Despite the significant uncertainty brought about by the current tariff issues, the industry still hopes to see more merger and acquisition transactions in fields such as orthopedics and interventional cardiology; major merger targets are expected to gradually shift towards publicly listed companies. Recently, the ranking of the top 100 global medical device companies was released. Based on the 2024 annual revenue, Medtronic ranked first with a revenue of $33 billion; Johnson & Johnson ranked second with a revenue of $30.4 billion; Abbott and Danaher followed closely with revenues of $27.9 billion and $24 billion, respectively. Other medical device companies in the top ten include Stryker, Siemens Healthineers, BD Medical, GE Healthcare, and Philips, all with revenues around $20 billion. In recent years, mergers and acquisitions in the medical device sector have driven the trend of "the strong getting stronger" among giant companies, benefiting from the ample cash flow of large enterprises. By acquiring and integrating a significant number of innovative technologies, medical device giants have further solidified their positions in certain specific fields. In 2024, Johnson & Johnson announced two major acquisitions, purchasing cardiovascular medical device company Shockwave for $13.1 billion and atrial shunt manufacturer V-Wave for $1.7 billion. Medtronic acquired Fortimedix Surgical, an innovative medical device company in the endoscopy field. BD Medical acquired the entire line of critical care products from Edwards Lifesciences for $4.2 billion in cash. Since 2025, the enthusiasm for mergers and acquisitions among major medical device companies has not waned. In January of this year, orthopedic giant Stryker announced its acquisition of venous thromboembolism (VTE) medical device company Inari Medical for a total cash consideration of $4.9 billion; Siemens Healthineers completed the acquisition of industrial simulation and analytics software provider Altair for $10 billion; Medtronic acquired part of the intellectual property used for the development of the next-generation PEEK intervertebral fusion devices from Nanovis, a nano-surface technology supplier; Medtronic also increased its investment in Contego Medical, a provider of blood revascularization therapy solutions. Despite the current tariff issues bringing significant uncertainty to the industry, there is still anticipation for more mergers and acquisitions. As the U.S. IPO market warms up, the motivation for private companies to be acquired may decrease, and the share prices of listed companies are far from reaching their peak. It is expected that major M&A targets will gradually shift towards listed companies in the future. Regarding the popular acquisition targets in the medical device industry, analysts believe that as more large medical device companies bet on the peripheral vascular market, leading companies in this field are worth paying attention to; surgical robots remain a hot sector that requires significant investment in research and development, and private companies urgently need the resources of large companies to survive; in addition, fields such as orthopedics and interventional cardiology will continue to be "strategic tracks." Johnson & Johnson expects to continue expanding its interventional cardiology product portfolio. Tim Schmid, the global chairman of Johnson & Johnson MedTech, stated last year that the company would triple its market size through acquisitions. Johnson & Johnson CEO Joaquin Duato has invested over $30 billion in mergers and acquisitions for the company's medical technology business within less than two years of taking office. In addition to the acquisition of Shockwave, Johnson & Johnson has also acquired artificial heart manufacturer Abiomed and heart implant developer Laminar in the past two years. Du Anqing previously stated that the company will continue to maintain its momentum in mergers and acquisitions, including small acquisitions and large deals, in order to achieve long-term growth. This is related to Johnson & Johnson's strong cash flow and balance sheet. Although the company mentioned in its recent quarterly financial report that its medical technology business might face a profit loss of $400 million in the fiscal year 2026 due to tariffs, industry insiders believe that Johnson & Johnson still has considerable flexibility to consider various types of transactions. "A company's abundant cash flow is the foundation for carrying out M&A transactions," Shen Yi, Danaher's Global Vice President and Head of Strategic Investment and M&A for the Asia-Pacific region, told the First Financial Daily. He also mentioned that Danaher's cash flow has exceeded the company's profits almost every quarter over the past decade. "In over 400 M&A transactions in its past history, Danaher has made all acquisitions except for one mega deal valued at $200 billion in cash, with 85% of its cash being used for acquisitions," said Shen Yi. Medtronic CEO Geoff Martha has indicated that the company will adopt a "top-down" precision strategy, focusing on small-scale acquisitions. Martha did not disclose specific targets, but he emphasized the importance of small acquisitions and portfolio management. Boston Scientific Corporation has also been quite active in mergers and acquisitions over the past year, benefiting from its relatively strong profit margins in recent years. Analysts predict that the company's PFA pulsed field ablation product, Farapulse, will drive continued profit growth in 2025. In 2024, Farapulse's annual revenue exceeded $1 billion.

ThermoFab, a supplier of heavy gauge plastic enclosures and related single use components for the medtech and other regulated industries, reports that it has acquired key reaction injection molding (RIM) assets from Mearthane Products Corp. All RIM components will be manufactured in ThermoFab’s USMCA-compliant Mexicali facility, allowing for efficient delivery throughout North America with no tariffs. This strategic investment significantly enhances ThermoFab’s RIM molding capacity, improving production efficiency and flexibility in manufacturing complex, high-performance enclosures, the company said in the announcement. Mearthane Products Corp., based in Apex, NC, is specialized in the development and manufacture of advanced polyurethane products. Supporting production of intricate, lightweight molded parts The newly acquired assets include multiple custom-built hydraulic down-stroke molding presses that can accommodate component sizes from 36 x 48 to 60 x 78 inches, with pressures up to 8,000 PSI. The machines are equipped with programmable logic controllers (PLCs), precision mixing heads, and advanced hydraulic systems, enabling the production of impact-resistant large, intricate, and lightweight molded components. The acquisition also includes advanced RIM dispensing systems with dual pressurized tank assemblies, high-performance temperature controllers, and integrated mixing technologies. The systems enhance material consistency, reduce cycle times, and allow for the processing of a range of polyurethane formulations — including high-impact structural foams and elastomers — for medical, industrial, and defense applications, said ThermoFab. The benefits of ThermoFab’s expanded RIM capabilities include: Expanded press sizes that accommodate larger and more intricate designs, suitable for medical device enclosures and robotics components. Enhanced material versatility, as high-performance polyurethane formulations provide superior strength, lightweight properties, and impact resistance. Faster cycle times and optimized material flow, resulting in improved lead times and reduced production costs. Seamless integration of RIM, thermoforming, injection molding, and CNC machining under one roof. Tariff-free production in new Mexican facility The integration of these assets into its new 50,000-square-foot Mexicali facility enables cost-effective nearshore manufacturing with enhanced capabilities and faster turnaround times, the company said. All RIM components produced in Mexicali are fully USMCA-compliant and exempt from tariffs, offering a significant advantage for North American customers, added ThermoFab. Applications of the technology cited by the company include surgical robotics, organ transport devices, genetic sequencing devices, people scanning technologies, autonomous robots, and information systems. ThermoFab said that its capabilities encompass the entire production lifecycle, from design and initial prototyping to full-scale production and assembly. Shirley, MA–based ThermoFab is a subsidiary of the Producto Group, a portfolio company of Culper Capital Partners. A contract manufacturer and supplier of precision tooling and components for the life sciences, semiconductor, aerospace, and defense sectors, Producto acquired ThermoFab in 2022.

Amcor has completed construction of its advanced coating facility in Selangor, Malaysia, less than a year after it opened a new innovation center in Europe and announced a merger with Berry Global Group Inc. The advanced coating facility marks a significant milestone for the company and the region, as the company noted it is the first in Asia to feature state-of-the-art air knife coating technology dedicated to healthcare packaging. The facility is an expansion of Amcor’s existing healthcare packaging plant in Selangor, creating an integrated manufacturing campus. With the addition, Amcor said it becomes the first company in Asia capable of producing both top and bottom substrates for medical device packaging at a single site. Company officials say the development enhances supply chain resilience and shortens lead times for customers across the region, while also setting a new benchmark for production standards. Outfitted with advanced systems including water-based coating, online inspection, and the new air knife technology, the facility is designed for precision and efficiency. The air knife system uses high-speed air streams to apply coatings evenly, improving product consistency and reducing material waste. Commitment to customers Chris Kenneally, president of Amcor Flexibles Asia Pacific, said the company’s investment in this new facility reflects its unwavering commitment to support customers across the Asia Pacific region. “By introducing advanced coating technology and boosting local production capacity, we are better positioned to meet the growing regional demand for sterile, reliable packaging and to offer our customers greater flexibility and security,” he said. Virginie Maes, vice president of global healthcare for Amcor, pointed out that by producing its industry-leading global product platform locally, it brings the company closer to its customers, enhancing supply security and flexibility. “By investing in advanced coating technologies and expanding our regional capabilities, we are not only addressing the growing demand for high-performance healthcare packaging but also reinforcing our promise to deliver a consistent and innovative value proposition to our customers worldwide,” she said.  This new facility is part of Amcor's broader commitment to expanding its healthcare capabilities in the Asia Pacific region, according to the company, which noted recent initiatives include the acquisition of healthcare packaging company MDK in China, the establishment of a grid lacquer paper unit in India, and the construction of a co-extrusion blown film and printing plant in Singapore. European innovation center open Amcor in 2024 opened a new Amcor Innovation Center Europe in Ghent, Belgium, which joins existing centers in the US, South America, and Asia Pacific markets. The facility adds approximately 6,000 square meters to the Amcor Ghent campus to include meeting space, offices, an R&D laboratory/development area, and warehousing space. The facility includes a material science center, consumer engagement center, eCommerce lab, and packaging and recycling test center.  Amcor has pledged to develop all its packaging to be recyclable, compostable, or reusable by 2025 and to increase its use of recycled materials significantly. In line with that commitment, the new facility is designed and built according to BREEAM sustainability certification standards. The new facility represents a "significant investment toward more sustainable, circular, and innovative packaging," according to Michael Zacka, president of Amcor Flexibles Europe, Middle East, and Africa. It includes multiple technologies and equipment spanning R&D, film extrusion processes, and packaging/filling operations, and services that follow the company's collaborative approach, called Catalyst, encompassing broader market, consumer, and sustainability needs. Merger nears close Amcor continues to move forward with its merger with Berry Global.  Last month, the companies received US antitrust clearance for the combination. As a result, the $8.4 million deal remains on track to close in the middle of calendar year 2025. The all-stock acquisition of Berry by Amcor is expected to bring $650 million in annual cost benefits and other synergies in three years. The new business will leverage more than 400 production facilities to serve customers in more than 140 countries.

Recently, Abbott released its Q1 2025 earnings report, with total revenue of $10.36 billion, a year-on-year increase of 4.0%. However, behind this seemingly steady report lie hidden concerns. The company's CEO, Robert Ford, warned investors during the earnings call that the U.S. government's additional tariffs on China would result in a loss of "hundreds of millions of dollars" for the company throughout the year, with the medical device business being the hardest hit. This statement confirms Barclays Bank's previous analysis - although Abbott is relatively less affected among top medical device companies, the field of medical devices still faces dual pressures of supply chain restructuring and rising costs.   01 leads the way, translates to "leads the way" or "takes the lead" in this context. Diagnostic services lag behind Abbott delivered a report card of "steady growth + improved profitability" in the first quarter of 2025. Total revenue: $10.36 billion, an increase of 4.0% year-over-year; excluding the COVID-19 testing business, organic growth was as high as 8.3%. Core Business Performance: Medical Devices: Revenue of $4.895 billion (accounting for 47% of total revenue), a year-over-year increase of 9.9%, with organic growth of 12.6%. Notable contributions from sub-segments such as Diabetes Management (+21.6%) and Structural Heart Disease. Nutrition business: Revenue of $2.146 billion, global organic growth driven by adult nutrition products Ensure® and Glucerna® by 8.7%. Diagnostic business: Revenue was $2.054 billion, a year-over-year decrease of 7.2%. Excluding COVID-19 testing revenue (which amounted to only $84 million), the core laboratory business barely achieved a 0.5% growth. Significant regional differentiation: The U.S. market grew by 8.4%, far exceeding the 1.2% growth of international markets. Particularly in the medical device sector, the growth rate in the U.S. (such as +27.1% for diabetes care business) was significantly higher than the global average. Profitability Optimization: Gross margin increased to 52.8%, and adjusted net profit grew by 10.9% year-over-year to reach $1.919 billion. This performance was driven by effective cost management and strong sales of high-margin products, such as the FreeStyle Libre® continuous glucose monitoring system.   02 Tariff Impact: Medical devices become a "disaster zone." Although Abbott's financial report performance is impressive, the "approaching tariff threat" it faces cannot be ignored, and Ford clearly outlined the specific impact pathway of this challenge. In the Sino-US tariff game, latest developments show that the Trump administration is planning to impose a 245% tariff on China, with medical devices not being exempted. Given that Abbott's revenues are about 45% reliant on the medical device sector, this means that its supply chain and export costs in the Chinese market will face significant pressure. At the same time, import restrictions implemented by Canada and Mexico, along with tariffs on steel and aluminum policies internationally that have created regional retaliatory tariffs, have further driven up the cost of raw materials. Due to the long production cycle of medical equipment and the fact that contract prices are often locked in, companies cannot resolve impacts in the short term by raising prices or transferring costs. From a potential risk perspective, if the tariff costs are entirely borne by the company, Abbott's medical device business, which currently has a gross margin of about 60%, may face the risk of decline; emerging markets such as Asia and Latin America, which rely on low-price strategies to open up markets, may also lose competitiveness due to rising costs.   03 5 Invest $500 million to build a factory in the U.S., what's the goal? To withstand the impact of the tariff storm, Abbott has unveiled two core strategies. Firstly, the construction of a distributed production network is carried out with 90 production bases to create an "anti-risk moat". CEO Ford uses FreeStyle Libre® as an example to explain the layout logic, stating that 2 factories in the United States serve domestic demand, and 4 other bases cover the global market. If all production capacity were concentrated in Southeast Asia or Europe, the risk would be uncontrollable. The strategy reduces reliance on a single supply chain through localized production, such as specializing in glucose monitoring sensors at the Irish factory and focusing on regional demand at the Chinese facility. Simultaneously, it implements redundancy by backing up critical components across multiple regions to ensure stable supply amid sudden tariffs or geopolitical conflicts. Secondly, to promote the expansion of production in the United States, Abbott announced two key investments, investing $500 million in the expansion of factories in Illinois and Texas, adding 300 new jobs, focusing on enhancing the research and development and production capacity of blood transfusion equipment. The main goal is to reduce dependence on imports through local production and strive for policy preferences brought by the "Made in USA" label. In the short term, this plan can reduce reliance on imported components and directly avoid cost pressures brought by Sino - US tariffs; in the long term, it focuses on the research and development and production of high - value - added products such as cardiovascular devices, consolidating its technological barriers and industry leadership in the high - end medical device field. However, the production cost in the United States is significantly higher than that in Asian regions, which may weaken the price competitiveness of products. Moreover, the construction cycle of the factory is relatively long, and it will not be put into operation until the end of 2025. In the short term, tariff pressure still needs to be borne. In terms of short-term buffer measures, Abbott opted to increase inventory of key raw materials, but Ford also warned that "hoarding is not a sustainable solution," while jointly lobbying with industry group AdvaMed to seek tariff exemptions for medical devices, despite slim chances of success.   04 No one was spared. Leading companies collectively under pressure Amid the ongoing impact of the tariff storm, leading companies in the global medical equipment sector are all affected, collectively bearing immense pressure. Johnson & Johnson (JNJ.US) warned in its financial report that by 2026, its tariff losses will reach $400 million, with the medical device division being hit the hardest. The main issues Johnson & Johnson faces are twofold: first, it is difficult to adjust the supply chain, as medical equipment transportation contracts have already locked in prices, making it hard to flexibly adjust costs in response to tariff changes in the short term; second, geopolitical risks are compounded, with Sino-American tariff conflicts being the primary source of losses, while retaliatory tariffs from Mexico and Canada add further pressure. In terms of strategy, Johnson & Johnson and Abbott show clear differences: Johnson & Johnson relies more on “acquisition + restructuring” to optimize its business (for example, by acquiring Abiomed to strengthen its cardiovascular sector), but it has relatively fewer proactive measures in response to tariff impacts; Abbott, on the other hand, places greater emphasis on enhancing the flexibility of its production network, reducing risks by diversifying its capacity layout. From an industry-wide perspective, this phenomenon conveys two important signals: for companies that struggle to pass on tariff costs to downstream entities, long-term profit margins may continue to erode; meanwhile, possessing a globalized supply chain layout and flexible adjustment capabilities is increasingly becoming a critical survival skill for leading enterprises to navigate geopolitical risks. In response to tariff shocks, Abbott has built a distributed network with 90 production bases, such as the decentralized production of FreeStyle Libre across 6 locations to reduce risks. At the same time, it has invested $500 million to expand its domestic U.S. factories, attempting to hedge tariffs through local production. However, high domestic costs and long construction cycles still put pressure on it in the short term. Within the industry, Chinese companies like Mindray are capturing market share with their local supply chains, accelerating the restructuring of the global medical device supply chain. As Ford said, tariffs are driving the medical industry towards Globalization 2.0, and companies need to find a new balance between technological barriers and cost control.

In April 2025, two of the world's leading medical device giants, Johnson & Johnson and Abbott, announced their financial reports for the first quarter. Although both companies revealed the impact of tariffs on their finances in the reports, they still maintained growth and demonstrated different coping strategies. The performance of these companies not only reflects the complexity of the global medical device industry but also shows the adaptability of multinational companies in the face of external pressures such as the China-U.S. trade war.   01 Johnson & Johnson: Steady Growth Tariff pressure resulted in a loss of 400 million dollars. Johnson & Johnson's Q1 2025 earnings report shows the company's total revenue reached $21.9 billion, a year-over-year increase of 2.4%. The performance of the medical technology division was particularly impressive, with revenue reaching $8.02 billion, a year-over-year increase of 2.5%. Among this, the cardiovascular business stood out, with sales reaching $2.1 billion, a year-over-year increase of 16.5%. However, despite the strong performance, Johnson & Johnson still faces significant tariff challenges and is expected to suffer a financial loss of $400 million in 2025 as a result.   Joseph Wolk, Chief Financial Officer of Johnson & Johnson, stated that this loss was mainly due to the high tariffs imposed by the U.S. on Chinese medical device exports and China's retaliatory tariffs on American products. Johnson & Johnson is mitigating this impact through price adjustments and cost pass-throughs, but the adjustment space is limited due to existing medical device contracts. Nevertheless, Johnson & Johnson has maintained its financial outlook for 2025 and plans to reduce future tariff impacts by restructuring its operations and optimizing production bases.   02 Abbott: Global Layout and Short-term Response Strategies Similar to Johnson & Johnson, Abbott also announced impressive financial results in the first quarter of 2025. The company's overall revenue was $10.36 billion, a year-on-year increase of 4%. Medical device sales were $4.9 billion, a year-on-year increase of 9.9%. Nevertheless, Abbott's CEO, Robert Ford, clearly stated in the earnings call that he expects tariffs to have a "hundreds of millions of dollars" negative impact on the company, mainly in the U.S. and Chinese markets. Ford further pointed out that Abbott's estimated tariff costs are about $300 million, close to Johnson & Johnson's estimated $400 million. Unlike Johnson & Johnson, Abbott has adopted a more proactive regional production layout and short-term relief plans. The company announced it will invest $500 million in Illinois and Texas to expand its manufacturing and R&D base for blood and plasma screening equipment. This investment not only helps Abbott diversify risks and mitigate the impact of tariffs on production, but also demonstrates the company's balanced approach between globalization and localization.   03 Tariff Impact: Global Medical Devices Challenges and Opportunities in the Industry As Sino-US trade friction intensifies, the global medical device industry is facing unprecedented challenges. The tariffs imposed by the United States on Chinese medical devices, particularly in high-end equipment such as CT and MRI imaging devices, have led to a significant increase in procurement costs. Additionally, tariffs on key components such as CT tubes and superconducting magnets have put considerable pressure on companies with high import reliance. For Chinese medical device companies that rely on the US market, tariffs have exacerbated their market challenges. Meanwhile, domestic medical device companies see an opportunity to catch up. Companies like Mindray and United Imaging have increased their R&D investments, driving technological innovation, and have gradually replaced some of the high-end equipment market share. For international giants, maintaining competitiveness, reducing costs, will be the core tasks in the coming years amid this global trade war.   04 Coping Strategy: Dual Layout of Globalization and Localization Facing tariff pressure, Johnson & Johnson and Abbott have adopted different but complementary strategies. Johnson & Johnson focuses on mitigating the rise in costs through price adjustments, optimizing production bases, and business restructuring, maintaining competitiveness in the global market. Abbott, on the other hand, has strengthened the global supply chain's risk resistance through a distributed production network and regional layout. The company has not only increased investment in the United States but also actively promoted the expansion of global production bases to cope with long-term tariff policy changes. Moreover, both Johnson & Johnson and Abbott are actively cooperating with industry organizations to seek tariff exemptions, but they remain cautious about the likelihood of success. Both companies have stated that once tariffs are implemented, they are difficult to retract. This historical experience has prompted them to place greater emphasis on adjusting their long-term strategies.   05 Conclusion: Globalization Challenges and Opportunities for Multinational Enterprises Overall, Johnson & Johnson and Abbott achieved steady growth in their Q1 financial reports despite the impact of tariffs. Through different coping strategies, the two giants demonstrated how they adjusted their strategies in the complex environment of globalization and localization to mitigate the negative effects of tariffs. Although tariff pressure poses challenges for global medical device companies in the short term, it also creates new opportunities for localized production, technological innovation, and supply chain optimization. As the China-US trade friction continues to develop, multinational companies will have to constantly adjust their strategies to maintain a competitive edge in the global market. For domestic companies, this is a good opportunity to accelerate innovation and promote domestic alternatives.

On April 16, 2025, Illumina announced through an internal email a global workforce reduction of approximately 3.5% to advance its $100 million cost-cutting target. Based on the employee count of 8,970 at the end of 2024, this layoff affects over 300 people. Illumina's layoffs are not an isolated incident, but part of a series of adjustments made in recent years. Since 2022, the company has implemented several layoff plans. In 2022, Inmune announced a large-scale layoff, reducing approximately 500 employees globally, accounting for 5% of its total workforce. This layoff is seen as an important measure for Inmune to cope with cost pressures and changes in the industry. 2023 Multiple rounds of layoffs: Due to continued optimization of personnel structure at Meina, the specific number of layoffs has not been disclosed, but it involves multiple departments and regions. In 2024, California Layoffs: Illumina terminated the positions of approximately 50 employees in California, signaling further adjustments in its U.S. domestic market. In February 2025, 96 employees were laid off, mainly at the headquarters in San Diego, indicating that Illumina is still continuously optimizing its internal resource allocation. This round of layoffs is Illumina's second layoff action after the major layoffs in February this year, but details such as specific layoff regions have not been disclosed yet. It remains unclear whether the layoffs are related to the business reduction caused by being included in the unreliable entity list by China's Ministry of Commerce. On April 15, Jacob Thaysen, CEO of Illumina, stated during an interview at the 2025 Abu Dhabi Global Health Week that China remains a very significant market force, and they are exploring ways to bring gene sequencers back to China. Jacob Thaysen emphasized in the above interview, "Our products are currently on the unreliable list, which means we cannot sell instruments to China. However, we will continue to provide consumables support to all our Chinese customers, especially Chinese patients who need high-quality sequencing to receive the right treatment." Due to its long-term monopoly in the global gene sequencing market, Illumina is also known as the "Google" of the genetic technology industry. Public information shows that Illumina was founded in 1998 and is headquartered in the United States. As a leading company in the global gene sequencing field, its business covers oncology, genetics and infectious diseases, reproductive health, and other areas, with core products including high-throughput gene sequencers and gene chips. Since entering the Chinese market in 2005, Illumina has held a significant position in China's gene sequencing instrument market. According to financial report data, in 2024, Illumina's revenue in China reached 2.2 billion yuan, with instrument revenue accounting for 20%-30% of the total. On February 4, China's Ministry of Commerce announced in a statement that Illumina was included in the "Unreliable Entities List" due to its violation of normal market transaction principles, interruption of normal transactions with Chinese enterprises, and discriminatory measures against Chinese enterprises, which severely harmed the legitimate rights and interests of Chinese enterprises. It was also revealed by industry insiders that Meina suddenly interrupted cooperation with several Chinese biopharmaceutical companies under the pretext of "supply chain security review," even seizing already paid orders, which caused dozens of domestic cancer early screening and genetic disease research projects to be forced to halt. The day after being included in the list, Illumina issued a statement saying that the company was "conducting a detailed assessment of the impact of the relevant matters and actively seeking solutions," while emphasizing that it "always adheres to market-oriented and rule-of-law principles in its global operations." On March 4, the Chinese Ministry of Commerce announced the inclusion of the American company Illumina on the unreliable entity list and prohibited it from exporting gene sequencing instruments to China. This decision takes effect immediately upon announcement. On March 11, Illumina responded to the aforementioned announcement, stating that it fully respects the decision of China's Ministry of Commerce and will continue to operate globally in accordance with market-oriented and legal principles, strictly complying with the laws and regulations of all countries or regions where it operates, including China. In addition, Ankur Dhingra, the Chief Financial Officer of Mena, stated, "Our new guidance for fiscal year 2025 indicates that revenue contributions from China will be relatively limited, and we expect the current macro trends to persist." In addition, Inmune has revealed that the company is developing an incremental cost reduction plan of about $100 million for the fiscal year 2025. These savings will help mitigate the impact of various potential scenarios related to the decline in revenue and associated operating income from its Greater China business. On April 8, the 91st China International Medical Equipment Fair (CMEF) grandly opened at the National Exhibition and Convention Center (Shanghai), but Illumina did not attend the exhibition. It is widely believed that Illumina's absence may be related to its inclusion on the "Unreliable Entity List." On the other hand, the industry generally believes that the ban on Illumina's export of gene sequencers to China is expected to accelerate the domestication process of China's gene sequencer market. A pharmaceutical researcher told the media in an interview that leading domestic companies such as MGI Tech and Genemind Biotech will benefit from this. For BGI Genomics, the ban on high-end products imported from the United States makes it easier for domestic equipment to enter the market, boosting performance recovery, while also buying time for the research and development of a new generation of high-throughput sequencing devices. According to media reports, in fact, some customers of Illumina have begun to switch to choose domestic options. Peking Union Medical College Hospital announced in April 2025 that it would suspend its collaboration with Illumina on a rare disease genomic program and instead adopt the BGI Genomics DNBSEQ-T20 sequencing platform. The contraction of Illumina's business in the Chinese market had already become evident in previous years. According to financial reports, Illumina's market share in China's gene sequencing instrument and consumables market, calculated by annual revenue, has declined from 64.50% in 2021 to 54.2% in 2023. Additionally, according to data from CIC, in 2023, MGI's market share in China has reached 47.3%, breaking Illumina's domestic monopoly.

01 Abbott CEO: Tariff shock could reach hundreds of millions of dollars. Yesterday (April 16, 2025), global medical device giant Abbott revealed in a earnings call that the company expects the tariff policies this year to impact the company by “hundreds of millions of dollars.” Although Abbott did not provide a breakdown of the tariff costs, according to Vijay Kumar, an analyst at the well-known global investment bank Evercore ISI, it is estimated that tariffs will have a negative impact of approximately $300 million (equivalent to about 2.2 billion yuan) on Abbott this year. Among them, the U.S. and Chinese markets will be the main pressure points. Reuters reported that China is the primary source of raw materials for the pharmaceutical and medical device industries. It is worth noting that just one day before Abbott disclosed this information, a senior executive at Johnson & Johnson also publicly stated that the increase in global tariffs would exacerbate the company's financial losses by $400 million (approximately 3 billion RMB), with 70% of the tariff costs stemming from medical device exports to China.   02 "Tackle challenges with a two-pronged approach" 3.65 billion yuan to enhance distributed network layout Faced with this situation, Abbott has initiated a short-term contingency plan and is leveraging its global network of 90 production bases to seek buffer space. Abbott also announced an investment of $500 million (approximately RMB 3.65 billion) in manufacturing and research projects in Illinois and Texas to produce equipment for screening blood and plasma donations. These projects are expected to be operational by the end of this year and will help Abbott mitigate the potential impact of the high tariffs imposed by President Donald Trump on China. Abbott CEO Robert Ford emphasized in the meeting that the company has established a "distributed production network" to mitigate risks through global supply chain optimization. Although Abbott is actively lobbying alongside the medical device industry association AdvaMed, he admitted to having "low expectations" for obtaining tariff exemptions. Citing the China tariff policies during Trump's first term, he noted, "Historical experience shows that once tariffs are imposed, they are difficult to roll back." Financial report data show that, excluding the impact of exchange rate fluctuations and the decline in COVID-19 testing business, Abbott's global sales in the first quarter of 2025 increased by 8.3% year-on-year to 10.36 billion US dollars. The company reiterated its full-year financial targets: revenue growth of 7.5%-8.5%, and adjusted earnings per share of $5.05-$5.25. Ford stated, "Before the tariffs were implemented, we had considered raising our earnings forecast. However, under the current circumstances, maintaining the original guidance already reflects the company's confidence." On that day, Abbott's stock price rose by 6% in early trading. Abbott's response strategy this time is a portrayal of how multinational medical device companies adapt to the squeeze between the waves of globalization and localized demands. As the China-U.S. trade friction continues, multinational companies are seeking a balance between political risks and market efficiency through measures such as regionalized production capacity layout and diversified supply chain construction.

Yesterday (April 15, 2025), executives at Johnson & Johnson stated in the company’s first-quarter earnings report that they expect the anticipated increase in global tariffs to result in a $400 million (approximately RMB 3 billion) financial hit for the company, with as much as 70% of this tariff impact coming from medical devices the company exports from the U.S. to China. Image source: Yahoo Finance In terms of revenue performance, Johnson & Johnson reported revenue of $21.9 billion in the first quarter, exceeding Wall Street's expectations by 1.4%. Adjusted earnings per share were $2.69, surpassing Wall Street's expectations by 6.7%. Amid mixed sentiments, Johnson & Johnson's stock fell less than 1% on the day. 01 Johnson & Johnson: Expected to incur a loss of 3 billion. 70% of medical device products exported from the United States to China Johnson & Johnson CFO Joseph Wolk said that based on the tariffs on goods and raw materials formally announced by the Trump administration so far and the retaliatory measures taken by the international community, the company's medical technology sector will bear the brunt of the burden. "I don't want to be cavalier about the $400 million," Wolk said on the investor call. "It's a program that phases in, and as that comes in, most of that will be capitalized into the cost of the goods," he added. "So that will come onto the balance sheet as inventory and come through the P&L over future periods." Wolk stated that this estimated figure takes into account the impact of import tariffs on products manufactured in Canada and Mexico that are not covered by the North American trade agreement, as well as the impact of international steel and aluminum tariffs— the latter having "a very small degree of influence." He said, "This includes tariffs on China and China's retaliatory tariffs. In terms of that $400 million, it might be the highest amount among all the tariffs. Therefore, what needs to be clarified to everyone is that this refers to American-origin products shipped to China - this could be the most severe punitive factor." CEO Joaquin Duato said that if the Trump administration's goal is to increase domestic production, imposing tariffs on medical products is not the right approach, and warned that these tariffs could "cause supply chain disruptions, leading to shortages." Duato stated, "If you want to establish manufacturing capabilities in the medical technology and pharmaceutical sectors in the United States, the most effective answer is not tariffs, but tax policies." "In fact, since President Trump's tax reform in 2017, investment in medical technology and pharmaceuticals has increased significantly," he added, citing Johnson & Johnson’s plan announced last month to increase its U.S. investment by 25%, equivalent to over $55 billion in investments over four years, including building a new biologics factory in North Carolina. " As for the future development direction, Wolk said that due to the fact that the contract for the transportation of medical equipment has been signed, the company's ability to mitigate the impact of tariffs by adjusting prices and passing on costs is "very limited". "We know that these tariffs are very unstable," said Wolk. "Our responsible action now is to quantify the impact we anticipate for 2026, and then see if it aids in negotiations with other countries, as well as what actual changes will occur by the second half of 2025." Following its recent financial guidance, the company's acquisition of Intra-Cellular Therapies and its Caplyta therapy for treating schizophrenia and bipolar disorder for $14.6 billion slightly raised its projected operational sales from $913 billion to $920 billion in January. 02 Continue to streamline and focus strategically, The orthopedic department is about to conclude its two-year restructuring plan. In the first quarter of this year, Johnson & Johnson's total sales reached $21.9 billion, reflecting a 4.2% growth compared to the beginning of 2024 after accounting for international currency fluctuations. This includes $8 billion in global medical technology revenue, with an adjusted growth rate of 4.1%. Duato attributed part of these gains to its acquisitions of Abiomed and Shockwave in the cardiovascular disease field, as well as its surgical vision and wound closure businesses. Moreover, after Johnson & Johnson paused the launch of its Varipulse pulsed field ablation system in the U.S., the company has now completed 5,500 procedures globally as cases resumed in February, he said. However, this performance was somewhat offset by one-time costs in its orthopedic division, which is nearing the end of a two-year restructuring plan aimed at exiting lower-margin areas. Meanwhile, Wolk stated that the company is implementing a similar plan to narrow the focus of its surgical business. "We are focusing on portfolio refresh, with plans to exit certain non-strategic product lines on a global basis and optimize selected sites across our network," Wolk said. "We anticipate minor short-term fluctuations in surgical revenue over the next two years, totaling approximately $250 million, but these initiatives will strengthen our ability to accelerate growth and enhance profitability. The project is expected to be completed by 2027, with an estimated cost of approximately $900 million."

On April 15th, U.S. time, the White House website reiterated that due to China's retaliatory measures, goods exported from China to the U.S. are now facing tariffs of up to 245%. As early as April 11, a spokesperson for China's Ministry of Commerce stated that the U.S. imposition of excessively high tariffs on China has turned into a numbers game, holding no practical economic significance. If the U.S. continues with this tariff numbers game, China will not pay it any heed. Actually, the latest statement from the White House "China now faces up to a 245% tariff on imports to the United States as a result of its retaliatory actions." That is, the maximum (up to) tariff that goods going from China to the United States might face could be 245%, not all goods. The number is not a newly imposed tariff, but the result of adding the 100% tariff on some goods (such as syringes, needles) during the 2018 trade war to the additional 145% tariff in 2025. For instance, The New York Times previously illustrated that the tariffs on certain medical products could reach up to 245% due to the==== rule. Attached figure.

The Trump administration promoted a trade investigation led by the Department of Commerce.Semiconductors and pharmaceuticalsThe plan to impose import tariffs. The measures announced on Monday in the Federal Register are a prelude to the imposition of tariffs and could potentially expand Trump's global trade war. The Ministry of Commerce stated in two notices that it has initiated an investigation"Semiconductor and semiconductor manufacturing equipment" "Medicines and pharmaceutical ingredients, including finished pharmaceutical products"The impact of imports on U.S. national security. These investigations, which began on April 1st, were ordered under Section 232 of the Trade Expansion Act and may last for months. According to the law, the Secretary of Commerce should submit the investigation results within 270 days, but Trump and other officials have indicated that these tasks might be concluded more quickly. Trump has long condemned the national security threat posed by foreign-made pharmaceuticals and chips and has threatened tariffs on imports to revive U.S. manufacturing of these products. But these tariffs also have the potential to seriously disrupt supply chains and raise costs for Americans. From cars to airplanes, from mobile phones to consumer electronics, these products all rely on semiconductors, with global semiconductor sales exceeding $600 billion. Currently, the supply chain is still feeling the chaotic effects caused by the COVID-19 pandemic and may now face new impacts from U.S. tariffs. Trump's frequent shifts in his comprehensive tariff plans have sent mixed signals to the markets, businesses, and trade partners, who are striving to negotiate with the White House to reach dozens of new agreements aimed at reducing trade imbalances. Trump said on Monday that he expects to impose tariffs on imported drugs “sooner rather than later.” Trump said to the reporter:"Listen, I'm a very flexible person. I don't change my mind, but I am very flexible." "I've been helping Tim Cook and the whole business recently," he continued, referring to the CEO of Apple Inc."I don't want to hurt anyone. But the end result is that our country will achieve greatness."However, Trump said last weekend that the exemption on tariffs for technology products (seen as a boon for tech giants like Apple and Nvidia) would be temporary, adding that these imports would eventually face different, industry-specific tariffs. The Ministry of Commerce's investigation into semiconductors has a wide scope, as it aims to assess the import situation of both traditional chips and advanced chips sought after for artificial intelligence applications. According to government notifications, this investigation will cover all semiconductors, equipment used to manufacture semiconductors, and electronic products that contain these components. The imposition of tariffs on the semiconductor industry could affect numerous companies that export billions of dollars worth of microprocessors and related products to the United States each year. These measures could also increase the cost of Trump’s vision for expanding domestic semiconductor production, especially if import duties are levied on chip manufacturing equipment from companies such as ASML Holding NV. Based in the Netherlands, ASML is a leading supplier of advanced lithography machines, which are used to produce the smallest computer chips utilized in artificial intelligence and other sensitive applications. Analysts warn that bringing chip manufacturing to the US will require years of arduous effort. Separate drug investigations will examine imports of all drugs, including generics and generic finished products as well as materials used to make those drugs. Investigators will also look into imports of key pharmaceutical inputs. Tariffs will also hit global pharmaceutical giants like Merck & Co. and Eli Lilly & Co., which have dozens of production bases around the world. Before tariffs may be imposed in the U.S., pharmaceutical companies have announced significant investments in the United States. Recently, Swiss pharmaceutical company Novartis AG announced plans to invest $23 billion in the United States over the next five years, following similar commitments from Eli Lilly, Merck, and Johnson & Johnson. However, experts warn that this is likely not enough to mitigate the impact of tariffs. Leerink Partners analyst David Risinger said in a note to clients ahead of the announcement, "We believe the companies impacted cannot quickly fix the problem. Reregistration would take years and be very costly." In this already the most expensive market in the world, pharmaceutical companies will face two choices: either absorb the costs brought by potential tariffs or raise drug prices. Trump has repeatedly criticized American pharmaceutical companies for their reliance on overseas production, and he is breaking with tradition that has lasted for decades. For many years, the pharmaceutical industry has managed to avoid trade wars and has been protected by international agreements, which largely shield medicines from tariffs on humanitarian grounds.    

The alliance, according to the partners, promises OEMs a faster path to market.THIERRY DOSOGNE/ISTOCK VIA GETTY IMAGES   In a strategic move to streamline fragmented supply chains and accelerate production timelines, digital manufacturing platform Fictiv has partnered with Evco Plastics, a global custom injection molder and contract manufacturer. The collaboration aims to create a fully managed, resilient supply chain solution that spans the entire product lifecycle — from concept to high-volume production. The partnership, announced this week, combines Fictiv's AI-driven platform and global logistics expertise with Evco's extensive manufacturing footprint, which includes more than 1 million square feet of production space and 270 injection molding machines, including presses up to 4,400 tons. The alliance, according to the partners, promises OEMs a faster path to market and reduced bill-of-materials (BOM) costs through enhanced material sourcing and design-for-manufacturability (DFM) services. Helping customers The partnership is about helping customers do more with less, according to Fictiv, and by integrating its technology with Evco's operations, Fictiv will be addressing key pain points such as tariff mitigation, secondary processing gaps, and Mexico's still-developing supply base. The partnership is particularly focused on supporting complex, highly engineered products in regions where the supply chain remains fragmented — especially in Mexico. Fictiv's GlobalFlex program, according to the company, blends cost-effective Chinese tooling inserts with localized production in next-generation facilities in the US and Mexico, improving gross margins and cutting lead times. Related:Fictiv Announces GlobalFlex Solution for Injection Molding in North America Capabilities span a range of advanced molding processes, including overmolding, gas-assist molding, in-mold decorating, and liquid silicone rubber (LSR) molding, the partners noted. Beyond molding, the alliance also supports 3D printing, assembly, testing, and packaging. The companies hold multiple certifications — including ISO 9001:2015, ISO 13485, IATF 16949, and FDA compliance — ensuring customers in industries like medical, automotive, and consumer products can count on quality, traceability, and regulatory readiness. "Our partnership with Evco marks a crucial step in simplifying global manufacturing supply chains," said Dave Evans, co-founder and CEO of Fictiv. "Together, we can reduce the overall number of suppliers and 'papercuts' involved in managing multiple suppliers to deliver efficiency and predictability in an unpredictable world." Carlos Gonzales, head of Evco Plastics de Mexico, noted that Fictiv's capabilities allow the company to concentrate on manufacturing excellence while Fictiv tackles the complex workflow and supply chain challenges that impact OEM margins. "It's the best of both worlds coming together," he said. Moreover, the Fictiv-Evco collaboration aims to provide scalable, tailored solutions, underscoring a shared commitment to innovation, quality, and sustainability in the manufacturing sector, according to the partners. Evco was founded in 1964, employs over 2,100 people, and is headquartered in DeForest, WI. The company also has three plants in Wisconsin, two in Georgia, three in Mexico, and one in China. Fictiv, a global manufacturing and supply chain company, has four global manufacturing centers in India, Mexico, China, and the US. GlobalFlex's debut GlobalFlex was rolled out by Fictiv earlier this year as an injection molding solution the company has engineered to mitigate global supply chain disruptions and optimize costs. According to the company, GlobalFlex integrates tooling inserts produced in China with Fictiv's mold frames, assembled across next-generation manufacturing facilities in China, the United States, and Mexico. The company said its new offering leverages the speed and cost efficiencies of overseas production while enabling manufacturers to rapidly pivot to domestic production in response to shifts in demand or tariffs. "Now more than ever, agility and regional flexibility are critical for maintaining resilient supply chains," Robbie Long, a product marketing manager at Fictiv, said in February. "Our expanded suite of injection molding offerings exemplifies our commitment to innovation, seamlessly streamlining operations and empowering manufacturers to navigate today's volatile global trade market." Additionally, Fictiv's injection molding import program enables full production molds to be built in China and deployed into its US or Mexico manufacturing partner network, according to the company.

According to CCTV News, on April 8th local time, US President Trump announced in a speech that the United States will impose tariffs on pharmaceuticals. Trump stated that the United States does not produce its own medications and other health-improving products. The prices paid for drugs in the U.S. are often many times higher than those in countries that produce pharmaceuticals. Trump believes that once tariffs are imposed on medications, pharmaceutical companies will establish factories in the U.S. because it is the "largest market." European pharmaceutical companies warned at a meeting with the President of the European Commission on the 8th local time that US tariffs will accelerate the trend of the industry moving from Europe to the US. EFPIA, a pharmaceutical industry trade lobbying group whose members include European pharmaceutical giants Bayer, Novartis, and Novo Nordisk, said that it has called on the EU President to push for "rapid and fundamental action" to mitigate the risk of an exodus to the US.

On April 8th, at the 91st China International Medical Equipment (Spring) Expo (CMEF), the international independent third-party testing, inspection, and certification organization TÜV Rheinland Greater China (referred to as "TÜV Rheinland") awarded Yinkang Life's Haier Biomedical medical low-temperature preservation box and blood refrigerator two types of products with the notified body certificate based on the EU Medical Device Regulation (Regulation(EU)2017/745, referred to as MDR). This is also the global first medical low-temperature storage equipment product MDR notified body certificate issued by TÜV Rheinland. Haier Biomedical General Manager Liu Zhanjie, TÜV Rheinland Greater China Medical Device Service Vice President Geng Wen and other representatives from both sides attended the certificate awarding event. Haier Biomedical has been awarded the world's first EU MDR certificate for medical low-temperature storage equipment. The acquisition of the EU MDR certificate signifies that Haier Biomedical's medical refrigeration storage equipment-related products have met international standards in terms of safety, efficacy, and lifecycle management. This not only fulfills the latest entry requirements for the EU market but will also expedite the registration process in regions such as Southeast Asia, the Middle East, and Africa. Currently, Haier Biomedical has accelerated its advancement into a new stage of its international strategy, setting a new benchmark for high-quality overseas expansion in the medical device industry. Obtained EU MDR certification, quality and technical standards in line with international standards Medical low-temperature storage equipment is specialized equipment used for storing tissues, cells, vaccines, blood, and blood products. In recent years, with the development of life sciences and biotechnology, there has been an increasing demand for precise and professional storage equipment, driving continuous growth in the medical low-temperature storage market. MDR compliance certification is a requirement for medical device products to enter the EU market, imposing higher requirements on product performance safety, pre-market clinical evaluation, clinical data collection, and post-market market surveillance, vigilance systems, and regulation. As the industry leader, Haier Biomedical has ( scientific and technological independent innovation) since its inception. As early as 2006, it independently broke through the key core technologies in the field of biological medical low-temperature refrigeration, achieving the localization of such equipment, and was awarded the Second Prize of National Science and Technology Progress in 2013. At the same time, to enhance industrial standard levels, Haier Biomedical took the lead in formulating China's first national standard for low-temperature storage boxes and is currently taking the lead in advancing the first IEC international standard project for medical low-temperature storage boxes, thus forging a path from technological breakthroughs to standard leadership. TÜV Rheinland Group is an internationally renowned third-party inspection, testing, and certification institution with strong professional testing capabilities and rich international certification experience in the medical device sector. Products that pass TÜV Rheinland certification represent high quality and reliability. Note: There was a segment in Chinese characters that did not translate seamlessly into English due to a potential typo or formatting issue. The direct translation of "" is included in parentheses for clarity. In this case, where there were no precedents for domestic medical refrigeration equipment receiving EU MDR certification, Haier Biomedical completed all necessary preparations including product testing, software assessment, cybersecurity testing and review, usability review, clinical evaluation, and MDR quality system construction. They successfully passed the EU MDR audit. It is understood that medical devices with EU MDR certification can simplify registration processes in other overseas markets such as Southeast Asia, the Middle East, and Africa due to their international recognition, reducing duplicate tests and documentation, thereby significantly accelerating relevant registration processes and helping companies quickly enter emerging markets. Liu Zhuanjie, General Manager of Haier Biomedical, stated that the EU MDR certificate is a significant manifestation of Haier Biomedical's commitment to technological innovation and quality-first principles. It plays a crucial role in accelerating the high-quality globalization of their "product + solution." Taking this opportunity, Haier Biomedical will provide high-quality solutions to medical institutions and research units in more countries, promoting the high-quality development of domestic medical devices in the international market, and contributing Chinese wisdom and strength to the construction of a global health community. Geng Wen, Vice President of TÜV Rheinland Greater China Medical Device Services, stated that the two products, medical low-temperature preservation boxes and blood refrigeration boxes, have passed the EU MDR certification. This not only highlights the technical strength of Haier Biomedical but also signifies a crucial step for Chinese intelligent manufacturing in the field of high-end medical equipment. Looking ahead, TÜV Rheinland will continue to coordinate global professional resources to promote China's outstanding medical device products and related technologies to go global and enter the EU market in a fast and compliant manner. At the same time, TÜV Rheinland is willing to work together with Haier Biomedical to create a better future for the medical device industry! Promoting internationalization through localization, creating a new paradigm of "product + solution" for overseas markets. Receiving the world's first medical low-temperature storage equipment EU MDR certificate is just a microcosm of Haier Biomedical's international innovation layout. In the wave of globalization, product certification is a crucial step in ensuring product quality and compliance, and it's also the "key" to entering the international market. Facing various product certification requirements from different countries and regions, Haier Biomedical strictly follows the relevant laws and regulations while adhering to independent innovation, committed to accelerating the pace of "product + solution" through high technology and high standards. With leading technical strength and excellent product performance, by the end of 2024, Haier Biomedical has accumulated more than 400 model products that have obtained overseas certification, including more than 200 EU CE certifications, more than 70 US FDA certifications, more than 140 US UL certifications, and 12 US AABB certifications. In the journey of going global, a stable and deep approach requires not only the "hard support" of technological innovation but also the continuous enhancement of the "soft power" of international operations by enterprises. With an international perspective, Haier Biomedical is continuously building a global market system that directly faces users, improving the interaction, customization, and delivery capabilities of scenario solutions. By promoting localized strategies of "one country, one policy," Haier Biomedical actively enhances regional delivery capabilities and establishes a local service response mechanism. By constructing localized operation centers that cover local products, marketing, logistics, and after-sales, the company achieves rapid insight and response to local user needs, upgrading the overseas model from "product output" to "ecosystem co-building." Currently, Hai'er Biomedical has established long-term cooperative relationships with nearly 80 international organizations such as the World Health Organization (WHO) and the United Nations Children's Fund (UNICEF). Its products and solutions have been applied in more than 150 countries and regions worldwide, contributing to the construction of a global community of health and wellness. At CMEF, Haier Biomedical was awarded the world's first MDR certificate for medical low-temperature storage equipment, which is just one of the dazzling footnotes in the journey of Chinese medical device companies going global. Currently, going global has become a new engine for Chinese medical device companies to create a second growth curve and is also a necessary path for leading brands to internationalize and globalize. Looking to the future, Haier Biomedical will continue to focus on user needs, further strengthen technological innovation capabilities, and adhere to the concurrent implementation of localization and internationalization strategies, making high-quality going global more stable and broader, injecting strong vitality into the progress and development of global life science and medical services, promoting global medical inclusiveness, and making life better!

March 27, 2025,CIRCULINE®The first commercial implantation of a dialysis artificial blood vessel was successfully completed at the Vascular Surgery Department of Longhua Hospital Affiliated with Shanghai University of Traditional Chinese Medicine, led by Professor Shi Yaxue and her team. This marks the first commercial implantation of this artificial blood vessel since its market launch.Baiyouda and its wholly-owned subsidiary ChangdiUnleashing a new chapter in domestic blood pathway innovation through comprehensive, independent innovation across the entire chain.CIRCULINEThe ® dialysis artificial blood vessel received the innovative medical device registration certificate issued by the National Medical Products Administration in December 2024, marking the official birth of China’s first domestically produced dialysis artificial blood vessel approved for market launch.According to reports, China's special review procedure for innovative medical devices targets products that possess Chinese invention patents, are technologically pioneering domestically and internationally leading, and have significant clinical application value. The approval of the CIRCULINE® dialysis artificial blood vessel for medical device registration signifies that China has broken the import monopoly in the field of dialysis artificial blood vessels."Compared to similar products on the market, the CIRCULINE® dialysis artificial blood vessel has undergone disruptive innovation in raw materials and product processes," said Dr. Du Guangwu, the founder of Baiyoda. This product is made of ePTFE artificial blood vessels and textile-type artificial blood vessels combined through medical-grade high-elastic silicone gel, resulting in an innovative dialysis artificial blood vessel with a three-layer structure consisting of inner, middle, and outer layers.CIRCULINE® dialysis artificial blood vessels are suitable for the establishment of arteriovenous fistulas, creating a vascular access that can withstand repeated punctures and has sufficient blood flow to meet the needs of hemodialysis. This product integrates the advantages of mainstream dialysis artificial blood vessels on the market, providing excellent blood compatibility, biocompatibility, and anti-bending performance, while also being resistant to puncture. Before approval, this product underwent over 300 randomized controlled clinical trials in China, compared to similar products from the American company Gore, which are currently the most used in clinical settings domestically, demonstrating comparable performance in patency rates, anti-thrombosis, and other metrics to imported products.Bai You DaJiangsu Biotemed Life Technology Co., Ltd. was established in 2015 and currently has production and RD bases in Shanghai and Nantong, with over 200 employees. In early 2022, the Biotemed Technology Park, covering an area of 25,000 square meters and located in the Nantong North High-Tech City, began construction. The first phase of the project, a 15,000-square-meter artificial blood vessel production facility, was put into operation in December 2022. The company has set up the Biotemed RD Center in Zhangjiang Medical Valley, Shanghai, which was officially launched in October 2022. The RD center's laboratory spans 6,500 square meters and can accommodate the development and production of various products.The company currently has more than 20 ongoing research projects, covering multiple departments such as cardiovascular surgery, vascular surgery, cardiac surgery, and general surgery. Relying on technical platforms such as polymer materials, biomaterials, and metal stent forming, the company is continuously launching more high-quality products that meet clinical needs, benefiting a wide range of patients.Since its inception, Baiyouda has consistently focused on the research, development, and production of high-end implantable and interventional medical devices, successively establishing wholly-owned subsidiaries Changdi and Baiheya. Its product line includes VASOLINE.®Artificial blood vessel, VASOPATH®Disposable Strap Retractor, MONOKNIT™Hernia patch, VASO™Non-absorbable surgical sutures and similar products are now on the market.

Recently, the Center for Medical Device Evaluation of the National Medical Products Administration released the review result announcement of the special review application for innovative medical devices (No. 3, 2025), proposing to agree14 modelsMedical devices enter the innovation channel.Image source: CMDE官网Translation:Image source: CMDE website1. Human Chromosome 3 and 10 Abnormal Cell Detection Kit (Fluorescence In Situ Hybridization Method): Zhuhai Santé Biotechnology Co., Ltd.Fluorescence in situ hybridization (FISH) is an advanced techniqueNucleic acid molecular hybridization methodIt utilizes known fluorescently labeled single-stranded nucleic acids as probes, which, based on the principle of base complementarity, undergo processes such as denaturation, annealing, and renaturation to specifically bind to unknown single-stranded nucleic acids in the sample, forming detectable hybrid double-stranded nucleic acids. The chromosome abnormality cell detection kit from Shengmei Biotech canLiquid biopsy technologyCapturing circulating abnormal cells from blood achieves over 90% sensitivity in early lung cancer screening, breaking the limitations of traditional biopsy.In March 2016, Saint Medical was jointly invested and established by US Cynvenio Biosystems and Zhuhai Livzon Reagent Co., Ltd., a subsidiary of Livzon Pharmaceutical. After years of development, Saint Medical has mastered the world's advanced tumor liquid biopsy technology. Currently, Saint Medical owns two core technologies: LiquidBiopsy rare cell enrichment and separation, and MDA TEST for benign-malignant pulmonary nodule auxiliary diagnosis. LiquidBiopsy is a circulating tumor cell enrichment and separation platform that can directly connect to downstream molecular testing, while MDA TEST technology is a leading technology for early lung cancer screening using Circulating Abnormal Cells (CAC).2. Biological Hernia Repair Mesh: Zhuo Ruan Medical Technology (Suzhou) Co., Ltd.Biological hernia repair patches are medical materials made using biotechnology, primarily used for treating hernias. These biological hernia repair patches are mainly made from animal tissues (such as from pigs or cows) and undergo special treatments, such as decellularization and cryogenic freeze-drying techniques, to enhance their biocompatibility and applicability.It is reported that this product is a naturally derived bio-regenerative material that can be completely degraded after implantation in the body. Its structural design is tailored to..."Submucosal layer + basement membrane" biomimetic structureThe material exhibits good histocompatibility, with interconnected pores throughout, facilitating the ingrowth of surrounding tissue cells and promoting the flow of tissue fluid.Zhurong Medical was founded in 2016 and is an innovative high-tech RD and production enterprise dedicated to surgical tissue reconstruction and regenerative medicine for tissue repair. It is worth noting that in 2021, Zhurong MedicalThe first in the countryThe innovative medical device Antisheng® biological hernia repair mesh based on "basement membrane biomaterials" has been approved for Class III certification and market launch.3. Single-use intracardiac ultrasound imaging catheter: Shanghai MicroPort Electrophysiology Medical Technologies Co., Ltd.Microsurgery Electrophysiology was established on August 31, 2010, and was listed on the Shanghai Stock Exchange's Star Market on August 31, 2022. It is a high-tech enterprise focused on the research, development, production, and sales of innovative medical devices in the field of electrophysiological interventional diagnosis and ablation therapy. The company comprehensively covers the product layout for cardiac electrophysiology procedures and is the first domestic manufacturer to provide a complete solution of three-dimensional cardiac electrophysiology equipment and consumables.Implemented the two mainstream ablation energy products of "radiofrequency + cryo".Collaborative layout.It is reported that the intracardiac ultrasound catheter that entered the innovative channel this time is a disposable type.Equipped with three-dimensional ultrasound positioning functionWhen used in conjunction with ultrasound imaging equipment and the Columbus® three-dimensional cardiac electrophysiological mapping system during cardiac interventional procedures, it enables the acquisition of high-definition intracardiac structures and images of other instruments while simultaneously obtaining corresponding three-dimensional positions. This facilitates precise visualization of the procedure, assisting surgeons in more accurately assessing treatment outcomes and enhancing surgical safety.According to the information retrieved from YaoZhi Patent Pass, MicroPort Electro-Physiology holds 221 authorized patents. Among them, a new patent was granted on March 21st of this year titled "Intracardiac Ultrasound Catheter and Intracardiac Ultrasound Imaging Device." This patent involves an intracardiac ultrasound catheter and intracardiac ultrasound imaging device.4. Magnetic Control Non-Invasive Extendable Prosthesis System: Beijing AK Medical Co., Ltd.Aikang Yicheng was established in 2003 and is a core subsidiary of Aikang Medical. Aikang Medical is one of the earliest companies globally to commercialize additive manufacturing technology (3D printing technology) and apply it to implants for joint replacement, spine, and trauma repair. The company possesses the 3D Printing Precise Construction Technology Platform, the Supravit Vacuum Plasma Spraying Technology Platform, the Navigation/Robotic Intelligent Technology Platform (VTS/IBot), and the Medical-Engineering Interactive Customization Platform (Innovative Custom Orthopedic Solution).Currently, AK Medical is a leading enterprise in the field of artificial joints in China, ranking first in market share in China and among the top ten in the global hip joint market.The magnetic-controlled non-invasive prosthesis system that entered the innovation channel this time, isUtilizing 3D printing technologyCustom bone scaffolds allow patients to adjust the length of the prosthesis without the need for a second surgery, bringing new hope for bone tumor treatment.5、Cerebral Protection Device against Embolization: Shanghai Shenqi Medical Technology Co., Ltd.Shenqi Medical is an innovative medical device enterprise integrating RD, production, and sales, with product portfolios covering cardiovascular intervention, structural heart disease, peripheral vascular intervention, and neurovascular intervention fields. Shenqi Medical also holds an affiliated company, HeartCare, which is China's first RD and production enterprise for heart failure ultrafiltration treatment devices.Currently, Shenqi Medical has 2 marketed products and 33 products in the pipeline, all of which are independently developed with comprehensive independent intellectual property rights. The anti-embolism cerebral protection device entering the innovation channel is used in neurointerventional surgery.Real-time interception of blood clots reduces the risk of stroke by 70%.In addition, in March 2025, Shenqi Medical's independently developed QiChuan® SQ-Surgipath® transjugular intrahepatic puncture device was officially approved for market launch by the NMPA. This product is suitable for transjugular intrahepatic portosystemic shunt procedures to reduce portal vein pressure.6. Glaucoma drainage tube: Mingche Biotechnology (Suzhou) Co., Ltd.Mingche Biotechnology is a high-tech enterprise focusing on the research, development, production, and sales of ophthalmic medical devices, guided by technology development. Currently, Mingche Biotechnology has formed a multi-product line layout centered around minimally invasive glaucoma drainage tubes, along with sensor platforms, microneedle drug delivery platforms, and magnetic control surgical robot platforms for ophthalmic micro-devices.The Gaira® glaucoma drainage tube entering the innovation channel this time is based on advanced structural design.实现了高效引流和防止低眼压的融合优势Achieved the integrated advantages of efficient drainage and prevention of low intraocular pressure, and on this basisInnovatively developed light-curing hydrogel materials.It can effectively overcome the problems of traditional drainage tubes being prone to breakage and easy to fracture after long-term implantation.Based on the concept of integrated diagnosis and treatment, a minimally invasive injectable intraocular pressure sensor has been developed, enabling 24/7 home-based real-time monitoring of intraocular pressure.The minimum detection accuracy can reach 0.1mmHg.7. Mycobacterium leprae Nucleic Acid Detection Kit (Fluorescence PCR Method): Suzhou Fangke Biotechnology Co., Ltd.Fangke Biology was established in 2018 and joined Baiyang Pharmaceutical Group in 2020. It focuses on the innovative product transformation for major disease screening and is a high-tech enterprise that integrates high-throughput gene sequencing, immune microenvironment analysis, advanced biochemical detection of proteins, and clinical big data analysis technologies.Leprosy is a chronic infectious disease caused by infection with *Mycobacterium leprae* (ML). The source of transmission is untreated leprosy patients, and the main routes of transmission include prolonged close skin contact and respiratory inhalation of droplets. Currently, leprosy is classified as a Category C legally notifiable infectious disease in China and has long been one of the major infectious diseases targeted for elimination by the national government.The leprosy Mycobacterium nucleic acid detection kit developed by Fangke Biotechnology.Early detection and rapid diagnosis can be performed for this group of leprosy patients who have not yet developed disabilities or are suspected to have leprosy., enabling timely treatment and effectively preventing the spread of the disease and disability. The reagent kit is based on multiplex fluorescence PCR technology, selecting Folp1, RpoB, and GyrA genes of Mycobacterium leprae as amplification targets, designing specific primers and fluorescent probes for detecting Mycobacterium leprae DNA in samples, providing important guidance for the early diagnosis of leprosy.8. Proton Therapy System: Varian Medical Systems Particle Therapy, LLCVarian Medical Systems was founded in 1948 and is a global leader in providing diagnostic and treatment solutions for cancer and other major diseases. Since the 1990s, Varian Medical Systems has been involved in the development and research of proton therapy technology. In 2009, it officially entered the proton therapy system market comprehensively, quickly establishing a proton therapy business with advanced technology platforms such as superconducting cyclotrons and pencil beam scanning technology.In 2021, the company was acquired by Siemens Healthineers.In November 2023, Varian Medical's proton therapy system was approved for market release by the NMPA. This product isFirst unitThe approved proton therapy system using superconducting cyclotron technology and 360-degree rotating gantry provides proton beams for radiotherapy, applicable for treating solid malignant tumors and certain benign diseases throughout the body. The system consists of an accelerator subsystem and a treatment subsystem.9. Renal artery ultrasound ablation device: Shanghai Hantong Medical Technology Co., Ltd.Hantong Medical is an innovative medical technology enterprise focusing on interventional ultrasound technology. Its core technology is a fully self-developed ultrasound energy platform, and its first product is the renal artery ultrasound ablation system (uRDN), mainly used for the treatment of hypertension.According to the different energy sources used for ablation, RDN pathways can be categorized into radiofrequency ablation, ultrasound ablation, cryoablation, and chemical (alcohol) ablation.Han Tong Medical has chosen a challenging path in the field of ultrasound ablation.It is reported that the renal artery ultrasound ablation system (uRDN) independently developed by Hantong Medical optimizes the sound field output range, providing more stable ablation effects. It is also a product capable of performing 360° uniform energy field ablation in both the main renal artery and its branches. In addition, Hantong Medical is developing the next-generation ultrasound energy platform, which integrates ablation therapy with ultrasonic diagnosis, offering clinical advantages such as targeted ablation and real-time monitoring of ablation effects.10. Implantable Neurostimulation System: Borui Kang Medical Technology (Shanghai) Co., Ltd.As the population ages, the prevalence of neurodegenerative diseases (such as Parkinson's disease, epilepsy, etc.) is increasing, driving up the demand for implantable neurostimulation systems.An implantable neurostimulation system is aMedical devices that treat various diseases by electrically stimulating the nervous systemIt typically consists of electrodes, a pulse generator, and a battery, capable of regulating neural activity through precise electrical signals, thereby improving or restoring function. This device usually requires implantation into the patient's body during surgery, utilizing either implantable or non-invasive techniques. It works by stimulating, inhibiting, or modulating specific neurons and neural networks through electrical, chemical, optical, magnetic, or ultrasonic means, helping patients improve their quality of life or enhance bodily functions.Neuracle Medical was founded on June 9, 2021. Its parent company, Neuracle Group, is one of the leading enterprises in China's brain science field. Its core products include video EEG machines, high-frequency high-channel EEG machines, brain function monitors, event-related potential devices, and transcranial electrical stimulation devices.11. Coronary Intervention Surgery Control System: Beijing Zhongke Hongtai Medical Technology Co., Ltd.Coronary heart disease is a common cardiovascular disease worldwide, with a high incidence and mortality rate. With the aging population and changes in lifestyle, the number of patients with coronary heart disease continues to grow. However, traditional coronary intervention surgery requires doctors to manually operate instruments such as guidewires and catheters under X-ray fluoroscopy. The precision of manual operation is limited, making it difficult to manage complex lesions, resulting in longer surgery times and relatively higher risks of complications for patients.With the increasing demand for treatment, the need for related equipment such as coronary intervention surgery control systems will continue to rise. Zhongke Hongtai's Coronary Intervention Surgery Control System will provide a new option for such patients.Zhongke Hongtai was incubated and established by the Institute of Automation, Chinese Academy of Sciences, led by internationally renowned experts in the fields of medical robotics and artificial intelligence, including researcher Hou Zengguang from the Institute of Automation. It is worth mentioning that it has independently developed...The world's firstMulti-channel pan-vascular interventional surgical robot, compatible with mainstream interventional devices and complex interventional procedures, equipped with self-developed specialized consumables, dedicated to creating a comprehensive intelligent catheter lab solution for multiple departments, diverse procedures, and integrated diagnosis and treatment workflows.12. Newborn TREC/KREC Gene Detection Kit (Fluorescence PCR Method): Shanghai Jieyi Biotechnology Co., Ltd.JYBIO is a high-tech enterprise dedicated to the clinical testing and translational research of genetic diseases. Starting from the entire chain of "screening-diagnosis-translational research-treatment," JYBIO comprehensively addresses the challenges in the prevention, diagnosis, and treatment development of hereditary rare diseases.Currently, Jiyi Biotech possesses a variety of technical platforms, including second-generation sequencing, peripheral blood chromosome karyotyping, flight nucleic acid mass spectrometry, tandem mass spectrometry/gas chromatography-mass spectrometry, and molecular platforms (MLPA/qPCR/first-generation sequencing), all of which contribute to the precise diagnosis of rare diseases. Additionally, it has two Nobel Prize-level technology platforms, iPSC and CRISPR/Cas9, combined with the NGS platform, enabling further functional studies on rare disease-related gene loci, rare disease drug screening, and new drug development.The newborn TREC/KREC gene detection reagent kit that entered the innovation channel performed excellently in previous clinical trials. According to the data, when compared with foreign SCID screening data, the screening positivity rate of this reagent kit is at the median level among the reported large-scale screening study detection positivity rates, and actual data supports SCID screening. Beyond a single rare disease, can benefit other non-SCID children.13. Colorectal Cancer Digital Pathology Image Microsatellite Instability Analysis Software: Suzhou K帮扶 Gene Technology Co., Ltd. Note: It seems there is a typo in the company name as "K帮扶" doesn't make sense in this context. It might be intended to be "Kbang" or another romanization of the Chinese characters. Please verify the correct spelling of the company name.Kebang Gene is a company specializing in molecular diagnostic products for precision oncology, focusing on high-throughput gene expression profiling and AI big data analytics. It is dedicated to the research, development, production, and sales of molecular diagnostic products for precision oncology, and provides related scientific research and testing services.Currently, it is deeply involved in tumor mRNA detection and artificial intelligence领域，with proprietary intellectual property rights for tumor marker products, and its core product isTumor Tissue Origin Gene Detection SystemIn addition, according to the patent map query on the pharmaceutical intelligence platform, KeyBang Gene currently owns 6 authorized patents, including methods and devices for pathological image analysis.The colorectal cancer digital pathology image microsatellite instability analysis software developed by Kebang Gene, based on advanced and leading RNA molecular diagnostic technology, provides a new solution for precise tumor diagnosis. It uses digital image recognition for microsatellite instability, completes diagnosis in 10 minutes, and improves accuracy by 30% compared to manual analysis.14. Degradable Magnesium Alloy Bone Screw: Huaron Kechuang Biotechnology (Tianjin) Co., Ltd.Biodegradable magnesium alloy materials exhibit extraordinary superiority in multiple dimensions such as degradability, mechanical properties, and biocompatibility compared to widely used biodegradable polymers like polylactic acid in clinical applications. Their emergence also ingeniously addresses long-standing challenges faced by traditional implants. Huarong Sci-Tech's biodegradable magnesium alloy bone screws have shown, compared to traditional material screws,Significant advantages and clinical value：Completely biodegradable, no need for secondary surgery to remove it.The ingredients are safe and non-toxic, and can promote bone growth.To avoid stress shielding effect and facilitate bone tissue healing;The degradation curve is slow at first and then accelerates, which is consistent with the human skeletal growth cycle.Imaging examination can be visualized without interference from artifacts.As the product progresses, it also symbolizes a significant breakthrough in China's degradable material technology, foreshadowing the broad prospects and infinite possibilities of degradable materials in medical applications.

According to foreign media reports, Stryker, a global orthopedic giant, announced yesterday (April 1) that it has completed the sale of its U.S. spinal implants business to Viscogliosi Brothers, LLC, a family investment company focused on the neuromusculoskeletal field.It is worth noting that,The transaction facilitated the establishment of a new company named VB Spine, LLC (VB Spine)., marking the official implementation of the business restructuring plan announced by Stryker in January. Previously, Stryker had stated that, apart from the US market, its international spinal implants business would also be gradually divested.From Stryker's 2024 financial report, it can be seen that its spinal implant business is no longer contributing to the company's revenue. The report shows that in 2024, its spinal implant business revenue was $707 million (a year-over-year decrease of 0.7%).The U.S. spinal implant business declined by 2.1% year-over-year.The specific financial terms of this transaction were not disclosed. In a statement at the beginning of the year, Stryker pointed out that this divestiture "will enable both parties to focus more on meeting the needs of customers and patients, and is expected to accelerate business growth and create greater value for all stakeholders."According to the agreement, after the transaction is completed,VB Spine will be Stryker's strategic partner.Obtained exclusive rights to use the Mako Spine system and its Copilot system for VB Spine's implants in spinal surgeries.Kevin Lobo, Chairman and CEO of Stryker, stated, "Through our interventional spine product line, neuromodulation technology platform, and enabling technology business, as well as the strategic collaboration with VB Spine, we will continue to be deeply engaged in the spine care field. We sincerely appreciate the historical contributions of the spine business team and believe they will continue to create value on the new platform." It is worth noting that this transaction comes at a time when competition in orthopedic robotics technology is intensifying. Stryker's retained Mako robotic technology already covers the joint replacement field, and the authorization granted to VB Spine to use its spinal version technology may become an important strategic move to seize the commanding heights of a niche market.

On April 1, 2025, Peijia Medical held a strategic innovation cooperation signing ceremony and press conference at its global headquarters, announcing a collaboration with the biomedical division of DSM-Firmenich, an innovator in nutrition, health, and beauty. The partnership will leverage ultra-high molecular weight polyethylene (UHMWPE) and thermoplastic polyurethane (TPU The high-polymer heart valve developed by RD has achieved results. The signing of the memorandum of strategic innovation partnership between the two parties will further focus on the RD and innovation of high-polymer valve materials, which is expected to lead a revolutionary change in the global high-end medical device materials field.Dr. Yi Zhang, Chairman and CEO of Peijia Medical, signed a strategic innovation cooperation agreement with Paul Spencer, President of the DSM-Firmenich Biomedical Business Unit.Peijia Medical is a leading company in China's structural heart disease and cerebrovascular介入高端医疗器械领域，拥有覆盖主要瓣膜疾病和下一代核心技术的结构性心脏病产品管线组合和产品开发团队，以及面向出血及缺血性脑卒中市场的完备商业化产品和创新术式组合。2024年沛嘉医疗销售收入6.15亿元人民币，同比增长约40%。Peijia Medical is a leading company in China's structural heart disease and cerebrovascular intervention high-end medical device sector. It has a comprehensive product pipeline and development team covering major valvular diseases and next-generation core technologies for structural heart disease, as well as a complete suite of commercialized products and innovative procedures targeting hemorrhagic and ischemic stroke markets. In 2024, Peijia Medical's sales revenue was 615 million RMB, representing a year-over-year growth of approximately 40%.Michelle Ortiz, Vice President of Research and Innovation for DSM-Firmenig Biomedical, introduces her company's biomaterial properties and applications.The DSM-Firmenich Biomedical business unit is headquartered in Pennsylvania, USA, and has an office and innovation application research center in Shanghai, China. As part of the DSM-Firmenich Group, the biomedical division possesses unparalleled expertise in the field of biomaterials and their applications, helping partners like TAE Medical create breakthrough innovations for patients worldwide.In this collaboration, Peijia Medical and DSM-Firmenich's biomedical business unit have joined forces to achieve new breakthroughs in the research and development of ultra-high molecular weight polyethylene and thermoplastic polyurethane (TPU) valve materials. According to the memorandum, both parties will establish a long-term, stable, and mutually beneficial strategic innovation partnership. Utilizing DSM-Firmenich's biomaterials, the RD teams from both sides will collaborate on the design and development of new high-end medical device products, performance optimization of key raw materials based on ultra-high molecular weight polyethylene materials, new material development, as well as the development and application of advanced manufacturing processes and technologies.National Health Commission expert group industry expert Jiang Tianjiao presented a report titled "Cardiac Valve Industry: Evolution of Technical Pathways and Future Trend Outlook."Ultra-high molecular weight polyethylene fiber is a lightweight and high-strength polymer material, with a strength 15 times that of steel structures of the same size. Using ultrafine fibers and employing unique weaving and multi-layer fusion technology, a polymer valve material is produced that can perfectly replace existing animal-derived heart valve materials. This product offers significant potential for improvement in flexibility and biocompatibility, promising a revolutionary upgrade in valve materials.Polymer valve materials are non-biological, inorganic materials with significant advantages in physical and biochemical properties, as well as lifespan, making them suitable for younger patients. Compared to traditional animal-derived valve materials, polymer valve materials have two major advantages: on one hand, they enhance product lifespan and expand indications; on the other hand, they reduce costs and are suitable for mass production. This is of great significance for the development of the heart valve market, benefiting a larger patient population.Peijia Medical's Chief Operating Officer Pan Kongrong introduced the progress of the Peijia polymer valve project and animal experiment data.The polymer valve independently developed by Peijia Medical is a new type of polymer valve that uses a five-layer bionic polymer fiber woven material as the valve material, simulating the functions of the corresponding layers of materials in the human autologous valve leaflets, making it closer to the functions of human autologous valves. This product has maintained stable hemodynamics after 400 million accelerated fatigue tests, demonstrating outstanding durability, with an expected lifespan far exceeding that of current biological valve materials. The development of this product has successfully been included in Suzhou's key core technology tackling project aimed at global challenges. Currently, the product has completed animal experiments and is preparing to enter clinical trials.Peijia Medical's Chief Operating Officer, Kanger Pan, stated that based on years of collaboration with DSM-Resins Functional Materials, the two parties will now enter into a deeper level of synergy. The development of high molecular weight valve material, as a core platform technology for Peijia Medical, will, once developed, be applied across various product lines to enhance their performance and open up applications of ultra-high molecular weight polyethylene in the field of structural heart disease.Paul Spencer, President of DSM-Firmenich's Biomedical Division, stated, "At DSM-Firmenich, we are committed to advancing the development of vascular applications through innovative biomaterial solutions, supporting the goals of achieving better clinical outcomes, reducing healthcare costs, and improving the lives of patients worldwide. We are very pleased to officially collaborate with Peijia to jointly promote this vision in China."

Oben Group is a globally leading manufacturer of packaging materials, primarily producing polypropylene (PP), polyester (PET), and nylon films.After acquiring KristaFilms in July 2023, the company plans to build a new production facility in Monterrey, Mexico. The facility will be equipped with the world's most advanced BOPP film production line, setting a new benchmark in the industry for output, speed, and roll diameter, provided by Bruckner.Recently, Oben Group has gained a competitive advantage with its new generation of BOPP production line. The plant is constructing the world's most efficient production line, with a speed of up to 700 meters per minute and a film width of 12 meters.Oben Group is one of Brückner's earliest and largest customers, and the two sides have maintained a close cooperative relationship. Markus Geschwentner, Managing Director of Brückner Maschinenbau GmbH, expressed his appreciation for this collaboration."I am particularly delighted that our long-term cooperation has led to the birth of the world's first 12-meter BOPP production line. This highlights our over 30 years of close relationship, which can now be considered the icing on the cake."The president of Oben Group emphasized the company's steadfast commitment to growth and innovation:"This new milestone demonstrates our commitment to突破效率和生产力的边界。与布鲁克纳的合作对于我们取得这些进步至关重要，我们期待进一步巩固我们在全球包装行业的领导地位。”It seems there's a part in Chinese that didn't get translated properly. The correct full English translation should be:"This new milestone demonstrates our commitment to breaking through efficiency and productivity boundaries. Our collaboration with Bruckner has been crucial for achieving these advancements, and we look forward to further solidifying our leadership position in the global packaging industry."Editor: Carrie

SHL Medical, a manufacturer of auto-injection systems headquartered in Switzerland, officially opened its most advanced new manufacturing facility in North Charleston, South Carolina. SHL Medical stated that the expansion, first announced in summer 2022 with an investment of $220 million, contributed to the local economy and created hundreds of new jobs in the region.South Carolina Governor Henry McMaster, North Charleston Mayor Reginald L. Burgess, and Swiss Consul General Urs Broennimann attended the grand opening ceremony last week.Ulrich Faessler, CEO of SHL Medical, welcomed Governor Henry McMaster to the grand opening ceremony of the company's new factory in North Charleston, South Carolina.Reliable domestic drug delivery device supplyThe factory, spanning 360,000 square feet, will produce SHL Medical's advanced auto-injectors for high-demand conditions such as obesity, autoimmune diseases, and rare disorders. SHL Medical stated that with the increasing demand for Glucagon-like peptide-1 (GLP-1) therapies to treat conditions like type 2 diabetes and obesity, the new facility will ensure reliable supply of related drug delivery devices to U.S. patients, while reducing lead times and transportation costs.According to data from the U.S. Centers for Disease Control and Prevention, more than 38 million Americans (1 in 10 adults) have been diagnosed with diabetes, and most of them have type 2 diabetes.Global market value 120 billion dollars"The facility marks a key step in our global expansion and enhances our ability to meet the growing demand for autoinjectors," said Ulrich Faessler, CEO of SHL Medical. In fact, according to data from Fortune Business Insights, the global autoinjector market was valued at $120 billion in 2023 and is expected to grow at a compound annual growth rate of 11.4% by 2032.SHL Medical is headquartered in Zug, Switzerland, with operations in Deerfield Beach, Florida; Sweden; and Taiwan. The company chose South Carolina as its U.S. flagship base because of the "strong skilled workforce pipeline and favorable business environment," CEO Ulrich Faessler said in a prepared statement. He added that the new facility will enable the company to "scale up production while contributing to the growth of the region."The new facility, equipped with advanced injection molding technology and fully automated assembly lines, complements SHL Medical’s established production site in Taiwan and its upcoming facility in Zug, Switzerland.The Swiss manufacturing plant is scheduled to open in 2026.Chugger Factory first announced in November 2020 that it is expected to be completed next year. The new global headquarters will cover 226,000 square feet and will seamlessly integrate office space with state-of-the-art manufacturing technology. SHL Medical expects an annual production capacity of approximately 80 million automatic injection devices, with nearly 350 employees. Once completed, it will make the company one of the few manufacturers of automatic injectors operating on three continents.By leveraging its existing operations in Florida and the recent acquisition of shares in SHL Advantec, the North Charleston facility has strengthened SHL Medical's presence in the United States, supporting large-scale production and advancing its mission to deliver world-class drug delivery devices. The company stated that it is on track to deliver 1.5 billion devices to customers by 2025."We are proud to expand our operations in the United States and support local communities," said Kimberlee Steele, Managing Director of North America. "One of the most trusted auto-injector brands is now made in the USA, ensuring patients have the essential equipment they need to manage their health independently."

Recently, the British Medical Journal (BMJ) released a latest data analysis, revealing serious delays in the submission of adverse event reports for medical devices in the United States. The data shows that more than 1.2 million adverse event reports for medical devices were not submitted to the U.S. Food and Drug Administration (FDA) by the deadlines stipulated in federal regulations.According to the researchers' analysis, more than 400,000 of these overdue reports were submitted more than six months after the manufacturers received the adverse event notifications. This finding has raised widespread concern, as delayed reporting of adverse events can seriously impede the early detection of patient safety issues.In the United States, most medical devices are required by manufacturers to report to the FDA when their devices malfunction or may cause or contribute to death or serious injury upon approval. According to federal law, manufacturers must submit a report to the FDA's Manufacturer and User Facility Device Experience (MAUDE) database within 30 days of becoming aware of an adverse event. However, the actual situation is far from optimistic.The MAUDE database, as a crucial tool for the FDA to monitor the safety of medical devices, has known limitations. Some media reports indicate that manufacturers have even failed to report adverse events to MAUDE years after the regulatory deadlines. To investigate this issue in depth, a team of U.S. researchers conducted a detailed analysis of manufacturer reports received by the FDA over a three-and-a-half-year period from September 1, 2019, to December 31, 2022.During this period, the FDA received a total of 4,432,548 reports involving 3,028 unique manufacturers and 88,448 unique devices, including 13,587 death reports, 1,552,268 injury reports, and 2,866,693 malfunction reports. However, it is concerning that only 71% (3,146,957) of the adverse event reports were submitted on time within 30 days, while 4.5% (197,606) were delayed between 31 to 180 days, and 9.1% (402,891) were submitted after 180 days.These delayed reports involve a total of 1,004 deaths, 198,051 injuries, and 401,442 malfunctions. Further analysis shows that more than 50% of the delayed reports are attributed to three manufacturers and 13 types of medical devices, many of which, such as infusion pumps and blood glucose monitors, are crucial for patient care.In addition, researchers found that nearly one-sixth (685,094 reports) had missing or invalid date data provided by the manufacturers. After excluding these reports with missing or invalid times, the percentage of delayed reports for high-risk devices (Class III devices) was higher at 22.4%, while for low-risk devices (Class I devices), the percentage of delayed reports was 6.9%.Although researchers have pointed out some limitations, such as manufacturers potentially misreporting dates and the inability to accurately identify harms caused by delayed reporting, they emphasize that delayed reporting is not permitted under existing regulations. This means that, regardless of the reason, more policy attention is needed to address this issue.The researchers wrote in the report: "The findings of this study collectively indicate that while the MAUDE database frequently informs the FDA's safety measures, this data source is incomplete for understanding medical device safety issues due to manufacturers' delayed reporting of adverse events. In addition to influencing how policymakers, clinicians, and patients make medical decisions, this may also impact future device development."In an editorial, the researchers further noted: "This study adds to the literature on important limitations of passive surveillance, not only for medical devices but also for pharmaceuticals and other products regulated by the FDA. The MAUDE database can be a useful adjunct to active surveillance efforts, especially if some of the issues identified in this study are addressed. Ultimately, supporting the use of data from routine health encounters for active surveillance is crucial for improving patient safety with medical devices."The release of this study once again sounds the alarm for the safety regulation of medical devices, reminding relevant authorities and manufacturers to strictly comply with regulatory requirements and report adverse events promptly and accurately to ensure patient safety.