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Digital diagnostic equipment development may jump
Recently, domestic digital diagnostic equipment has ushered in a major positive policy - the Ministry of Science and Technology has issued the "Digital Diagnostic Equipment Key Special Implementation Plan (Draft for Comment)" (hereinafter referred to as "the Program"), for the domestic digital diagnosis and treatment equipment for the next 5 years. Development goals and major tasks are deployed. Once implemented, the "Program" will vigorously promote the development of domestic digital diagnostic equipment, and greatly enhance the technological level and market competitiveness of digital diagnostic equipment in China.
The state attaches great importance
"Digital diagnosis and treatment equipment is the most important basic equipment in the construction of medical service system and public health system. It is an important support for leading the development of medical diagnosis and treatment technology to early diagnosis, accurate diagnosis, minimally invasive treatment and precise treatment. It is also a new round of healthy economy. The core engine of development has a high degree of strategic, driving and growth." The staff of the Department of Social Development Science and Technology of the Ministry of Science and Technology said that the research and development and industrialization of digital medical equipment have been highly valued by the Party Central Committee and the State Council. In order to further improve the scientific and technological level and market competitiveness of digital diagnostic equipment in China, according to the overall requirements of the State Council's "Proposal on Deepening the Management Reform of the Central Financial Science and Technology Plan (Special, Fund, etc.)", the Ministry of Science and Technology, together with relevant departments, launched the national key R&D plan. The key special pilot project of digital diagnosis and treatment equipment. At present, the key special items of “Digital Diagnostic Equipment†have entered the stage of preparation of the implementation plan. The implementation plan mainly includes the importance of key special implementation, development trends, existing foundations, overall goals, and main tasks.
According to the "Program", according to the clinical needs of disease prevention and treatment in China and the actual needs of the development of the medical device industry, on the basis of the preliminary work deployment, the Ministry of Science and Technology will work with the Health and Family Planning Commission, the Ministry of Industry and Information Technology, the Food and Drug Administration, and the General Administration. The Ministry of Health and other departments jointly proposed the key research and development plan for “Digital Diagnostic Equipment R&Dâ€, and through scientific and technological innovation, upgraded the independent research and development technology level of China's medical device industry, promoted industrial transformation and upgrading, and fostered new economic growth points.
Narrowing the gap with developed countries
In recent years, international technological innovation in the field of digital diagnosis and treatment equipment has been highly active, innovative products are constantly emerging, and the scale of the industry is expanding. It is gradually showing “small size, integration, and networking; integration of multi-source diagnostic information; early diagnosis and physiology And new features such as functional evaluation, integration of diagnosis and treatment; minimally invasive, interventional, and precise treatment integration.
It is understood that in recent years, the average growth rate of digital medical equipment in China is above 20%.
Industry insiders pointed out that at present, a number of major products such as digital flat panel X-ray machine, 64-row CT, high-end color ultrasound, 1.5T magnetic resonance imaging system, PET-CT, implantable rechargeable bilateral brain pacemaker have successfully broken foreign countries. The monopoly has achieved localization, and a number of cutting-edge technologies have made breakthroughs. The industrial fields such as medical imaging have shown a trend of accelerating the evolution to the high-end of the value chain. The competitiveness of science and technology and industry in the medical device field in China has significantly improved. However, judging from the comprehensive strength of the overall development of the industry, due to the lack of technological innovation capability, the combination of production, education and research is not tight, the innovation chain and industrial chain are incomplete, the policy measures are not matched, and the application environment is imperfect. Medical devices, especially advanced digital diagnostic equipment, rely mainly on imports, and national health protection is subject to people.
The United States, Japan, and some European countries have long been leading the way in the technology and industry of digital diagnostic equipment. Compared with developed countries, there is still a big gap in China. The main performance is that some core components are mainly dependent on imports. The functional properties of the products can not effectively meet the clinical needs. There is still a gap between the stability and reliability of the products. Insufficient recognition of domestically produced equipment, etc., it is not necessary to adopt a full chain design and integrated implementation, and provide strong technical support for solving the above problems through the implementation of relevant scientific and technological plans.
“The medical device industry has become one of the industries that measure a country's level of science and technology and industrial manufacturing. Digital medical equipment is the core product of the medical device industry, which can best reflect the technological level of a country's medical device industry. Reduce the gap with developed countries. The key is to vigorously promote the development of domestic digital diagnostic equipment," said a staff member of the China Medical Device Industry Association.
Four tasks outline the development blueprint
The "Proposal" proposes to seize the opportunity of a new round of scientific and technological revolution in the health field, promote the development of "digital, network, and intelligent" medical equipment industry, strengthen core components and key technologies, and break through a number of leading-edge technologies. Promote the improvement of testing technology, standard system construction, application solutions, demonstration application evaluation, etc., and accelerate the localization and innovation transformation of China's medical device field. According to the overall idea of ​​the whole chain layout and integrated implementation, it is specifically decomposed into four tasks: major equipment R&D, cutting-edge and common technology innovation, application solution research, application demonstration and evaluation research.
- Major equipment research and development. Focusing on medical imaging diagnosis and advanced treatment products with outstanding import dependence, focusing on multimodal molecular imaging, new magnetic resonance imaging system, new computed tomography, low-dose X-ray imaging, new generation ultrasound imaging, and composite endoscopy 10 new strategic products, new microscopic imaging, large-scale radiotherapy equipment, surgical robots, and medical active implantable devices. Focus on solving the bottleneck problem that core components are subject to industrial development and market competition. Accelerate the product development and industrialization of major products such as surgical robots, new microscopic imaging, proton/heavy ion radiotherapy, which have accumulated certain technologies.
- Frontier and common technological innovation. In the frontier technology, we focus on new imaging frontier technology, advanced treatment frontier technology, and research and development of cutting-edge technology. In terms of common technology, we will focus on the quality and safety testing, evaluation and control technology and normative research of digital diagnostic equipment, and the development of its special inspection and testing equipment; engineering technology, and accelerated verification method of reliability; biological effects evaluation and Long-term biocompatibility and safety rapid evaluation studies.
- Application solution research. In the integration research of new medical treatment technology solutions, a number of innovative medical device clinical application research centers have been established to integrate and develop integrated solutions for major diseases, and the system has strengthened research on equipment configuration standards, clinical application specifications, diagnosis and treatment paths, and training tools. In the research and development of new service model solutions, the focus is on medical imaging cloud services, radiotherapy planning system cloud services, surgical planning cloud services and other technical application specifications, public platforms and solutions.
- Application demonstration and evaluation research. In the application demonstration and evaluation of the top three hospitals for innovative medical equipment, we have established a number of clinical application demonstration and training centers for domestically produced innovative products in different regions of the country, systematically carrying out clinical evaluation and demonstration application research of domestically produced innovative products. In the regional application demonstration of innovative medical equipment, a number of regional demonstration bases were established, combined with the construction of a common multi-disciplinary stratified diagnosis and treatment system in the region, focusing on promoting the popularization and application of domestically-used diagnosis and treatment equipment at the grassroots level.
According to the person in charge of the relevant departments of the Ministry of Science and Technology, according to the relevant spirit of the national science and technology plan management reform and the actual needs of the development of digital medical equipment, it is proposed to establish an organizational management system of departmental synergy, expert participation, diversified input, and classification organization to ensure special implementation. First, establish a special cross-departmental organization and coordination mechanism, strengthen the grasp of the overall overall objectives and supervision of implementation progress, study and improve targeted policy safeguards, and promote the industrialization and scale application of innovative digital diagnosis and treatment equipment; The overall expert group and task expert group assist in the organization, demonstration, inspection, evaluation and acceptance of relevant topics; thirdly, guided by the central government's financial input, encourage local, social capital, self-raised units and other diversified inputs to participate in the special organization and implementation. The fourth is to focus on the innovation chain of digital medical equipment, classify and organize different types of projects, pay attention to the breakthrough of bottleneck technology and core components, and focus on improving the independent innovation ability of enterprises.