体外诊断试剂产品研发项目范围管理的研究

发布时间：2018-03-08 23:36

本文选题：项目范围管理　切入点：体外诊断试剂　出处：《中国科学院大学（工程管理与信息技术学院）》2014年硕士论文　论文类型：学位论文

【摘要】：本文课题来源于作者所在企业体外诊断试剂新产品研发项目管理实践的需要。本文所述的项目范围包含了“产品范围”和“项目范围”两个范畴。由于体外诊断试剂新产品从研发到上市,一切顺利的情况下至少需要一至两年。而市场是日新月异的,致使产品上市后所面对的情况,与最初研发立项时确定的产品范围存在诸多差异了,企业不得不面临研发产品范围变更,甚至是项目自身取舍的抉择。因此,如何准确获得、分析并评估客户需求显得尤为重要,从而在产品研发项目立项时准确领会客户需求,作出前瞻性决策,使研发项目范围管理能有所侧重。受体外诊断试剂行业性质的影响,在公开的文献中,尚未找到针对体外诊断试剂产品研发项目范围管理的相关内容,但可以借鉴公开发表的其他产品研发项目范围管理的相关文献。本文的研究目标在于为企业产品研发项目管理的实践,找到体外诊断试剂产品研发项目范围管理规范化可行的路径,为规范研发项目范围管理确定方向。作者完成的主要工作如下： 1.将项目范围管理理论与方法,应用到体外诊断试剂产品研发项目范围管理中去。 2.利用质量功能展开等方法与工具,尝试建立体外诊断试剂产品直接使用的客户需求与体外诊断试剂产品技术特性之间的关联途径。 3.利用建立的客户需求与产品技术特性的关联数据,为产品研发项目范围管理,特别是产品范围,建立评价标准以及标准流程。 4.在实际工作中,验证项目范围管理方法应用的实际效用。本文研究后的结果,为体外诊断试剂公司新产品研发立项提供了一个可行的、经过实践证明的项目范围管理方法,这将有利于新产品研发项目管理,以及后期产品上市推广工作的开展。
[Abstract]:This paper comes from the need of R & D project management of in-vitro diagnostic reagents. The project scope described in this article includes two categories: product scope and Project scope. Since it takes at least one to two years for a new product of an in vitro diagnostic reagent to be developed to market, it will take at least one to two years for everything to go smoothly. And the market is changing with each passing day, resulting in the situation faced by the product after it has been put on the market. There are many differences from the product scope that was determined when the project was first developed. Enterprises have to face the choice of product scope change of R & D, or even the choice of the project itself. Therefore, how to accurately obtain, It is very important to analyze and evaluate customer needs, so as to accurately understand customer needs and make forward-looking decisions when product R & D projects are established, so that R & D project scope management can be focused on. Affected by the nature of in vitro diagnostic reagents industry, in the open literature, there has not been found for in vitro diagnostic reagents product R & D project scope management related content, However, we can draw lessons from the published literature on the scope management of other product R & D projects. The research goal of this paper is to find a feasible way to standardize the scope management of product R & D project in vitro diagnostic reagent for the practice of enterprise product R & D project management. In order to standardize the scope management of R & D projects, the main work accomplished by the author is as follows:. 1. The project scope management theory and method are applied to the in vitro diagnostic reagent product R & D project scope management. 2. By using the methods and tools of quality function expansion, this paper attempts to establish the correlation between the customer demand for direct use of in vitro diagnostic reagents and the technical characteristics of in vitro diagnostic reagents. 3.Use the relevant data of established customer demand and product technical characteristics to establish evaluation criteria and standard flow for product R & D project scope management, especially product scope. 4. In the actual work, verify the practical utility of the project scope management method application. The results of this paper provide a feasible and proven project scope management method for the in vitro diagnostic reagent company's new product development project, which will be beneficial to the new product R & D project management. And the later stage of product marketing and promotion work.
【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】：2014
【分类号】：R954

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