Study On Scope Management Method For IVD Product R&D Projects

The subject of this thesis is originally from the author’s enterprise project of scope management of the new products of In vitro diagnostic reagents.The projects scope in this context includes two categories:the "Project Scope" and the "Product Scope"It will take usually one or two years at least for a new product development from R&D to the market. Due to the dynamic changing market the final product scope appeared in the market can be very different from the originally planned. In this case enterprises must deal with a drastic change of product scope, even abandon the new product at worst. Therefore it can be very important to collect, analyze and evaluate customer demands, so as to apprehend the requirement of the customers while the project is setting up with a prospective decision making, so that the certain prospects of project scope management can be focused.There is less relevant data about the project scope management of the In vitro diagnostic reagents available in literature. In this study, project scope management for other products R&D can be referenced however.Objectives of this thesis are to find out a feasible technical route for the project scope management of the In vitro diagnostic reagents and to set up a project scope management process in enterprise’s product R&D activities. More specifically:1. To make sure that the theory and the method of the project scope management will be used in the In vitro diagnostic reagents product scope management;2. Try to establish an association pattern between the customer demand of In vitro diagnostic reagents and the technical characteristic of the In vitro diagnostic reagents by using the tools of quality function development;3. To establish the evaluation criterion and the standard process for the project scope management of R&D, particularly for the project scope with using the association data of the customers and the technical characteristic of the product. 4. To verify the effectiveness of the method of project scope management in the real work.Conclusion of this thesis provides a feasible and proved method of project scope management for the In vitro diagnostic reagents new product research and development. It will benefit the new product development project management and also the future promotion of a new product launched in the market.