Application Of Stage-gate In New Product Of Medical Devices

The lagging development level of domestic innovative drugs and medical devices has seriously restricted the development of the medical industry.With the development of bio-information technology,the intensive introduction of policy incentives and the strong demand for healthy life of the people,pharmaceutical and medical devices also ushered in the opportunity of rapid development.Thus,the enthusiasm for new product development is booming.How to standardize the product development process,avoid the failure of product development caused by process and regulation factors,and quickly push the product to the market has become an urgent problem to be solved.The author read a lot of books about project management theory,approach management,new product development process and innovation process framework: 7 principles of new product innovation,innovation management and new product development,and related laws and regulations of medical device industry.In view of the current situation of the development process of medical devices in the newly established K company,through finding out the problem points,researching and analyzing,using the method of gate management,combining with the special process requirements of medical devices products,specific solutions are put forward,the management system of the gate of medical devices is established,and the development of new medical devices is set to five stages and four thresholds.It is divided into 22 small steps,defines the tasks of different stages,clearly defines the responsibilities of the relevant functional departments,and strictly manages and controls the various thresholds.Each threshold is based on six criteria and specific evaluation indicators: strategic adaptability,product competitive advantage,technology/manufacturing feasibility,medical device safety/effectiveness,marketing,financial returns and so on.According to the requirements of medical device laws and regulations for product access,under this framework,how to shorten the product development cycle,establish cross-functional teams,cost control,risk control,quality control,so as to better seize market opportunities.According to the requirements of national standards,industry standards and GMP standards for medical devices,this paper cites the processes of quality system operation,clinical application,registration and declaration,administrative supervision,etc.How to develop safe and effective medical device products efficiently,to promote the products to the market more quickly and to benefit the patients better.Through the application research on the development of electronic blood pressure measuring instrument as the second kind of medical device,we find out a suitable development process of medical device products for K company.This process has certain reference significance for similar domestic enterprises of class II electronic medical devices.