Based On Capacity-building Medical Device R & D Management Model

This paper mainly studies the R&D management on medical devices. At first, the author analyzes the problem about R&D management of medical devices and it's characteristics. Secondly, based on the study results of mainstream R&D pattern both at home and abroad, using its core managing thoughts for reference, targeting at promoting R&D core capacity of medical devices enterprises roundly, the author puts forward the R&D management pattern which grounds on capacity building.And then, the paper centers on the major contents of the pattern. It conducts a comprehensive discussion and analysis, which are based on the R&D quality management capacity of regulations, R&D process management capacity of the SGS checkpoint, R&D knowledge management capacity oriented to continual value creation, R&D team management capacity concentrating on improving performance, R&D advantages accumulation capacity supported by R&D platform. And through theoretical analysis and empirical case studies, this paper forms a complete systematic management pattern of R&D on medical devices based on capacity building. Finally, the author discusses the scientificity and the effectiveness of the pattern through enterprises'specific practices and applications. R&D management of medical devices has been rarely discussed in the current literature, so the R&D management pattern which grounds on capacity building presented by this article offers certain value for reference.