Who fired the first shot of high-end equipment independent controllability?

With the marginal easing of the centralized procurement policy and the exemption of innovative devices, "medicine is not as good as equipment" has become effective again.

The degree of internal involution of medical devices is light, the leading position is relatively solidified, and the logic of going overseas is also smooth (according to the revenue caliber in 2020, the overseas income of the 20 A-share medical device companies accounts for more than 30%). The domestic production rate and penetration rate in the field of high-end devices are very low, and the medium and long-term growth logic is stronger, which can be called the strongest track in medical treatment.

In addition to coronary stents and artificial valves, most of the domestic high-end equipment field is still dominated by foreign capital, and today excavate domestic leaders in various subdivisions to be the first to break the import monopoly.

Gene sequencing

The upstream of the gene sequencing industry chain has the highest barriers to entry, and the world's enterprises with independent research and development and mass production of clinical-grade high-throughput gene sequencers were once only Illumina and Thermo Fisher. In 2013, BGI acquired CG, a US sequencer manufacturer, to acquire DNA nanospheres and other technologies.

At that time, the BGI R&D team obtained the prototype of CG's gene sequencer, shaped like a black tower, the entire equipment design is extremely precise, the pursuit of hardware system perfection, but also created a weight of two tons and a price of tens of millions of yuan, from the positioning and product form like a very "supercomputing". After digestion and absorption, BGI relies on self-developed capabilities to iteratively innovate and turn the sequencer into an economical and reliable desktop device with higher performance.

In 2016, BGI Intelligent Manufacturing was officially established. At present, BGI Intelligent Manufacturing has become one of the three enterprises in the world that can independently develop and mass-produce clinical high-throughput gene sequencers, and has established an independent and controllable source core technology system, including DNBSEQ sequencing technology, regular array chip technology, sequencer opto-electromechanical system technology, etc., and has reached the international advanced level.

BGI's core products can not only compete with the same level of products in the United States, but also lead in some key indicators. In September this year, Illumina released its breakthrough new NovaSeq X series, while BGI has released instruments DNBSEQ-T7 and DNBSEQ-T10X4 in 2018 and 2020 respectively for high-throughput sequencing customers. DNBSEQ-T10X4 has a daily flux of up to 17-18Tb, and can sequence 50,000 human standard genomes per year, much higher than the NovaSeq X series products. At the same time, the DNBSEQ-T7 platform is faster than the NovaSeq X series products at the same throughput level of 6T for customers with high data delivery effectiveness.

Medical imaging

Domestic medical imaging equipment started late, and United Imaging Medical rose to pursue foreign monopoly from upstream components to cutting-edge technology.

Most of the components of United Imaging Medical can be self-developed and self-made, and has realized the independent research and development of core components of high-end medical imaging and radiotherapy products such as PET digital optical guide detectors, MR superconducting magnets, MR gradient power amplifiers, MR RF power amplifiers, CT space-time detectors, RT multi-leaf gratings (of which all core components of magnetic resonance products are 100% self-developed and self-produced), domestic substitution of high-voltage generators and CT tubes is also being promoted, and low-end high-voltage generators have been used in the company's XR and CT products. The research and development of the high-end high-pressure generator scientific research prototype is progressing smoothly, the R&D sample tube of the high-end ball tube has passed the design and acceptance, and mass production will take some time. But once a supply risk arises, United Imaging Medical has enough capacity to deal with it.

United Imaging Medical applies new materials and technologies to the research and development of next-generation core components, including CT photon counting detectors, MI next-generation TOF detectors, and RT next-generation power source systems.

United Imaging Medical's breakthrough in high-end medical imaging can be described as world-class, completing the independent research and development of the world's first 2-meter PET-CT (Total-body PET-CTuEXPLORER), allowing mankind to observe the whole process of drug flow, diffusion and metabolism throughout the body with the naked eye for the first time in history, known as the "Hubble Telescope" for detecting the human body. Launched the world's first detector expandable PET-CT, so that the software and hardware equipped have the possibility of free iteration. The world's first human whole body 5.0T magnetic resonance uMR Jupiter can be called the country's heavy weapon, breaking through the limitation of ultra-high field magnetic resonance limited to brain imaging for the first time, and realizing ultra-high field whole body clinical imaging. The world's first integrated CT linear accelerator has been introduced to the market, and the performance of the whole machine has been run parallel with that of foreign-funded enterprises, and some of the performance has achieved international leadership.

Future black technology - liquid-free helium magnetic resonance imaging system, photon counting CT, high-end radiotherapy equipment are all being developed and promoted.

More than 90% of the domestic flexible endoscope market share has long been occupied by the three Japanese giants Olympus, Fujifilm and Pentax Medical, and Olympus alone occupies 80%. The Japanese department masters endoscopic staining technology, Olympus NBI narrowband imaging technology, which can highlight the mucosal surface structure and microvascular morphology, which helps to accurately diagnose and protects layer by layer through patents.

Domestic enterprises independently develop dyeing technology, bypassing Olympus NBI patents, Aohua endoscopic CBI-Plus technology through 440nm wavelength blue light and 540nm wavelength green light combined with composite light to achieve optical staining of blood vessels and superficial fiber structure, so that doctors will not miss small early lesions during routine white light observation.

The new generation flagship AQ-300 of Aohua endoscopy was launched at the end of the year, with a localization rate of 95% of parts, benchmarking against the latest Olympus model, and the 4K ultra-high-definition flexible mirror system has complete high-end functions, focusing on the high-end market of tertiary hospitals. This marks the progress of domestic soft mirrors from follow-up innovation to parallel innovation, ushering in a turning point to break the import monopoly.

Peripheral intervention

In the field of peripheral vascular intervention, most of the core products have been monopolized by foreign capital for a long time, among which, in the field of venous diseases, the market of import manufacturers accounts for more than 95%. Most of China's medical polymer materials are particularly dependent on imports, and Xianruida Medical has realized the independent and controllable upstream raw material supply chain, and then broke through the neck technology, and has developed 5 high-end devices that break the import monopoly or precede foreign brands.

Syntruda has the layout of upstream polymer materials and metal materials, and has the core technology of precision catheter tube preparation, which can be applied to the independent research and development of high-end microcatheters and balloons, get rid of the dependence on imported polymer materials, and greatly reduce production costs. It has built a pipe raw material production line in Shenzhen, which can produce precision catheter raw materials with an annual production capacity of 135,000 units. The famous Knee DCB (Peripheral Drug Balloon) product was approved in China in 2016, becoming the first peripheral DCB product in China, about 4 years ahead of competitors. The DCB product was approved in China at the end of 2020, becoming the first BTK DCB product in China and the first clinically verified in the world.

The technical barriers of thrombosuction catheters are high, and clinically there are high requirements for anti-folding performance, intratube coating, and passability, and the domestic market has long been monopolized by Becton Medical and Boston Scientific. At the end of last year, Cenruida launched the first domestic peripheral thrombus aspiration system, becoming the only domestic enterprise in this field with original research technology and can provide overall solutions. Energy ablation is the first-line treatment of varicose veins, the domestic venous radiofrequency ablation system is also long-term monopoly by two foreign companies, in April this year, Cyrada launched the only domestic radiofrequency ablation system AcoArt Cedar (radiofrequency generator + intravenous radiofrequency catheter). In July this year, Vericor, a peripheral disposable support catheter for peripheral use, was approved, which is the first domestic access product for peripheral complex vascular access. In November, Vericor went to the next step and received FDA registration approval.

Electrophysiology

The electrophysiological field is also stuck in the neck, and the cost of domestic atrial fibrillation surgery (three-dimensional ablation) is even much higher than that of the United States, because the market is monopolized by the three giants of the United States, Johnson & Johnson, Abbott, and Medtronic, and domestic manufacturers cannot produce some core components.

High-precision mapping catheter: Achieve high-precision signal mapping and rapid modeling with the three-dimensional cardiac electrophysiological mapping system. The market is occupied by Johnson & Johnson, Abbott and Boston Scientific, and domestic manufacturers have not launched similar products before October this year.

Pressure-sensing magnetopositional perfusion injection frequency ablation catheter: with the three-dimensional cardiac electrophysiological mapping system, it provides real-time force value of the catheter in contact with the inner wall of the heart cavity to achieve accurate ablation. The atria have thin walls and a high demand for pressure sensing. The market is occupied by Johnson & Johnson and Abbott, and domestic manufacturers have not yet had similar products on the market.

Cryoablation: Atrial fibrillation treatment is an innovative procedure that uses balloon-type cryoablation catheters designed for electropulmonary venous isolation to act ablation energy on tissues, using continuous band-like transmural injuries, revolutionizing the traditional radiofrequency ablation method of point-by-point pulmonary vein isolation. The market is exclusively occupied by Medtronic, and domestic manufacturers have not yet launched cryoablation systems.

Micro-electrophysiology high-precision mapping catheter has been approved in October, another core component pressure-sensing magnetic positioning perfusion injection frequency ablation catheter was approved today, domestic enterprises will enter the field of atrial fibrillation surgery in the high-end market of electrophysiology monopolized by foreign capital for the first time, and the cryoablation system will be launched next year.

Surgical robots

In the field of surgical robots, the sales price of da Vinci products in Chinese mainland has also increased significantly compared with the global average price, with a single price of about 20 million yuan ~ 35 million yuan, and there is a start-up fee, up to 30,000-60,000 yuan.

In 2006, Beijing 301 Hospital introduced the first da Vinci surgical robot, and there were no domestic competitors for 15 years.

Laparoscopic surgical robots are the most widely used, accounting for more than 60% of the market share, and are the main position for the head company. The minimally invasive robot Toumai generation is the first domestic four-arm laparoscopic surgical robot approved for marketing, which is in line with the third generation of da Vinci's Si series. Now da Vinci's shipments are mainly based on the fourth generation of products, updating the design of the robotic arm and the connection of the instruments, optimized for complex cases and surgeries, and the robotic arm can operate flexibly in a space of 540°, which is 3 times the range of human hand.

Because of the backwardness of the generation and the single surgical method, the Toumai generation is not the focus of commercialization, and the second generation of Toumai is expected to be approved in the first half of next year, and will become the world's second and domestic first laparoscopic surgical robot that fully covers important and complex operations in the field of chest, abdominal cavity and pelvis.

Toumai is also one of the most domestically produced surgical robots, using the company's self-developed robotic arm and independently installing and producing by purchasing upstream parts. The second generation of Toumai is benchmarked against the fourth generation of da Vinci, with comprehensive functional updates and good surgical performance, which is expected to achieve commercial volume with cost-effective advantages and officially open the curtain on the domestic replacement of surgical robots.

With the autonomy and control of the underlying technology or upstream supply chain, the above leaders challenge powerful multinational giants and can be called the top companies in the hard technology manufacturing industry. The penetration rate of high-end medical devices is generally low, and it is still in its infancy, and there is huge room for improvement. The domestic substitution rate and treatment penetration rate jump from a very low level, and the subdivision leader stands in the first echelon of innovation and will enjoy the double-click logic of growth.