Gateway Management Of New Medical Device Product Development

China’s economy has changed from a high-speed growth stage to a high-quality development stage.As a special industry,medical devices pay more attention to the safety and effectiveness of product quality.How to standardize the research and development of medical devices,improve product quality,and quickly and legally go public has become a matter of concern in the industry.Taking the new product development of company n as the research object,based on the door management theory,supplemented by the total quality management theory and PDCA cycle theory,this paper studies and discusses the whole new product development project.Firstly,this paper studies the research status of project quality management and path management methods at home and abroad,the existing regulations and standards,quality management system and path management methods in medical device industry,it is pointed out that the method of door diameter management can be applied to the new product development of medical devices.On the basis of the door path management theory and combined with total quality management and PDCA cycle theory to optimize the new product development technology model,the whole new project development process from the beginning to the market is divided into 5 stages,set 4 thresholds,subdivided into 10 steps.As the quality control point and key point of the whole project,the threshold setting is the summative review of the previous stage and plays a decisive role in the operation of the whole project process.In each stage,the PDCA cycle theory is applied to continuously improve and optimize the problems found,ensuring the quality of the whole new product development project.After that,the optimized new product technical model was applied in the new product development project of N Company.Through the implementation of the optimized technical model,the new product development process of N Company was optimized,saving 350,000 yuan,shortened the RESEARCH and development cycle by6 months,and the qualified rate of the product was increased by 6%.The effectiveness of the new process is analyzed and summarized,and the measures to ensure the implementation of the new process are pointed out.Finally,the paper concludes that the optimized door path management model can solve the problems of long development cycle and low qualified rate of new medical device products.It can fit well with the medical device quality management system,improve the quality of product development and optimize the r&d process.It provides reference ideas for improving quality management of medical device product development.