(2) Product objective: To build 50-80 new medical devices such as prevention, diagnosis, treatment, rehabilitation and first aid that are urgently needed in clinic, focus on developing basic equipment and medical materials with great demand and wide application, and actively develop new medical devices such as chronic disease screening, minimally invasive diagnosis and treatment, regenerative repair, digital medical care and rehabilitation nursing.
(3) Industrial objectives: Focus on supporting 10- 15 large medical device enterprise groups, support 40-50 innovative high-tech enterprises, establish 8- 10 medical device science and technology industrial base and 10 national innovative medical device product demonstration and application base, improve the industrial chain, optimize the industrial structure, and improve.
(4) Capacity objective: Improve the innovation and industrialization capability of medical devices in China, train and introduce a group of academic leaders and innovation teams, establish 20-30 technology research and development platforms, build 10 national engineering technology research centers and national key laboratories, improve the standard, testing and evaluation system of medical devices in China, give full play to the strategic alliance role of industrial technology innovation, promote the deep integration of Industry-University-Research medical services, and effectively guarantee the sustainable development of China's medical device industry. Study the biological effects of physical actions such as force, light, sound, electricity and magnetism. , focusing on bioelectronics, Biomechanics, Biophotonics, Bioacoustics and biomagnetism, especially the laws and mechanisms of physical-chemical-biological coupling in different levels of life activities such as molecules, cells, tissues, organs, systems and human bodies, as well as the modeling and simulation of life phenomena at different levels; Study the biological effects of different substances, focusing on the interaction mechanism between biomaterials and cell tissues, as well as the biological effects of different scales, especially nano-scales.
Strengthen the application of new theories, methods, materials and technologies in the basic research of medical devices; Focus on new biomedical imaging, medical image processing, physiological signal collection, biochemical, immune and microbial detection, tissue repair and regeneration, medical neuroengineering and other basic research. In order to meet the needs of medical diagnosis and treatment, health service and industrial development, we will focus on the following technologies around the development trends of medical devices such as digitalization, intelligence, automation, precision, no/minimally invasive, low load, personalization, networking and collaboration:
Principles and methods: Make full use of the latest progress in basic medicine, biochemistry, information science, electronic science, materials science, high-energy physics and other fields, strengthen the application research of new principles and methods, and focus on the technical research of multimodal fusion imaging, biosensing, weak signal detection, nerve interface and stimulation, high-energy particles and radiotherapy, Qualcomm mass/micro/rapid in vitro detection, and modification of biomedical materials.
Design and manufacture: make full use of the latest progress in advanced manufacturing, micro-nano technology, biomechanics, ergonomics, computer science and other fields, and focus on technical research such as precision transmission and control, precision machining and assembly, modification of biomedical materials, personalized design and manufacture. Efforts should be made to break through the technical bottlenecks in the design, preparation and manufacture of large-scale diagnostic equipment and core components such as computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET), PET-CT and electron linear accelerator, high-precision components such as micro-pump valves, micro-sensors and micro-optical lenses, and new medical materials such as interventional stents, artificial joints and bone repair.
Application services: Make full use of the latest progress in information technology, bioinformatics, network communication, Internet of Things, cloud computing and other fields, actively promote the combination of medical imaging technology with surgery planning, radiotherapy, navigation and positioning, medical robots and other technologies, and accelerate the development of new service technologies such as digital medical care, mobile medical care and remote diagnosis and treatment.
1, major frontier technology
Focus on breaking through neural interface and stimulation, low-dose photon detection imaging, accurate 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, personalized design and manufacture of cell tissue induction materials and implants. Reserve and develop cutting-edge technologies such as multimodal fusion imaging, molecular imaging, terahertz wave detection and microfluidic.
2, * * * key technologies
Focus on the development of digital medicine, medical virtual reality, human-computer interaction design, biomedical materials processing and preparation, precision manufacturing, electromagnetic compatibility, reliability design and other technologies. Actively promote the research on supporting technologies closely related to the research and 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. During the "Twelfth Five-Year Plan" period, focusing on the needs of prevention and treatment of major diseases and clinical diagnosis and treatment, we will focus on developing a number of advanced and practical products suitable for grass-roots units and high-end products mainly imported, actively develop innovative products adapted to the transformation of medical models, and significantly enhance the market competitiveness of the medical device industry.
In the field of prevention, according to the development requirements of putting prevention first, moving forward strategically and shifting the center of gravity, we will focus on supporting non-/minimally invasive detection products of physiological and biochemical indicators such as blood pressure, blood sugar and blood lipid, and screening products of major diseases such as malignant tumors, cardiovascular and cerebrovascular diseases and birth defects, and actively develop low-load physiological parameter detection and monitoring equipment, personal health index detection and functional state evaluation devices, mobile physical examination systems and other products to meet the needs of rural grassroots/communities and individuals/families for preventive medical care.
In the field of diagnosis, aiming at the development trend of non-invasive, early, accurate, low-load and quantitative disease diagnosis, it mainly supports superconducting MRI, high-performance color ultrasound imager, high-resolution endoscope, multi-slice spiral CT, PET, PET-CT, digital flat-panel X-ray machine, low-dose digital subtraction angiography (DSA) system, high-performance immunoassay system, automatic Qualcomm biochemical analyzer and high-performance five-classification blood cell analyzer. Actively develop new products such as biochip, POCT, elastic ultrasonic imaging, and strive to change the situation that China's high-end products rely on imports, domestic products are poor in reliability, and long-term follow-up counterfeiting.
In the field of treatment, according to the development trend of micro/non-invasive treatment, precise treatment, intelligent and personalized treatment technology, key products such as image navigation assistant system, real-time intensity modulated radiotherapy system, hemodialysis system, nerve stimulator, high-intensity focused ultrasound treatment system, surgical treatment equipment such as high frequency/laser, radiofrequency ablation system, new interventional stent, artificial joint, bone repair material, artificial blood vessel, oral implant system and so on are supported. Develop surgical robots, artificial heart AIDS and other products, effectively changing the status quo that high-performance therapeutic products are monopolized by foreign countries and the treatment cost is high.
In the field of rehabilitation, focusing on the demand of "everyone enjoys rehabilitation" in China, according to the development trend of universality, intelligence and individuality, we will study technical products such as structural substitution, functional compensation, skill training and environmental transformation, actively develop products such as intelligent prostheses such as electromyography and nerve control, intelligent walking/hearing/vision AIDS such as cochlear implants, behavioral function training systems for the elderly, rehabilitation training systems for stroke patients and dyskinesia patients, and accelerate intelligence and intellectualization.
In the field of emergency rescue, around the different needs of disaster medical rescue, public health emergency, war wound treatment and primary medical emergency, we will develop emergency medical rescue chain equipment and systems such as casualty search, on-site first aid, transport treatment and in-hospital first aid, and actively develop mobile intensive care systems, defibrillators, life-support ventilators, rapid hemostasis and blood transfusion equipment to ensure the construction needs of urban and rural first aid systems and public health emergency systems.
1, basic medical device products
Focusing on the needs of primary medical care and routine diagnosis and treatment, we will focus on developing low-cost, high-performance and universal basic equipment such as digital X-ray machine, color ultrasonic imager, biochemical analyzer, blood analyzer, microbial analyzer, electrocardiograph, monitor, defibrillator, breathing/anesthesia machine and blood purification equipment, and accelerate the breakthrough of spiral CT, MRI, PET-CT, endoscope, electronic linear accelerator and immunoassay system.
2. New medical device products
Focusing on the needs of disease prevention, clinical diagnosis and health promotion, we will highlight the development direction of new technologies such as fusion imaging, non-invasive detection, dynamic monitoring, minimally invasive treatment, and precise treatment, and actively develop new medical images, non-/minimally invasive detection and dynamic physiological parameter monitoring, molecular biological analysis instruments, on-site rapid detection instruments (POCT), new minimally invasive treatment, intraoperative monitoring/positioning/navigation, medical machinery combination products, and medical robots.