health care and rehabilitation. However, research and development of medical equipment products are similar to drug research and development, such as high investment, high risk, long cycle and low success rate. Therefore, the risk management of the research and development process of medical devices will help ensure the smooth development of the product. At present, many scholars in China have carried out the theoretical research on the research and development management of medical products, but mainly focus on the research and development of new drugs, and the actual cases of medical device research and development, especially the project management of medical instruments implanted. Based on the above realities, this paper takes the "biological diaphragm" of M company as a risk management model and uses the theoretical basis of risk management to plan, identify, evaluate, control and control the risk of R & D. In the process of risk identification, the "biological diaphragm" is identified by the brainstorming method. Risk mainly includes decision risk, technical risk, management risk, environmental risk, financial risk and production risk. In the qualitative analysis of risk, the overall risk level of the project is calculated according to the subjective scoring method. The overall risk level of the "biological diaphragm" R & D project is acceptable, according to the order of risk. The second is technology, management, decision making, production and financial risk. In the quantitative analysis of risk, the analytic hierarchy process (AHP) is used to construct the judgement matrix, and the risk degree of each level of risk is obtained. In the risk control, we should pay special attention to the success risk and the pilot magnification risk. This article is a research on the theory and practical application of the project risk management in the process of medical device research and development. The results will provide reference and reference for the risk management of the product.
【学位授予单位】：华南理工大学
【学位级别】：硕士
【学位授予年份】：2015
【分类号】：F426.4;F272.3
【参考文献】
相关期刊论文 前2条
1 徐凤玲;;风险管理在医疗器械中应用的探讨[J];中国医疗器械杂志;2006年02期
2 张素敏;张亮;;国内外医疗器械风险管理现状分析[J];中国医疗器械杂志;2010年06期
，本文编号：2119025
本文链接：https://www.wllwen.com/guanlilunwen/xiangmuguanli/2119025.html
