Dongmai Medical Completes Nearly RMB 10 Million Angel Funding Round to Build a Medical Device Compliance Research Platform
VCBeat has learned that Dongmai Medical Technology (Suzhou) Co., Ltd. (hereinafter referred to as “Dongmai Medical”), a medical device compliance research platform, recently announced the completion of an angel financing round of nearly RMB 10 million. The investor was Suzhou Gaoxin Fengqiao Emerging Industry Investment Co., Ltd. It is understood that the proceeds from this financing will be primarily used to construct Phase I of the Medical Device Compliance Research Center (including testing laboratories and benchmarkGMP facilities, medical device pilot production lines), and market promotion.
Dongmai Medical was established in 2019 through a joint venture between the Southeast University Suzhou Medical Device Research Institute and an industry-leading team. Located in the Suzhou Life Health Town, its facility covers a construction area of approximately 2,500 square meters. Leveraging the expertise of Southeast University, Dongmai Medical specializes in compliant design, development, and engineering translation for medical devices. The company operates two production lines—one for active medical equipment and another for sterile medical devices—and has established a benchmark quality management system in accordance with ISO 13485 standards. Additionally, Dongmai Medical has built an in-house testing platform compliant with the ISO/IEC 17025 framework and assembled elite teams specializing in regulatory registration, quality systems, and clinical affairs to provide one-stop services—from R&D and design to mass production—for medical device enterprises.
The two shareholders introduced by Dongmai Medical have both provided significant assistance to the company.
Among them, the Suzhou Medical Device Research Institute of Southeast University (hereinafter referred to as the “Institute”) leverages the scientific research strength of Southeast University and multiple national and provincial/ministerial-level key laboratories, possessing robust capabilities in scientific innovation and the industrialization of technological achievements. Currently, the Institute has established four R&D centers and an engineering translation center, focusing on biomedical materials, bionic organs and organ-on-a-chip technologies, imaging and big data, and IVD and detection technologies. It also operates nineteen specialized laboratories, including a cell culture laboratory, a microfluidics application technology laboratory, and a molecular biology laboratory. In terms of scientific talent, the Institute employs more than 70 R&D personnel, with 55% holding master’s degrees or higher.
Dr. Chen Tao, CEO of Dongmai Medical, stated, “As a technology shareholder, the Research Institute has provided substantial support to Dongmai Medical in areas such as the introduction of research projects, medical device R&D, intellectual property protection, and research project applications.”
Suzhou Gaoxin Fengqiao Emerging Industry Investment Co., Ltd. is a local government investment institution in Suzhou, affiliated with the listed company Suzhou New District Hi-Tech Industrial Co., Ltd. (SNDHT). SNDHT was initiated and established by the Administrative Committee of Suzhou National New & Hi-Tech Industrial Development Zone, becoming the first listed company in Suzhou New District and among the first batch of listed companies in Suzhou City.
Dr. Chen Tao stated, “The investment by Suzhou New District Fengqiao Emerging Industry Investment Co., Ltd. in Dongmai Medical will better assist Dongmai Medical in integrating local resources, securing industrial support, and expanding its business market.”
An investor told VCBeat, “Suzhou is planning to vigorously develop its biopharmaceutical industry, aiming to establish a world-class biopharmaceutical hub with a scale of RMB 1 trillion by 2030. In this plan, the biopharmaceutical and medical device industries in Suzhou High-Tech District are positioned as a key pillar of Suzhou’s ‘two wings and multiple poles’ landmark strategy for its biopharmaceutical sector. The establishment of Dongmai Medical in the Life Health Town of Suzhou High-Tech District will effectively enhance the level of professional services in the region and promote entrepreneurship and innovation in Suzhou’s medical device industry. Furthermore, Dongmai Medical’s founding team possesses strong professional expertise and extensive industry resources. Its business philosophy aligns with current industry and regulatory requirements, and its platform development fits into Suzhou’s strategic layout for the medical device industry. Therefore, we firmly believe that Dongmai Medical will quickly stand out in the third-party service sector for medical devices.”
Overall, the most critical factor behind Dongmai Medical’s successful fundraising lies in its core team and operational philosophy. In terms of team composition, members of Dongmai Medical hail from “talent hubs” such as drug regulatory and technical oversight agencies, universities, research institutions, large medical device manufacturers, CROs, and third-party testing centers. Core team members each bring nearly 20 years of experience in the medical device industry, with expertise in regulations, standards, quality management systems, and product registration. Notably, Dr. Chen Tao, founder of Dongmai Medical, possesses extensive experience in both the medical device sector and entrepreneurship. Committed to serving industrial innovation, he is an outstanding entrepreneur.
In terms of business philosophy, Dongmai Medical emphasizes "compliance," which aligns well with government and industry requirements. Therefore, there is certainly room for Dongmai Medical to grow and thrive in the market.
From R&D to market launch, medical devices must overcome numerous challenges, such as slow product registration, difficulties in establishing quality management systems, prolonged commercialization cycles, and high barriers to product development.
To support the innovative development of medical device enterprises, Dongmai Medical leverages its industry-leading team to manage key risk control points in rectifications and supplementary submissions, thereby controlling risks throughout the registration process, maximizing time efficiency, and accelerating the market launch and sales of innovative products. Meanwhile, Dongmai Medical assists device companies in establishing quality management systems through benchmark system management and professional team guidance, helping to reduce corporate risks. Additionally, Dongmai Medical operates its own active and passive production lines, enabling device companies to lower investment costs and shorten implementation cycles. In entrusted R&D, Dongmai Medical safeguards clients’ interests by leveraging Southeast University’s compliant R&D team and a comprehensive confidential information management system.
Dr. Chen Tao stated, “Addressing the pain points of entrepreneurs, we focus on research into medical device regulations, standards, and quality management systems to resolve practical challenges in medical device commercialization. However, compliance is a prerequisite for our operations. Dongmai Medical is a semi-public welfare platform with state-owned capital background. Leveraging our accumulated expertise and advantages in regulations, standards, and systems, we have taken the lead in China in championing compliance research for medical devices. We approach this from two aspects: product output compliance and quality management system compliance. By utilizing the platform’s practical training strengths to cultivate skilled professionals, we help medical device entrepreneurs and practitioners achieve low-risk, low-cost, short-cycle, and high-efficiency full lifecycle management. We are also willing to assist regulatory authorities by providing third-party professional services for full lifecycle oversight.”
Currently, there are more than ten well-known companies in the medical device CRO/CDMO industry, along with hundreds of small and micro enterprises, resulting in intense competition. The "Innovation Report on the Medical Device R&D Outsourcing Services Industry" released by VCBeat indicates that the medical device CRO/CDMO industry is still in its growth stage and has significant room for development. Although Dongmai Medical is a new company, its core team consists of industry veterans. Furthermore, the establishment of Dongmai Medical aligns with current market and regulatory demands, presenting substantial growth opportunities.
Compared with existing CDMO platforms in the market, Dongmai Medical’s Compliance Research Center focuses on active medical devices and sterile medical consumables. Unlike some platforms that prioritize in vitro diagnostics (IVD) as their entry point, Dongmai Medical’s Compliance Research Center emphasizes regulatory compliance for medical devices. By implementing robust compliance management systems and delivering compliant product solutions, it helps entrepreneurs and industry practitioners reduce risks, shorten development cycles, and lower costs.
Dr. Chen Tao told VCBeat, “Dongmai Medical will collaborate with universities boasting strong medical device programs, such as Southeast University and Shanghai University of Medicine & Health Sciences, to jointly advance research on medical device compliance and contribute to the healthy development of the industry.”
Regarding future planning, Dongmai Medical will first establish a strong foundation in active medical devices and sterile medical consumables, and launch its IVD reagent business at the appropriate time. Geographically, Dongmai Medical will center its operations in Suzhou, a hub for medical devices, covering the Yangtze River Delta region and extending its reach across China, while steadily advancing the construction of regional bases based on its professional strengths.
Dongmai Medical believes that “the medical device industry remains in its golden age, with the post-pandemic startup boom in the sector intensifying rather than waning.” Therefore, Dongmai Medical is committed to providing entrepreneurs and practitioners with practical project strategies and risk analyses, leveraging a shared platform to address clients’ real-world challenges.