China's medical device industry continues to grow with the growth of human health needs, and is known as the sunrise industry. It is an area in which global developed countries compete for competition. As of 2017, the total size of China's medical device market is about 445 billion yuan, an increase of 75 billion yuan from the 370 billion yuan in 2016, with a growth rate of about 20.27%. However, although the "cake" is large, the "squatter" is scarce. According to industry insiders, the industry has high thresholds and low concentration. Faced with the strong pressure of foreign-funded enterprises, it is a challenge for domestic medical device companies. As the medical device packaging industry, which is the most closely related industry in the medical device industry, the challenges are even more severe. However, with the gradual advancement of policies such as grading medical treatment, the future market potential of the medical device industry and the packaging industry is still considerable.

　　Analysis of the pain points in the development of China's medical device industry and packaging industry

　　1. The high-end market is occupied by multinational companies.

　　China's medical device industry and medical device packaging industry started relatively late, and there is still a certain gap with international medical device giants, especially large equipment and high-end medical equipment. Domestic medical institutions still tend to use imported equipment, and the high cost of imported medical equipment. It is also one of the reasons why medical expenses remain high. Domestic medical device packaging manufacturing enterprises mainly focus on low-end, price-competitive conventional products, including small and medium-sized equipment and consumable products. Only some products have the strength to compete with imported medical devices, such as monitors, anesthesia machines, Blood cell analyzer, color ultrasound and biochemical analyzer.

　　2. There are long regulatory issues

　　From the perspective of the medical device industry and the medical device packaging industry as a whole, there are many ministries involved in industry management. The Development and Reform Commission, the Health Planning Commission, the Food and Drug Administration, the Ministry of Commerce, the Ministry of Industry and Information Technology, the General Administration of Quality Supervision, the Ministry of Science and Technology, etc. are all promulgating and Industry-related policies and regulations, the phenomenon of cross-management of the medical device industry by government departments has occurred from time to time. The formulation of industrial policies involves the Food and Drug Administration, the National Development and Reform Commission and the Legislative Affairs Office of the State Council; the safety supervision involves the Health Planning Commission and the Food and Drug Administration; the production development involves the Food and Drug Administration and the Ministry of Industry and Information Technology; and the circulation channels involve the Food and Drug Administration and the Ministry of Commerce. .

　　The multi-head management of many ministries and commissions has affected the management efficiency of the industry, hindered the pace of development of the industry, resulting in the difficulties of comprehensive management and poor overall planning. It not only increased the waste of administrative resources, but also increased the burden on enterprises, thus affecting the industry. healthy growth.

　　3, the company is generally small

　　China's medical device industry and medical device packaging industry are low in concentration, and there are tens of thousands of production enterprises, and the scale is generally small. Mindray Medical, the largest medical device manufacturer in China, has sales of more than 11 billion yuan in 2017. Compared with the international giants, there is still much room for growth; the medical device packaging industry is almost uncompetitive internationally. Most of China's enterprises are small in scale and insufficient in R&D investment, which seriously restricts independent innovation of enterprises and leads to weaker competitiveness in the market.

　　4, high financial barriers

　　The research and development process of medical devices is complex and lengthy, requiring a large amount of capital investment to attract high-level professionals and scientific research innovation. The construction and maintenance of the sales network and after-sales service system require a lot of financial support. Strong capital requirements have become a financial barrier to enter the medical device industry. The medical device packaging industry also has much higher R&D and production costs than other packaging because of its strict quality management standards and complex system structure.

　　Five positive factors promote development

　　1. The policy is favorable for development.

　　The medical device industry is one of the important indicators to measure the progress of a country's scientific and technological progress and the modernization of the national economy. Therefore, countries around the world generally attach importance to the strategic position of the development of the medical device industry. In recent years, China has also introduced a series of support policies such as planning and guiding measures to promote the healthy development of the medical device industry.

　　"Made in China 2025" clearly identifies new materials, biomedicine and high-performance medical devices as one of the top ten areas for key development, and proposes to improve the innovation capability and industrialization level of medical devices, and gradually get rid of the situation that high-end medical devices rely on imports. The "13th Five-Year National Science and Technology Innovation Plan" particularly emphasizes the key technologies for the development of digital diagnosis and treatment equipment, in vitro diagnostic products, health promotion key technologies, health service technologies, and old-age disability technologies during the 13th Five-Year Plan period. The "Healthy China 2030" Planning Outline proposes that in the next 15 years, it will deepen the reform of the medical device circulation system, strengthen the supervision of medical device safety, strengthen the construction of high-end medical device innovation capabilities, and promote the localization of medical devices.

　　2. Market demand continues to grow

　　The downstream of the medical device industry is a medical and health institution. The demand for medical device equipment is directly driven by the investment of medical and health institutions. In the long run, it is determined by the needs of Chinese residents for medical services: from the perspective of investment in medical and health institutions, Driven by the policy, the number of private hospitals and primary medical institutions will continue to grow rapidly in the next few years. The Ministry of Health's equipment allocation regulations for various types of hospital departments will drive the demand for related medical equipment. Import substitution and upgrading are also High-end medical device products leave a broad space; from the perspective of the demand for medical services of Chinese residents, the per capita disposable income, the coverage of medical insurance and the increase in the proportion of reimbursement have all enhanced the ability of medical practitioners to pay. China's population structure has gradually entered an aging period, and the aging of the society and the enhancement of residents' health awareness have led to an increase in medical expenditures.

　　3. Benefit from the trend of globalization

　　China has formed a medical device industry cluster and has a large cost advantage. Enterprises in developed countries have moved into the whole of China, such as technology research and development. China has a high-quality R&D team and skilled workers who are able to respond quickly and promptly to customer needs and provide products with a high price/performance ratio. The medical device industry is a globally competitive industry. After completing the technological breakthrough, the cost advantage will be an important factor in global competition. Domestic medical device companies are expected to benefit from the globalization process.

　　4, the technical level continues to improve

　　With the smooth flow of international academic exchanges, the exchange of cutting-edge technology in the industry has become more rapid, laying the foundation for the development and advancement of medical devices. Through years of accumulation of technology, talents and manufacturing processes, the outstanding enterprises in China's medical device industry have gradually narrowed the gap between the functions and quality of foreign-funded enterprises, and even reached the international leading level in some sub-sectors.

　　Since 2018, medical equipment development and technological breakthroughs have been continuously innovated. The project “CRP lateral flow immunochromatographic test strip and its supporting automatic fluorescent immunoassay instrument” passed, and some products have been iteratively upgraded; the national science and technology support plan project “Drug gastrointestinal detection and imaging microsystem development” passed the acceptance Providing safe, comfortable and more effective disease diagnosis tools for patients, reaching the international leading level; Gansu Wuwei Medical Heavy Ion Accelerator System has completed the test report and entered the clinical trial stage, marking the completion of the medical heavy ion accelerator system. Basic research is a key step in the application of people's livelihood.

　　5, domestic equipment is gradually recognized

　　In 2014, China began to launch a selection of excellent domestic medical equipment products. The "Government Procurement Law of the People's Republic of China" stipulates that domestically produced drugs and medical devices can meet the requirements. In principle, government procurement projects must purchase domestically produced products and gradually improve the level of domestic equipment configuration of public medical institutions. In the reform of the medical device approval system, the domestic innovative medical devices have opened up a fast track. Some provinces and cities have also shown a significant inclination to the domestic medical devices in the tendering system. The downstream hospitals are also increasingly confident in domestically produced equipment, and gradually accept domestically produced equipment.