China's Innovation-Driven Medical Device Sector: MicroPort Leads, United Imaging Ranks Third, Medtronic and Boston Scientific Enter Top 5

Dec 09, 2024 19:26 CST Updated 19:26

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On the journey towards high-quality development in the healthcare industry, innovative medical devices are becoming a crucial force in safeguarding the life and health of the public.

Since 2023, the support from the state for medical science and technology innovation has significantly increased.

On December 6, information was conveyed at the National Health Commission conference that the National Health Commission has established a Science and Innovation Leadership Group and has introduced 50 policy measures aimed at promoting science and technology innovation in the health sector, including:

Build a highly efficient and collaborative scientific and technological management system between the central and local governments, and create innovation hubs for science and technology in Beijing, Shanghai, and the Guangdong-Hong Kong-Macao Greater Bay Area.
Leverage the advantages of the new national system to build a "1+2+2+3+X" organizational management system, mobilizing all parties to innovate together.
Create a favorable innovation environment, improve the innovation policies of medical institutions, universities, and research institutes, and promote the transformation of basic research into clinical applications.

These measures have activated the "pond of spring water" for innovation in the medical industry in an all-round and multi-level way.

At the clinical application level, starting from 2023, the speed and intensity of the approval process for innovative medical devices have continued to accelerate.

*** In 2018, the National Medical Products Administration (NMPA) revised and released the Special Review Procedure for Innovative Medical Devices. This procedure establishes a special approval channel for medical devices that hold Chinese invention patents, are domestically首创 and internationally领先 in technology, and have significant clinical application value.

*** For innovative medical devices that have been reviewed and approved for this procedure, the National Medical Products Administration (NMPA) and relevant technical institutions will prioritize their processing in accordance with the principles of "early intervention, dedicated personnel responsibility, and scientific review," while ensuring that standards are not lowered and procedures are not reduced.

According to MedTrend statistics: As of November 30, 2024, 307 medical devices have been approved for marketing in China through the "Special Review Procedure for Innovative Medical Devices" (Green Channel). Among them, 57 were approved in 2024 (as of the end of November). This channel has become the main pathway for innovative pharmaceuticals and medical devices to enter the Chinese market.

*** Data source: NMPA

In 2024, the top five companies with the highest number of approvals are MicroPort Group (19), Pins Medical (19), United Imaging Healthcare (11), Medtronic (8), Boston Scientific (6), and Intuitive Surgical (6). The approval of innovative devices also exhibits new characteristics: foreign companies begin to hold their own against Chinese companies in terms of quantity; from the perspective of细分领域 of innovative medical devices, cardiovascular intervention has become a fiercely contested area.

2024: Foreign and Domestic Investment Advances Together

For a long time, the approved products of innovative medical devices seem to be mainly from domestic enterprises.Until 2019, Medtronic's Micra Transcatheter Leadless Pacemaker System, acclaimed as "the world's smallest pacemaker," gained approval, breaking the gap in foreign products.

As the country highly encourages innovation and deepens the reform of the evaluation and approval system, providing a favorable development environment for innovative medical devices at the registration and payment ends, the vast Chinese market is becoming increasingly attractive to foreign enterprises.In 2023, the number of approved imported innovative medical device products increased by 367% year-on-year.

As of the end of November 2024, the number of approved imported innovative medical device products has exceeded that of the entire year of 2023.，up to 17 models.

Among these approved products, Boston Scientific and Intuitive Surgical lead with six each, followed closely by Medtronic with four approvals, while Japan's Fujirebio has one approved product.

From a regional perspective,Enterprises that have obtained approval for innovative medical devices are mainly concentrated in Beijing, Shanghai, Guangdong, and Jiangsu, accounting for approximately 67%.

In 2024, Beijing, Shanghai, Guangdong, and others took the lead in launching a series of policies to support innovative medical devices, including:

Beijing Medical Device Industry Quality Improvement and Upgrade Action Plan (2024-2026):By 2026, the overall scale will exceed 50 billion yuan; more than 5 professional industrial parks will be built; the cumulative number of innovative products will exceed 100; we strive to cultivate more than 10 new products at the 100-million-yuan level; by the end of the "15th Five-Year Plan," we aim to build a high-end innovative medical device industry cluster that meets world-class standards. Key areas of focus include four major fields: high-end medical equipment, high-value medical consumables, efficient in vitro diagnostics, and artificial intelligence medical devices.
Shanghai Action Plan to Enhance the International Competitiveness of Biopharmaceutical Enterprises (2024-2027):By 2027, the export value of pharmaceuticals and medical device products will exceed 50 billion yuan, with 2-3 companies achieving overseas market sales of over 10 billion yuan; support will be given to biopharmaceutical companies to strengthen forward-looking layouts in cutting-edge international fields and new tracks such as synthetic biology, cell and gene therapy, nucleic acid drugs, brain-computer interfaces, and AI + medicine. Products entering the special review process for innovative medical devices at the national and Shanghai levels will be granted up to 3 million yuan in support according to regulations; for the first-time acquisition of a registration certificate and subsequent production, an additional grant of up to 40% of R&D investment, with a maximum of 8 million yuan, will be provided according to regulations. The total annual support amount for each entity will not exceed 30 million yuan.
Ten Measures by the Guangzhou Municipal Health Commission to Support High-Quality Development of Innovative Pharmaceuticals and Medical Devices:Encourage medical institutions with appropriate conditions to accelerate the application of innovative medical devices such as powered surgical instruments, passive implantable devices, medical software, medical imaging, radiation therapy, and surgical robots; promptly include innovative pharmaceuticals and medical devices as well as innovative medical technologies in the city's medical insurance reimbursement scope according to regulations; support cases utilizing innovative pharmaceuticals, medical devices, and medical technologies in applying for special case reimbursement.

From the perspective of enterprises,As of the end of November 2024, among the approved innovative medical device products, the top five companies with the highest number of approvals are MicroPort Group (19), Pins Medical (19), United Imaging Healthcare (11), Medtronic (8), Boston Scientific (6), and Intuitive Surgical (6).

As the participation of foreign enterprises continues to increase, competition in China's innovative medical device market is expected to become more intense.Whether it is the centralized procurement policy or the DRG/DIP payment model, both tend to offer more support to innovative medical devices.。

For instance, the DRG/DIP 2.0 scheme has established special provisions and exclusion mechanisms. Innovative medical devices with strong innovation, high clinical value, but temporarily difficult to be included in routine grouping can be specially handled through these mechanisms, allowing them to enter clinical application more quickly and receive reasonable medical insurance reimbursement.

Therefore, companies that excel in innovation capabilities and commercialization are expected to capture a larger share of the incremental market.

Competitive Hotspot: Cardiovascular Intervention

From the perspective of细分 fields of innovative medical devices,High-end Imaging Diagnostic Equipment Achieves Remarkable Results, The localization process of CT, MRI, PET/CT and other equipment is accelerating. Domestic manufacturers represented by United Imaging, with technological breakthroughs and cost-performance advantages, are aggressively capturing market share in China. Some products have been exported overseas, driving revenue to soar.The field of implantable and interventional devices also shows outstanding performance.Cardiac stents and artificial joints have undergone multiple generations of evolution, moving from metal materials towards biodegradable materials, with remarkable innovative achievements and steadily increasing market sales.In Vitro Diagnostics Sector, the rise of precision medicine has spurred a large number of innovative reagents and instruments through cutting-edge technologies such as gene sequencing and tumor marker detection, which have been widely used in the prevention and control of infectious diseases and early cancer screening, leading to a rapid expansion of the market size.

In 2024, the intense competition in innovative medical devices for cardiovascular pulsed field ablation and renal artery radiofrequency ablation also reflects the development trends in the cardiovascular intervention field for 2024.

In the innovative products of renal denervation (RDN) and cardiac pulsed field ablation (PFA), Chinese cardiovascular companies are now advancing side by side with global leaders.

Renal Artery Sympathetic Radiofrequency Ablation SystemBy precisely delivering radiofrequency energy, it blocks the abnormally active signal transmission between the sympathetic nerves around the renal arteries and the brain, thereby reducing blood pressure.

*** RDN technology is a minimally invasive procedure with minimal trauma and quick recovery; it offers a new treatment option for patients who respond poorly to or cannot tolerate the side effects of antihypertensive medications.

In April 2024, Medtronic's Symplicity Spyral Renal Denervation System received approval from China's NMPA, becoming the first such product approved in China.

And within less than four months thereafter, two products from Chinese manufacturers were approved for marketing in China.

The msRDN system developed by Xinmai Medical is the world's first renal artery RF ablation product capable of mapping renal nerves. It also provides effective feedback during and after the procedure to evaluate the immediate effectiveness of renal sympathetic denervation.

The Netrod® StarBand™ System, a disposable mesh renal artery radiofrequency ablation catheter developed by MeiLi WeiYe, features six helical electrodes to enhance ablation efficiency. Its basket design ensures unobstructed blood flow and is a first-of-its-kind innovation both in China and internationally.

In addition, the renal artery radiofrequency ablation system products of Bioheart and MicroPort's subsidiary, MicroPort EP, have also entered the "Special Review Procedure for Innovative Medical Devices" (Green Channel).

Cardiac Pulsed Field AblationProducts approved through the green channel not only include global top-tier products from Boston Scientific, Medtronic, and others. In March 2024, CardiPulse by D&N Electrophysiology was also approved for marketing in China, becoming the first domestically approved petal/basket-shaped catheter. Meanwhile, products from Beixing Life, and Johnson & Johnson Medical have also entered the green channel.

In the field of treating calcification of coronary and peripheral arteriesThe most competitive field in China is the intravascular lithotripsy (IVL) product market. In addition to the five domestically produced coronary IVL product registrations already approved, recently, the disposable coronary intravascular lithotripsy catheter from the American company Shockwave has also been officially approved for marketing in China through Jianwei Medical under the identity of a "domestically produced" product.

Boston Scientific's JETSTREAM Atherectomy System is currently the only debulking device approved in China that features both active aspiration and plaque excision capabilities.

The Vascular Plaque Rotablation System integrates a forward rotational cutting tip, an active aspiration system, and lateral expansion blades into a "three-in-one" design. It is capable of grinding calcified areas, excising plaques, and aspirating debris while offering flexible treatment size options to maximize luminal gain. The system also features differentiated cutting technology, which ensures that during high-speed rotational grinding of calcified areas and plaque removal, the vascular walls and other soft tissues are not damaged, providing enhanced safety for patients during surgery.

Clinical needs are always the "guiding star" for innovative medical devices. With the intensification of aging, the spread of chronic diseases, and the increasing health demands of the population, the call for precise diagnosis and efficient therapeutic devices is becoming more urgent.

Looking ahead, the future of China's innovative medical devices is incredibly bright. On the technological front, cutting-edge technologies such as artificial intelligence, big data, and nanotechnology will deeply empower the field, giving rise to more unimaginably innovative products; biodegradable materials and bioelectronic devices are expected to shine, rewriting the paradigm of device-based treatments. In terms of industrial landscape, the effects of scaling and clustering will continue to amplify. Medical device industry clusters in regions like the Yangtze River Delta and the Pearl River Delta will accelerate resource integration, fostering more "hidden champions" in niche fields and enhancing international influence with comprehensive industrial chains.

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