Research And Development Of In Vitro Diagnostic Reagents Stage-gate Management

IVD major use of biotechnology tools in disease prevention, diagnosis and treatment play an important role, IVD development is characterized by technological innovation, strict quality requirements, diverse varieties. Stage-gate management can successfully bring new products from concept to promote products to market, is a programmatic, guiding the process, before the formal requirements of the development, to do a more adequate market research activities to ensure the correctness of the market-oriented products. Unique in this study is that Stage-gate management theory and IVD combined with new product development, R&D management by WT company to analyze the current situation and the deep-seated problems, we set up at different stages of screening study mode, select project meets the requirement of the next session, to terminate undesirable projects, focusing on the company’s resources into line with the company’s strategy, in line with market development projects. Integrated whole thesis, the main findings and conclusions, including:First, the project management of multiple projects IVD research foundation established Stage-gate management theory. The development of in vitro diagnostic reagents from the scoping process to promote the market is subdivided into18steps, respectively, in the project developed "project, into the laboratory research, clinical assessment validation, marketing" four key positions established entrance, a gateway to manage R&D project management model diagnostics can be operated.Second, we have established a mathematical model of the project screening. This can be applied to research and development projects in vitro diagnostic reagents for screening for different projects at different inlet comprehensive sort, even some of the market or technology defective item can be clearly pause, while distinguishing key projects, for project selection provides the basis of scientific data.Third, the use of expert evaluation methods Brainstorming and cluster analysis, factors affecting the development of IVD summarizes21evaluation index, is divided into five areas of factors, while establishing a21rating scale factors of the merits of the specific division method to facilitate the actual operation.Fourth, the use of AHP method, using a YAHHP software,21R&D-related indicators IVD weights were analyzed and found that "sales capacity, technology research, sales prices, the main source of raw materials, product reviews regulatory classification" is the product five main factors research and development, this analysis has a correspondence with the actual environment.Finally, at different stages of development of six diagnostic reagents research project as a case study, we verified the data model is established Stage-gate management, the actual R&D background made the final determination result is consistent with the project, further evidence of the data model is scientific reasonable model.