【摘要】：隨著改革開放的發(fā)展和人口老齡化的到來,我國的醫(yī)藥產(chǎn)業(yè)發(fā)展迅速,醫(yī)藥行業(yè)成為我國國民經(jīng)濟的重要組成部分。醫(yī)療器械,特別是三類植入醫(yī)療器械,它的安全性和有效性是與大眾醫(yī)療健康和生命安全密切相關(guān)的,是一種特殊的商品,是現(xiàn)代醫(yī)學(xué)用于疾病預(yù)防、診斷、治療、保健和康復(fù)的重要手段。但是醫(yī)療器械產(chǎn)品研發(fā)與藥品研發(fā)具有相類似的特點,如高投入、高風(fēng)險、周期長、成功率低等。它的研發(fā)是一項復(fù)雜的系統(tǒng)工程,任何一個環(huán)節(jié)出現(xiàn)問題即可能導(dǎo)致項目的失敗。因此,對醫(yī)療器械產(chǎn)品研發(fā)過程進行風(fēng)險管理將有利于保證產(chǎn)品的順利研發(fā)。目前國內(nèi)有很多學(xué)者進行了醫(yī)藥產(chǎn)品研發(fā)管理的理論研究,但是主要集中于新藥的研發(fā);對于醫(yī)療器械研發(fā)特別是植入醫(yī)療器械的項目管理的實際案例研究較少。基于以上現(xiàn)實情況的基礎(chǔ)上,本文以M公司的“生物膜片”研發(fā)產(chǎn)品為風(fēng)險管理模型,運用風(fēng)險管理的理論基礎(chǔ),對研發(fā)的風(fēng)險進行了規(guī)劃、識別、評估、控制等。本文在風(fēng)險識別過程中,通過頭腦風(fēng)暴法識別出“生物膜片”研發(fā)風(fēng)險主要有決策風(fēng)險、技術(shù)風(fēng)險、管理風(fēng)險、環(huán)境風(fēng)險、財務(wù)風(fēng)險和生產(chǎn)風(fēng)險;在風(fēng)險定性分析中,根據(jù)主觀評分法計算出風(fēng)險整體水平小于預(yù)設(shè)項目整體評價基準(zhǔn),判斷“生物膜片”研發(fā)項目的整體風(fēng)險水平可以接受,按風(fēng)險大小順序依次為技術(shù)、管理、決策、生產(chǎn)、財務(wù)風(fēng)險;在風(fēng)險定量分析中,采用層次分析法構(gòu)造判斷矩陣,得到各層級風(fēng)險的風(fēng)險度,在風(fēng)險控制時要特別重視能否開發(fā)成功風(fēng)險和中試放大風(fēng)險;根據(jù)不同的風(fēng)險類型制訂了合理的風(fēng)險應(yīng)對措施,并進行監(jiān)控。本文是對醫(yī)療器械研發(fā)過程從項目風(fēng)險管理理論和實際應(yīng)用的探索研究,其成果將為同行進行產(chǎn)品的項目風(fēng)險管理提供借鑒和參考。
[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.
【學(xué)位授予單位】：華南理工大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2015
【分類號】：F426.4;F272.3

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本文編號：2119025