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The nine-story platform starts from the base of the earth
.
Just one small chip or part can cause a whole set of large medical equipment to be paralyzed in production
.
Most of the ventilators assembled from more than 1,000 components need to be imported, and domestic substitution cannot be achieved at present
.
With millions of testing equipment, there is only one supplier in the world
.
These are the "stumbling blocks" that "stuck" on the road of medical device entrepreneurs
.
Medical imaging equipment is the largest segment of the medical device industry.
In recent years, although local leading companies such as Neusoft Medical, Mindray Medical, and United Imaging Medical have gradually introduced new equipment and achieved domestic substitution in some products, some high-end products However, there are still many challenges to compete with "GPS" (GE Healthcare, Philips, Siemens)
.
The problem isn't just with the overall device
.
In a previous interview with the media, Fan Yubo, Dean of the School of Biological and Medical Engineering, Beihang University, introduced that some medical devices have broken the monopoly of foreign high-end products, but they are not in the original innovation, core invention patents, core production line equipment, inspection equipment, core raw materials, etc.
still rely on imports
.
For example, core components such as CT X-ray tubes, high-voltage generators, MR superconducting magnets, and DR flat panel detectors are still concentrated in the hands of a few European and American companies
.
This situation also exists in the largest medical device, the heavy ion accelerator
.
Medical heavy ion accelerators are one of the largest medical equipment, with high technical difficulties, complex systems, high production and control process requirements, and large capital investment.
At present, only a few developed countries in the world have mastered this high-end technology.
.
The "bottleneck" of domestic heavy ion accelerators is mainly concentrated at the chip level.
Yang Wenjie, deputy general manager of Lanzhou Kejin Taiji New Technology Co.
, Ltd.
, a high-tech enterprise under the Chinese Academy of Sciences Holdings Co.
, Ltd.
and the Institute of Modern Physics of the Chinese Academy of Sciences, told E-Pharma Manager People, "Large medical equipment is integrated and comprehensive.
Going to the bottom depends on chips, such as the CPU on the controller, the chips of high-end integrated circuits, etc.
, but at present these all need to be imported, which leads to the most prominent problems.
It is because of the strong uncertainty and the occasional out-of-stock situation
.
" This is where Yang Wenjie felt "uncomfortable", "We purchased imported controllers some time ago, and the original supply cycle was about 4 to 5 months.
However, we are suddenly notified by the supplier that we need to wait for a year or even longer
.
Affected by the epidemic, if the other party informs us not to produce, this is a big problem for us
.
" At present, the supply of chips is compared with the previous stage.
Although it has improved, if this problem is not fundamentally solved, there will still be a situation where the supply cycle time is too long
.
01 "Stuck" in basic scientific research "Stuck neck" is only the appearance of the problem, and the deep level is the lack of basic theoretical research and innovation
.
At the R&D level, medical devices are similar to drugs, and the basic research in the early stage and the R&D innovation and breakthrough applications in the back-end are in the same line
.
Yang Wenjie believes that the fundamental reason for "not as good as others" in chips and core technologies is the lack of original innovation breakthroughs and core technologies due to weak basic research
.
Medical devices involve many industries such as medical treatment, machinery, and electronics.
It is a multidisciplinary, knowledge-intensive, and capital-intensive high-tech industry
.
Especially in large-scale medical devices, the performance is more obvious.
Only after the intersection, innovation and integration of multiple basic disciplines can there be such a large-scale device
.
There are only some breakthroughs in a certain field, and innovation is not enough to subvert large medical devices as a whole
.
Taking a ventilator as an example, an invasive ventilator requires more than 1,000 components, of which the core components, such as turbine fans, sensors, chips, proportional valves, and voice coil motors, are mostly supplied by European and American companies
.
"Like the development and production of chips, it includes basic research in the fields of physics, optics, electronics, etc.
Without these original innovations, we can only imitate and copy other people's models, always catching up, but it is difficult to find another way.
, there has been a breakthrough progress
.
" Yang Wenjie said
.
In addition to the complex manufacturing process of the equipment itself and high requirements for product quality and functional stability, the weak upstream supply capacity of the domestic industrial chain is also one of the limiting factors
.
Breaking down barriers such as raw material supply and component assembly is also crucial
.
Fan Yubo believes that it is not feasible to imitate all the time when the key core technologies and equipment in medical devices rely on imports
.
Only by strengthening the basic theoretical innovation at the source can it be expected to break through the "stuck neck" problem in the field of medical devices and achieve real localization "from start to finish"
.
02 Confusion of Interdisciplinary With the layout and development of relevant national scientific research institutes, the current "stuck neck" link may not achieve "domestic freedom" in the future
.
In very few subdivisions, there are still "forgotten corners"
.
Yang Wenjie found that in daily scientific research, some frequently used testing equipment and instruments have not been developed in China, or have been monopolized by foreign countries
.
"Some of the high-precision instruments and meters we use for measurement and testing are rarely available from domestic manufacturers, and there are almost no products that can reach the same level and accuracy as foreign countries
.
In the process of scientific research, the transformation of results needs to rely on some instruments.
, instruments, but these things are not in the hands of their own people, but they use other people's instruments to verify their R&D experiments, and such high-end measurement equipment has almost been monopolized by foreign companies, such as Fluke, Agilent, etc.
.
In addition, there is also a QA device that specializes in dose detection for patients before receiving heavy ion accelerator treatment, which is also monopolized by a German company
.
Even domestic companies and hospitals are doing it, but from the perspective of equipment reflection, short-term use It's ok, but the long-term stability is poor
.
"Several millions are spent on such a small device, but only one company's products are available in the world, and the stability and experience of domestic devices cannot meet the requirements of clinical use
.
"Yang Wenjie said that although domestic medical devices have achieved remarkable development in recent years, there are still some areas that have not been fully covered in terms
of subdivisions.
He believes that foreign companies can achieve "uniqueness" in some subdivisions The reason for "being a beast" lies in the persistence for decades
.
Even if the market volume of a product is small, a product can only be made well with continuous investment from beginning to end
.
In the production process of heavy ion accelerators, the RFQ cavity used for acceleration needs to use high-purity oxygen-free copper.
Even if the amount is not large, it needs to be imported .
"We have not yet found this material in China.
There are only one or two suppliers in the world that can make this material, which currently needs to be imported
.
Yang Wenjie said
.
In addition to the materials that cannot be produced, there is also a certain gap between the existing domestic materials and imported products
.
Yang Wenjie introduced that in order to facilitate the use and promotion, the heavy ion accelerator equipment will be more miniaturized in the next step.
A large number of superconducting materials are used
.
However, there are various concerns in the selection of superconducting materials
.
Domestic manufacturers have broken through the technology of superconducting materials, and they are not inferior to imported materials in terms of performance and product parameters
.
However, superconducting materials The raw material of niobium is niobium, and Brazil accounts for more than 95% of the global reserves
.
Once the source material is in short supply, it will have a serious impact on the entire industry chain
.
An employee of the medical and engineering department of a tertiary hospital in Beijing told the manager of E-pharmaceutical that the localization rate of some basic inspection equipment in the laboratory department of the hospital has gradually increased, but in the field of high-end inspection, domestic equipment still needs to be strengthened in technology
.
The medical device commonly used in cardiac interventional surgery, the core raw material of the stent (thin-diameter thin-walled metal tube) in the cardiac stent, cannot be produced in China and needs to be imported
.
In addition to the device itself, there are some software levels involved, which also need to be continuously improved
.
There are currently two software systems for the heavy ion accelerator: one is self-developed, and the other is imported RayStation
.
Among them, RayStation is a treatment planning system with a high market share in the field of radiotherapy
.
Judging from the experience feedback from doctors, almost every doctor specified to use RayStation
.
A similar problem exists with software at the research level
.
Yang Wenjie pointed out that in the early stage, among the software used, the simulation software, simulation software and design software involved were all imported
.
"Compared to a large structure of the product, these seem to be insignificant
.
However, without the results obtained by these software, subsequent production cannot be continued
.
That is to say, the core key technology from the source has been controlled by people.
In this regard, Fan Yubo pointed out that promoting the cross-integration and collaborative innovation of medicine and industry is the key element to break the "bottleneck" of innovation in China's medical device industry
.
It is also suggested that we should fundamentally increase investment in innovative research and development in the field of medical devices, increase the training of innovative leaders in biomedical engineering, and at the same time increase electronics, machinery, materials, software, information technology and other disciplines, industries and medical devices.
Cross-integration in the field; increase the intensity of the integration of production and education of medical devices and the integration of science and education
.
Yang Wenjie suggested that with the support of relevant national policies, the cooperation of industry, academia and research should be strengthened.
.
For example, hospitals support domestic medical devices and equipment when purchasing equipment, and build a feedback platform that connects hospitals, patients, and R&D departments to share data and resources
.
References: 1.
2021-05-01 Financial National Weekly "Compared to chips, the neck in this field is more "dead"! 2.
Science and Technology Daily, "Clumsy detectors blur medical images" 3.
Shanghai Shenyin & Wanguo Securities Research Institute "Medical equipment highland, XR and CT are becoming mature" 4.
China Merchants Bank Research Institute "The rise of domestic equipment, import substitution and internationalization is an important development direction”
.
Just one small chip or part can cause a whole set of large medical equipment to be paralyzed in production
.
Most of the ventilators assembled from more than 1,000 components need to be imported, and domestic substitution cannot be achieved at present
.
With millions of testing equipment, there is only one supplier in the world
.
These are the "stumbling blocks" that "stuck" on the road of medical device entrepreneurs
.
Medical imaging equipment is the largest segment of the medical device industry.
In recent years, although local leading companies such as Neusoft Medical, Mindray Medical, and United Imaging Medical have gradually introduced new equipment and achieved domestic substitution in some products, some high-end products However, there are still many challenges to compete with "GPS" (GE Healthcare, Philips, Siemens)
.
The problem isn't just with the overall device
.
In a previous interview with the media, Fan Yubo, Dean of the School of Biological and Medical Engineering, Beihang University, introduced that some medical devices have broken the monopoly of foreign high-end products, but they are not in the original innovation, core invention patents, core production line equipment, inspection equipment, core raw materials, etc.
still rely on imports
.
For example, core components such as CT X-ray tubes, high-voltage generators, MR superconducting magnets, and DR flat panel detectors are still concentrated in the hands of a few European and American companies
.
This situation also exists in the largest medical device, the heavy ion accelerator
.
Medical heavy ion accelerators are one of the largest medical equipment, with high technical difficulties, complex systems, high production and control process requirements, and large capital investment.
At present, only a few developed countries in the world have mastered this high-end technology.
.
The "bottleneck" of domestic heavy ion accelerators is mainly concentrated at the chip level.
Yang Wenjie, deputy general manager of Lanzhou Kejin Taiji New Technology Co.
, Ltd.
, a high-tech enterprise under the Chinese Academy of Sciences Holdings Co.
, Ltd.
and the Institute of Modern Physics of the Chinese Academy of Sciences, told E-Pharma Manager People, "Large medical equipment is integrated and comprehensive.
Going to the bottom depends on chips, such as the CPU on the controller, the chips of high-end integrated circuits, etc.
, but at present these all need to be imported, which leads to the most prominent problems.
It is because of the strong uncertainty and the occasional out-of-stock situation
.
" This is where Yang Wenjie felt "uncomfortable", "We purchased imported controllers some time ago, and the original supply cycle was about 4 to 5 months.
However, we are suddenly notified by the supplier that we need to wait for a year or even longer
.
Affected by the epidemic, if the other party informs us not to produce, this is a big problem for us
.
" At present, the supply of chips is compared with the previous stage.
Although it has improved, if this problem is not fundamentally solved, there will still be a situation where the supply cycle time is too long
.
01 "Stuck" in basic scientific research "Stuck neck" is only the appearance of the problem, and the deep level is the lack of basic theoretical research and innovation
.
At the R&D level, medical devices are similar to drugs, and the basic research in the early stage and the R&D innovation and breakthrough applications in the back-end are in the same line
.
Yang Wenjie believes that the fundamental reason for "not as good as others" in chips and core technologies is the lack of original innovation breakthroughs and core technologies due to weak basic research
.
Medical devices involve many industries such as medical treatment, machinery, and electronics.
It is a multidisciplinary, knowledge-intensive, and capital-intensive high-tech industry
.
Especially in large-scale medical devices, the performance is more obvious.
Only after the intersection, innovation and integration of multiple basic disciplines can there be such a large-scale device
.
There are only some breakthroughs in a certain field, and innovation is not enough to subvert large medical devices as a whole
.
Taking a ventilator as an example, an invasive ventilator requires more than 1,000 components, of which the core components, such as turbine fans, sensors, chips, proportional valves, and voice coil motors, are mostly supplied by European and American companies
.
"Like the development and production of chips, it includes basic research in the fields of physics, optics, electronics, etc.
Without these original innovations, we can only imitate and copy other people's models, always catching up, but it is difficult to find another way.
, there has been a breakthrough progress
.
" Yang Wenjie said
.
In addition to the complex manufacturing process of the equipment itself and high requirements for product quality and functional stability, the weak upstream supply capacity of the domestic industrial chain is also one of the limiting factors
.
Breaking down barriers such as raw material supply and component assembly is also crucial
.
Fan Yubo believes that it is not feasible to imitate all the time when the key core technologies and equipment in medical devices rely on imports
.
Only by strengthening the basic theoretical innovation at the source can it be expected to break through the "stuck neck" problem in the field of medical devices and achieve real localization "from start to finish"
.
02 Confusion of Interdisciplinary With the layout and development of relevant national scientific research institutes, the current "stuck neck" link may not achieve "domestic freedom" in the future
.
In very few subdivisions, there are still "forgotten corners"
.
Yang Wenjie found that in daily scientific research, some frequently used testing equipment and instruments have not been developed in China, or have been monopolized by foreign countries
.
"Some of the high-precision instruments and meters we use for measurement and testing are rarely available from domestic manufacturers, and there are almost no products that can reach the same level and accuracy as foreign countries
.
In the process of scientific research, the transformation of results needs to rely on some instruments.
, instruments, but these things are not in the hands of their own people, but they use other people's instruments to verify their R&D experiments, and such high-end measurement equipment has almost been monopolized by foreign companies, such as Fluke, Agilent, etc.
.
In addition, there is also a QA device that specializes in dose detection for patients before receiving heavy ion accelerator treatment, which is also monopolized by a German company
.
Even domestic companies and hospitals are doing it, but from the perspective of equipment reflection, short-term use It's ok, but the long-term stability is poor
.
"Several millions are spent on such a small device, but only one company's products are available in the world, and the stability and experience of domestic devices cannot meet the requirements of clinical use
.
"Yang Wenjie said that although domestic medical devices have achieved remarkable development in recent years, there are still some areas that have not been fully covered in terms
of subdivisions.
He believes that foreign companies can achieve "uniqueness" in some subdivisions The reason for "being a beast" lies in the persistence for decades
.
Even if the market volume of a product is small, a product can only be made well with continuous investment from beginning to end
.
In the production process of heavy ion accelerators, the RFQ cavity used for acceleration needs to use high-purity oxygen-free copper.
Even if the amount is not large, it needs to be imported .
"We have not yet found this material in China.
There are only one or two suppliers in the world that can make this material, which currently needs to be imported
.
Yang Wenjie said
.
In addition to the materials that cannot be produced, there is also a certain gap between the existing domestic materials and imported products
.
Yang Wenjie introduced that in order to facilitate the use and promotion, the heavy ion accelerator equipment will be more miniaturized in the next step.
A large number of superconducting materials are used
.
However, there are various concerns in the selection of superconducting materials
.
Domestic manufacturers have broken through the technology of superconducting materials, and they are not inferior to imported materials in terms of performance and product parameters
.
However, superconducting materials The raw material of niobium is niobium, and Brazil accounts for more than 95% of the global reserves
.
Once the source material is in short supply, it will have a serious impact on the entire industry chain
.
An employee of the medical and engineering department of a tertiary hospital in Beijing told the manager of E-pharmaceutical that the localization rate of some basic inspection equipment in the laboratory department of the hospital has gradually increased, but in the field of high-end inspection, domestic equipment still needs to be strengthened in technology
.
The medical device commonly used in cardiac interventional surgery, the core raw material of the stent (thin-diameter thin-walled metal tube) in the cardiac stent, cannot be produced in China and needs to be imported
.
In addition to the device itself, there are some software levels involved, which also need to be continuously improved
.
There are currently two software systems for the heavy ion accelerator: one is self-developed, and the other is imported RayStation
.
Among them, RayStation is a treatment planning system with a high market share in the field of radiotherapy
.
Judging from the experience feedback from doctors, almost every doctor specified to use RayStation
.
A similar problem exists with software at the research level
.
Yang Wenjie pointed out that in the early stage, among the software used, the simulation software, simulation software and design software involved were all imported
.
"Compared to a large structure of the product, these seem to be insignificant
.
However, without the results obtained by these software, subsequent production cannot be continued
.
That is to say, the core key technology from the source has been controlled by people.
In this regard, Fan Yubo pointed out that promoting the cross-integration and collaborative innovation of medicine and industry is the key element to break the "bottleneck" of innovation in China's medical device industry
.
It is also suggested that we should fundamentally increase investment in innovative research and development in the field of medical devices, increase the training of innovative leaders in biomedical engineering, and at the same time increase electronics, machinery, materials, software, information technology and other disciplines, industries and medical devices.
Cross-integration in the field; increase the intensity of the integration of production and education of medical devices and the integration of science and education
.
Yang Wenjie suggested that with the support of relevant national policies, the cooperation of industry, academia and research should be strengthened.
.
For example, hospitals support domestic medical devices and equipment when purchasing equipment, and build a feedback platform that connects hospitals, patients, and R&D departments to share data and resources
.
References: 1.
2021-05-01 Financial National Weekly "Compared to chips, the neck in this field is more "dead"! 2.
Science and Technology Daily, "Clumsy detectors blur medical images" 3.
Shanghai Shenyin & Wanguo Securities Research Institute "Medical equipment highland, XR and CT are becoming mature" 4.
China Merchants Bank Research Institute "The rise of domestic equipment, import substitution and internationalization is an important development direction”
