| In vitro diagnostic reagents industry is affected by national policy guidance and international market competition. The enterprises to survive in this environment of opportunities and challenges, need to improve innovation ability of product and technology, in order to improve the competitiveness sustained. An effective method to resolving the problem of domestic IVD enterprises faced in the process of product development is the implementation of the project management. This thesis combines the current problems of enterprises in the product development process, bases on the literature research of project time management application in various industries, comprehensive use of the theories and methods of critical chain project management in the topic research.The main work is as follows:(1) Discussing the content and characteristics of domestic in vitro diagnostic products R&D, established product R&D project process, based on these to establish the critical chain project management model of IVD product development. Using work breakdown structure method to create the project plan, combine responsibility matrix and resource allocation, using the program evaluation and review technique to make out project plan, simplifies the identification of critical chain. Further integration of three time evaluation method, factors will affect the progress of the project R&D resources demand, process complexity, process flexibility, process activity and management preference level for the calculation of comprehensive, buffer, the buffer is more reasonable. And the project buffer consumption and project schedule with a buffer, the decision matrix, dynamic monitoring implementation project.(2) The critical chain model has been applied to HIV microfluidic detection reagent R&D project to identify its effect, mainly through the specific project implementation process, using critical chain model, establishing of project decomposition estimate time and resources, making the network planning chart, identifying the critical chain, setting the buffer, progress control and other steps, s identify its actual application value. Using this model, enhance enterprise development efficiency, optimize the project plan, overcome the reason of project delay because uncertainty, complexity, regulatory and other reasons, shorten the cycle of R&D projects.Provides a solution to solve the existing project management IVD products, the main uncertainty high, in certain degree make up for the shortage of domestic IVD industry product development management, provide experience and guidance for other similar projects. |