Setting Sail with the Wind: 2023 China Medical Device Global Expansion Innovation Case Release

Amid the wave of domestic substitution, Chinese medical device companies are increasing their R&D investment to achieve technological upgrades and innovation. The normalization of centralized procurement has intensified competition in the domestic market, while significant demand exists in overseas markets, making global expansion an inevitable trend. A growing number of Chinese medical device enterprises are actively entering the international arena, expanding their overseas operations, and seeking new growth opportunities to ensure sustainable development.

In 2022, the third year of the global fight against the pandemic, global import and export trade gradually returned to rationality as the epidemic situation adjusted. China’s medical device export volume reached $59.549 billion, a year-on-year decrease of 23.04%. Although global demand for anti-pandemic supplies relatively declined, demand in traditional medical markets was gradually recovering. The structure of China’s medical device exports continued to optimize, with an increasing proportion of high-end medical device products, demonstrating a positive development trend. Meanwhile, the proportion of domestically produced medical devices exported to countries along the “Belt and Road” continued to rise.

Through research and development and innovation, China’s medical device companies have enhanced the international competitiveness of their products, thereby playing an increasingly important role in global medical device trade. Therefore, based on intuitive trade data, we aim to explore pathways for Chinese-made medical devices to expand overseas through innovation by analyzing the internationalization strategies and real-world case studies of these enterprises, seeking new directions for industry upgrading and development.

Based on this, VCBeat VB100 and VCBeat Research Institute jointly launched the “Call for Innovative Case Studies of Chinese Medical Device Companies Expanding Overseas in 2023”, targeting innovative medical device companies with overseas market layouts in China and service agencies facilitating the global expansion of medical devices for solicitation and evaluation.

This case study collection and selection initiative is grounded in the ecosystem of medical device global expansion, evaluating and selecting entries from two perspectives: global strategic layout and enablement services for international market entry.“Best Strategic Layout Enterprise for Overseas Expansion of Medical Devices in 2023” and “Best Empowerment Service Enterprise for Overseas Expansion of Medical Devices in 2023”Among them, the “Best Strategic Layout Enterprise for Medical Device Overseas Expansion in 2023” award was added“Best Layout Case in North America/Europe/Asia-Pacific”; Addition of the “2023 Best Empowerment Service Enterprise for Medical Device Overseas Expansion”“Best Market Access/Overseas Agency/Export Trade Empowerment Case”This selection process primarily evaluated the innovation highlights, distinctive advantages, achievements, role division and contributions of all participating parties, as well as the significance for global expansion of medical devices, demonstrated in the overseas case studies submitted by applicant organizations during the review year. After a rigorous two-month screening process, a total of 23 innovative cases were ultimately selected.

June 30–July 1,2023 China Medical Device Overseas Expansion ConferenceHeld in Tianjin. At this premier event for the global expansion of medical device companies, the Organizing Committee released the “2023 Innovative Case Studies for Medical Device Global Expansion” at the main forum on July 1. Representatives from the award-winning enterprises were invited to attend the award ceremony to receive their awards and engage in interactive sessions.

Innovation Case Release

Best Enterprise Empowerment Service Provider

Company Abbreviation:Haihe Biologics

Case Name:Haihe Facilitates the U.S. Market Launch of China’s First 4K Fluorescence Endoscopy System

Selection Recommendation:

Haihe Bio is a platform-based company that provides full-lifecycle product services to research institutions, R&D and manufacturing enterprises, and regulatory authorities in the medical device and pharmaceutical sectors. It is dedicated to delivering professional, independent third-party testing services for the fields of medical devices, pharmaceuticals, cosmetics, and disinfection products, offering customers testing services and validation/qualification solutions throughout the entire product lifecycle. Based on clients’ market development strategies and product characteristics, Haihe Bio customizes global market access strategic planning to facilitate earlier product launch and commercialization.

Upon receiving the client’s commission, Haihe Biotech conducted a comprehensive and holistic assessment. Tailoring the experimental protocol to the client’s specific circumstances, Haihe Biotech facilitated the regulatory success of the client’s independently developed 4K fluorescence endoscopic camera system, which became the first product of its kind from China to gain approval for marketing in the United States. This achievement marked a groundbreaking leap, transitioning Chinese exports of such products to the U.S. market from nonexistence to reality. The rapid and precise regulatory submission for this project demonstrates Haihe Biotech’s robust capabilities and expertise in providing professional overseas registration services for medical devices, ranging from endoscopes to the full spectrum of medical device categories. By empowering Chinese medical devices to expand globally, Haihe Biotech helps shorten regulatory cycles, improve approval success rates, save time and R&D costs, and accelerate market entry, thereby assisting Chinese medical device companies and products in capturing global market share. Furthermore, it facilitates faster layout and occupation of overseas markets. This accomplishment highlights the global competitiveness of China’s medical device innovations, signaling that China’s medical device technology has reached a world-leading position and achieved advanced outcomes.

Company Abbreviation:Giant Yi Technology

Case Name:Juyi Technology's Global Dual-Center Strategic Layout -- Juyi Technology Singapore

Selection Recommendation:

Juyi Technology (Shanghai) Co., Ltd. is a leading professional platform for innovative medical device R&D and technical services (Device R&D + CDMO). It aims to provide global medical device companies and clinical institutions with a comprehensive suite of contracted product development, clinical, and contract manufacturing services. Its service scope covers the entire process from innovative concept and technology research, collaborative product R&D, supply chain management, to contract manufacturing, clinical trials, regulatory registration, and product commercialization. Juyi Technology has established advanced medical device R&D service centers and laboratories in Shanghai and Suzhou, and set up contract manufacturing bases for advanced active and sterile medical devices in Suzhou, Changsha, and Changzhou. To date, it has provided one-stop contracted R&D, regulatory registration, and contract manufacturing services to nearly 30 renowned medical device enterprises both domestically and internationally.

Juyi Technology established its Singapore sub-center in May 2023. The Singapore center aims to meet the needs of Chinese enterprises for global market expansion. Juyi Singapore will gradually establish advanced manufacturing and R&D bases to safeguard Chinese companies as they expand overseas.

Company Abbreviation:Pure Evidence

Case Name:Global AI-Empowered Life Sciences Service Provider

Selection Recommendation:

PureReg is an industry-leading, global AI-empowered life sciences service provider, with a global service network spanning multiple countries and regions, including China, the United States, Sweden, and Poland. Leveraging a team of top-tier global experts with extensive regulatory certification and clinical experience, along with its own professionally accredited laboratories in multiple locations worldwide, PureReg provides end-to-end consulting services for global market compliance and access for medical devices, in vitro diagnostic (IVD) products, and other related fields, as well as one-stop solutions such as overseas clinical trials. In 2023, PureReg pioneered the launch of the world’s first AI-powered application for automatically generating product instructions for use, garnering significant attention within the industry. To date, PureReg has successfully served hundreds of clients, securing over a thousand registration certificates in Europe and the United States, as well as hundreds of registration certificates in other countries, including the United Kingdom, Saudi Arabia, Thailand, and Colombia. Tailoring appropriate solutions to the entire lifecycle of medical devices, PureReg continuously optimizes its technology-driven products around its core digital and intelligent CRO capabilities, aiming to provide efficient solutions and applications for the tool and data needs of medical device companies expanding into international markets, thereby facilitating their global expansion and revenue growth.

Company Abbreviation:Tigermed Jietong

Case Name:Tigermed Jietong -- Integrated Global R&D Service Platform for Innovative Medical Devices

Selection Recommendation:

Tigermed Jietong, a wholly-owned subsidiary of the listed Tigermed Group, is a leading medical device CRO in China. It provides full-lifecycle CRO services across all product domains for medical device and in vitro diagnostic (IVD) companies, including R&D strategy consulting, testing and inspection, quality system guidance, clinical trials, regulatory submission, and post-market support. Headquartered in Beijing, Tigermed Jietong leverages the resources of the Tigermed Group to operate more than 150 service outlets across major cities in mainland China, Hong Kong, and Taiwan. It also maintains two third-party testing laboratories in Suzhou and Hangzhou, both accredited with CNAS qualifications and national-level CMA certifications. Furthermore, Tigermed Jietong has established overseas service outlets in 29 countries and regions, including South Korea, Japan, Malaysia, the United States, and Europe.With a deep understanding of the challenges faced by Chinese medical device R&D and manufacturing enterprises in global expansion, as well as the cultural differences between Chinese and foreign enterprises, Tigermed Jietong offers comprehensive strategic solutions. By leveraging its global expertise, extensive experience in overseas regulatory submissions and clinical trials, and local senior expert teams, Tigermed Jietong conducts thorough assessments of market trends and demands, regulatory environments and changes, and local healthcare reimbursement systems worldwide. Based on these insights, it formulates optimal strategic plans and effective business expansion roadmaps, empowering medical device companies to successfully launch their products into target markets.

Corporate Abbreviation:Yaxincheng

Case Name:Yaxincheng Medical Language Services: Committed to Accelerating the Internationalization of Medical Products

Selection Recommendation:

Beijing Yaxincheng Medical Information Technology Co., Ltd. was founded in Beijing, China, in July 2000. As a leading medical translation service provider in China, the company boasts a professional team of over 400 members and more than 800 collaborative translation experts, currently serving over 630 clients. With over two decades of operational experience, Yaxincheng has remained dedicated to providing translation services in the life sciences sector, covering the entire product lifecycle from early-stage R&D, non-clinical studies, clinical trials, regulatory submissions, post-market surveillance, to market promotion and training. In December 2020, Yaxincheng officially became a wholly-owned subsidiary of Tigermed Group. Leveraging Tigermed’s global service network, we are committed to delivering professional translation services to an expanding base of pharmaceutical companies, medical device manufacturers, CROs, government regulatory agencies, and medical research institutions worldwide. Our mission is to facilitate the internationalization of medical products and contribute to improving patient outcomes.

Certified with ISO 9001 Quality Management System, ISO 17100 Translation Services Management System, ISO 27001 Information Security Management System, and ISO 45001 Occupational Health and Safety Management System; recognized as a National High-Tech Enterprise. In the CSA Research’s 2023 Global Top 100 Language Service Providers ranking, Yaxincheng is ranked 51st.

Best Market Access Enablement Case

Company Abbreviation:MedRhein

Case Name:MedRhein Empowers Chinese Enterprises to Expand Globally

Selection Recommendation:

MedRhein focuses on the German-speaking region, serving as a full-process service provider that leverages digitalization to facilitate the expansion of medical device companies into this market. Its parent company, CTG, was established in 1993 and is an expert in cross-border exports of medical products between China and Europe. By leveraging CTG’s decades of profound accumulation in the German-speaking region and MedRhein’s own strengths, the company has rapidly established a complete pathway for Chinese IVD enterprises to enter the German-speaking market. Through data analysis, MedRhein efficiently identifies market demands in the German-speaking region, assisting domestic companies with product compliance, warehousing and logistics transportation, localized packaging, and market sales. To date, it has partnered with over 50 domestic IVD enterprises. As a bridge connecting the German-speaking region and China, MedRhein remains committed to removing barriers for Chinese companies expanding into the German-speaking region, facilitating their entry into the German-speaking and EU markets, and enhancing the international influence of Chinese IVD enterprises.

Best Case of Empowering Overseas Agents

Company Abbreviation:Jilian Group

Case Name:The Premier Global Expansion Service Provider for Medical Device Companies

Selection Recommendation:

Jilian Group, established in 2014, is a leading one-stop comprehensive service group for Chinese enterprises expanding overseas, specializing in cross-border corporate services. It offers six core integrated services: cross-border mergers and acquisitions, company registration, qualification and license applications, finance and tax services, equity structure design, factory establishment, and equipment installation. To date, Jilian Group has established its business presence in 116 countries and regions worldwide, building a global service network.

Jilian Group provides comprehensive, end-to-end services for medical device enterprises, ranging from overseas company registration to the establishment of manufacturing facilities abroad. Leveraging its one-stop professional capabilities for global expansion and an extensive worldwide service network, the company has delivered specialized, efficient, and compliant globalization solutions to more than 50 leading domestic biopharmaceutical and medical device enterprises. Additionally, it has supported numerous healthcare companies with overseas facility implementation and cleanroom construction.

Jilian Group will continue to leverage its advantages in one-stop comprehensive services, empowering Chinese medical device companies to expand into overseas markets and contributing to the global development of Chinese enterprises.

Best Case Study in Export Trade Empowerment

Company Abbreviation: AroundDeal

Case Study: The Shortest Path to Global Growth for Medical Device Companies with AroundDeal

Selection Recommendation:

AroundDeal is an AI-powered global business information SaaS platform dedicated to providing B2B commercial intelligence to enterprises worldwide through AI and data technologies. AroundDeal offers hundreds of millions of records on companies, corporate contacts, and business insights, covering 249 countries and regions globally as well as over 10,000 niche categories. With continuously updated data, the platform ensures precise marketing for users and helps businesses identify the shortest path to global growth.

Best Strategic Layout Enterprise

Company Abbreviation:BGI Genomics

Case Name:BGI Genomics’ Precision Medicine Testing Products Go Global, Boosting Public Health Development in Multiple Regions

Selection Recommendation:

As a pioneer of China’s genomics industry, BGI Group upholds its mission of “making genomic technology benefit humanity.” Leveraging over two decades of talent accumulation, scientific research expertise, and industrial experience, and anchored by its advanced, comprehensive, and large-scale multi-omics production platform, BGI has become one of the few global providers of scientific and technological services and operator of precision medicine solutions.

BGI Group is always committed to advancing life science research, promoting the application of life big data, and improving global healthcare. It strives to apply genetic research findings and precision testing technologies to public health. By accelerating technological innovation and deepening its expertise in reproductive health, cancer prevention and control, infectious disease prevention and control, and chronic disease management, BGI Group comprehensively supports the development of precision medicine.

Headquartered in Shenzhen, China, the company has established branches and medical laboratories in major domestic cities including Beijing, Tianjin, Shanghai, Wuhan, Chongqing, Changsha, and Guangzhou. It also operates overseas centers and core laboratories in Europe, the Americas, and the Asia-Pacific region, forming a marketing network that serves more than 100 countries and regions worldwide.

Company Abbreviation:MGI Tech

Case Name:MGI Tech’s “Million Microbiome” International Collaboration Initiative

Selection Recommendation:

MGI Tech is primarily engaged in the research and development, production, and sales of products in the fields of life sciences and biotechnology, including instruments and equipment related to gene sequencers and laboratory automation, as well as reagents and consumables. The “Million Microbiome” International Cooperation Program is currently the largest international microbiome research initiative worldwide. By leveraging MGI Tech’s proprietary DNBSEQ sequencing technology, the program aims to map human microbiomes across diverse ethnicities, ages, genders, and health statuses, thereby establishing a large-scale, population-level baseline for microbiome research. The “Million Microbiome” International Cooperation Program brings together scientists from China, Sweden, Denmark, France, Latvia, and other countries to conduct collaborative metagenomic research on microorganisms. Participating entities span 21 institutions across 10 European countries. To date, sequencing has been completed for 60,000 samples, covering microbiome specimens from organs such as the gut, oral cavity, skin, and reproductive tract, thus constructing the world’s largest human microbiome database. All these samples were processed using MGI Tech’s sequencing platforms, demonstrating that MGI Tech’s sequencing platforms have gained recognition among leading European biological research institutes.

Company Abbreviation:Ganawei Medical

Case Name:Ganawe Medical's Overseas Strategic Layout for Minimally Invasive Interventional Diagnostic and Therapeutic Devices

Selection Recommendation:

Ganawei Medical, founded in 2014 and headquartered in Hangzhou, is dedicated to the research and development, manufacturing, and sales of high-end medical devices in the field of minimally invasive procedures. Its business focuses on two key areas: precise interventional oncology and trend-based treatment solutions for common diseases. By benchmarking against advanced technologies of international brands, the company provides patients with high-quality treatment options characterized by minimal trauma, fewer complications, and faster recovery, thereby achieving win-win outcomes for all stakeholders.

The core business in oncology interventional medicine has established a multi-dimensional product portfolio, comprising biopsy needles for pathological sampling, energy-based ablation therapies, and intelligent surgical positioning systems for assisted biopsy and ablation. The biopsy needle series has been fully launched in the market; in addition to domestic registration certificates, it has obtained approvals from the European CE, the U.S. FDA, and Brazil’s ANVISA. Currently, these products have been sold in nearly 40 countries worldwide, with Europe being the most active region where the brand has become a well-known Chinese manufacturer. Meanwhile, the European CE and U.S. FDA registrations for the energy-based ablation devices and intelligent positioning systems are proceeding concurrently. Notably, the combined irreversible electroporation system for tumor ablation therapy has received U.S. FDA clearance, making the company the first in China and the second globally to achieve this certification. This milestone signifies that high-end Chinese-made medical devices in the field of electric field ablation have entered the international forefront.

By leveraging marketed consumables to establish channel advantages and brand influence, companies can strategically position themselves in target countries and clinical departments ahead of time. This paves the way for expanded collaborations with distributors in related fields, thereby further driving future overseas sales of their products. With the advancement of medical imaging, a number of leading Chinese imaging medical device companies have gone global. These firms can collaborate with interventional medical device enterprises to introduce follow-up therapeutic products, promoting comprehensive Chinese solutions for interventional therapy.

Company Abbreviation:Jianshi Technology

Case Name:Lux-Valve-Plus: Global Multi-Center Strategic Layout

Selection Recommendation:

Jianshi Technology is a China-based medical device company with global influence, deeply engaged in the large, under-penetrated, and rapidly growing field of structural heart disease treatment. We are committed to developing independently innovated products for the treatment of structural heart diseases, striving to provide comprehensive solutions for physicians and patients.

LuLux-valve-plus is indicated for patients with severe tricuspid regurgitation who are deemed high-risk and unsuitable for conventional surgical intervention following clinical assessment. It effectively addresses challenges associated with the significant structural heterogeneity, difficult positioning, and susceptibility of right-heart tissues to injury inherent in tricuspid valve pathology. Its unique non-radial support fixation design, combined with multiple proprietary technologies, helps prevent conduction block, reduce paravalvular leak, and improve cardiac function.

The delivery system features five-directional adjustment capabilities, facilitating precise intraoperative adjustments by the surgeon. Compared with traditional surgical procedures, it offers lower surgical risk and shorter recovery time, providing patients with a safer, more comfortable, and convenient surgical option, while enabling physicians to perform more accurate and easier operations.

In 2019, it ranked fourth globally in the TCT Shark Tank Innovative Device Competition; in 2020, it received the Subramanian Innovation Award from the International Society for Minimally Invasive Cardiothoracic Surgery (ISMICS). After being accepted into the National Medical Products Administration’s (NMPA) innovative medical device approval pathway, it obtained Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) in 2021. Clinical trials are currently underway in Europe, North America, and other regions.

Company Abbreviation: Conatus

Case Name: Conmed's Global Strategic Layout

Selection Recommendation:

Conmedtron is a leader in China’s innovative surgical robotics industry, primarily engaged in the development, manufacturing, and sales of high-end surgical robots. Guided by clinical needs and committed to independent innovation, the company strives to build a safe and efficient surgical robotics platform, enhance the accessibility of high-quality healthcare services in China and globally, and enable more patients and healthcare providers to benefit from advanced medical devices.

Conmedtek was established in September 2019. It currently has branches in Shenzhen, Hong Kong, and Beijing in China, as well as in the United States, and has set up three major R&D centers worldwide. The company’s core team consists of leading surgical robotics experts with deep industry expertise and professionals from various disciplines, possessing extensive experience in scientific research, technological development, clinical translation, and industrialization of medical robots. Leveraging its strong technical capabilities, the team has overcome critical “chokehold” challenges, fully mastering core technologies such as mechanical architecture, electrical architecture, software architecture, complex algorithms, and visual imaging, thereby establishing a foundational technology platform for surgical robots.

To date, Conatus Robotics has established a multi-pipeline portfolio encompassing soft-tissue surgical robots and other major specialized surgical robotic systems. The company’s independently developed first-generation laparoscopic surgical robot has entered human clinical trials and will pursue global medical device regulatory approvals. It is expected to receive market authorization in stages, thereby serving healthcare professionals worldwide and benefiting a broader patient population.

Conmed has established a mass production facility in Shenzhen, China. In the future, Conmed will leverage the robust supply chain of the Greater Bay Area to achieve localized manufacturing in China, providing safe and efficient surgical robots globally and injecting Chinese strength into the global market.

Company Abbreviation:Broncus Medical

Case Name:Broncus Medical’s Global Strategic Layout

Selection Recommendation:

Broncus Medical focuses on critical pulmonary diseases that threaten patients’ lives, such as lung cancer and chronic obstructive pulmonary disease (COPD). Leveraging its navigation platform, the company has established a comprehensive portfolio of devices and consumables for interventional pulmonary diagnosis and treatment, pioneering novel diagnostic and therapeutic approaches for lung diseases. It provides global physicians and patients with precise, one-stop minimally invasive diagnostic and treatment solutions. In the future, the company will continue to strengthen technological innovation and product development, consistently enhancing product quality and service levels to bring greater benefits to patients worldwide.

Company Abbreviation:Phontech

Case Name:Pintai Technology - Digital Dental Impression Scanner

Selection Recommendation:

Pintai Technology is dedicated to the research and application of 3D imaging technology, with R&D spanning six major disciplines: optics, mechanics, electronics, algorithms, software, and materials. The company has been granted more than 40 patents domestically and internationally. Its core team members hail from prestigious research institutes and universities, including the Chinese Academy of Sciences, the University of Electronic Science and Technology of China, and Harbin Institute of Technology. Pintai’s intraoral digital scanner has gained recognition from customers both in China and abroad.

Suzhou Pintai is a subsidiary of Pintai Technology, primarily responsible for overseas exports. Panda Scanner is the registered brand of Pintai Technology. In February 2023, Panda Scanner launched its new PANDA series of intraoral digital scanners in the overseas market. Weighing only 138g, the device features a pen-style design equipped with function buttons and motion-sensing remote control, enabling one-touch operation to prevent cross-contamination. With a scanning accuracy of up to 7 microns and a newly optimized single-line design that supports plug-and-play functionality, it makes dental scanning more efficient and straightforward. Additionally, the product introduces rainbow color options, breaking away from the traditional color schemes of dental medical devices and embodying a truly undefined aesthetic upon its new market launch.

The PANDA series of intraoral digital scanners has earned high acclaim and trust from international customers for its powerful features, resulting in demand outstripping supply since its launch. Currently, PANDA intraoral digital scanners have successfully entered more than 70% of countries worldwide, achieving 100% coverage in developed nations. With exclusive agents and distributors in multiple countries, cumulative sales have exceeded 10,000 units.

Company Abbreviation:Venus Medtech

Case Name:Charting a Global Structural "Heart" Blueprint with a New Path to Glocalization

Selection Recommendation:

As a leading enterprise in China’s minimally invasive interventional therapy field for heart valves, Venus MedTech not only maintains its commercial leadership in China but also continues to deepen its presence in global innovation markets, constantly improving its global innovation system and product portfolio.

The innovativeness of Venus Medtech’s global strategic layout is reflected not only in the continuous development of technologies and products that are “unavailable in China but novel worldwide,” but also in its proactive exploration of innovative pathways for overseas clinical trials and regulatory registrations, the establishment of a comprehensive global patent system, the implementation of stringent production and quality control standards aligned with international mainstream practices, and the creation of a robust international operational management framework—demonstrating the exploration and execution of a complete and comprehensive internationalization strategy.

This not only demonstrates the growing maturity of China’s capabilities in developing independently innovated products, but more importantly, provides a concrete model for the global expansion of Chinese medical device manufacturers, holding significant practical value for bolstering confidence in domestic industries and realizing the vision of “Intelligent Manufacturing in China.”

Company Abbreviation:Ruipai Medical

Case Name:Global Strategic Layout for Single-Use Endoscopes

Selected Recommendation:

Ruipai Medical, established in 2015, is a national high-tech enterprise dedicated to the R&D, manufacturing, and sales of disposable endoscopes. Its product portfolio includes disposable endoscopes, medical endoscopic image processors, and disposable therapeutic instruments for endoscopic procedures.

After years of dedicated development, Raypare Medical has established robust barriers in R&D, manufacturing, supply chain, and commercialization, emerging as a leading platform for single-use endoscopes. In recent years, with accelerating globalization, Raypare Medical is rapidly advancing toward becoming an internationally leading single-use endoscopy platform, enabling patients worldwide to access affordable, high-quality medical resources made in China.

The company has successively made its debut at key international professional academic conferences, including Digestive Disease Week (DDW), the American Urological Association (AUA) Annual Meeting, and the European Association of Urology (EAU) Congress. It has engaged in clinical trials, academic collaborations, and publication of scholarly papers with experts from multiple countries, receiving positive feedback from numerous specialists. Certain departmental products have already obtained U.S. FDA clearance and European CE certification. Moving forward, Ruipai Medical will continue to accelerate the registration and promotion of its full portfolio of departmental products, thereby completing the global strategic layout for its single-use endoscope product line.

Company Abbreviation:RainMed Medical

Case Name:Coronary Angiography Microvascular Resistance Index (caIMR) System

Selection Recommendation:

RainMed Medical Group (Stock Code: 2297.HK), founded in 2014, is committed to becoming a global leader in vascular interventional surgical robotics. The company currently focuses on the design, research and development, and commercialization of two core products within the functional diagnostic module of its vascular interventional surgical robotics platform—the Coronary Angiography-based Fractional Flow Reserve System (caFFR System) and the Coronary Angiography-based Index of Microcirculatory Resistance System (caIMR System)—as well as the Vascular Interventional Surgical Robot (FlashBot).

caIMR System Highlights:

· The world’s first non-invasive diagnostic product for microcirculatory lesions;

· The world's only commercially available non-invasive microcirculatory resistance index measurement system;

·Compared with guidewires, IMR achieves an accuracy of up to 93.81%, demonstrating high consistency, sensitivity, and specificity;

Currently, Runmai Medical’s core product in its digital functional diagnostics module, the coronary flow fractional reserve (caFFR) system, has obtained EU CE certification and Australian TGA certification. It has already achieved commercial deployment in 10 countries, including France, Spain, Austria, and South Korea, while strategically laying the groundwork for the overseas launch of the caIMR system.

Company Abbreviation:Tongyi Medical

Case Name:Tongyi Medical's Brand Layout for the Belt and Road Initiative

Selection Recommendation:

Taizhou Tongyi Medical Device Co., Ltd., along with its subsidiary Jiangsu Tongyi Medical Device Co., Ltd., was established in June 2015 as a provider of respiratory equipment for both children and adults. The company is dedicated to building an ecosystem centered on pediatric medical devices, integrating design, R&D, production, and sales. It enters the global market through respiratory equipment and strategically deploys a comprehensive portfolio of respiratory consumables.

The company holds comprehensive ISO 13485 medical device quality management system certification, and its products have obtained international medical device certifications including CE, FDA, and CFDA.

The company focuses on the research, development, and manufacturing of respiratory products, has obtained multiple invention patents, and maintains long-term scientific research collaborations with Germany’s Aircontrol, Chang Jung Christian University in Taiwan, and Nanjing Medical University. It has established China’s first Sino-German joint venture R&D center for respiratory products, focusing on products such as those for diffuse lung diseases, cardiopulmonary exercise testing, neonatal lungs, pediatric ventilators, FeNO (fractional exhaled nitric oxide) analyzers, and neonatal cardiopulmonary resuscitation devices. The company currently plans to operate 10 production lines for respiratory medical devices. It has partnered with over 1,200 hospitals in China and exports its products to more than 30 countries and regions overseas.

The company is currently a member unit of the “Belt and Road” Information Industry Development Alliance, and has been honored with titles such as “National High-Tech Enterprise” in 2020, Third Prize at the “Innovative China” Awards in 2021, and Top 30 in the Spring Season of the 2022 “Specialized, Refined, Differential, and Innovative” Dark Horse Competition.

Leveraging its robust R&D capabilities, extensive channel resources, and the rich industrial background of its shareholders, Tongyi adopts a global perspective, committed to advancing the development and progress of pediatric medicine.

Company Abbreviation:Left Dot

Case Name:Strategic Roadmap for the Global Expansion of Home Healthcare Solutions

Selection Recommendation:

Zuodian was established in December 2014, with its operational headquarters located in Wuhan Optics Valley. Over the past nine years since its inception, the company has defined its product matrix based on consumer needs, positioning itself in the realms of health preservation, maintenance, and therapeutic care. It provides full-lifecycle health management services to diverse populations, striving to become a globally leading provider of all-scenario lifestyle technology and healthcare solutions.

The company officially began fundraising in 2019 and completed four rounds of financing within two years. It received hundreds of millions of yuan in capital support from prominent Chinese investment firms, including Tiantu Capital, Gaoling Venture Capital, Qingliu Capital, Cowin Capital, Country Garden Ventures, and Haiquan Fund.

The Company integrates research and development (R&D), design, and production. It owns two wholly-owned, self-built manufacturing facilities in Xuchang, Henan Province, and Changsha, Hunan Province, covering a total area of over 20 mu. Additionally, the Company has established R&D centers in Wuhan and Shenzhen. In recent years, the Company has continuously increased its R&D investment, resulting in more than 3,000 patent applications. To date, it has been granted 21 invention patents, 839 utility model patents, and 425 design patents, as well as 25 computer software copyrights. The Company holds 15 Medical Device Registration Certificates issued by the National Medical Products Administration of the People's Republic of China. Meanwhile, ZuoDian is actively expanding and establishing overseas sales channels with the aim of promoting this national brand to the international market. Several of the Company’s products have received IF Design Awards and Red Dot Design Awards. Furthermore, the Company has obtained EU CE certification, EU RoHS compliance, US FCC certification, and US FDA clearance.

Best Practice for North American Regional Layout

Company Abbreviation: Burning Rock Biotech

Case Study: Burning Rock US Lab Supports the Entire Process of Precision Oncology Diagnosis and Treatment

Selection Recommendation:

Burning Rock Biotech (LSE/NASDAQ: BNR), founded in 2014, is driven by the mission to “safeguard the light of life through science,” focusing on the development of innovative, reliable, and clinically valuable cancer companion diagnostics and early detection products.

Burner US Laboratory, located in California, has established an experienced global regulatory team and has obtained dual accreditation from the internationally authoritative CAP and CLIA. Integrating high-throughput sequencing, early cancer detection R&D, and the production of genetic testing kits, it boasts world-class technological innovation and R&D manufacturing capabilities. Burning Rock Biotech continuously expands the boundaries of its products and services, persistently developing and launching high-quality innovative medical devices globally to lead industry development. Meanwhile, it vigorously engages in collaborative services with global pharmaceutical companies, efficiently supporting the entire clinical development process of oncology drugs worldwide.

The Company’s proprietary multi-cancer early detection product, “OverC™ Multi-Cancer Detection Blood Test,” was granted “Breakthrough Device” designation by the U.S. FDA in 2023. Previously, the OverC™ kit had also obtained CE marking for in vitro diagnostic medical devices in the European Union. In addition, three of the Company’s tumor next-generation sequencing (NGS) testing reagents have received CE certification in the EU.

Currently, Burning Rock Biotech has provided central laboratory testing and companion diagnostic development services to more than 70 renowned pharmaceutical companies and over 220 clinical research projects worldwide, supporting the global development of innovative drugs.

Best Practices for European Regional Layout

Company Abbreviation:LifeShield Medical

Case Name:LifeShield: R&D of Innovative Medical Devices and Expansion into the EU Market

Selection Recommendation:

LifeShield Medical is a Sino-German multinational medical device company dedicated to the research, development, and manufacturing of innovative medical devices in the field of internationally advanced extracorporeal life support technologies. We are committed to providing high-quality products and treatment solutions for patients with cardiovascular diseases and respiratory failure, helping to alleviate their suffering and improve their quality of life. The company owns two wholly-owned subsidiaries: LifeShield Medical Technology (Suzhou) Co., Ltd. and enmodes GmbH in Germany. Positioned as the European headquarters of the LifeShield Medical Group, enmodes GmbH oversees the global R&D center and market expansion within the European Union. By leveraging Germany’s advanced technology and high-quality R&D capabilities, while integrating China’s efficient, rapid-driven spirit and unique cost advantages, the company effectively facilitates the translation of technology into commercial products.

LifeShield’s three products currently in development will, while establishing a firm foothold in the Chinese market, actively expand into major hospitals across the European Union. Its wholly-owned subsidiary, Enmodes, will be primarily responsible for penetrating the EU market, leveraging its products’ significant advantages in both efficacy and pricing to provide European patients with more effective and cost-efficient medical solutions.

Best Asia-Pacific Regional Layout Case

Corporate Abbreviation:Haier Biomedical

Case Name:Haier Biomedical's Localized Strategic Layout in the Asia-Pacific Region

Selection Recommendation:

Haier Biomedical was established in 2005, starting with the research and development, production, and sales of low-temperature storage equipment. It is a digital scenario solution provider for life sciences and medical innovation, based on IoT transformation. The company focuses on digital scenario solutions for life sciences and medical innovation, centering on smart public health, smart blood management, smart laboratories, digital hospitals, and smart biological cultivation. Through technological innovation and integration, it provides users with comprehensive digital scenario solutions covering multiple products and services. Currently, the company’s products and solutions have been applied in more than 130 countries and regions worldwide, maintaining long-term cooperative relationships with over 40 international organizations such as the World Health Organization (WHO) and the United Nations Children's Fund (UNICEF).

In the Asia-Pacific region, enterprises are enhancing the market share of their flagship products, accelerating the expansion of new products and solutions, and actively exploring the overseas replication of IoT scenario-based solutions by building a dual-wheel operational system comprising “network + localization.”

In China, Haier Biomedical has established the world’s largest biosafety science and technology innovation industrial park. The Life Sciences and Medical Innovation Industrial Park has also been completed. In other Asia-Pacific regions, Haier Biomedical adheres to a “network + localization” operational strategy, continuously expanding its user coverage. Building on the accelerated expansion of its channel network, the company remains committed to local development. By establishing training centers, implementing localized marketing, setting up branch offices, and customizing and upgrading solutions, Haier Biomedical enhances its ability to rapidly identify and respond to local user needs, thereby building a sustainable platform for its overseas market growth.

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