Technological innovation in medical devices is not only an important part of the national technological innovation system, but also the key energy and support for promoting the construction of a healthy China. The intellectual property represented by patents is the accumulation and embodiment of technological innovation. Through patent analysis, the technical status of relevant fields can be mastered, and the frontier technologies can be followed so as to provide reference for industrial development, technological promotion and product development. The characteristics and trends of patent development and technological innovation are revealed by analyzing the present situation of patents in the field of medical devices, and the suggestions on the solutions for existing problems are put forward.
A large number of patents but insufficient transformation of technological achievements
Patents are one of the indicators that measure national technological innovation and progress and they are also the most important manifestation of scientific research activities. With the ceaseless improvement of comprehensive national strength, China has been increasing the investment in the technological development, and the overall research strength of China's medical device industry is also improved ceaselessly. In recent years, technological innovation in the field of medical devices in China mainly has the following characteristics:
First, technological innovation is highly active, but the original innovation capacity is insufficient. From 2008 to 2017, about 1.99 million patents of medical devices are applied for around the world, and over 610,000 patents of medical devices are applied for in China (the data from 2008 to 2017 are retrieved from the incoPat technological innovation platform). China had 27,646 patents (accounting for 16.57% of total global patents that year) in 2008 and 66,976 patents (accounting for 50.30% of total global patents that year) in 2017. Compared with patents applied for in other countries, it is shown that the application for medical device patents remains highly active, and China has had an advantage in the number of patents since 2009, more than that of the US and Japan. The increase in the applications for patents means the ceaseless improvement in innovative vitality.
Applications for patents in the field of medical devices have been increasing rapidly, but overall original innovation capacity is insufficient in China. How to further improve patent quality on the basis of keeping the growth of patents is still an important topic in the field of medical devices.
Second, the subjects of patent achievements are diversified, but the dominant position of enterprises is weak. In terms of patent applicants, top ten patent applicants worldwide are large enterprises, but patent applicants in China are diversified, including colleges, universities and enterprises (especially foreign-owned enterprises). It can be seen that the innovative development and technologies in medical devices in China mainly depends on colleges and universities, different from such an international development model that enterprises are deemed as subjects of innovation. Currently, the number of enterprises with strong patent innovation capacity is not large in China and their overall level is still medium or slightly lower, so the situation of technological innovation is not optimistic. Due to the late start of medical devices and immature overall development, China is still in the early stage of the transition from imitation and tracking to independent innovation, and it faces many problems, including weak overall innovation capacity of the industry, low industrial concentration, many small medical device enterprises and the dependence of the competition on resource advantages instead of technical advantages. The improvement in independent innovation capacity of Chinese medical device enterprises has a profound impact on the further development of the whole industry.
Third, patent transfers increase, but the overall transfer benefit is not high. Since 2008, patent transfers in China have been increasing, and, especially after 2014, patent transfers have increasing rapidly. Totally 57,122 patents were transferred in 2015. In terms of transferors, the patentees who transfer their patents are mainly enterprises, followed by individuals and research institutes. However, according to the patent transfer rate between the patent transfers and the patent applications in the same year, the patent utilization rate is still low in China, and many patents haven't transformed into actual productivity.
As a systematic project, the R&D of medical devices follows the law of "basic research - invention patent - applied research - industrialization - commercial profits - basic research". The subjects of innovation and development of medical devices mainly include research institutes, colleges, universities and enterprises. Research institutes carry out scientific research based on interests and hot spots, colleges and universities carry out teaching according to the teaching program, and enterprises produce products according to market value. At present, the three parties need to improve innovation cooperation, technology integration and other aspects. Only the cooperation among the three parties can effectively drive the technological innovation in the field of medical devices, achieve the sharing of resources and technologies, promote the new breakthroughs in medical device technologies and create new value.
Focus on four innovations to take the road with Chinese characteristics
According to the analysis above, the writer suggests that the ways to improve the technological innovation in medical devices shall be explored for so as to further improve the independent innovation capacity and core competitiveness of Chinese medical devices.
Focus on institutional innovation to improve top-level overall planning mechanism
In recent years, competent Chinese departments have issued a series of laws, regulations and rules to standardize the supervision and management of medical devices, provide strong support in policy, capital, personnel, technology and other fields, and create a favorable policy environment for healthy and steady development of medical device industry. The medical device industry in China started relatively late, so top-level design shall be optimized and the regulatory system shall be improved. First, policies on science and technology are promulgated to mainly support innovation in domestic medical devices, prepare a list of key fields, do a good job in the top-level design of scientific and technological work and optimize the layout of technological innovation so as to carry out standardized management and scientific implementation of technological innovation in medical devices. Second, traditional concepts in supervision are broken through to achieve the transition of ideas from "giving priority to product safety and then considering the industrial development" to "carrying out regulation in the development process", intensify process management, and make a reasonable layout for the standardization of production environment of medical device enterprises, approval before product marketing, regulation after marketing, adverse event monitoring and recall etc. to meet the requirements for technological innovation in the new era.
Focus on method innovation to deepen the collaborative innovation mechanism
Not only government departments as leaders but also the research institutes, testing institutions and medical institutions as the backbone and main force should be fully brought into play, enterprises should be encouraged to actively participate in the technological research, and the collaborative innovation between governments, industry, universities, research sectors and application sectors should be strengthened to form a strong force for innovation. There exist many uncertainties at every stage from product development to application promotion. Research institutes are mainly involved in research on science and technology, enterprises mainly undertake the achievement transformation and industrialization, government departments are responsible for the approval before product marketing and the regulation after marketing, and medical institutions are the users of products. The linkage between all stages is particularly important.
Focus on team innovation to build an interconnected innovation network
For the implementation of the strategy of "healthy China", the building of scientific and technological team should be strengthened, and the trend of technological development should be accurately grasped. First, the technological innovation teams should be strengthened as medical devices are involved in such advanced technologies as precision machine, detection & sensing technology, biomedical engineering technology and information technology etc., and there is a serious shortage of creative and innovative talents in the field. Colleges and universities should focus on the cultivation of high-skilled compound talents. Second, the scientific and technological innovation abilities of the teams should be improved, so it is necessary to establish platforms for the cultivation of talents, create a favorable environment for technological innovation, build talent training bases that combines teaching, scientific research and production practice together, promote the mode of training talents for industry, universities, research sectors and application sectors. it is also necessary to improve the employment mechanism, combine major scientific & technological projects with talent gathering and training, and pay attention to the cultivation of scientific and technological talents in strategic emerging industries. Moreover, it is necessary to improve the incentive policies for talents and fully inspire the innovation enthusiasm of researchers.
Focus on model innovation to accelerate industrial development
The development goal is to improve the overall competitiveness of Chinese medical devices. It is an effective means for the goal to strengthen the transformation of technological achievements, especially the transfer and transformation of technological achievements. Thus, the new models of the transformation of technological achievements should be ceaselessly explored for to ensure the industrialization of technological achievements. First, technology transfer centers should be built, technological achievements transformation project databases and data service platforms should be established, the sharing and mining of technological achievements and the use of information resources should be achieved, and the smooth channels between technology providers and technology demanders should be ensured so that the strategy of independent innovation is market-oriented rather than policy-driven. Second, the investment in industrialization should be increased. The industrialization of technological achievements is a long process, including laboratory results, bench-scale test, pilot test, industrial demonstration, large-scale industrialization and commercial practice. For a long time, China mainly guides and invests in the early development in the field of medical devices, but invests little in the industrialization of technological achievements. It is difficult for small enterprises to independently undertake the capital and technological investment in the pilot test. It is suggested that the state should help enterprises complete the pilot test by building engineering platforms, introduce funds from investment organizations to solve the problem of insufficient funds for enterprises and carry out a special scientific & technological plan for industrialization to support the industrialization process of enterprises.
It is noteworthy that the number of patents cannot fully reflect scientific and technological innovation abilities, but it just measures regional core competitiveness or scientific and technological innovation ability to a certain extent. In recent years, in terms of Chinese medical devices, the total number of patents has been on the rise and the quality has been constantly improving. Great progress has been made in the field. Moreover, some breakthroughs have been made in the field of medium- and high-end medical devices, especially in some frontier and hot fields. Therefore, China will gradually lead the technological development of international medical devices and develop the industry with Chinese characteristics.
It is predictable that, driven by the strategy of innovation-driven development, China will ceaselessly strengthen collaborative innovation between governments, industries, universities, research sectors and application sectors, constantly improve innovation vitality and research strength, further enhance the international prospect in medical device research in China, and solve scientific and technological problems in disease control and health management to meet the people's growing demands for health.
Source: China Pharmaceutical News
A large number of patents but insufficient transformation of technological achievements
Patents are one of the indicators that measure national technological innovation and progress and they are also the most important manifestation of scientific research activities. With the ceaseless improvement of comprehensive national strength, China has been increasing the investment in the technological development, and the overall research strength of China's medical device industry is also improved ceaselessly. In recent years, technological innovation in the field of medical devices in China mainly has the following characteristics:
First, technological innovation is highly active, but the original innovation capacity is insufficient. From 2008 to 2017, about 1.99 million patents of medical devices are applied for around the world, and over 610,000 patents of medical devices are applied for in China (the data from 2008 to 2017 are retrieved from the incoPat technological innovation platform). China had 27,646 patents (accounting for 16.57% of total global patents that year) in 2008 and 66,976 patents (accounting for 50.30% of total global patents that year) in 2017. Compared with patents applied for in other countries, it is shown that the application for medical device patents remains highly active, and China has had an advantage in the number of patents since 2009, more than that of the US and Japan. The increase in the applications for patents means the ceaseless improvement in innovative vitality.
Applications for patents in the field of medical devices have been increasing rapidly, but overall original innovation capacity is insufficient in China. How to further improve patent quality on the basis of keeping the growth of patents is still an important topic in the field of medical devices.
Second, the subjects of patent achievements are diversified, but the dominant position of enterprises is weak. In terms of patent applicants, top ten patent applicants worldwide are large enterprises, but patent applicants in China are diversified, including colleges, universities and enterprises (especially foreign-owned enterprises). It can be seen that the innovative development and technologies in medical devices in China mainly depends on colleges and universities, different from such an international development model that enterprises are deemed as subjects of innovation. Currently, the number of enterprises with strong patent innovation capacity is not large in China and their overall level is still medium or slightly lower, so the situation of technological innovation is not optimistic. Due to the late start of medical devices and immature overall development, China is still in the early stage of the transition from imitation and tracking to independent innovation, and it faces many problems, including weak overall innovation capacity of the industry, low industrial concentration, many small medical device enterprises and the dependence of the competition on resource advantages instead of technical advantages. The improvement in independent innovation capacity of Chinese medical device enterprises has a profound impact on the further development of the whole industry.
Third, patent transfers increase, but the overall transfer benefit is not high. Since 2008, patent transfers in China have been increasing, and, especially after 2014, patent transfers have increasing rapidly. Totally 57,122 patents were transferred in 2015. In terms of transferors, the patentees who transfer their patents are mainly enterprises, followed by individuals and research institutes. However, according to the patent transfer rate between the patent transfers and the patent applications in the same year, the patent utilization rate is still low in China, and many patents haven't transformed into actual productivity.
As a systematic project, the R&D of medical devices follows the law of "basic research - invention patent - applied research - industrialization - commercial profits - basic research". The subjects of innovation and development of medical devices mainly include research institutes, colleges, universities and enterprises. Research institutes carry out scientific research based on interests and hot spots, colleges and universities carry out teaching according to the teaching program, and enterprises produce products according to market value. At present, the three parties need to improve innovation cooperation, technology integration and other aspects. Only the cooperation among the three parties can effectively drive the technological innovation in the field of medical devices, achieve the sharing of resources and technologies, promote the new breakthroughs in medical device technologies and create new value.
Focus on four innovations to take the road with Chinese characteristics
According to the analysis above, the writer suggests that the ways to improve the technological innovation in medical devices shall be explored for so as to further improve the independent innovation capacity and core competitiveness of Chinese medical devices.
Focus on institutional innovation to improve top-level overall planning mechanism
In recent years, competent Chinese departments have issued a series of laws, regulations and rules to standardize the supervision and management of medical devices, provide strong support in policy, capital, personnel, technology and other fields, and create a favorable policy environment for healthy and steady development of medical device industry. The medical device industry in China started relatively late, so top-level design shall be optimized and the regulatory system shall be improved. First, policies on science and technology are promulgated to mainly support innovation in domestic medical devices, prepare a list of key fields, do a good job in the top-level design of scientific and technological work and optimize the layout of technological innovation so as to carry out standardized management and scientific implementation of technological innovation in medical devices. Second, traditional concepts in supervision are broken through to achieve the transition of ideas from "giving priority to product safety and then considering the industrial development" to "carrying out regulation in the development process", intensify process management, and make a reasonable layout for the standardization of production environment of medical device enterprises, approval before product marketing, regulation after marketing, adverse event monitoring and recall etc. to meet the requirements for technological innovation in the new era.
Focus on method innovation to deepen the collaborative innovation mechanism
Not only government departments as leaders but also the research institutes, testing institutions and medical institutions as the backbone and main force should be fully brought into play, enterprises should be encouraged to actively participate in the technological research, and the collaborative innovation between governments, industry, universities, research sectors and application sectors should be strengthened to form a strong force for innovation. There exist many uncertainties at every stage from product development to application promotion. Research institutes are mainly involved in research on science and technology, enterprises mainly undertake the achievement transformation and industrialization, government departments are responsible for the approval before product marketing and the regulation after marketing, and medical institutions are the users of products. The linkage between all stages is particularly important.
Focus on team innovation to build an interconnected innovation network
For the implementation of the strategy of "healthy China", the building of scientific and technological team should be strengthened, and the trend of technological development should be accurately grasped. First, the technological innovation teams should be strengthened as medical devices are involved in such advanced technologies as precision machine, detection & sensing technology, biomedical engineering technology and information technology etc., and there is a serious shortage of creative and innovative talents in the field. Colleges and universities should focus on the cultivation of high-skilled compound talents. Second, the scientific and technological innovation abilities of the teams should be improved, so it is necessary to establish platforms for the cultivation of talents, create a favorable environment for technological innovation, build talent training bases that combines teaching, scientific research and production practice together, promote the mode of training talents for industry, universities, research sectors and application sectors. it is also necessary to improve the employment mechanism, combine major scientific & technological projects with talent gathering and training, and pay attention to the cultivation of scientific and technological talents in strategic emerging industries. Moreover, it is necessary to improve the incentive policies for talents and fully inspire the innovation enthusiasm of researchers.
Focus on model innovation to accelerate industrial development
The development goal is to improve the overall competitiveness of Chinese medical devices. It is an effective means for the goal to strengthen the transformation of technological achievements, especially the transfer and transformation of technological achievements. Thus, the new models of the transformation of technological achievements should be ceaselessly explored for to ensure the industrialization of technological achievements. First, technology transfer centers should be built, technological achievements transformation project databases and data service platforms should be established, the sharing and mining of technological achievements and the use of information resources should be achieved, and the smooth channels between technology providers and technology demanders should be ensured so that the strategy of independent innovation is market-oriented rather than policy-driven. Second, the investment in industrialization should be increased. The industrialization of technological achievements is a long process, including laboratory results, bench-scale test, pilot test, industrial demonstration, large-scale industrialization and commercial practice. For a long time, China mainly guides and invests in the early development in the field of medical devices, but invests little in the industrialization of technological achievements. It is difficult for small enterprises to independently undertake the capital and technological investment in the pilot test. It is suggested that the state should help enterprises complete the pilot test by building engineering platforms, introduce funds from investment organizations to solve the problem of insufficient funds for enterprises and carry out a special scientific & technological plan for industrialization to support the industrialization process of enterprises.
It is noteworthy that the number of patents cannot fully reflect scientific and technological innovation abilities, but it just measures regional core competitiveness or scientific and technological innovation ability to a certain extent. In recent years, in terms of Chinese medical devices, the total number of patents has been on the rise and the quality has been constantly improving. Great progress has been made in the field. Moreover, some breakthroughs have been made in the field of medium- and high-end medical devices, especially in some frontier and hot fields. Therefore, China will gradually lead the technological development of international medical devices and develop the industry with Chinese characteristics.
It is predictable that, driven by the strategy of innovation-driven development, China will ceaselessly strengthen collaborative innovation between governments, industries, universities, research sectors and application sectors, constantly improve innovation vitality and research strength, further enhance the international prospect in medical device research in China, and solve scientific and technological problems in disease control and health management to meet the people's growing demands for health.
Source: China Pharmaceutical News