I. Status of Development of Medical Device Industry at Home and Abroad
(I) Development of foreign medical device industry
The medical device industry is an emerging industry related to human life and health. The developed countries in the world have maintained a very high annual growth rate for more than ten years and are known as the Chaoyang industry. In the 1990s of the 20th century, the global economy experienced a recession, but the medical device industry still maintained a good momentum of development. During this period, the US medical device industry grew by 6% to 7%, exceeding the economic growth rate of 2.7%-4.4% over the same period. The overall economic growth in Western Europe is difficult, and the growth rate of the medical device industry in the European Community is more than 3%. Japan's economic growth rate is about 3.5%, while the medical device industry's growth rate is 8%. At the same time, the medical device market is also booming: sales growth in the US market was 5.1%; European Community was 6.1%; Japan was 8.3%.
At present, the United States is the world's leading medical device market and advanced medical technology leader, accounting for more than 40% of the global medical device market, and its compound growth rate from 1999 to 2004 reached 9%. Western Europe is the second largest market for medical devices and accounts for nearly 25% of the global medical device industry. In Asia, Japan is the most advanced advanced medical technology and economic development market. China and India have large populations and large markets. It has developed rapidly and has great potential for growth. Latin America has become more industrialized with Mexico, Brazil, Argentina and Chile, and the medical device industry is growing rapidly.
According to the report of the HIMA (Healthcare Industry Manufacturers Association), the global market for medical devices (BME industry including medical devices and medical biomaterials) was US$120 billion in sales in 1995, US$130 billion in 1996, and 137 billion in 1997. The dollar, which was 153 billion U.S. dollars in 1999, has continued to increase at a rate of 6% to 7% in recent years. According to the 2004 market analysis report of Frost & Sullivan, the global medical device market capacity in 2003 was US$248.4 billion. In 2005, the global medical device sales exceeded US$250 billion, and it is expected that the growth rate will reach 6.5% in the next three years or so. Meanwhile, medical services The international trade volume of equipment products is growing at a rate of 25% every year, and the sales profit can reach 40-50%. It is an industry sector with the fastest economic development, active trade relations, and high value-added products in the world today.
The United States is both the world's largest producer and largest consumer nation, and the developed countries represented by the United States currently have a 1:1 ratio of medicines and equipment in the per capita consumption of medicine and health, and their product technology and demand are still growing. The medical device industry has become a very active new economic growth point in the 21st century.
Medical instrument products are the mainstream products in the modern medical device industry and play a leading and leading role in industrial development. Modern medical instrument products gather and incorporate the latest achievements in modern science and technology. They are the products of high-tech combined with medical science and various disciplines. They are modern computer technology, precision machinery technology, laser technology, radiation technology, nuclear technology, and magnetic technology. , Detection and sensing technology, chemical detection technology and biomedical technology, information technology, together constitute a modern high-tech products, digitization and computerization are its basic characteristics. Because of its high technological content and high profits, it has become the commanding heights for each major science and technology and large multinational corporation to compete with each other. Its level of development has actually become an important symbol of a country’s overall economic and technological strength and level.
The global digital medical instrument market is currently monopolized by a few multinational companies in the United States, Japan, Germany, and a few other countries, including GE, Siemens, Philips, and Toshiba and Hitachi. Occupy 90% of the global digital medical imaging equipment field.
(II) Development Profile of Domestic Medical Device Industry
In recent years, China's development has also been rapid. The annual growth rate has reached 14 to 15%. After years of efforts, there have been some domestically produced high, refined and sharp products such as magnetic resonance imaging (MRI) in medical instruments and equipment. CT, digital B-mode, medium-low energy linear accelerator, rotary gamma knife, digital subtraction imaging system, laser surgical device, fiber optic endoscope, etc., all Chinese direct digital X-ray medical imaging system that meets international technical standards (DR In China, it has also been successfully developed and put into clinical applications. In addition, there are a number of newer digital medical equipment and technologies that have been successfully developed and obtained national patents.
However, in general, the gap in quality, quantity, and level of the medical device industry in China is still relatively large compared with developed countries. The medical device industry's sales account for only 2% of the world's medical device sales, and it is far from being able to meet China's health care business. The demand, but also with China's economic output accounted for 7% of the world's economic development level is also very disproportionate, the current product can only account for the domestic medical device market, the annual capacity of 50-60%, drug, machinery per capita consumption ratio is only 10: 1. The high-end medical device market is basically occupied by foreign or multinational companies. At present, the domestic market for medical devices, especially high-end digital precision medical devices, is basically monopolized by foreign or multinational companies. According to the statistical data of 2001, the import volume of medical devices based on precision medical instruments is approximately 40 to 50% of the total sales volume of the domestic medical device industry.
Second, the domestic and foreign medical instrumentation technology and industry development trend analysis
(I) Trends and Status of Medical Instrument Technology Development
1. The rapid development of digital information-based medical instrument products and technologies
"Early disease detection, non-invasive or minimally invasive precise treatment, personalized service" is the 21st century medical clinical direction. Medical digitization and informationization are the most important technical guarantees. Digitalization of medical equipment is the basis for the realization of informatization; informationization is the basic guarantee for the realization of the sharing of medical resources and the realization of the humanization of medical services. Digital medical products are the core of the modern medical device industry and are the product of the development of modern science and technology and health care. The development of digital medical devices and technologies is a trend in the development of modern medical devices. The emergence of a number of modern digital imaging, diagnostic and therapeutic equipment and hospital informatization equipment in the past decade has not only pushed the medical device industry to a new stage of development, has driven the rapid development and advancement of the entire medical device industry, and has promoted The development of clinical medicine and the growth of the national economy. As a result, the governments of all countries have paid great attention.
2. The upgrading of modern large-scale medical instrument products is accelerated.
The goal of product replacement is to facilitate the early screening of health conditions and early diagnosis of diseases, which is conducive to the humanization of medical services;
The driving force of product upgrading comes from people's constant pursuit of improving health and quality of life;
The conditions for product updates are medical-related scientific and technological advances; product replacement and medical technology are mutually reinforcing. The advancement of medical technology has promoted the upgrading of products, and the upgrading of medical device products has also promoted the improvement of medical service technology.
3. General attention is paid to the transfer of new technologies, high-performance, and important functions of high-end products in large-scale medical instrument equipment to medium-low and low-end products in order to reduce costs, reduce medical burdens, and meet the needs of a wider range of medical personnel.
4. The modern medical and health business has gradually evolved from a simple hospital-based diagnosis and treatment model to a multi-dimensioned modern medical security system that integrates pre-hospital emergency care, clinical diagnosis and treatment, and rehabilitation and community health care and home care to develop new types of small-scale medical care systems. High-precision, high-precision and user-friendly medical instrument products have become new highlights of the medical device industry in recent years. In vitro diagnostic instruments and reagents, diagnostic medical imaging equipment, patient monitors, and other categories of increased growth in recent years.
(II) Changes in industrial structure and production concept
1. The cross-border mergers and acquisitions in the global modern medical instrument industry are surging, and the wave of localization in product production and operation has increased.
In the last few years of the late 1990s, the merger and reorganization of medical device companies continued. Since 1998, GE has merged Elscint's MRI production department with OEC Medical System, which is known for its production of C-type X-ray systems, and SMV (Sopha Medical Vision), which designs and produces nuclear medicine instruments and PET (Positron Tomography). the company.
The original intention of the merger is to expand the professional technical team, increase the technological development capability of certain products or increase the supply capacity of the same medical special equipment. The American company Medtronic, known for its heart pacemaker production, has merged several cardiovascular surgical instruments and equipment companies to enhance its cardiovascular equipment supply. Another example is Philips' acquisition of ATL and Agilent, Maconi's Medical Products Division, and ADAC Laboratories to enhance the development capabilities of ultrasound imaging devices, nuclear medicine and other medical imaging equipment.
In recent years, multinational corporations in the field of medical device industry have begun to attach importance to establishing local production bases and R&D bases in developing countries so as to make full use of the resources of developing countries, including medical resources such as talents and markets, to develop themselves better. .
For example, after China’s accession to the WTO, foreign investors’ investment in China has gradually evolved from the initial processing of raw materials, the establishment of joint ventures to the phase of mergers and acquisitions of Chinese companies and sole proprietorships. Some of the world's largest manufacturers of multinational medical imaging products (such as GE, Siemens, Philips, etc.) have established local production and operation bases and R&D bases in China. This not only effectively enters the Chinese market, but also makes good use of and integrates resources that are useful for its development, providing very favorable conditions for its production of products with good reliability, high performance, and low price that are suitable for the Chinese market.
2. The concept of development and production has undergone a change. The international optimization operation has expanded from the cooperation of components to the entire manufacturing chain.
In pursuit of improving product quality and reducing costs, and speeding up the pace of research and development of new products, in the entire chain of product design, experimentation, development, manufacturing, testing, sales, and after-sales service, we are not relying on individual advantages, but we are giving full play to the global diversity of professionalism. Advantages, re-orientation of the company, re-allocation of various resources of the company, concentration of resources in the areas that best reflect the relative advantages of the company, building their own competitive advantages, acquiring the ability for sustainable development of the company, and significantly shortening the comprehensive high-tech innovation Medical device product development cycle.
(3) Basis and conditions for accelerating the development of China's medical device industry
1. China has the most abundant clinical resources in the world and the most extensive market resources
China has a large number of high-level clinical medical experts and a large number of medical institutions and diseases and cases, and constitutes an excellent medical device clinical application research environment that is beyond the reach of developed countries. With a population of 1.3 billion, there are 280,000 medical institutions, of which 17764 are hospitals and 3 million beds; from 1995 onwards, the average occupancy of special equipment per bed is around 5,000 yuan, an increase of 16%-20. %between. In 2001 it had reached 57,800 yuan. There are 4.3 million health technicians, including 1.46 million doctors and 1.25 million nurses; the absolute number of diseases, cases, out-patients, and hospitalizations is extremely large. In 2003, there were 2.1 billion medical visits and the number of hospital admissions was 61 million.
2. Ten years of "Ninth Five-Year Plan" and "Tenth Five-Year Plan" constitute changes and development in China's medical device industry, which has made it possible for China to independently develop new medical devices.
a. The adjustment of the industrial organization structure and the adjustment of the regional structure are gradually advancing. At the end of the 1980s, the organizational structure of the national medical device manufacturing enterprises began to evolve from the original structural model of the state-owned economy plus the collective economy of the original single-subordination system to an open, multiple economic ownership system. In terms of regional structure, the Pearl River Delta, the Yangtze River Delta and the Bohai Bay of the Beijing-Tianjin-Hebei region rely on the region’s industrial technology, scientific and technological talents, clinical medicine, and policy advantages to become the three major industrial clusters of the medical device industry. With complete statistics, the sum of the total output value of the three regions and their sales accounted for more than 80% of the national total.
b. Nurturing a certain amount of talents.
c. Accelerated adjustment of product technology structure, major changes in the technical structure, research and development of some products with high technical content, and product quality and after-sales services have also been valued.
d. The level of basic research has been improved, and some areas have already established the basis for source innovation. With the increase in the level of basic industries, the advantages of modern manufacturing have gradually emerged.
3. The reform, opening up, and accession to the WTO have gradually allowed the internationalization of technical resources, human resources, management resources, and industrial resources. The overall environment for industrial development has gradually improved, and there is a possibility of technological integration and development in the global context.
4. With the prosperity of China's national power, technological advancement, and the development of the people's health and health undertaking, the demand for modern medical devices is increasing. How to narrow the gap with the medical device industry in developed countries and promote the development of related economies and technologies has aroused great attention from the state and relevant government agencies. R&D spending on medical devices by countries and developers continues to increase.
III. Reflections on the Development Direction of Medical Instruments in the Next 5-10 Years in China
1, the overall idea:
1. According to the development trend of modern medical devices, establish the direction and entry point for accelerating the development of China's medical device industry.
According to the global trend of modern medical device development, the development of medical digital instruments and equipment should be regarded as the key direction of the development of China's medical device industry, and the development of the medical device industry in the entire country should be promoted. At this stage, we must focus on clinical needs, with special emphasis on the development of digital medical core equipment and core technologies that can affect the overall situation, and focus on products that can enter the main battlefield.
2. Selection and determination of conditions for core equipment and key technologies
1 advanced technology, which has a leading role in the current and future development of the industry;
2 have a technical foundation that can be achieved through hard work and integration of available scientific and technological resources;
3 The capital investment is within its reach, and it has a wide range of applications and has broad market prospects.
The selected conditions can be summarized as:
3, the development of the guiding ideology: demand-oriented, adhere to innovation. In order to carefully grasp the needs of China's health care industry and track the development of leading foreign technologies, we attach importance to the intersection of disciplines and adhere to innovation in the application field. Take the development road of independent research and development, technological innovation, master core technology and independent intellectual property rights.
4. Recent development goals: To promote the overall development of the national medical device industry with digital core equipment and key technologies.
Focus on solution: system design of modern digital diagnosis and treatment equipment; advancement of key digital technologies such as medical image acquisition, pattern recognition, intelligent control and tracking, and medical information extraction, processing, and processing; breakthrough in the development of the core components of digital medical instrumentation equipment . To provide a digital technology foundation and support for the development of modern medical device industry in China.
Key support: R&D of new radiotherapy, hyperthermia, medical robotic surgery, digital medical ultrasound, DR, permanent magnet MRI, automated and intelligent clinical testing equipment, and development of a number of product prototypes with international competitiveness; The digital R & D and manufacturing capabilities of the core digital medical equipment such as digital control, digital imaging, and clinical testing, and the promotion of independent innovation and core competitiveness of modern digital medical equipment companies.
Key objectives: Provide technical support for the upgrading of secondary and tertiary hospital equipment in China, modernization, localization, and product participation in international market competition; adequate development of advanced technology, leading technology for the development of the industry leading large-scale sophisticated digital medical Instrument products and technologies; built several national digital medical technology innovation platforms to provide services for the technological innovation and sustainable development of China's medical device industry.
IV. Modern digital medical instrument products that are suitable for the national conditions and needs and have the conditions to focus on development
1. DR (Digital Radiography)
Since the official launch of the RSNA, the annual meeting of the North American Radiological Society in 1997, DR has been the technology of the past RSNA. Because all the imaging examinations in the hospital account for more than 50% of the routine X-ray imaging, it is very important in clinical imaging. Important position. After more than ten years of development, the DR technology has entered a mature stage. Both the technical performance and the price of the product have reached universally applicable levels. At the recent 2004 North American Radiological Conference (RSNA), there was once again a boom of DR, reflecting that after more than 10 years of development, DR technology has gradually matured and is entering a stage of large-scale commercialization.
At present, there are a large number of line scan detection DR systems and flat panel DR systems applied to the clinical, and achieved significant results. In the future, it is entirely possible for the DR system to replace traditional X-ray radiography systems. The development of flat panel detector technology accompanied with DR, especially the development of cesium iodide and amorphous selenium flat panel technology, has demonstrated new application prospects for medical applications of X-rays. Mammography machines, gastrointestinal machines, vascular machines, simulators, and various applications involving radiation therapy using flat panel technology have been produced or are being developed, and the development of flat panel CT has received extensive attention. A new era of digital medical X-rays has arrived.
China has already ranked among the few countries in the world that have a few flat-panel DR systems. Since 1999, China’s first commercialized DR system with independent intellectual property rights has come out. In a few short years, it has been able to produce a full range of advanced international technologies. The series uses DR products of amorphous selenium flat panel detectors. The products not only have a certain market share in China but also have begun to enter the international market. In addition, there are some companies' OEM products have entered the market.
In 2004, China launched the latest generation of line scan detection DR system with independent property rights. The advantages in performance and price ratio are obvious; the advantages of low radiation dose and high density resolution are prominent; the spatial resolution index exceeds that of similar foreign products. The installed capacity in China that has been implemented in 2005 has reached more than 100 units and has begun to receive orders from abroad.
China has the world's largest installed capacity of X-ray machines. It may only be a matter of time before China becomes a major producer of DR systems.
2. MRI (magnetic resonance)
MRI plays an important role in current and future clinical medicine because of its role and potential in tumor imaging, interventional imaging, vascular imaging, functional imaging, and molecular imaging. The development momentum is very strong. At present, the industry of MRI equipment advances in two directions: one direction is toward the development of high field and cutting-edge products; the other direction is towards the development of medium and low magnetic field products with full opening and special purpose. The former is driven by the need for high signal-to-noise ratio, high image quality, and high functionality. It is also an inevitable trend of scientific and technological advancement; the latter's motivation comes from actual patient needs such as patient comfort and intraoperative imaging.
Taking GE as the representative, it is developing in the direction of 3T system; Siemens, Philips, Hitachi as the representative, and developing towards the open system, including: Siemens' 1.25m ultra-short cavity, 1.5T system + open concept of TIM technology, Philips's The 1.0T open system concept and the concept of a boutique open permanent magnet system represented by Hitachi 0.3T. The biggest event that occurred within the MRI industry in 2004 was the affirmation of the status of 3T MRI as a routine clinical product. The reason why 3T MRI is popularized is mainly brain imaging. Followed by ultra-short 1.5T MRI and Philips's fully open 1.0T superconducting MRI system, debuted at the annual meeting of the North American Radiological Society, becoming the highlight of the 2004 conference.
China has a certain industrialization base in MRI. Although there is a large gap between high-field superconducting MRI technology and foreign countries, low-field permanent magnet MRI products have a relatively large share in China, and in recent years, domestic permanent magnets have The MRI industry has further developed. At present, more than three manufacturers have proposed to implement 0.5T permanent magnetic MRI. As China has the advantage of magnetic material resources, if it can be transformed into a product with high added value, it may gain an advantage in the international market. China should further strengthen its research and development work. While engaging in system integration, it must focus on the key components and technologies. Including the promotion of complete machine manufacturing enterprises and the cooperation of magnet component suppliers with large-scale production capabilities; promote independent research and development of high-level spectrometer technology; strive to develop excellent software for high-end functional imaging of permanent magnets, so that China's permanent magnet MRI products in comparison In a short period of time, it better meets the needs of the domestic market and gains a competitive advantage in the international market.
3, digital medical ultrasound diagnostic apparatus
Medical ultrasound imaging technology, together with X-CT, MRI and nuclear medicine imaging, are recognized as the four modern medical imaging technologies. It is an irreplaceable pillar in modern medical imaging technology. Compared with other imaging technologies, it has unique advantages such as real-time, no damage, and low cost. It is widely used in routine medical examinations, and it has become increasingly prominent in medical diagnostics, surgical positioning, guidance, and monitoring. It is one of the most important, most widely used and most demanding imaging equipment in clinical practice.
At present, China has a big gap with foreign countries in terms of high-end color super products and technologies. There is a good foundation for ultrasound in black and white: low-grade and universal, with an annual output of more than 10,000 units, and it is generally equipped with basic medical services and birth control service stations in China. In recent years, high-quality black-white ultrasonic diagnostic technologies and products that are in clinical need in China have been well developed, and have accumulated considerable technical and market advantages. At present, there are many companies in the country's all-digital medical black and white ultrasound products into the market, including high-speed black and white ultrasound diagnostic products have been competing with foreign products with the same level, with further development of high-low-end digital ultrasound products with our own characteristics Based on the foundation, it is possible to gradually solve the demand for black and white ultrasound products in various hospitals in China by relying on their own efforts. In contrast, foreign companies currently have less input and output of digital black-and-white ultrasonic products, and put the main force on research and development of high-end color ultrasound.
The development of color Doppler ultrasound is also imperative in our country, but we must step out of our own development path. The development of the next five years should emphasize demand orientation, solve and launch our own clinically applied color ultrasound products according to national conditions, and solve and master the core and key technologies among them, including: pulse and continuous Doppler technology, reliable low-velocity blood flow Detection technology, high-quality broadband ultrasound probes and digital broadband technology, harmonic imaging and imaging technologies.
4, linear accelerator and radiotherapy
Radiation therapy is currently one of the three major methods for cancer treatment. 70% of cancer patients need radiotherapy. The IAEA and the WHO organization propose that there should be an average of 2-3 or so per million population in the world. The United States currently has 8.2 units per million people. The developing countries, including China, have a large gap in their equipment. There are only 750 units in China, namely 0.58 units/million people, and the market demand is vast.
At present, high-, medium-, and low-energy radiotherapy machines in the world are rapidly developing at the same time. However, mainstream technologies are related to precise radiotherapy. It is required to be able to accurately position and adjust the intensity distribution. Conformal intensity modulated radiation therapy and image-guided radiation therapy represent advanced levels of modern radiotherapy techniques.
X-knife and γ-knife are continuing to develop; tomography treatment systems, Cybertron, etc. are the latest international radiotherapy products; R&D of high-tech, high-priced products such as high-energy accelerators (MM50), proton-knife, and heavy-ion radiation therapy equipment. Continue to get attention.
After 30 years of development, the domestic linear accelerator has considerable core technical strength (self-developed core components, its own innovative technology) and a relatively large industrial scale (50% of market share). , Low-energy products enter the market, but there is still a big gap between the overall level and foreign products.
"Precise radiotherapy" is the direction of future development of the linear accelerator and its supporting equipment. Accelerating the development of radiotherapy technology and equipment centered on linear accelerators in China is of great significance to meet clinical needs, reduce medical costs, and revitalize and promote the development of modern medical devices in China.
Based on our national conditions, we should focus on the development of highly reliable, highly stable, digital medical linear accelerators, three-dimensional stereotactic radiotherapy planning systems, and radiotherapy information systems.
5. Directional energy therapy and tumor hyperthermia
Directed energy surgical systems are based on the needs of medical clinics. With the development of modern technologies, a series of new types of physical energy therapy devices have emerged. It includes medical lasers, microwaves, radio frequency, ultrasound, and freezing. Due to: foundation provided by electronics industry, aerospace industry and military technology; broad coverage of surgical treatment; significance in non-invasive and minimally invasive treatment; diversification of products, etc. Such products and technologies have been developed in the medical device industry. Gradually occupy an important position, especially in the field of tumor hyperthermia has caused medical attention.
(1) Classification of tumor hyperthermia
a. Tumor thermocoagulation and ablation therapy: image guided radiofrequency, microwave, laser interventional treatment of tumor damage; HIFU and so on.
b. Conventional hyperthermia (tumor hyperthermia, sub-hyperthermia hyperthermia): high-power microwave, radiofrequency non-invasive local irradiation; thermal infusion therapy; whole body hyperthermia (infrared cabin, microwave high power irradiation, extracorporeal circulation blood warming) and so on.
c. Photodynamic therapy, magnetic hyperthermia, and gene therapy combined with hyperthermia
(2) A comprehensive review of the current development level of cancer hyperthermia in China:
a. Local thermal ablation refers to the treatment of direct tumor killing by heat energy generated by different physical means under image guidance. The main clinical applications are radiofrequency, microwave, high intensity focused ultrasound (HIFU) and laser. In recent years, it has developed rapidly and has a significant effect. It has become one of the important means for tumor treatment after surgery, radiotherapy and chemotherapy.
b. Conventional hyperthermia based on heat-induced apoptosis of tumor cells can be used as one of the means for comprehensive treatment of tumors, and has a synergistic effect on radiotherapy and chemotherapy. Whole body hyperthermia is now mainly used as a palliative auxiliary therapy.
c. Novel hyperthermia technologies such as photodynamic therapy, magnetic hyperthermia, and gene therapy combined with hyperthermia are worthy of further in-depth basic and clinical research.
The focus of future development should be on solving non-invasive temperature measurement, conformity control of temperature field, thermal dosimetry and other core technologies, and developing new high-efficiency hyperthermia machines.
6, precision CNC medical equipment and medical robots
Robotics is a high-tech industry that is rapidly developing and widely used in modern automation and digitization. Medical robots are a new type of high-tech digital instruments and equipment developed through the organic combination of medical devices and information technology, microelectronics, new material technologies, and automation technologies. At present, it has begun to be successfully applied in the field of medical applications, especially in the precise positioning, minimally invasive treatment has played an important advantage. It is a forward-looking development area in medical instruments. The technical realization of the medical robot: The application of modern medical imaging equipment and technology to achieve medical image navigation, planning and virtual operation of medical surgery, and finally achieve the auxiliary positioning and surgical operation of the multi-sensor robot. The current research and application generally have the following four aspects:
a. Robotic surgery planning navigation and auxiliary operating systems: Example: Planar orthopedic robot positioning system.
b. Surgical robots: such as the US "Zeus" "Da Vinci" surgical robot.
c. Robotic treatment system: typical products such as "cyber knife"
d. Medical micro-mechanical systems: Miniature diagnostic probes and miniature therapeutic actuators that can enter human or implanted tissue. Example: Human digestive tract diagnosis and treatment microcapsule system (endoscope, parameter detection, remote release of drugs). At present, wireless endoscope microcapsule systems have entered the market in China and Israel.
In the early evening of the research on assisted surgery and robotic systems in China, there are still some gaps between the developed countries and some basic and key researches (such as image-guided surgery, medical robot structure, sensor technology, etc.) and achievement transformation. However, many achievements have been made and some experience has been accumulated. If we can increase R&D investment in time under the current conditions, strengthen the research on key products and technologies, and seize the current development opportunities, we will be able to greatly promote our technology. The creative development of China's medical equipment industry has formed a new field of digital medical equipment.
In our country's current research on computer navigation and assisted surgical robot systems, there are many research and application results for neurosurgery and orthopedics. Image-guided interventional minimally invasive surgery also has a good clinical basis. Based on the original scientific research foundation in China, in the future, this field can be used as an entry point for orthopaedic and minimally invasive interventional surgery. Image-guided assisted surgery and robot system research will be conducted, focusing on medical robots, image registration, and guided surgery. Surgical planning and virtual simulation, surgical training and evaluation, etc., establish experimental platforms in computer navigation, orthopaedic surgical robot systems, and various types of minimally invasive surgical robot systems, and develop digital, intelligent economical auxiliary surgical procedures. Equipment and robotics systems to improve our technology, clinical application, and market share in digital medical devices and surgical treatment.
7, IVD in vitro diagnosis and clinical examination
All kinds of clinical inspection instruments are medical equipment necessary for the hospital. Clinical inspection medical equipment (including reagents) belongs to the in vitro diagnosis (IVD) industry. IVD refers to in vitro diagnosis through experimental means. It is an industry developed based on biology, biomedicine, and other related disciplines. At present, the product technology covered by the IVD industry is more and more, mainly including immunity, biochemistry, molecular biology, microbiological blood and histological examination and other categories. Mainly used for the detection of human health conditions, disease prevention, disease diagnosis, treatment monitoring and so on.
In 2003, the global in vitro diagnostic market was US$24 billion, and it is expected to reach US$26.9 billion by 2006, with a compound annual growth rate (CAGR) of 6%. The market is mainly concentrated in the developed countries and regions such as the United States, Europe, and Japan, and its market share is as high as 85%.
Clinical laboratory medical equipment and technology is a medical device industry and technology category that involves many fields such as electronics and computer technology, biochemical technology, clinical medicine, precision mechanics, optics, etc., and has a very comprehensive and rapid development. At present, there are many core technologies in clinical laboratory medical equipment, such as the core technology related to automatic blood cell analyzers, core technologies related to automatic biochemical analyzers, core technologies related to automated immunoassay analyzers, and biosensing technologies.
Automation, intelligence, standardization, and personalization are the main directions for the development of clinical laboratory medical equipment in the future, especially in the areas of instant inspection, automation, digitalization, modular design, and standardization. Laboratory medicine has entered a new era with automation, information, and networking as the main features. High-end product technologies, especially those advanced and applicable technologies that can reduce costs, improve performance, and enhance reliability, are rapidly shifting to middle- and low-grade products, and the cost-performance ratio of clinically-tested medical instruments continues to increase. The small portable inspection equipment POCT is another important development direction.
The development and application of molecular biology technology and related clinical testing equipment and equipment are a bright spot for future development and may bring revolutionary changes to clinical laboratory medicine. It uses DNA, RNA, or nucleic acid probes, including the use of specific short-range nucleic acid sequences to bind and detect the presence of genetic material. The most typical technologies and instruments are polymerase chain reaction (PCR) technology, various PCR instruments, Biochip technology, various gene chips, protein chip analysis and detection systems, mass spectrometry technologies, and various mass spectrometers. The clinical application of these molecular biology techniques and instruments will not only make the disease forward from the current post-mortem examination, improve the proportion of early diagnosis, but also provide targeted guidance and evaluation of the use of drugs to provide assistance for individualized treatment.
IVD in vitro diagnostic and clinical testing equipment is one of the weakest categories in the modern medical instrument industry in China. The development of the health care industry requires that the development of such products must be promoted. In fact, most of the medium and low-grade clinical instruments and some high-end laboratory equipment imported at present are not high-precision technologies. The mechanical, electronic, optical and gas and liquid circuit designs adopted are also very mature. Most of the production plants in China are very mature. Fully mastered. In recent years, there have also been many small and medium-sized enterprises that produce and develop clinical testing equipment. They have begun to introduce better products with certain grades in the market, including automatic biochemical analyzers and blood cell analyzers. However, there is still a need to accelerate the pace of development for the entire industry.
8, e-Health and hospital information
(1) e-health (also abbreviated to ehealth) is a new international concept that can be understood as: Electronic information technology platforms and e-government, electronic services and management for universal health Concepts such as e-business and e-community belong to the same family and are the product of the extension of modern information industry from the general communications field, government affairs, and business fields to population and health.
E-health is the product of modern electronics and information science and life sciences (in succession, bioinformatics, medical informatics, health informatics, neuroinformatics, etc.) is a combination of modern information and communication technology (ICT) and digital medical technology. The product (HIT, CIS, PACS, RIS, LIS, etc.) is a product of the combination of hospital information and social information. Its connotation and extension have been continuously expanded with the progress of science and technology and the development of major health services. Health service, management, scientific research, training and other functions. It can be considered that the e-health system is an e-platform for national health services, management, security, and related scientific research. It can provide scientific and technical support for adapting to changes in the spectrum of diseases and the general trend of changing health patterns and advancing the reform of the health system and the development of the health industry. To provide people with the necessary basic technology and knowledge conditions to satisfy their personalized health service needs and their long-cherished wish for health and longevity. At the same time, it also provides a huge application space for the development of the information industry.
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