The development objectives of the "Twelfth Five-Year Plan" for the medical device science and technology industry

(1) Technology goal: breakthroughs in 20-30 key technologies and core components, the formation of 200 core patents; in a number of cutting-edge technology to achieve important breakthroughs, and the formation of industrial advantages.

(2) Product target: create 50-80 new preventive, diagnostic, therapeutic, rehabilitative, and emergency medical device products that are urgently needed in clinics, focus on the development of basic equipments and medical materials that are in great demand, widely used, and mainly dependent on imports, and actively develop the new medical device products of chronic disease screening, minimally invasive diagnostic and therapeutic treatment, regenerative repair, digital medical treatment, and rehabilitative care.

(3) Industrial target: focus on supporting 10-15 large-scale medical device enterprise groups, supporting 40-50 innovative high-tech enterprises, establishing 8-10 medical device science and technology industrial bases and 10 national innovative medical device product demonstration and application bases, perfecting the industrial chain, optimizing the industrial structure, increasing the market share, and significantly enhancing the international competitiveness of the medical device industry.

(4) Ability goal: to significantly improve China's medical device innovation and industrialization capacity, cultivate and introduce a number of discipline leaders and innovation teams, establish 20-30 technology R&D platforms, build 10 new national engineering technology research centers and national key laboratories, improve China's medical device standards, testing and evaluation system, play the role of industrial technology innovation strategic alliance, promote the The deep combination of industry, academia, research and medicine will effectively guarantee the sustainable development of China's medical device industry. Research on the biological effects of physical effects such as force, light, sound, electricity and magnetism, focusing on bioelectronics, biomechanics, biophotonics, bioacoustics, and biomagnetism, especially the research on the laws and mechanisms of the coupled effects between physics-chemistry-biology at different levels of life activities such as molecules, cells, tissues, organs, systems, and the human body, and the modeling and simulation of life phenomena at different levels; research on the biological effects of different substances, focusing on the modeling and simulation of life phenomena at different levels; research on biological effects of different substances, focusing on the mechanism of interaction between biomaterials and cell tissues, as well as research on biological effects at different scales, especially at the nanoscale.

Strengthen the basic research on new theories, methods, materials and technologies applied to medical devices; focus on new types of biomedical imaging, medical image processing, physiological signal acquisition, biochemical, immune and microbial detection, tissue repair and regeneration, and medical neural engineering, and other basic research. To meet the needs of medical diagnosis and treatment, health service and industrial development, focusing on the development trend of medical devices, such as digitalization, intelligence, automation, precision, non-/minimally invasive, low load, personalization, networking, and synergism, we will focus on the development of the following technologies:

Principles and Methods: Making full use of the latest progress in basic medicine, biochemistry, information science, electronic science, material science, high-energy physics, etc., and strengthening new principles and methods of medical devices.

To strengthen the applied research of new principles and methods, focusing on the research of multi-modal fusion imaging, biosensing, detection of weak signals, neural interface and stimulation, high-energy particle and ray therapy, high-throughput/microscopic/rapid in-vitro detection, and modification of biomedical materials and other technologies.

Design and Manufacturing Category: Making full use of the latest advances in advanced manufacturing, micro-nano technology, biomechanics, ergonomics, computer science and other fields, focusing on precision transmission and control, precision machining and assembly, biomedical material modification, personalized design and manufacturing technology research, focusing on breakthroughs in computed tomography (CT), magnetic **** vibration imaging instrument (MRI), positron emission Computed tomography scanner (CT), magnetic *** vibration imaging machine (MRI), positron emission tomography (PET), PET-CT, medical gas pedal and other large-scale diagnostic and therapeutic equipment and core components, micro-pumps and valves, micro-sensors, micro-optical lenses and other high-precision parts, as well as interventional scaffolds, artificial joints, bone repair, and other new types of medical materials, such as the design of the design, preparation, manufacturing and other technical bottlenecks.

Application service category: make full use of the latest advances in information technology, bioinformatics, network communications, Internet of Things, cloud computing and other fields, and actively promote the combination of medical imaging technology with surgical planning, radiation therapy, navigation and positioning, medical robotics and other technologies, and accelerate the development of digital healthcare, mobile healthcare, remote diagnosis and treatment and other new service technologies.

1, major cutting-edge technologies

Focus on breakthroughs in neural interfaces and stimulation, low-dose photon detection and imaging, precise positioning and navigation, dynamic shape adjustment, electrical impedance functional imaging, detection of weak optoelectronic signals, electrochemical/biochemical sensing, non-invasive physiological signal acquisition and parameter identification technology, cell and tissue-inducing materials and implantation and interventional body of the personalized design and manufacture of such technologies. Reserve the development of multimodal fusion imaging, molecular imaging, terahertz (THz) wave detection, microfluidics and other cutting-edge technologies.

2, **** key technologies

Focus on the development of digital healthcare, medical virtual reality, human-computer interaction design, biomedical materials processing and preparation, precision manufacturing, electromagnetic compatibility, reliability design and other **** technologies. Actively promote research on support 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, advanced manufacturing technology. "During the 12th Five-Year Plan period, focusing on the prevention and treatment of major diseases and clinical diagnosis and treatment needs, focusing on the development of a number of advanced and practical products suitable for grass-roots level and medium- and high-end products which are mainly dependent on imports, and actively developing innovative products adapted to the transformation of the medical model, to significantly enhance the market competitiveness of the medical device industry.

In the field of prevention, according to the development requirements of prevention first, strategy forward and center of gravity downward, focusing on supporting the non-/minimally invasive testing products of physiological and biochemical indexes such as blood pressure, glucose, blood lipids and other products, as well as screening products of malignant tumors, cardio-cerebral and cerebral vascular diseases, birth defects and other major diseases, and actively developing the low-load physiological parameter testing and monitoring equipment in different states, personal health index testing and functional status evaluation devices, mobile medical checkup systems and other products. Evaluation devices, mobile medical examination systems and other products to meet the needs of rural grassroots/community and individual/family for preventive medical devices.

In the diagnostic field, focusing on the development trend of non-invasive, early, precise, low-load and quantitative requirements for disease diagnosis, the company will focus on the support of super-conducting MRI, high-performance color ultrasound imager, high-resolution endoscopy, multi-row spiral CT, PET, PET-CT, digital flat-panel X-ray machine, low-dose digital subtraction angiography (DSA) system, high-performance immunoassay system, Automatic high-throughput biochemical analyzer, high-performance five-classification blood cell analyzer, automated microbial testing analyzers and other key products, core components, and new diagnostic reagents; actively develop biochips, field rapid detection instruments (POCT), elasticity of ultrasound imaging, and other new products, and strive to change the country's reliance on imports of high-end products, poor reliability of domestically produced products, and long-term tracking of imitation of the situation.

In the therapeutic field, according to the new therapeutic technology development trend of micro/non-invasive treatment, precise treatment, and intelligent, personalized, etc., we focus on supporting the image navigation assistance system, real-time shape-adapted intensity-modulated radiation therapy system, hemodialysis system, neurostimulator, high-intensity ultrasound focused therapy system, high-frequency/laser and other surgical treatment equipment, radiofrequency ablation system, new interventional scaffolds, artificial joints, Bone repair materials, artificial blood vessels, oral implant systems and other key products; the development of surgical robots, artificial heart assistive devices and other products, and effectively change the high-performance treatment products are monopolized by foreign countries, the status quo of high treatment costs.

In the field of rehabilitation, focusing on China's "Rehabilitation for All" needs, according to the development trend of universality, intelligence, personalization, etc., research on structural substitution, functional compensation, skills training, environmental modification and other technological products, and actively develop the myoelectricity and neurological control of intelligent prosthetic limbs, cochlear implants and other intelligent walking/hearing/vision aids, behavioral function of the elderly, and the development of the elderly, the hearing/behavioral function of the products. Vision aids, behavioral function training systems for the elderly, rehabilitation training systems for stroke patients and patients with motor function deficiencies, accelerating the research and development of intelligent, low-cost advanced rehabilitation aids, and increasing the popularity of rehabilitation equipment.

In the field of emergency rescue, focusing on the different needs of disaster medical rescue, public ****health emergency response, war trauma treatment and primary medical emergency, research and development of casualty search, on-site first aid, transit treatment, in-hospital first aid emergency medical rescue chain of equipment and systems, and actively develop the mobile intensive care treatment system, defibrillator, life support ventilator, rapid hemostasis and blood transfusion equipment products, to protect Urban and rural emergency system, public **** health emergency system construction needs.

1, basic medical equipment products

closely focusing on primary medical care and routine diagnosis and treatment needs, focusing on the development of low-cost, high-performance, universal digital X-ray machine, color ultrasound imaging instrument, biochemical analyzer, hematology analyzer, microbiology analyzer, electrocardiogram machine, monitor, defibrillator, respiratory/anesthesia machine, blood purification equipment, and other current grassroots configuration of the urgently needed basic equipment

2, new medical device products

Centered closely on the needs of disease prevention, clinical diagnosis and treatment, health promotion, highlighting the integration of imaging, non-invasive detection, dynamic monitoring, minimally invasive treatment, precision treatment and other new directions of technological development, and actively develop a new type of medical imaging, non-/minimally invasive dynamic physiological parameter detection and monitoring, molecular bio-analytical instruments, on-site rapid detection instruments ( POCT), new minimally invasive treatment, and new types of medical imaging, non-/ minimally invasive dynamic physiological parameter detection and monitoring. POCT), new minimally invasive treatment, intraoperative monitoring/localization/navigation, medicine and device combination products, medical robots, new Chinese medicine diagnosis and treatment and other medical equipment products and systems, as well as digital healthcare, telemedicine, mobile healthcare and other new products, and continuously improve the level of medical diagnosis and treatment and service capabilities.