Research On The Life-Cycle Management Of Class-? Medical Devices R&D Project

Medical equipment industry is an important part of medical and health industry in China,with the development of economy and technology and the support of the government,the backward situation of this industry is changing.As knowledge and capital intensive industry,class-III medical devices industry developed rapidly.It is gradually to break the monopoly of the United States,Japan and European countrise.The development level of class-III medical devices industry is also the embodiment of China's power,therefore,to develop the medical device industry(especially class-III medical devices)is imperative.The class-III medical devices R&D project has the characteristics of strict safety,strict requirements,high professional requirements,high complexity,long cycle and high failure risk.This industry has some disadvantages in the project management,such as unscientific project decision-making,low level of project management team,lack of effective incentive mechanism,and neglect of project life-cycle management,at the same time,the industrial development is very urgent,demanding higher achievements conversion rate and faster speed,therefore,introducing the life-cycle management into class-III medical devices research and development project is becoming more and more urgent.Based on the study of project management,medical equipment research and development and the life-cycle management,this paper established the life-cycle model of class-III medical devices research and development project.This modeldivided the whole life-cycle into four stages: the project application stage,the product design and research stage,the verify stage,the register and approval stage;and eight sub-stages: the new product development proposals,the design input,the design output,the small test,the pilot-scale test,the clinical trials,the preparation for approval and the obtain of licence.In this paper,the scope,the goal,the content of work and the deliverables in each stage is detailed decomposition.In case study part,this paper selected the artificial cornea R&D project of A company as the research object,and carried out the scope,the stakeholders and risk analysis based on the life-cycle of artificial cornea R&D projects,and the project's organizational structure,WBS,responsibility assignment matrix are designed to verify the effectiveness of the model of life-cycle,which also provided a framework for the implementation and management of other medical equipment R&D project.Finally,the paper combined with the progress of artificial cornea R&D projects of A company,summarized the achieved results in whole life-cycle management,hoping to provide references to class-III medical devices research and development project management.