Characteristic And Ploicy Analysis For Technological Innovation In Medical Devices Industry

Medical devices industry is a special newly risen and rapidly growing high-tech industry, in which technology innovation provides essential motivation to impulse the sustainable development. However, presently high-tech medical devices market is mainly monopolized by a few foreign countries. Along with the continuing development of our national economy, population growth, aging, the expansion of rural pharmaceutical markets and the improvement of people's standard of living, our medical devices market has great potential for development. How to impel the technology innovation in our medical devices industry, promote development of the industry, seize market opportunities and meet the people's increasing demand for health is becoming a matter of great concern..This paper started from the analysis of the characteristics of the medical devices industry innovation, which needs high input and long R&D cycle, depends strongly on intellectual property rights and has high requirements of effectiveness and safety and broad impact on society. Then we relied on the innovation process of the industry, divided it into two stages of before and after listing and found the relevant policies which played an important role at various stages of the innovation. Financial policy mainly provides support for the R & D investment. Medical devices regulatory policy not only guarantees the quality of the products and shorten the R&D cycle by improving the registration system of examination, but also further improves the corresponding supervision and management measures after the products are listed and hence ensures the safety and effectiveness use of the products. Intellectual property protection policy protects the innovation enthusiasm of the medical devices manufacturing enterprises and brings corresponding high income for innovators' high input. We also analyzed these policies and excavated the problems existing in the fiscal policy, medical devices regulatory policy and intellectual property protection policy in the technological innovation of the industry, and gave the following several aspects of the suggestions for improvement:I. Increase the input intensity of the fiscal policy; enhance the use efficiency of funds and improve the fiscal management system for science and technology; develop special financial support policy for the technological innovation of the medical devices industry.II. Medical devices regulatory policy carries out complete and unified management for the medical devices and all products are managed by the State Department of Drug Administration; no longer set individual production enterprises permit and enterprises operate the medical devices production preparations according to the industry business licenseIII.Intellectual property protection policy changes the scientific and technological achievements evaluation system of the medical devices products as soon as possible, and intensifies efforts to enforce the protection of intellectual property rights.This paper has innovated from the following aspects:I. summarize the technical innovation characteristics of the medical devices industry;II. Analyze the policy support of technical innovation in view of the characteristic of the industry rather than the general analysis in the past;III.Research the whole process of the technical innovation of medical devices industry and analyze the policy and give proposals. We use sample survey methodology to study the technology innovation situation of the medical devices industry in Zhejiang province, and obtain the first-hand data and information by giving the questionnaire to medical devices manufacturing enterprises throughout the province through the honorary director of the Pharmaceutical Supervision Bureau and the Economic Commission of the city and the medical devices industry associations.