Insufficient level of innovation is the biggest constraint in the development of domestic medical devices

Source: People's Political Consultative Conference

   [Global Medical Resources] “In recent years, the level of innovation in domestic medical devices has improved, but we still lack original innovation capabilities, which is the biggest bottleneck restricting the development of domestic medical devices.” Cardiovascular disease by the Chinese Medical Association on January 31st At the "Homemade Medical Device Innovation and Development" salon jointly organized by the Credit Committee and the People's Political Consultative Conference, Huo Yong, member of the National Committee of the Chinese People's Political Consultative Conference and chairman of the Cardiology Branch of the Chinese Medical Association, said that improving the level of innovation in domestic medical devices requires the joint efforts of all parties. Do not allow doctors to watch.


Domestic medical device innovation doctors cannot be seen


Huo Yong introduced that in 2013, the number of cardiac interventions in China exceeded 450,000, and nearly 700,000 stents were used, of which more than 3/4 of the market has been occupied by domestic stents, but the originality is not in our hands. Although we may have some local or detailed improvements, such as the first in the world to produce a biodegradable drug coating, there is not yet a truly overall original product.


Huo Yong pointed out that medical device innovation must come from doctors. The company may also have good ideas, but because he is not in the clinic, it is impossible to fully understand the needs of the disease diagnosis and treatment, so the demand for and lack of the equipment will not be as clear as a doctor. However, Chinese doctors can't even finish watching patients every day. They simply don't have time to innovate. They also lack such awareness. What is more important is the lack of motivation, such as how to protect intellectual property rights and how to distribute benefits. “At present, the People's Hospital of Jiangsu Province has conducted beneficial explorations. They stipulate that doctors' innovations are owned by themselves and that the resulting 80% of the benefits are attributable to them. From the national level, policies should also be introduced to encourage clinicians to participate in the research and development of medical devices.”


Domestically produced imported medical devices should be of the same quality


"China's medical device market is still dominated by imported products, and even if it is domestic medical devices with superior quality and reasonable prices, the proportion of people entering public hospitals in the country is still low," said Yu Guangyan, member of the National Committee of the Chinese People's Political Consultative Conference and former president of the Stomatological Hospital of Peking University. There are objective reasons, such as the quality of some domestic medical devices, or lack of stability, some manufacturers or sales departments, poor after-sales service, low user satisfaction, etc. Of course, some people, such as patients and their families often The use of imported medical devices is required, and medical personnel are not actively using domestic products.


“There are also some problems in the direction of national policies, such as the different prices of domestically imported homogenous products in tender pricing.” Dong Heyan, chairman of Liaoning CPPCC and chairman of Liaoning Biomedical Materials R&D Center Co., Ltd., for example, said that domestic cardiac stents and imported heart stents are currently There is no difference in the level, but in the tender pricing, the average price of domestic bracket 0.8 million, the average price of imported stents 16,000 yuan, a difference of 1 times; in orthopedic implant devices, the gap can reach 2 to 3 times. In addition, due to the tendering of the scaffold with the historical lowest price as the benchmark, the original innovation product is lower than the imitation product. This tender pricing policy has seriously dampened the enthusiasm of corporate innovation. In the long run, it is not conducive to the healthy development of China's medical device industry.


Dong Heyan also stated that at present, high-tech enterprises in China are paying VAT and income tax at a tax rate of 17% and 25%, with heavy tax burden.


Dong Heyan suggested that domestically-made stents and imported stents should have the same quality and equal competition. She also called on the country to issue a ceiling price to give companies appropriate bargaining power under this price line; and to tax a domestic stenting company by reducing the tax burden on domestically produced scaffolding companies by 4%.


Yu Guangyan suggested studying Japan and South Korea experiences, introducing effective policies to promote the development of the country’s medical device industry, setting up a research fund for domestic medical device R&D, and vigorously supporting the research and development of related companies’ products; strengthening research collaboration between companies and medical researchers to adapt to medical devices The need for product development. Relevant companies should have a strong sense of quality and strive to adopt advanced country standards to make products and ensure the quality of products entering the market.


At the same time, medical insurance policy adjustment and media publicity should also be adopted to strengthen the awareness of medical personnel, medical institutions, management personnel, patients, and family members in developing the national pharmaceutical industry and increase the awareness of using domestically produced medical devices.


Medical equipment review and supervision personnel need to be expanded


As our government has increased investment and promoted the rapid development of the medical device industry, China’s product categories have been continuously enriched and its technical content has gradually increased, presenting new challenges to the supervision of medical devices. Chi Hui, a member of the National Committee of the Chinese People's Political Consultative Conference and the deputy director of the Institute of Information Research of the Chinese Academy of Medical Sciences, said that currently there is a serious shortage of medical device supervision personnel in China. At the end of 2012, there were 15,348 medical device manufacturers and 185,575 enterprises in operation nationwide. There were 2,459 medical device production supervisors nationwide, 966 full-time employees, 3,683 regulatory personnel, and 1,158 full-time employees, ie, each full-time production/ Business supervisors must assume the supervision tasks of 27 production companies/160 operating companies.


In addition, the lack of strength of registered reviewers is also a major bottleneck restricting the development of domestic medical devices. According to reports, there are currently only 103 staff responsible for the registration of medical devices in the country, and there are about 200 medical device technical reviewers from the provincial bureaus and the State Food and Drug Administration. Among them, the technical reviewers of the Center for Medical Device Evaluation of the State Administration of State 60 people are far away from the need to effectively complete the basic tasks.


Chi Hui suggested increasing government support, increasing the talent team and capacity building of medical device regulatory agencies at all levels, and increasing the establishment and expansion of medical device administrative supervision personnel.

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