The "Twelfth Five-Year Plan" is a crucial period for China to build a well-off society in an all-round way。 It is an important stage for improving independent innovation capability, cultivating strategic emerging industries, and building an innovative country。 It is also a crucial period for further deepening the reform of the medical and health system。 Dental medical equipment is an important foundation for the construction of medical and health systems. It has a high degree of strategic, driving and growth. Its strategic position has been universally recognized by all countries in the world and has become an important symbol of the country's scientific and technological progress and the level of national economic modernization.
In order to accelerate the development of the medical device industry, better meet the health needs of the broad masses of the people, support the construction of China's medical and health service system, and promote the smooth implementation of the medical and health system reform, in accordance with the National Medium- and Long-Term Science and Technology Development Plan (2006-2020) ")), "The 12th Five-Year Plan for National Economic and Social Development of the People's Republic of China", "Decision of the State Council on Accelerating the Cultivation and Development of Strategic Emerging Industries" and "The Central Committee of the Communist Party of China and the State Council on Deepening the Reform of the Medical and Health System" Opinions and other related requirements, special plans for the medical device technology industry "12th Five-Year Plan"。
I. Situation and needs
(1) The important foundation for the construction of medical and health systems
Medical equipment is the most important basic equipment in the construction of medical service system and public health system. In recent years, with the support of the state finance, the overall level of medical equipment in China has been greatly improved, but the overall pattern of low equipment allocation level in China's primary medical institutions has not changed, and there are still few functions, low performance, and poor use. Not applicable to other issues. Equipment in big cities, large hospitals, especially tertiary hospitals, has reached or is close to the equipment level of general hospitals in developed countries, but large and medium-sized medical equipment, high-end medical equipment and high-value medical materials are mainly imported. Expensive, it puts a heavy burden on the country and patients.
(2) Major needs for the development of medical diagnosis and treatment technology
The innovative development in the field of medical devices has revolutionized many problems that cannot be solved by previous medical treatment methods, and promoted the continuous improvement of disease diagnosis and treatment and medical services. At present, modern medicine accelerates the development of early detection, accurate quantitative diagnosis, micro-non-invasive treatment, individualized diagnosis and treatment, intelligent services, etc., and constantly puts forward new demands for the innovation and development of medical devices. In the process of transforming from disease-centered to health-centered medical model, the direction of health status identification and regulation, disease early warning, health management, and rehabilitation care for grassroots, family and individuals is becoming a new research hotspot. Innovative developments in the field of devices have created new demands.
(3) The frontier highland of technological innovation
Medical equipment is a typical high-tech industry。 It has the characteristics of high-tech application intensive, wide-ranging disciplines, and integrated technology integration。 It is a concentrated expression of the country's cutting-edge technology development level and technology integration application capability, and is the driving and leading multidisciplinary technology development。 The important engine。 At present, the technological innovation in the field of international medical devices is highly active, and the innovation of advanced technologies such as electronics, information, network, materials, manufacturing, and nanotechnology is increasingly infiltrating into the medical device field, and innovative products are constantly emerging. However, due to weak innovation capability, imperfect innovation system, and incomparable combination of production, education and research, there is a big gap between the development level of medical device technology in China and developed countries.
(4) Focus areas of industrial competition
In recent years, the global medical device industry has developed rapidly and trade has been active. The average growth rate has reached 7%, which is about twice the growth rate of the national economy in the same period. As the focus of global high-tech industry competition, the medical device industry is expanding its competition to technology, talents, management, services, capital, and standards. Compared with developed countries, China's medical device industry has a weak foundation, the industry chain is incomplete, the overall competitiveness is weak, and there is a certain gap between the comprehensive performance and reliability of basic products。 Some core key technologies have not yet been mastered and are at a disadvantage in industrial competition。
(V) Development focus of China's strategic emerging industries
In recent years, the average growth rate of China's medical device industry is around 25%, much higher than the average growth rate of the national economy in the same period. China has initially established a multi-disciplinary medical device research and development system。 The industrial development has begun to take shape, and some regions have shown a cluster development trend。 With the implementation of the new medical reform policy and the expansion of the domestic demand policy, especially the investment in the construction of the primary health system, the market prospect of China's medical device industry is very broad. In 2010, the research and development and industrialization of biomedical engineering products such as advanced medical equipment and medical materials were included in the development of China's strategic emerging industries. China's medical device industry ushered in an unprecedented important strategic development opportunity.
Second, guiding ideology and development principles
(1) Guiding ideology
Implementing the scientific development concept, implementing the "Decision of the State Council on Accelerating the Cultivation and Development of Strategic Emerging Industries" in accordance with the development priorities set by the National Medium- and Long-Term Plan for Science and Technology Development (2006-2020), closely surrounding the national health protection Demand and medical and health system reform needs, demand-oriented, enterprise-oriented, innovation-driven, integration as a means to coordinate the layout of projects, talents, bases, alliances, platforms and demonstrations, strengthen multidisciplinary cross-cutting, and vigorously promote Combining production, education and research, we actively explored the optimized organization model under the market mechanism, effectively promoted key technologies, core components and major product innovations in the medical device field, greatly improved the core competitiveness of the medical device industry, and effectively supported the construction of the medical and health service system.
(2) Development principles
Government promotion and market mechanisms are combined。 Highlight market demand, take enterprises as the mainstay, strengthen guiding technology investment support and organizational model optimization, and accelerate technological innovation, product development and industrial development. Focus on investment in basic research, common key technologies, core components and innovative development of major products.
System layout and key breakthroughs are combined。 System layout medical device innovation chain, product chain, industry chain and talent chain, overall optimization of innovation system and development environment; efforts to break through a number of common key technologies and core components that seriously restrict industrial development, focusing on the development of a number of configuration needs, market capacity Basic equipment and innovative products with outstanding clinical value.
The current urgent need and future development are combined. We will focus on the development of advanced and practical products that are urgently needed for the construction of grassroots health systems, as well as high-end medical devices that are essential for clinical diagnosis and treatment and that rely heavily on imports。 Grasp the development trend of cutting-edge technologies, strengthen technical reserves, and accelerate the development of innovative medical device products around early detection and early warning of diseases, precise/intelligent diagnosis, micro/non-invasive treatment, and adaptation to future medical model changes.
Innovation drive and demand pull combined。 Based on independent innovation, we will focus on breaking through a number of major technical bottlenecks, create a number of major products, change the situation of imitation, and make innovation truly an important driving force for industrial development; vigorously optimize the application environment and improve supporting policies to strengthen innovative products。 Demonstration application, actively expand the domestic demand market, and take the basic configuration, primary care and basic equipment as the traction to promote the rapid development of the medical device industry。
Based on domestic and international oriented. Coordinate domestic and international resources and two markets, strengthen international scientific and technological cooperation and open innovation, allocate R&D resources on a global scale, accelerate innovation breakthroughs in major products, actively explore international markets, and accelerate the promotion of Chinese manufacturing and innovative products in China. Globally, promote the international development of medical device products.
Third, development goals
(1) Overall goal
By 2015, the medical device R&D innovation chain will be initially established, and the medical device industry's technological innovation capability will be significantly improved; a number of common key technologies and core components will be broken, and a number of independent intellectual property rights, high performance, high quality, low cost and Mainly rely on imported basic medical device products to meet the needs of China's primary health care system construction and clinical routine diagnosis and treatment needs; further improve the policy environment for technological innovation and industrial development, cultivate a number of innovative brands, and greatly enhance industrial competitiveness, medical device technology industry Development achieves rapid leapfrogging。
(2) Specific targets
(1) Technical objectives: Break through 20-30 key technologies and core components, and form 200 core patents; make important breakthroughs in several frontier technology fields and form industrial advantages.
(2) Product goal: to create 50-80 clinically needed new preventive, diagnostic, therapeutic, rehabilitation and emergency medical device products, focusing on the development of large-scale, wide-ranging applications and basic equipment and medical materials that rely mainly on imports, and actively develop New medical device products such as chronic disease screening, minimally invasive diagnosis and treatment, regenerative restoration, digital medical treatment, and rehabilitation care.
(3) Industry target: Focus on supporting 10-15 large medical device enterprise groups, supporting 40-50 innovative high-tech enterprises, establishing 8-10 medical device technology industrial bases and 10 national-level innovative medical device product demonstration applications Base, improve the industrial chain, optimize the industrial structure, increase market share, and significantly enhance the international competitiveness of the medical device industry。
(4) Capability target: Greatly improve the ability of medical device innovation and industrialization in China, cultivate and introduce a group of academic leaders and innovation teams, establish 20-30 technology research and development platforms, and build 10 national engineering technology research centers and national key experiments. Room, improve China's medical device standards, testing and evaluation system, give play to the role of industrial technology innovation strategic alliance, promote the deep integration of production, education and research, and effectively protect the sustainable development of China's medical device industry.
(III) Indicator system
Table 1 Main indicators of the development of the "Twelfth Five-Year Plan"
Category serial number indicator attribute
Technology 1 core patent 200 binding
2 Focus on developing 50-80 basic equipment and new products
3 New 10 national engineering technology research centers and national key laboratories
4 Establish 8-10 national science and technology industry bases
5 Establish 20-30 technology research and development platforms
Economy 1 The value of new medical devices brought by scientific and technological progress and demonstration applications is 200 billion yuan, and the proportion of exports to the total international market has increased to more than 5%.
2 Forming 8-10 production value of more than 5 billion large medical device enterprise groups
Society 1 Basic medical device products have significantly improved the price/performance ratio, effectively meeting the expectations of primary care and routine medical treatment needs.
2 Establish 10 demonstration and application bases for innovative medical device products, and promote the application of 100,000 sets of innovative products.
Fourth, the development focus
(1) Basic research priorities
Study the biological effects of physical effects such as force, light, sound, electricity, magnetism, etc。, focusing on bioelectronics, biomechanics, biophotonics, bioacoustics, biomagnetism, especially molecules, cells, tissues, organs, systems , the study of the laws and mechanisms of the coupling between physics-chemistry-biology in different levels of life activities, and the modeling and simulation of different levels of life phenomena; studying the biological effects of different substances, focusing on biological materials and cellular tissues Interaction mechanisms, as well as studies of biological effects at different scales, especially at the nanoscale。
Strengthen new theories, new methods, new materials, and new technologies for basic research in medical devices; focus on new biomedical imaging, medical image processing, physiological signal acquisition, biochemistry, immunology and microbial detection, tissue repair and regeneration, medical nerves Basic research such as engineering。
(II) Key technology development priorities
To meet the needs of medical diagnosis and treatment, health services and industrial development, focusing on the development trend of digitalization, intelligence, automation, precision, no/minimum creation, low load, individualization, networking and synergy of medical devices, we will focus on the following technologies:
Principles and methods: make full use of the latest advances in basic medicine, biochemistry, information science, electronic science, materials science, high-energy physics, etc。, strengthen the application of new principles and methods, and focus on multimodal fusion imaging and biosensing。 , weak signal detection, neural interface and stimulation, high-energy particle and radiation therapy, high-throughput / micro / rapid in vitro detection, biomedical material modification and other technical research。
Design and manufacturing: make full use of the latest advances in advanced manufacturing, micro-nano technology, biomechanics, ergonomics, computer science, etc., focusing on precision transmission and control, precision machining and assembly, biomedical material modification, personalized design and Manufacturing and other technical research, focusing on breakthrough computer tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET), PET-CT, medical accelerators and other large-scale medical equipment and core components, miniature High-precision parts such as pump valves, micro-sensors, and micro-optical lenses, as well as technical bottlenecks in the design, preparation, and manufacturing of new medical materials such as interventional stents, artificial joints, and bone restorations.
Application Service: Make full use of the latest developments in information technology, bioinformatics, network communication, Internet of Things, cloud computing, etc., and actively promote the combination of medical imaging technology and surgical planning, radiation therapy, navigation and positioning, medical robots, etc. Develop new service technologies such as digital medical, mobile medical, and remote medical treatment.
1。 Major cutting-edge technology
Focus on breakthrough neural interface and stimulation, low-dose photon detection imaging, precise positioning and navigation, dynamic conformal intensity modulation, electrical impedance functional imaging, weak photoelectric signal detection, electrochemical/biochemical sensing, non-invasive physiological signal acquisition and parameter identification technology, Techniques for individualized design and manufacture of cell tissue-inducing materials and implants. Reserve development of multimodal fusion imaging, molecular imaging, terahertz (THz) wave detection, microfluidics and other cutting-edge technologies.
2。 Common key technologies
Focus on the development of digital medical, medical virtual reality, human-computer interaction design, biomedical materials processing and preparation, precision manufacturing, electromagnetic compatibility, reliability design and other common technologies. Actively promote research on supporting technologies closely related to the development and application of medical devices, including engineering physics technology, optical technology, wireless communication technology, mobile computing technology, Internet of things technology, and advanced manufacturing technology.
(III) Key directions for product development
During the "Twelfth Five-Year Plan" period, focusing on the prevention and treatment of major diseases and the needs of clinical diagnosis and treatment, we will focus on the development of a number of advanced practical products suitable for the grassroots and medium and high-end products that mainly rely on imports, actively develop innovative products that adapt to the transformation of medical models, and significantly enhance the medical device industry. Market competitiveness.
In the field of prevention, based on the development requirements of prevention, strategic advancement and downward shift of focus, we will focus on non-invasive detection products such as blood pressure, blood sugar, blood lipids and other physiological and biochemical indicators, as well as malignant tumors, cardiovascular and cerebrovascular diseases, and birth defects. Such as major disease screening products, actively develop low-load physiological parameter detection and monitoring equipment under different conditions, personal health indicators detection and functional status evaluation devices, mobile medical examination systems and other products to meet rural grassroots/community and individual/family prevention The need for medical devices.
In the field of diagnosis, the development trend of non-invasive, early, accurate, low-load, quantitative and other requirements for disease diagnosis, focusing on superconducting MRI, high-performance color ultrasound imager, high-resolution endoscope, multi-row spiral CT, PET, PET-CT, digital flat panel X-ray machine, low dose digital subtraction angiography (DSA) system, high performance immunoassay system, fully automatic high-throughput biochemical analyzer, high-performance five-class blood cell analyzer, automated microbial detection analyzer Such as key products, core components and new diagnostic reagents; actively develop new products such as biochips, on-site rapid detection instruments (POCT), elastic ultrasound imaging, etc., and strive to change the situation that China's high-end products rely on imported and domestic products with poor reliability and long-term tracking and counterfeiting.
In the field of treatment, according to the development trend of new therapeutic technologies such as micro/non-invasive treatment, precise treatment, and intelligent and personalized, the focus is on image navigation aid system, real-time conformal intensity-modulated radiation therapy system, hemodialysis system, nerve stimulator, High-intensity ultrasound focusing treatment system, high-frequency/laser surgical treatment equipment, radiofrequency ablation system, new interventional stent, artificial joint, bone repair material, artificial blood vessel, oral implant system and other key products; development of surgical robots, artificial heart assist devices, etc。 Products, effectively change the status quo of high-performance therapeutic products that are monopolized by foreign countries and have high treatment costs。
In the field of rehabilitation, based on the demand of "recovery for everyone" in China, according to the development trend of generalization, intelligence, individualization, etc., research on structural alternatives, functional compensation, skill training, environmental transformation and other technical products, and actively develop myoelectric And intelligent control such as nerve control, artificial cochlear and other intelligent assist / hearing aid / assistive aids, elderly behavioral training system, stroke patients and rehabilitation system for motor function patients, etc., accelerate intelligent, low cost The development of advanced rehabilitation aids to improve the penetration rate of rehabilitation equipment.
In the field of emergency rescue, we will develop emergency medical rescue chain equipment and systems such as casualty search, on-site first aid, transshipment and rescue, and hospital emergency around the different needs of disaster medical rescue, public health emergency, war wound treatment and primary medical emergency。 Intensive care system, defibrillator, life support ventilator, rapid hemostasis and blood transfusion equipment, etc。, to ensure the urban and rural emergency system, public health emergency system construction needs。
1。 Basic medical device products
Closely focus on the needs of primary medical care and routine medical treatment, focusing on the development of low-cost, high-performance, inclusive digital X-ray machines, color ultrasound imagers, biochemical analyzers, blood analyzers, microbiological analyzers, electrocardiographs, monitors, Vibrometers, respiratory/anesthesia machines, blood purification equipment, etc。, which are urgently needed for basic equipment, accelerate the breakthrough of spiral CT, MRI, PET-CT, endoscopy, medical accelerators, immunoassay systems and other high-end mainstream equipment that mainly rely on imports。 Commonly used high-value consumables such as vascular stents and artificial joints to promote universal application。
2. New medical device products
Closely focus on the needs of disease prevention, clinical diagnosis and treatment, health promotion, highlight new development directions such as fusion imaging, non-invasive detection, dynamic monitoring, minimally invasive treatment, precise treatment, and actively develop new medical imaging, no/minimally invasive dynamic physiological parameter detection And medical devices and systems for monitoring, molecular bioanalytical instruments, on-site rapid detection instruments (POCT), new minimally invasive treatments, intraoperative monitoring/positioning/navigation, medical and medical products, medical robots, new Chinese medicine, and digital medical, New products such as telemedicine and mobile medical care continue to improve the level of medical diagnosis and treatment and service capabilities.
V. The key task layout of the "12th Five-Year Plan"
During the "Twelfth Five-Year Plan" period, we will strive for technological breakthroughs, product innovation, capacity building and application popularization, and focus on the implementation of five basic tasks: basic equipment upgrade, high-end product breakthrough, frontier direction innovation, innovation capability enhancement and application demonstration project。
(1) Basic equipment upgrade
Closely combine the urgent needs of the construction of grassroots medical and health institutions and the upgrading of medical equipment allocation at county level, township, community, etc., and focus on supporting a group of medical equipment products suitable for grassroots, high reliability, low cost, advanced and practical, and improve the equipment level of primary medical institutions. And service support capabilities.
Focus on the development of basic X-ray machines, color ultrasound imagers, immunoassays, blood analyzers, biochemical analyzers, electrocardiographs, multi-parameter monitors, defibrillators, respiratory/anesthesia machines, blood purification equipment and other basic equipment , consumables and application solutions to improve product reliability, safety, ease of use, reduce costs, meet the basic equipment needs of primary health care institutions; accelerate the screening of chronic diseases at the grassroots level, general medical care, health management, Chinese medicine treatment, Development of new products such as rehabilitation care and home care, as well as application technologies such as digital medical, mobile medical, and telemedicine.
(2) Breakthrough in high-end products
Efforts will be made to break through the bottlenecks of high-end equipment and localization of core components, and achieve independent manufacturing of high-end mainstream equipment, core components and medical high-value materials, break import monopoly, reduce medical expenses, and improve industrial competitiveness.
Focus on the development of 64-row spiral CT, 1.5/3.0T superconducting MRI, PET-CT, real-time three-dimensional color ultrasound imager, high-definition endoscopy and other high-end imaging equipment; development of automatic tubular chemiluminescence immunoassay system, fully automatic Qualcomm In vitro diagnostic systems and reagents such as biochemical analyzers; advanced imaging equipment such as image navigation assisted therapy systems, real-time conformal intensity modulated radiation therapy systems, and neuroelectric stimulators; development of interventional stents, artificial joints, artificial blood vessels, bone repair materials, and High value medical materials such as oral materials. Focus on breakthrough core components such as superconducting magnets, multi-channel magnetic resonance spectrometers, high-resolution PET detectors, large heat capacity CT tubes, X-ray flat panel detectors, ultrasonic transducers, as well as precise positioning and navigation technology, weak signal detection Key technologies such as technology, electrochemical/biochemical sensing technology, and regenerative repair materials technology。
(3) Innovation in the frontier direction
Strengthen research on new principles, new materials, new methods and new processes, accelerate cutting-edge technological breakthroughs and innovative product development, and seize the commanding heights of future technological industry competition.
Actively develop multimodal fusion imaging, molecular imaging, terahertz wave detection, low-dose photon detection imaging, electrical impedance functional imaging, in vivo optical coherence imaging, ultrasound focusing therapy, neural interface and stimulation, weak physiological signal acquisition, microfluidics and Leading edge technologies such as micro-nano manufacturing; accelerate the development of cutting-edge innovative products such as precision surgical robots, carbon nanotube CT, non-invasive blood glucose, fully degradable vascular stents, tissue-inducing biomaterials, central nervous regenerative repair materials, and new Chinese medicine diagnostic equipment。 Actively promote the development and application of new service technologies such as human health perception, management and promotion combined with human sensor networks, cloud computing and Internet of Things.
(4) Improvement of innovation capability
Coordinate planning projects, talents, alliances, platforms, and bases, vigorously strengthen systems, mechanisms, and management innovations, effectively integrate superior scientific and technological resources through various forms such as industry-university research and technology innovation alliances, systematically build a national medical device innovation system, and greatly enhance China's The independent innovation capability of the medical device industry。
First, focus on cultivating and introducing a group of leading scientists, academic leaders, senior engineering and technical personnel, and young and middle-aged experts with world-leading levels. The second is to strengthen the construction of strategic alliances for industrial technology innovation, and establish and improve research and development alliances for major products and core components。 The third is to strengthen the construction of a common technology platform for medical devices, focusing on the construction of 20-30 technology research and development platforms for medical electronics, medical imaging, physical therapy, in vitro diagnostics, medical materials, personalized design and manufacturing, and reliability assurance, and 10 national engineering projects. The Technical Research Center and the State Key Laboratory will strengthen the construction of the medical device strategy research system. The fourth is to strengthen the construction of regional innovation and industrialization bases, and focus on the construction of 8-10 national science and technology industrial bases.
(5) Application demonstration project
With the tenet of "Innovative Development, Benefiting People's Livelihood", the "Innovative Medical Device Product Application Demonstration Project" and "Digital Medical Demonstration Project" will be implemented to accelerate the application and promotion of innovative medical device products, optimize medical resource allocation, and make scientific and technological innovations better. Serve the construction of the health care system and benefit the broad masses of the people.
The first is to implement the demonstration project of innovative medical device products application. Select a batch of innovative medical device products, popularize and promote on the basis of scientific evaluation, vigorously optimize the application environment of innovative medical device products, create a platform for demonstration application and popularization of innovative medical device products, and realize the joint development of innovation drive and demand pull. The second is to implement a digital medical demonstration project. To build a large number of large-scale digital hospitals and regional medical service collaborative demonstration projects in large comprehensive hospitals, specialist hospitals and different regions, improve the medical treatment level and service capacity of medical institutions, and promote medical information sharing, collaborative medical care and integration services among different medical institutions. .
Sixth, safeguard measures
(1) Strengthening innovation and guidance
Taking enterprises as the mainstay, increasing national science and technology guidance investment, coordinating multi-channel resources, and combining various funding models; strengthening departmental unity, military-civilian integration, and encouraging international cooperation; promoting the construction of industry-university research-medicine alliances, promoting interdisciplinary, technological integration and resources Integration; increase innovation talents, innovation team cultivation and talent introduction.
(2) Improve policy measures
Strengthen multi-sector coordination, improve medical equipment clinical trials, registration, supervision, pricing, fees, medical insurance, configuration, procurement, standards and other related policies and regulations, strengthen intellectual property protection, and support the development of innovative medical device products.
(3) Optimizing the industrial environment
Improve the application environment of innovative products, corporate financing environment, promote enterprise innovation; promote mergers and acquisitions, optimize industrial structure, improve industrial chain; strengthen regional development, strengthen park construction, promote industrial agglomeration development; optimize trade policy and expand international market share。
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