21st Century Business Herald Xi reporter Han Liming Shanghai reports In recent years, with the release of relevant national industrial policy dividends, the innovation and development of medical devices has been accelerating. According to public information, in 2022, a total of 68 medical device products will enter the innovation approval channel, a year-on-year increase of 9.68%, and as of August 2023, a total of 463 medical device products have entered the special approval channel for innovative medical devices, and 229 innovative products have been approved for marketing.
The "14th Five-Year Plan" for the development of medical equipment industry proposes that by 2025, the medical equipment industry base will be advanced, the modernization level of the industrial chain will be significantly improved, the mainstream medical equipment will basically be effectively supplied, and the performance and quality level of high-end medical equipment products will be significantly improved, and a comprehensive support capacity for public health and medical health needs will be initially formed.
The domestic upgrading, high-end, and intelligent innovation and development of medical devices in mainland China have become the main theme, and behind the increasingly fierce competition is the huge medical demand and market opportunities. The "2023 China Medical Device Industry Development Report" predicts that the operating income of Chinese medical device manufacturers is expected to exceed 1.8 trillion yuan by 2025, achieving the goal of doubling from 2020. More and more multinational medical device giants are intensively upgrading their "localization" strategies.
Yu Jing, vice president of Medtronic and general manager of China Orthopedics and Shenwai Business Group, told the 21st Century Business Herald that China is the largest market for medical technology in the future, and in recent years, multinational medical device companies are also thinking about how to accelerate business expansion in China. "The development of the medical device field will definitely accelerate in the future, and it is very difficult for only a few companies to undertake the innovation demand. In other words, there are also areas that we don't have a layout for, but products and technologies that are very interesting. Therefore, it is very important to join forces to establish an ecosystem, and it is also the trend of the future development of the industry. ”
"From 0 to 1", go through the most difficult stage
According to the data of the State Food and Drug Administration, in 2022, the main business revenue of medical devices in mainland China will reach 1.3 trillion yuan, becoming the second largest market in the world. More and more multinational medical device companies are strengthening their localization layout in order to meet the needs of the Chinese market more quickly and accurately.
"Over the past eight years, more than 1,000 sets of advanced machining equipment have been put in place at Medtronic's Kanghui Changzhou base, because the market not only needs products with quality assurance, but also has high requirements for efficiency. Yu Jing said, "Medtronic Kanghui Science and Technology Park has completed the construction of clean workshops and intelligent robot production lines, and will be equipped with intelligent equipment R&D and production facilities in the future." With the development of more and more localized products by Medtronic Kanghui and the conversion of products from the U.S. headquarters, Medtronic Kanghui's product line will expand in the direction of diversification. ”
This year, Medtronic China Orthopedics and Shenwai Business Group officially released the "AiBLE™ Digital Intelligence Innovation Ecosystem". The ecosystem organically integrates internal implants and surgical robots, surgical navigation systems, intraoperative imaging systems, surgical power systems and other intelligent equipment, and is centered on a digital and intelligent integration platform empowered by big data links and AI, integrates industrial chain capabilities, digitalization and artificial intelligence technologies, actively builds a collaborative platform for industry, academia, research and medicine, and jointly develops intelligent collaboration in the operating room with clinical experts, medical institutions, and industry partners in the industry. Cutting-edge technologies such as big data analysis of special diseases, artificial intelligence-assisted diagnosis, and medical informatization have comprehensively empowered the development of orthopedics to digitalization and intelligence.
Promoting local innovation is the direction that medical device companies are aiming at, but how to effectively transform and implement clinical scientific research achievements is a difficult hurdle that must be overcome to improve the overall level of domestic medical devices.
As an important role in the transformation of medical device scientific research achievements, clinicians are the promoters and users of medical device product innovation. According to public information, no more than 10% of China's scientific research and technology transformation is achieved, while in developed countries it accounts for about 40%.
In this context, it has become the general trend of the development of the industry to allow clinicians to actively participate in and integrate into the R&D and production of medical devices, which also requires enterprises and clinicians to form a good cooperative relationship.
Liu Wei, upstream marketing director of neurosurgery and orthopedic trauma therapy of Medtronic China's orthopedic and neurosurgery business, explained that "there are many difficulties in the reduction and fixation of posterolateral fracture fragments of tibial plateau, low clinical attention, and obvious pain points in existing solutions. ”
"Focusing on how to put the needs of patients in the first place, improve the diagnosis and treatment effect, and solve clinical pain points, Medtronic Kanghui cut in from a technical point of view, and Beijing Jishuitan Hospital cut in from the clinical needs, with the help of the Medtronic platform, to transform the clinical concepts of doctors into actual products. Liu Wei said, "Among them, there are four patents. The product is currently in the manufacturing process and is expected to be available for clinical use in one year. "
"In addition to the collision of clinical needs and technology, the core breakthrough point in the cooperation between Medtronic and Beijing Jishuitan Hospital lies in the ownership and valuation of intellectual property rights. Solving these problems reasonably and compliantly will enable Medtronic to go through the most difficult process of 'from 0 to 1' in localized cooperative research and development, and such a model can be replicated and promoted in the future. Yu Jing said bluntly.
With the acceleration of localized cooperative research and development and the improvement of the efficiency of achievement transformation, mainland medical devices will gradually impact the world market. In April this year, Medtronic Kanghui Changzhou Science and Technology Park successfully laid the foundation stone in Changzhou National High-tech Industrial Development Zone. According to reports, the science and technology park contains two positions, one is as an important global production base of Medtronic, where 70% of Medtronic's spinal implant tools are produced and sold to the world, and the other is as the global headquarters of Kanghui Medical, which sells China's innovative products overseas and serves patients around the world.
The incubator accelerates the transformation of achievements and expands the ecosystem
Clinical research achievements and cutting-edge technologies of innovative enterprises are the key to promoting the domestic upgrading of medical devices. Different from other industries, medical devices have a high threshold, industry supervision and regulations are stricter, and a lot of manpower, material resources, and financial resources need to be invested before products are launched.
In an interview with 21st Century Business Herald, Medtronic China's business development director of orthopedics and Shenwai business Le Lei analyzed, "At different stages of the project, the medical device innovation team needs to solve various problems, such as how to obtain the registration certificate in terms of quality regulations, may face difficulties that cannot be overcome, and will also face challenges in terms of capital or policy." ”
Therefore, the importance of platform construction and resource integration is becoming increasingly prominent. "The Innovation Incubation Center of Medtronic Kanghui Changzhou Science and Technology Park, which was officially unveiled on December 23, has the function of comprehensively empowering start-up teams, integrating government support, R&D accumulation, quality, regulations, IP and other functional departments to help start-up teams solve problems that are easy to encounter in all aspects of innovation projects. We also hope to use the incubator to promote product launch and future industrialization development more quickly. Le Lei said.
According to reports, the incubation center will undertake the achievements of collaborative innovation of industry, academia, research and medicine, and at the same time extensively contact various innovative projects and teams in the industry, explore high-potential projects, accelerate the transformation and implementation of innovative technologies, and complete the innovation closed loop of the ecosystem.
The development of medical device enterprises not only depends on their own strength, but also needs to link multiple resources. Medtronic looks forward to further improving the AiBLE™ digital intelligence orthopedics and digital intelligence neurosurgery integration solutions through the successful transformation of these innovative technologies, expanding the AiBLE™ innovation ecosystem, promoting industrial innovation and upgrading, and promoting the high-quality development of the industry.
Yu Jing added, "The new construction project of Medtronic Changzhou Science and Technology Park successfully obtained the construction permit in December, and two new buildings will be built in the future, one for production facilities and the other for office buildings, which will also be the location of the innovation incubation center. The production area will be equipped with a trial production workshop to provide trial production space for start-up teams. The new project is expected to be completed within two years. ”
At present, in the field of neuroscience, "digital intelligence" has become the mainstream trend in innovation and development. The heavy burden of diseases and a large number of clinical needs that need to be solved urgently are prompting generations of industry parties to explore, and the application of cutting-edge technologies such as brain-computer interface, surgical robots, 3D imaging, and AI assistance has also become a hot track for technological innovation.
This also makes high-quality innovative projects in the fields of neuroscience and brain science, such as innovative medical devices, smart devices, digital medicine, and medical services, favored by multinational medical device giants. We hope that more local innovative medical device companies will become part of the Medtronic ecosystem in the future. Yu Jing emphasized.
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