In-depth interpretation | "14th Five-Year" Medical Equipment Industry Development Plan

2024-06-13 13:13

Recently, 10 departments including the Ministry of Industry and Information Technology, the National Health Commission, the National Development and Reform Commission, the Ministry of Science and Technology, the Ministry of Finance, the State-owned Assets Supervision and Administration Commission of the State Council, the State Administration for Market Regulation, the National Medical Insurance Administration, the National Administration of Traditional Chinese Medicine, and the National Medical Products Administration jointly issued the "14th Five-Year" Medical Equipment Industry Development Plan. This is the first plan for the national level to promote the development of the medical equipment industry, and it also marks the opening of a new stage of systematic development of the medical equipment industry in China.


Opportunities and challenges coexist


During the "13th Five-Year" period, China's medical equipment industry achieved rapid development, with the market size increasing from 480 billion yuan in 2015 to 840 billion yuan in 2020, with an average annual compound growth rate of 11.8%; a product system of more than 1,100 categories in 22 categories has been formed, covering all aspects of health. "Basically meet the needs of Chinese medical institutions for diagnosis and treatment, elderly care, chronic disease prevention and control, and emergency rescue." Wang Weiming, director of the First Department of the Ministry of Industry and Information Technology, said that during the "14th Five-Year" period, the development of China's medical equipment industry faces both major opportunities and major challenges. On the one hand, the in-depth advancement of the new round of scientific and technological revolution and industrial transformation, and the提速 of the integration of manufacturing and the new generation of information technology, bring new opportunities for the development of medical equipment. At the same time, the global "big health" and "big health" industries are developing rapidly, and the development space of the medical equipment industry is huge. On the other hand, the COVID-19 epidemic has accelerated the regionalization and localization adjustments of the global industrial chain and supply chain, and the competition for the medical equipment competition highland among developed countries is becoming increasingly fierce, and the resistance and competitive pressure faced by China's medical equipment to move towards the middle and high ends of the industrial chain and value chain have significantly increased.


"At the current stage, it is very timely and necessary for multiple departments to jointly formulate the medical equipment industry development plan." Mao Quan'an, director of the Department of Planning, Development and Information of the National Health Commission, pointed out that the "14th Five-Year Plan for National Economic and Social Development and the Long-Range Objectives Through the Year 2035" clearly states the need to develop high-end medical equipment and promote the innovative development of the medical equipment industry. Promoting the development and application of medical equipment is not only an important task for the comprehensive promotion of healthy China during the "14th Five-Year" period, but also an important content of the in-depth implementation of the strategy of building a strong country in manufacturing. The next step is to conscientiously implement the various target tasks identified in the "Plan", seize historical opportunities, aim at the forefront trends, adhere to integrated innovation, accelerate the high-quality development of medical equipment, and provide a strong guarantee for the safety and health of the people.


"The sudden outbreak of the COVID-19 epidemic has sounded the alarm for the development of the medical equipment industry in China and even the world, exposing the lack of preparedness for the emergency support of the medical equipment industry in China and the lack of an industry emergency support mechanism." Li Zhiyong, secretary-general of the China Medical Equipment Association, said that regarding how to further improve the global epidemic prevention and control and treatment capabilities and the ability to provide emergency medical rescue for major natural disasters, the "Plan" has deployed this in key tasks and special actions. The "Plan" makes it clear that it is necessary to strengthen the capacity building of epidemic prediction and early warning, emergency inspection and testing, disease prevention and control, emergency medical rescue, and medical equipment emergency mobilization to ensure medical equipment support for major public health emergencies and other emergency needs. For example, it is necessary to carry out research on complete sets of rapid detection equipment for infectious diseases and large-scale epidemic prevention and control emergency equipment and solutions to improve the level of source of infection identification and transmission route interruption.


In the opinion of Huang Jin, the executive vice president of West China Hospital, the "Plan" is very meaningful. He said that the development of the medical equipment industry is a systematic project that covers all aspects of work. And this document integrates various parts and is a programmatic guideline, which enables government agencies, industry organizations, production enterprises, medical institutions, etc. to unify their thinking, perform their duties, and work towards one direction. "The biggest advantage is that we can look at the issue of the development of the medical device industry systematically, and at the same time, the document also puts forward work requirements for various business units involved in promoting the development of equipment, points out the direction of work, and gives everyone confidence in development."


The application scenarios are basically in medical institutions


The seven key areas emphasized in the "Plan", namely, diagnostic and testing equipment, therapeutic equipment, monitoring and life support equipment, traditional Chinese medicine diagnosis and treatment equipment, maternal and child health equipment, health and rehabilitation equipment, and有源 implantable and interventional devices, basically cover the needs of the whole population for full-process, full-life-cycle medical and health service equipment from prevention, diagnosis, and treatment to recovery, care, and maintenance, while the application scenarios that meet these needs are basically in medical institutions.


Huang Jin said that the "Plan" makes it clear that the hospital is the most important application scenario for medical equipment, and also makes the work and responsibilities of the hospital clearer. For example, how to quickly get the developed equipment into the clinic and carry out corresponding clinical trials. Medical institutions, especially national medical centers, should actively promote the application demonstration of high-end innovative medical equipment, establish application demonstration bases, and provide platforms for the improvement, publicity and promotion of new technologies and products. In the process of using, if problems and deficiencies of medical equipment are found, and the final product is guaranteed to be safe, it can effectively provide clinical services.


"Through demonstrations, people can know where the equipment is suitable for use, what kind of and what level of clinical problems it can solve, and how to solve them." Huang Jin believes that through demonstrations, the application scenarios of medical equipment can be better identified, so that these products can better, faster, and more safely serve the clinic.


Data shows that the number of medical equipment pieces above 10,000 yuan in medical institutions in China increased from 2.82 million pieces in 2010 to 9.2 million pieces in 2020, with an average annual growth rate of 12.6%, and the total value of equipment above 10,000 yuan reached 1.5634 trillion yuan, compared with an average annual growth of 15.1% in 2010. The number of equipment pieces above 1 million yuan increased from 51,000 pieces in 2010 to 258,000 pieces in 2020, with an average annual growth rate of 17.6%.


It can be seen from the "Plan" that it focuses on the close collaboration and mutual promotion of the development of medical equipment and medical service models, and increases the cultivation of "medicine + X" compound high-level medical talents and skilled talents, vigorously develops "5G + medical health", and promotes remote medical care. The comprehensive development of new formats such as mobile medical care, smart medical care, precision medical care, and traditional Chinese medicine characteristic medical care. In recent years, the Ministry of Industry and Information Technology and the National Health Commission have successively organized more than 10 types of medical equipment such as orthopedic surgical robots and PET/CT to carry out clinical demonstration applications, and have received responses from more than 300 third-class A medical institutions.


In strengthening the collaboration between medicine and engineering, the "Plan" has devoted a lot of ink, proposing to build a platform for cooperation between medical enterprises, and improve the innovation system of "technical innovation-product development-clinical evaluation-demonstration application-feedback improvement-level improvement-radiation promotion" for medical equipment products, to rapidly enhance the supply capacity of safe, effective, advanced and high-quality medical equipment products. For example, focusing on the construction needs of national medical centers such as cardiology, respiratory, oncology, trauma, and pediatrics, support medical institutions, scientific research institutions, and production enterprises to form a research team to strengthen the basic frontier research of medical equipment, break through a number of disruptive and original technologies, and develop a number of medical equipment that meet the needs of medical teaching, clinical research, and scientific research, leading the transformation of medical models.


"For medical institutions, especially the construction units of national medical centers, it is the responsibility to promote the integration of medicine and engineering and innovation." Huang Jin said that both Sichuan University and West China Hospital attach great importance to the collaboration between medicine and engineering, and have established the "three centers and one platform" of the collaboration between medicine and engineering, namely, the medical + manufacturing center, the medical + information center, the medical + material center, and the 5G application innovation and transformation platform. "In fact, the core of these efforts is to be guided by clinical needs, effectively combine medicine and engineering, and quickly achieve marketization. At present, we have done some work in the collaboration between medicine and engineering, and in the next step, we will further refine the direction and focus in combination with the content of the "Plan" and accelerate the promotion."


The "Plan" specifically points out that the development of medical equipment should balance development and safety, adhere to the basic principle of safety first, regard safety production and product quality as the lifeline of development, and use various safety technologies to enhance the product's safety protection capabilities and information data security protection capabilities, and筑牢 the barriers and dams for risk prevention. 




Help the innovative development of new medical equipment


At present, the demand for remote medical care and smart medical care is increasing day by day. Under the new situation of the rapid development of medical service models, it is very urgent to promote the innovative development and application of new medical equipment.


Qi Guixin, a first-class巡视员 at the Department of Planning, Development and Information of the National Health Commission, said that in recent years, the National Health Commission and other departments have guided industry associations to select seven batches of a total of 73 categories of medical equipment product catalogues, and累计 more than 1,600 excellent medical equipment have entered the catalogues, and have carried out 5G + medical health, remote medical care, and other pilot demonstrations. In particular, the "big test" of the COVID-19 epidemic has further highlighted the importance of the construction of the public health system. As an important part and support of the construction of the public health system, medical equipment has made important contributions to ensuring the major strategic achievements of epidemic prevention and control, and the innovative development of medical equipment has also ushered in new opportunities.


"China's medical equipment industry is still in the 'catch-up stage' overall, especially for high-end medical devices, the technical foundation is relatively weak, and the rate of scientific and technological achievements conversion is low. Some enterprises lack core technologies with independent intellectual property rights." Hou Yan, vice chairperson of the China Medical Equipment Association, said that in the new development pattern of the "dual circulation", it is recommended to promote the deep integration of industry, academia, research and application. Build an information gathering and exchange platform to form a whole chain of services such as the invention and creation of medical equipment technology, intellectual property assessment, application, transformation, and protection, stimulate the enthusiasm of clinical medical staff to participate in medical equipment innovation, and inspire the innovation group, production enterprises, universities and research institutes, investment and financing institutions, intellectual property service institutions, etc. to carry out collaborative application and transformation of intellectual property, and form deep and extensive integration of medicine and engineering.


Hou Yan hopes to support enterprises to work with medical and health institutions to jointly tackle key problems, and build application demonstration centers by medical enterprises to carry out verification of reliability, effectiveness, etc., and form a virtuous cycle of "application evaluation-feedback improvement-level improvement-radiation promotion"; strengthen the collaboration of enterprises, and through project support and organizing enterprises to jointly carry out R & D of generic technologies and core components, improve the independent innovation ability of the industry.


Qi Guixin pointed out that the "Plan" incorporates the innovative and integrated development of medical equipment into the key tasks. For example, support deep cooperation among medical institutions, scientific research institutions, and production enterprises, benchmarking against international advanced levels, strengthening the collaborative development of medicine and engineering, conducting innovative research on the clinical application of medical equipment, improving the performance and quality level of medical equipment, and accelerating the promotion and application of innovative products. At the same time, the "Plan" proposes to accelerate the development of intelligent medical equipment; encourage industry enterprises to focus on the needs of smart hospital construction, accelerate the development of medical robots such as hospital guide, outpatient screening, throat swab collection, blood drawing, auxiliary testing, and intelligent contactless scanning, and focus on the development of internationally leading original intelligent medical equipment.


"Population aging will be the basic national condition of China for a relatively long period of time in the future. However, currently, the types of medical equipment products suitable for the needs of the elderly are not rich enough, and medical and health services are not yet convenient and diverse enough." Qi Guixin introduced that the "Plan" has made key deployments in this regard. For example, it is clearly stated that new types of medical equipment at the community level such as home and community should be developed.


The "Plan" proposes to strive to achieve by 2025 that the foundation of the medical equipment industry is highly advanced, the modernization level of the industrial chain is significantly improved, the mainstream medical equipment basically realizes effective supply, the performance and quality level of high-end medical equipment products are significantly improved, and the initial formation of a comprehensive support capability for public health and medical and health needs.


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