Three levels of medical instrument R & D to improv

2022-08-02
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On April 26, the third stop of China International Medical Electronic Technology Conference (cmet2011) was grandly held in Beijing National Convention Center. Dr. wangxiaoqing, member of the expert committee of China Medical Device Industry Association, executive director of the medical instrument branch of China instrumentation society and director of Beijing Taijie magnetoelectric Research Institute, delivered a wonderful speech on the three levels of medical device research and development. The following is an excerpt of the speech:

three levels and concepts of medical device research and development

the application results of medical devices are different from general instruments. They are directly oriented to the human body, The final result depends on the doctor's knowledge, experience, operation level and other capabilities. Therefore, the development of medical devices needs to take medical technology as the core, and the development of medical device technology is a system level event, with equal emphasis on technology promotion and demand pull

the R & D of medical instruments is generally divided into three levels: the first is method, the second is engineering, and the third is clinical

method research and development: refers to the process of seeking a breakthrough in the working principle through new physical, chemical, biomedical and technical methods; Engineering R & D: refers to the implementation of the project and the application of new technologies, new materials and new processes on the basis of a certain defined principle. Therefore, the selection must be carefully handled and used, as well as technical improvement and innovation; Clinical research and development: refers to the exploration of applying medical instrument technology to clinic and expecting to obtain new and useful information. Clinical research and development specifically includes two aspects: one is to correspond medical information in the process of instrument application, and the other is that many clinics have participated in the research of methods

Method R & D belongs to applied basic research, with a relatively long cycle, and requires relevant scientific instruments such as basic functions and basic principles. It is a search for possibility and uncertainty; Engineering R & D belongs to the research of application realization process. It has a clear completion time. The processing equipment and related testing instruments that need to be implemented are the comprehensive optimization design of technology and have a clear expected goal; Clinical research and development can be divided into two categories: one is equipment application research and development, which is the basis of engineering research and development, which is relatively simple; the other is equipment function research and development, which is basic application research and development, which is uncertain

the difference between these three levels lies in: first, the R & D subject, which is a difficult time for battery enterprises. Method R & D reflects the strategic needs. Basic research has certain uncertainty, but basic application research has a clear direction, which reflects the national strategic needs. Engineering R & D reflects the interest demand, clinical R & D determines the final value, and its main body is doctors and hospitals. There are also some internal relations between them. The trend of gradual integration in the future is not only the integration at the technical level, but also the deeper integration; Advanced institutions are the guarantee. According to the conclusion of advanced economic institutionalism, institutions often promote technological progress more than technology; The R & D process is wavy

development law of products in three levels

the cycle of a product will go through infancy, growth, maturity and recession. In terms of patent level, first of all, the level of original patent is the highest. After reaching a certain level through a series of application breakthroughs, it will become lower and lower. In terms of the number of patents before the animal protection association has sued these companies, after reaching the peak, there are some junk patents in the later period. The economic benefits are paid in the early stage, and only in the late stage will there be benefits

industrialization process of new products

industrialization process of new products

each product has several overlapping levels. When a new concept comes out, it should be led by market demand and technology. For example, in the early stage of B-ultrasound development, many small manufacturers developed B-ultrasound, but now only Ge, Philips, Siemens and other giants are left to monopolize. When a product enters the mature stage, it should focus on function, performance, quality and appearance, and win the market by relying on cost and brand. In Europe and the United States, most of their products move from concept to brand, while Japan is famous for its advanced technology, which moves from brand to concept. So far, China still lacks brands. In the research and development of methods, there are two factors: necessity and contingency. Necessity refers to basic strength. The United States is not strong in basic strength, but it is an accidental collision of new methods in specific R & D achievements. Of course, there are fewer and fewer good things to get gold by chance, fewer and fewer personal heroes, and more and more tend to become a systematic device; Innovation needs system guarantee. When it is more and more difficult to find components, cooperative development and suppliers, it is a deeper reflection that our country's system in this regard is not very sound. The foreign system is often led by large enterprises, which provide their own equipment as a platform for clinical research and basic research and development. At present, China has not formed a system. It is conceivable that when domestic enterprises compete with a foreign system with patents, it is almost impossible to win the market

research and development status and innovation conditions at all levels in China

China has made rapid progress in engineering research and development, and the industrial chain has been increasingly improved. Some products are not inferior to foreign products in terms of quantity, but there is still a gap in quality. The unsound innovation chain is the fundamental reason for the lack of domestic innovation ability, while the development of basic and clinical R & D is restricted due to the lack of engineering R & D support

the improvement of China's innovation capability requires three conditions: first, mechanism guarantee, the integration between technologies, between technologies and needs, and between technologies and clinics; The second is the supporting platform, which can carry the process of verification, correction, revalidation and deliverables; The third is the professional talent training platform, where potential talents grow rapidly through the process of verification, revision, re verification and deliverable of achievements

current situation of medical instrument development at all levels

ge has proposed that GE is superior to other enterprises in industrial chain management, and industrial chain management can effectively reduce product costs. Unlike the medical device industry, it is a technology oriented industry relying on continuous innovation. In the whole innovation chain, it needs to go through the processes of creativity, engineering realization, industrialization, clinical application, marketization, service, etc. the process from creativity to engineering realization is the most challenging stage for enterprises, and many enterprises are struggling here. The clinical application is the most easily neglected stage, which is a part of the lack of macro-control and market regulation mechanism in China

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