本文選題：體外診斷試劑　切入點：新產(chǎn)品開發(fā)　出處：《中國科學(xué)院大學(xué)(工程管理與信息技術(shù)學(xué)院)》2013年碩士論文　論文類型：學(xué)位論文

【摘要】：隨著人類平均壽命的增加,醫(yī)學(xué)模式、疾病譜和人們對醫(yī)療衛(wèi)生服務(wù)需求的變化,人們更重視疾病的防治,健康的維護(hù)以及提高生命質(zhì)量,體外診斷技術(shù)作為最客觀的疾病輔助診斷技術(shù)為提高醫(yī)療質(zhì)量、保障公眾健康,發(fā)揮著越來越重要的作用。新技術(shù)、新方法的不斷引進(jìn)和新產(chǎn)品的出現(xiàn),使體外診斷行業(yè)呈現(xiàn)前所未有的井噴式發(fā)展。因此,新產(chǎn)品開發(fā)是體外診斷企業(yè)生存和發(fā)展的戰(zhàn)略核心之一,適時的新產(chǎn)品開發(fā),才能使其在市場上保持競爭優(yōu)勢,占據(jù)領(lǐng)先地位。 由于國內(nèi)外生物醫(yī)藥研發(fā)和創(chuàng)新模式的變遷,新的生物醫(yī)藥研發(fā)和創(chuàng)新活動已不再是一種純粹的科學(xué)活動,更多的是一種產(chǎn)學(xué)研的技術(shù)合作。而合作的一個重要的基礎(chǔ)就是合作各方對新產(chǎn)品項目的價值認(rèn)同,因此在生物醫(yī)藥企業(yè)的研發(fā)項目決策中新產(chǎn)品項目的技術(shù)評估作用越顯重要。 本研究調(diào)研了國內(nèi)外相關(guān)行業(yè)新產(chǎn)品開發(fā)技術(shù)評估進(jìn)展,分析歸納體外診斷新產(chǎn)品開發(fā)的特點及其影響因素,針對體外診斷新產(chǎn)品從調(diào)研到市場準(zhǔn)入獲得生產(chǎn)許可的整個新產(chǎn)品實現(xiàn)過程,運用專家咨詢法、層次分析法、秩和比法以及模糊綜合評估法等方法,建立了體外診斷新產(chǎn)品立項的技術(shù)評估指標(biāo)體系,設(shè)定了指標(biāo)權(quán)重,為體外診斷新產(chǎn)品立項的技術(shù)評估等工作提供了一個有益的工具,最后結(jié)合實例對體外診斷新產(chǎn)品的立項進(jìn)行了技術(shù)評估實施和驗證。其主要工作和研究成果如下： 首先,介紹了體外診斷新產(chǎn)品開發(fā)的重要意義,重點說明了國內(nèi)外各行業(yè)對新產(chǎn)品開發(fā)技術(shù)評估的幾種方法。對本文研究的理論基礎(chǔ)層次分析法和模糊綜合評估法做了重點分析和說明,包括模型評價的主要步驟和過程。 其次,結(jié)合體外診斷行業(yè)現(xiàn)狀和影響新產(chǎn)品開發(fā)的關(guān)鍵因素,采用專家咨詢法對其關(guān)鍵影響因素進(jìn)行賦值,并應(yīng)用層次分析法和秩和比法對關(guān)鍵因素的一級指標(biāo)和二級指標(biāo)分別進(jìn)行權(quán)重加權(quán)和秩次分析,得出影響新產(chǎn)品開發(fā)的度量指標(biāo)權(quán)重值,并應(yīng)用模糊綜合評估法對新產(chǎn)品開發(fā)進(jìn)行評分。 最后,應(yīng)用構(gòu)建的體外診斷新產(chǎn)品技術(shù)評估體系,結(jié)合實例實施技術(shù)評估和驗證,為該技術(shù)評估模型體系在實際中的良好應(yīng)用提供了現(xiàn)實依據(jù)。 本研究的結(jié)果表明,在體外診斷新產(chǎn)品技術(shù)評估中最應(yīng)關(guān)注的指標(biāo)是技術(shù)因素,它是體外診斷產(chǎn)品最核心的問題。其次應(yīng)該關(guān)注的是市場因素,能夠快速、準(zhǔn)確反映人們疾病健康水平的體外診斷產(chǎn)品才是關(guān)鍵。第三應(yīng)該關(guān)注的是體外診斷產(chǎn)品的政策法規(guī)因素,這是保障產(chǎn)品的行政手段。內(nèi)部基礎(chǔ)因素排在第四位。 本研究建立的體外診斷新產(chǎn)品技術(shù)評估指標(biāo)體系、權(quán)重系數(shù)、評估計算方法經(jīng)專家咨詢和試評估驗證具有科學(xué)性和可行性,可以作為體外診斷產(chǎn)品研發(fā)、風(fēng)險評估、技術(shù)引進(jìn)、項目立項時的參考。
[Abstract]:As life expectancy increases, medical patterns, disease spectrum and demand for health services change, people pay more attention to disease prevention, health maintenance and quality of life. As the most objective auxiliary diagnosis technology, in order to improve the quality of medical treatment and protect public health, in vitro diagnosis technology plays a more and more important role. The introduction of new technology and new methods and the emergence of new products are becoming more and more important. Therefore, the development of new products is one of the core strategies for the survival and development of in vitro diagnosis enterprises, and the timely development of new products can make them maintain competitive advantage in the market. Take the lead. Due to the changes of the domestic and foreign biomedical R & D and innovation models, the new biomedical R & D and innovation activities are no longer a pure scientific activity. More is a kind of industry-university-research technical cooperation. And an important foundation of cooperation is the value recognition of the new product project. Therefore, it is more and more important to evaluate the technology of new product projects in the R & D project decision of biomedical enterprises. This study investigated the development of new product development technology in related industries at home and abroad, analyzed and summarized the characteristics and influencing factors of in vitro diagnosis of new product development. In view of the whole process of realizing new products in vitro from investigation to market access, the methods of expert consultation, analytic hierarchy process, rank sum ratio and fuzzy comprehensive evaluation are used. The technical evaluation index system of new product in vitro diagnosis is established, and the index weight is set up, which provides a useful tool for the technical evaluation of in vitro diagnosis of new product. Finally, the technical evaluation and verification of the new product in vitro diagnosis are carried out with examples. The main work and research results are as follows:. First of all, the importance of developing new products for in vitro diagnosis is introduced. Several methods for evaluating new product development technology in various industries at home and abroad are emphatically explained. The theoretical basis analytic hierarchy process and fuzzy comprehensive evaluation method of this paper are emphatically analyzed and explained, including the main steps and processes of model evaluation. Secondly, combined with the status quo of in vitro diagnosis industry and the key factors affecting the development of new products, the key factors are assigned by expert consultation. By using the analytic hierarchy process and the rank sum ratio method, the weight weighting and rank analysis of the first and second grade indexes of key factors are carried out, respectively, and the weight values of the metrics that affect the development of new products are obtained. The new product development was evaluated by fuzzy comprehensive evaluation method. Finally, a new product technology evaluation system for in vitro diagnosis is constructed, which provides a practical basis for the good application of the technology evaluation model system in practice. The results of this study show that the most important indicator in the evaluation of new products in vitro diagnosis is the technical factor, which is the core problem in the in vitro diagnosis of the product. Secondly, the market factor should be paid attention to, which can be rapid. The key is to accurately reflect the health level of people's disease in vitro. Third, we should pay attention to the policy and regulation factor of the product, which is the administrative means to ensure the product. The internal basic factor is ranked at 4th. The new product technology evaluation index system, weight coefficient and evaluation calculation method established in this study are scientific and feasible after expert consultation and trial evaluation, and can be used as R & D and risk assessment of in vitro diagnostic products. Introduction of technology, project establishment of the reference.
【學(xué)位授予單位】：中國科學(xué)院大學(xué)(工程管理與信息技術(shù)學(xué)院)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2013
【分類號】：F426.72;F273.1

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