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From following to catching up, the localization of high-end medical equipment has taken another big step. On September 26, the State Food and Drug Administration approved the application for the registration of innovative products of the "Proton Therapy System", becoming the first domestically produced proton therapy system approved for marketing in China. In fact, the proton therapy system also outlines the outline of the original innovation of my country's medical device companies. my country has a huge medical device market scale, and at the same time, support policies have been introduced one after another. How can Chinese enterprises achieve overtaking in corners and get through the "last mile" of landing applications?

Sprint "black technology"
It is understood that my country's first domestic proton therapy system approved for listing is produced by Shanghai Aipuqiang Particle Equipment Co., Ltd. This product is a key support project of the Ministry of Science and Technology's key research and development plan "Digital Diagnosis and Treatment Equipment Special" during the "Thirteenth Five-Year Plan" period, and it is also the first domestic proton therapy system approved for listing in China. The approval of this product on the market marks another step forward in the localization of high-end medical devices and equipment in China, which is of great significance for improving the means and level of medical tumor diagnosis and treatment in my country.

Its listing is also the epitome of my country's medical device hard technology innovation.

According to the observation of Deng Zhidong, general manager of Hainan Boao Medical Technology Co., Ltd., at present, the technological innovation of my country's medical device industry is increasingly showing "non-invasive, intelligent, refined, aggregated, efficient, portable, integrated, diversified, localized" "Nine characteristics, medical devices are being integrated with intelligent technology software and hardware such as artificial intelligence, cloud computing, big data, 5G, chips, sensors, etc., and the treatment efficiency, effect and accuracy are greatly improved. "In the field of medical devices, Chinese enterprises are striving to realize the original innovation and diversified flowering of the whole system, and each 'black technology' has sprung up like mushrooms after a rain."

The domestic single-hole minimally invasive surgical robot that easily peels off the thin quail eggshell, the fully automatic nucleic acid extraction equipment, and the world's first micron-level precise positioning and visual identification to operate ophthalmic medical devices, etc.... At the International Service Trade Fair, the stunning appearance of many new "domestic products" of medical devices also demonstrated the hard power of my country's medical device innovation.

Statistics show that during the "Thirteenth Five-Year Plan" period, the average annual compound growth rate of my country's medical device market is 13.6%, and a large number of domestic medical device manufacturers with leading technology have emerged.

"Although the development of my country's medical device industry is improving, there are still issues that need to be paid attention to." Deng Zhidong bluntly said that domestic medical devices have not yet formed a "high-tech" scientific research division and intensive collaborative development pattern. In terms of capacity, there is still a gap between my country's medical devices and developed countries."

"Platform" innovation
"Domestic medical devices can go from following to catching up, and the policy has played an important role in leading and promoting." Deng Zhidong said.

A reporter from Beijing Business Daily noticed that in order to promote the innovation of domestic medical equipment products, as early as May 2014, the National Health and Family Planning Commission launched the selection of excellent domestic medical equipment products. As of the end of 2020, six batches have been carried out.

In 2017, the General Office of the Central Committee of the Communist Party of China and the General Office of the State Council issued the "Opinions on Deepening the Reform of the Review and Approval System and Encouraging the Innovation of Drugs and Medical Devices". , another programmatic document for deepening the reform of the drug and medical device review and approval system, which has greatly promoted the willingness of medical device companies to research and develop and innovate.

Driven by many new policies, the number of domestically-made innovative devices approved has continued to rise. According to the research information compiled by Firestone from the National Medical Device Evaluation Center, as of October 9, 2021, the National Medical Insurance Bureau has approved a total of 147 first-time registration of three types of medical device products, of which 119 are domestically produced and 28 are imported.

At the same time, the margin of centralized procurement policy continues to ease, which also provides space for domestic innovative devices. On September 3 this year, the National Medical Insurance Bureau made it clear for the first time that it will set aside a certain market in addition to the centralized procurement, leaving room for innovative products.

"This statement by the National Medical Insurance Administration on the exemption of centralized procurement of innovative medical devices, and the measures taken by the Beijing Municipal Medical Insurance Bureau to set up an 'excluded payment' mechanism for new drugs and new technologies in the payment of medical insurance by disease diagnosis-related groups (CHS-DRG) in July, They all represent a clear stand to encourage innovation," said Liang Jialin, secretary-general of the Value Healthcare Advisory Committee.

Problem solving roadmap
Data from China Business Industry Research Institute shows that from 2017 to 2021, the market size of my country's medical device industry continues to increase, from 443.5 billion yuan to 964 billion yuan, with a compound growth rate of 21.47%. It is estimated that in 2022, the market size of China's medical device industry will reach 1.171 trillion yuan, a year-on-year increase of 21.47%.

It should be pointed out that, in addition to the market size, the National Health and Health Commission issued a notice in September of this year to use financial discount loans to update and transform medical equipment. The loan amount for each hospital is not less than 20 million yuan; the loan use direction includes the purchase of various medical equipment such as diagnosis and treatment, clinical examination, critical care, rehabilitation, and scientific research transformation.

In this context, how can domestic medical devices seize the opportunity and open up the "last mile" of landing applications?

"The innovation and development of the medical device industry involves many links and requires the cooperation of many parties to form an innovative ecosystem." Deng Zhidong gave suggestions from the perspective of technology research and development: the innovation and development of the medical device industry must have innovative sources, such as basic academic research institutions and key experiments. Laboratories, research hospitals, etc., to form regional industrial clusters, which can bring together a group of medical technology companies and large and medium-sized technology industrial enterprises; there must be industrial development funds and achievement transformation funds; there must be human resources related to the innovation and development of medical devices, including Scientists, engineering technicians, medical experimenters, etc.

In addition, some people in the industry believe that DRG/DIP is accelerating from the pilot to the full implementation, which will also affect the field of medical devices.

"DRG/DIP medical insurance payment method takes into account the interests of medical insurance, hospitals and patients, and achieves a balance between medical quality and cost, reducing the cost of insured persons and the reasonable expenditure of medical insurance funds." Liang Jialin analyzed that, focusing on innovation and upgrading, speeding up Pharmaceutical companies that develop exclusive and innovative products that are urgently needed in the market will gain market opportunities; domestic companies that focus on transforming technological advantages into cost advantages and producing both efficacy advantages and price advantages will also win a larger space for development.