Domestic medical equipment faces four major problems, seven methods can be cracked
Since the reform and opening up, especially in the past ten years, China's medical device industry has made great progress, and the average annual compound growth rate has remained above 20%. Many high-end medical devices or large-scale medical devices have been independently developed and produced, and exported to In many countries and regions, according to statistics, the export of medical devices in 2014 reached more than 20 billion US dollars. At the same time, however, China's medical device industry also has problems such as fewer innovative products and serious homogenization in the development process.
I. Development status of China's medical device industry
Since the reform and opening up, especially in the past ten years, China's medical device industry has made great progress, and the average annual compound growth rate has remained above 20%. Many high-end medical devices such as large-scale X-ray machines, CT, magnetic resonance devices, and color B-mode ultrasound Vascular stents, artificial joints, etc. have been developed and produced, and exported to many countries and regions. In 2014, medical equipment exports reached more than 20 billion US dollars.
China's medical device manufacturing enterprises have reached more than 16,000, and a number of key enterprises such as Shenzhen Mindray, Shandong Xinhua, Lepu Medical, and Shandong Weigao emerged. At present, the three medical equipment industry concentrated areas of the Yangtze River Delta, the Pearl River Delta and the Bohai Bay have been formed. It has been able to produce products in 47 categories, more than 3,500 varieties and more than 12,000 specifications, which can basically meet the needs of disease diagnosis and treatment.
Second, the problems in China's medical device industry
1. There are more domestically produced medical device imitation products, and fewer R&D innovative products;
2. There are more low-end products in domestic medical equipment, and there are fewer high-end products;
3. The phenomenon of homogenization of some domestic medical equipment is very serious;
4. The overall scientific and technological level of domestic medical devices is 10 years or so compared with developed countries or regions.
Third, the road to innovation and development of domestic medical devices
1. China's medical device enterprises are generally small in scale and weak in competitiveness. If calculated according to the annual output value of 400 billion yuan, the average annual output value of each industrial enterprise is only 25 million yuan. Mindray, the largest medical device manufacturer in China, has an annual output value of about 7 billion yuan, while Johnson & Johnson's medical equipment has annual sales of 27.5 billion US dollars. Medtronic's medical equipment has annual sales of 18.3 billion US dollars. The world's top ten medical device manufacturers have 7 in the United States;
2. Insufficient investment in research and development funds for medical device companies in China. The total investment in research and development of China's medical device enterprises accounts for about 3% of its total sales, while the R&D investment of medical device companies in developed countries or regions accounts for about 10-15% of its total sales. The investment in research and development of medical devices by a few foreign large enterprises is as high as 15%. -20%. For example, Johnson & Johnson has invested nearly 2 billion US dollars in research and development, and Medtronic’s annual research and development expenses amounted to nearly 1.7 billion US dollars;
3. Insufficient policies for medical institutions to purchase and use domestic medical devices, it is difficult for domestically-made independent brands of innovative medical devices and high-end medical devices to enter large hospitals;
4. Compared with the industrial development level of developed countries or regions, China's industrial base is still slightly weak. High-end medical devices are a comprehensive product of multidisciplinary knowledge and technology, and innovation and development are bound to be limited by the industrial base;
5. At present, the overall level of science and technology in China's medical device industry is about 10 years away from developed countries or regions. If we catch up with the current development speed, China's medical device industry will be difficult to surpass developed countries or regions in the next 10 years. The situation that foreign high-end medical devices occupy the market of China's tertiary hospitals will continue to exist.
Fourth, domestic medical equipment innovation development thinking
1. Enhance the sense of urgency in the development of medical device innovation
Medical device manufacturers, relevant research and development institutions, hospitals and governments should all increase their sense of urgency and put innovation and development in the most important position in accordance with the requirements of the Party Central Committee and the State Council. Only the whole society really attaches importance to innovation and development, and China's medical device industry will have hopes in catching up with developed countries or regions in the next 10 years!
2. The State Council shall organize the formulation of the "13th Five-Year Plan for the Development of China's Medical Device Innovation" to clarify development goals and policy measures.
Due to the technology and discipline of high-end medical devices, it is impossible to rely solely on the importance of enterprises, research institutions, or universities. It is necessary for the government to organize the formulation of the "13th Five-Year Plan for the Development of Medical Devices in China". Strength, joint research.
3. It is necessary to effectively increase investment in the development of medical device innovation.
As far as China's current medical device industry is concerned, first, medical device manufacturers should increase R&D investment; secondly, the government should set up a medical device innovation development fund to support R&D work; venture capital companies can also invest in promising R&D projects. Support the innovation and development of medical devices.
4. New ideas for the development of medical device innovation
Learning the experience of foreign companies is a very necessary shortcut, but advanced technology is patented and confidential, and it is difficult to learn or copy. In the development of medical device innovation in China, it is recommended to seek innovations and breakthrough points from medical institutions and medical personnel, to understand what medical devices are needed by frontline medical personnel, and to collect their opinions and suggestions on existing medical devices.
5, should attach great importance to the construction of medical equipment innovation R & D talent team
The key to the development of medical device innovation in China lies in the government's policy of perfecting and encouraging the construction of relevant talent teams. The state sets up medical device departments or certain types of medical device professions in universities, and enterprises timely discover and train relevant talents.
6. Improve the incentive and innovation policy for medical device enterprises
The country is currently undergoing industrial transformation and upgrading. Medical device production and operation enterprises should seize the opportunity, make good use of relevant policies, and make enterprises bigger and stronger through mergers and acquisitions.
7. Further improve the review and approval policy for innovative medical device evaluation
The State Food and Drug Administration has issued the "Special Approval Procedure for Innovative Medical Devices", which gives policy encouragement to the review and approval of innovative medical devices. Through practice, the specific operational links will be more perfect.
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