体外诊断新产品立项的技术评估

发布时间：2018-03-11 22:01

本文选题：体外诊断试剂　切入点：新产品开发　出处：《中国科学院大学(工程管理与信息技术学院)》2013年硕士论文　论文类型：学位论文

【摘要】：随着人类平均寿命的增加,医学模式、疾病谱和人们对医疗卫生服务需求的变化,人们更重视疾病的防治,健康的维护以及提高生命质量,体外诊断技术作为最客观的疾病辅助诊断技术为提高医疗质量、保障公众健康,发挥着越来越重要的作用。新技术、新方法的不断引进和新产品的出现,使体外诊断行业呈现前所未有的井喷式发展。因此,新产品开发是体外诊断企业生存和发展的战略核心之一,适时的新产品开发,才能使其在市场上保持竞争优势,占据领先地位。由于国内外生物医药研发和创新模式的变迁,新的生物医药研发和创新活动已不再是一种纯粹的科学活动,更多的是一种产学研的技术合作。而合作的一个重要的基础就是合作各方对新产品项目的价值认同,因此在生物医药企业的研发项目决策中新产品项目的技术评估作用越显重要。本研究调研了国内外相关行业新产品开发技术评估进展,分析归纳体外诊断新产品开发的特点及其影响因素,针对体外诊断新产品从调研到市场准入获得生产许可的整个新产品实现过程,运用专家咨询法、层次分析法、秩和比法以及模糊综合评估法等方法,建立了体外诊断新产品立项的技术评估指标体系,设定了指标权重,为体外诊断新产品立项的技术评估等工作提供了一个有益的工具,最后结合实例对体外诊断新产品的立项进行了技术评估实施和验证。其主要工作和研究成果如下：首先,介绍了体外诊断新产品开发的重要意义,重点说明了国内外各行业对新产品开发技术评估的几种方法。对本文研究的理论基础层次分析法和模糊综合评估法做了重点分析和说明,包括模型评价的主要步骤和过程。其次,结合体外诊断行业现状和影响新产品开发的关键因素,采用专家咨询法对其关键影响因素进行赋值,并应用层次分析法和秩和比法对关键因素的一级指标和二级指标分别进行权重加权和秩次分析,得出影响新产品开发的度量指标权重值,并应用模糊综合评估法对新产品开发进行评分。最后,应用构建的体外诊断新产品技术评估体系,结合实例实施技术评估和验证,为该技术评估模型体系在实际中的良好应用提供了现实依据。本研究的结果表明,在体外诊断新产品技术评估中最应关注的指标是技术因素,它是体外诊断产品最核心的问题。其次应该关注的是市场因素,能够快速、准确反映人们疾病健康水平的体外诊断产品才是关键。第三应该关注的是体外诊断产品的政策法规因素,这是保障产品的行政手段。内部基础因素排在第四位。本研究建立的体外诊断新产品技术评估指标体系、权重系数、评估计算方法经专家咨询和试评估验证具有科学性和可行性,可以作为体外诊断产品研发、风险评估、技术引进、项目立项时的参考。
[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.
【学位授予单位】：中国科学院大学(工程管理与信息技术学院)
【学位级别】：硕士
【学位授予年份】：2013
【分类号】：F426.72;F273.1

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