China News Service, Hangzhou, February 27 (Zhao Yejiao and Guo Tianqi) In recent years, domestic medical device independent innovation has made a series of breakthroughs, but the overall level is still not high. Compared with the foreign medical device industry, there is a certain gap. The market share of domestic medical devices Insufficient medical devices have become one of the main reasons why medical treatment is expensive. In an exclusive interview with China News Service, Wang Jian'an, a member of the National Committee of the Chinese People's Political Consultative Conference, an academician of the Chinese Academy of Sciences, and the director of the National Key Laboratory of Transvascular Implantable Devices, suggested promoting innovation and standardized management of implantable medical devices. .
The picture shows the team of Professor Wang Jianan (middle) and the R&D team discussing the functions of the transcatheter artificial valve system.
Photo courtesy of the Second Affiliated Hospital of Zhejiang University School of Medicine
"As an important medical method, implantable medical devices play an increasingly important role in improving patients' quality of life and improving disease treatment effects," Wang Jian'an said.
According to Wang Jian'an, there is a big price difference between imported and domestically produced implantable medical device products. For example, transcatheter aortic valve replacement products, the price of imported products currently in clinical use is about 300,000 yuan, and the domestic price is about 200,000 yuan. On the basis of ensuring high-quality curative effect, a trend of domestic substitution can gradually be formed, thereby reducing the medical burden of many families.
"However, the current market share of domestic medical devices is still insufficient. Taking the cardiovascular field where I work as an example, China's domestic implantable pacemaker market share will only account for 6.46% in 2021." Wang Jian'an said.
Faced with a series of development problems of implantable medical devices, how to solve the problem?
Wang Jian'an suggested that relevant departments open a "green channel" for the entire chain of implantable medical device research registration, application, protection, and management, and support the establishment of national key laboratories and other national scientific research institutions in conjunction with high-level medical institutions and high-tech enterprises. The Implantable Medical Device R&D Alliance strives to explore a healthy and sustainable development path of "industry, academia, research and medicine".
The picture shows the team of Professor Wang Jianan (right in the picture) performing multiple surgical demonstrations to cardiovascular colleagues from all over the world at China Valve (HANGZHOU).
Photo courtesy of the Second Affiliated Hospital of Zhejiang University School of Medicine
At the same time, in order to reduce the concerns of scientific researchers and promote the smooth transformation of scientific and technological achievements, Wang Jian'an suggested that the Ministry of Science and Technology should take the lead in relevant departments to further promote the reform of the ownership of scientific and technological achievements, promote the successful experience of empowering and transforming scientific and technological achievements, organize science and technology, industry, law, etc. Experts in the field established a service invention definition committee and established a detailed due diligence exemption system.
In addition, Wang Jian'an believes that relevant departments should better support and protect the interests of all parties involved in the research of original implantable medical devices, strictly innovate the medical device approval process, and limit low-level, highly repetitive, and meaningless implantable medical devices. The entry of equipment into the market will further stimulate the innovation momentum of high-tech enterprises and form a healthy competition mechanism.
In Wang Jian'an's view, implantable medical devices are high-tech and interdisciplinary products with rapid technological development and high risks. Laws should be applied to ensure the development momentum and sustainability of innovative actions.
"It is recommended that the State Food and Drug Administration work with relevant departments to promote the promulgation of the "Medical Device Management Law" as soon as possible, encourage scholars to carry out scientific research on regulatory science with Chinese characteristics, and select some provinces and cities to carry out pilot research and development of implantable medical devices, and appropriate approval authority Decentralize it to the provincial and municipal levels, and strengthen the full life cycle supervision of implantable medical devices on the market." Wang Jian'an also suggested that the National Medical Insurance Administration establish a procurement catalog for implantable medical devices to promote domestic innovative medical devices to be put into use as soon as possible and reduce the cost of patient care. cost.
(over)