From Medical Robotics Innovation to 'CDMO+X' Services: ShuiMu Oriental Empowers Advanced Medical Device Development
In recent years, China has become the world’s second-largest medical device market. With the rapid development of the domestic medical device industry, high-end medical devices such as surgical robots and extracorporeal membrane oxygenation (ECMO) systems have successively filled gaps in domestic production. The industrial chain is becoming increasingly well-defined, with upstream and downstream enterprises focusing on their respective areas of specialization, driving the industry toward a stage of specialized division of labor.The Rise of Medical Device CDMO Services: Accelerating Innovation for Startups and De-risking Expansion for Industry Leaders
Riding the policy tailwinds of the Medical Device Registrant System, which decouples product registration from manufacturing licensing, the medical device CDMO market has experienced rapid growth, witnessing several large-scale financing rounds and three IPOs: Kairui Biology, Meihao Medical, and Haitai New Light. Numerous medical device CDMO companies have emerged like mushrooms after rain, offering partial or end-to-end services spanning R&D, small-scale pilot production, regulatory registration, and mass production. Meanwhile, some medical device CROs and pharmaceutical CDMOs have expanded their portfolios to include medical device CDMO services, leading to intense competition (“involution”) even before the industry has reached significant scale.
As a national hub for medical device innovation, Beijing is home to leading enterprises and innovative companies. According to statistics from Zhongcheng Shuke, the scale of Beijing’s medical device industry reached RMB 67.287 billion in 2022, with an existing stock of 13,873 product registrations and filings, among which Class II and Class III devices accounted for 61.6%. Haidian District, in particular, has gathered some of the most prestigious Grade A tertiary hospitals, universities, research institutes, and innovative enterprises not only in China but also globally, generating substantial demand for medical product design, prototype manufacturing, and registration services. However, prior to 2021, due to constraints such as policies and operational costs, there were no enterprises in Beijing offering CDMO (Contract Development and Manufacturing Organization) services for high-end medical devices.
“Since there are no CDMO services in Beijing, we had to seek providers from other regions, which involved a considerable detour,” remarked a company that had previously filed for a Class III medical device registration certificate in Beijing.
This groundbreaking achievement was accomplished by a company based in Haidian.In late 2017, Beijing Medical Robotics Industry Innovation Center was established., having accumulated extensive experience and resources in the translation of innovative medical devices during its long-term promotion of innovation in the medical robotics industry, it established Beijing’s first high-end medical device CDMO platform in 2021 under government guidance. Today, the growth rate of the company’s CDMO business has far exceeded the founding team’s initial expectations, with the number of device clients increasing by over 60% annually.
In 2018, under the guidance of the Beijing Municipal Government, Shuimu Dongfang established the Beijing Medical Robotics Industry Innovation Center. This initiative aimed to concentrate innovative resources within the industry, achieve breakthroughs in key technologies such as configuration design optimization for medical robots, mechanisms and actuation technologies for miniature medical robots, and artificial intelligence technologies for medical robots. Furthermore, it sought to establish a system for training, industrial commercialization, and application promotion of scientific and technological achievements in medical robotics, thereby building an innovative ecosystem for the medical robotics industry to lead its development.
Shuimu Dongfang empowers the commercialization of innovative domestic medical robotics projects and the market entry of overseas innovative products through professional services, offering multidimensional support including clinical assistance, expert guidance, and investment and financing matchmaking.Successfully facilitated the implementation of multiple medical robotics innovation projects from China, the United States, Germany, and Japan in Beijing. In 2019, the Innovation Center was awarded the “Surgical Robot Application and Big Data Public Service Platform"title."
During the pandemic, Beijing Medical Robotics Industry Innovation Center maintained strong growth momentum and continued to enhance its industry influence. Several companies and institutions served by the center were featured in Nature’s special issue “Focus on Chinese Medical Robots.” In 2020, Tinavi Medical Technologies, one of the founding shareholders of Beijing Medical Robotics Industry Innovation Center, successfully listed on the STAR Market, becoming China’s first publicly traded company specializing in orthopedic surgical robots. Meanwhile, medical robotics projects incubated by the company in their early stages are advancing rapidly, with the Surgerii Surgical Robot entering the National Medical Products Administration’s “Green Channel” for expedited review and approval.
During the project incubation process,Shuimu Dongfang has established a robust medical-engineering collaboration mechanism and product commercialization pathway, forming a complete industry-academia-research-application translation chain.。
Meanwhile, in promoting the development of innovative medical robots, Shuimu Dongfang identified a common need in the advancement of high-end medical devices: efficient R&D design and mass production. After an exhaustive search across Beijing yielded no suitable supply chain partners for high-end CDMO services, and upon learning that many medical researchers in Beijing were also seeking such services—with some even having to travel to the Jiangsu and Zhejiang regions to produce product prototypes—Shuimu Dongfang decided to launch its own CDMO services. This strategic decision, based on both industry demands and the company’s capabilities, not only addresses the needs of incubated enterprises but also extends services to a broader range of innovative companies and research institutions.
“Situated in Beijing and Haidian, a globally premier ecosystem for scientific research and innovation, we are committed to delivering world-class CDMO services for medical devices."Speaking of the new business venture, Shuimu Dongfang, the founding team still recalls the boldness and confidence they felt at the time."
One year before the announcement of the Medical Device Registrant System, Shuimu Dongfang seized the opportunity for early development by adding high-end medical device CDMO services as a key focus of its business operations.Transitioning from incubation and nurturing operations to specialized services centered on high-end CDMO。
Following the announcement of the Medical Device Marketing Authorization Holder (MAH) system in June 2021, Shuimu Dongfang officially launched its CDMO business. Previously, the company primarily focused on asset-light services such as knowledge transfer and resource provision; since then, it has shifted to core customized services for medical device R&D and manufacturing. In the same year, Phase I of the company’s high-end medical device CDMO platform was officially put into operation, with a floor area of approximately 6,000 square meters, serving asBeijing’s First High-End Medical Device CDMO Platform。
Leveraging its robust technical foundation, deep product expertise, and integrated resources across industry, academia, research, and clinical applications, Shuimu Dongfang’s CDMO business has achieved rapid growth. In 2022, Phase II of the company’s CDMO platform, featuring production lines for IVD and sterile products, was completed. To date,Shuimu Dongfang has become a leading CDMO platform in China, providing end-to-end services for Class II and III active medical devices, IVD, and sterile consumables.. In Beijing’s high-end medical device sector, particularly in the field of active devices, Shuimu Dongfang has served nearly half of the innovative projects.
CDMO services represent a sector with significant regional advantages. According to Wang Binbin, Managing Director of Shuimu Dongfang, CDMO companies in Hunan and Hubei provinces entered the market by leveraging a period of lenient rapid-approval policies for medical devices implemented by the National Medical Products Administration (NMPA). In contrast, CDMO firms in Suzhou and Shanghai have developed by capitalizing on local innovation resources and strong industrial foundations. Beijing boasts a fertile environment for innovation, hosting numerous leading medical device companies, while the government provides substantial support for the development of innovative medical devices.
However, at the same time, the high operational costs in Beijing pose a significant challenge to medical device CDMO services, which require self-built R&D and production facilities.Leveraging its long-standing accumulation in the Beijing region and government support, Shuimu Dongfang has taken the lead in launching CDMO operations at its Beijing headquarters, achieving local production and manufacturing in Beijing.。
Beijing Medical Robotics Industry Innovation Center provides one-stop services covering product R&D, manufacturing, inspection, registration, commercialization, and mass production for medical device companies, research institutions, and physicians/medical facilities., helping to reduce comprehensive operational costs such as R&D and production, shorten product time-to-market, and improve the conversion rate of innovative achievements.
Shuimu Dongfang has established its own professional R&D and production base, featuring dedicated production lines for active medical devices, in vitro diagnostic (IVD) products, sterile products, radiation-based products, and medical robots. The facility is equipped with high-precision machining workshops, integrated simulated operating rooms, reliability testing laboratories, quality inspection centers, and automated立体 warehouses, along with a comprehensive suite of advanced measurement, manufacturing, and testing equipment required for medical device R&D.
Furthermore, the company operates under government guidance and support, possessing all necessary operational qualifications. It has previously obtained ISO 13485 certification for medical device quality management systems, becoming the first medical device CDMO platform in China to achieve certification scope for “contract manufacturing of active medical devices,” thereby meeting international standards.
To date, Shuimu Dongfang has served over 300 medical device companies, with its service portfolio covering a wide range of high-end medical devices. In the first half of this year alone, it served more than 95 clients. Previously, when demand for medical oxygen in Beijing surged and hospitals faced an urgent shortage of ventilator oxygen connectors, teams from R&D, measurement, procurement, production, and testing at Shuimu Dongfang worked in close coordination. They rapidly prototyped samples using 3D printing equipment and delivered them to hospitals for fit verification, followed by mass production in their high-precision machining workshop. Within two days, they supplied hundreds of components to hospitals, addressing critical clinical needs.
Medical device classification is complex, with different product types placing varying emphasis on aspects such as R&D and manufacturing, necessitating specialized, vertically focused CDMO services. Moreover, the growth potential of a company’s CDMO business is determined by the development space available in its target end markets. Wang Binbin stated: “CDMO enterprises must be strategic in their choices, focusing on their core competencies to establish differentiated advantages."When expanding into new markets, it is essential to build a corresponding talent team to gain an in-depth understanding of customer needs."
Shuimu Dongfang, leveraging its industry experience and the technical expertise of its team, has chosen to focus on high-growth, innovation-driven niche markets. These include Class II and III active medical devices such as surgical robots and medical imaging systems; in vitro diagnostic (IVD) reagents; and sterile consumables. For instance, China’s medical robotics market is experiencing rapid expansion, with a market size exceeding RMB 7.9 billion in 2021. Orthopedic and laparoscopic surgical robots have successively obtained regulatory approvals, driving strong demand for customized R&D and manufacturing of core components and products. In these niche segments, Shuimu Dongfang actively seeks collaborations with leading enterprises.
Wang Binbin noted, “The selection of industry leaders will drive the development of CDMO services, but currently, many companies’ mindsets are still focused on in-house manufacturing.” The growth of overseas giants such as Medtronic and Johnson & Johnson demonstrates that medical device CDMO services are essential. However, to encourage leading enterprises to adopt CDMO services, domestic medical device CDMO providers must not only engage in market education but also further develop specialized, niche services that offer greater cost-effectiveness. Meanwhile, CDMO providers that secure resources from industry leaders gain a stronger competitive position; by serving these key players, they can rapidly establish themselves within the industry and build more standardized service systems.
Currently, Shuimu Dongfang has partnered with leading enterprises in fields such as surgical robots and medical imaging equipment, establishing a standardized service system and achieving highly efficient response capabilities.
China’s medical device CDMO industry is still in its nascent stage, with domestic penetration rates far lagging behind those in developed regions such as Europe and the United States. The full implementation of the Medical Device Registrant System has put domestic medical device CDMO services on a proper track, attracting numerous enterprises to enter this sector. However, the quality of participants varies significantly, and service quality and standardization remain to be improved. Meanwhile, competition within the sector is becoming increasingly homogeneous, with most companies concentrated in areas such as regulatory registration and small-batch production, lacking core competitiveness.
Wang Binbin believes, “This is a normal phenomenon in the early stages of industry development. The sector offers significant opportunities and numerous entry points, giving rise to many small, fragmented participants and service models. However, as the market gradually matures and services become more standardized, customer resources will increasingly concentrate among a few enterprises, exhibiting the Pareto principle (80/20 rule).” For these select few, factors such as building professional teams, establishing robust service systems, accumulating core technologies, and maintaining a strong track record of service reputation are critically important.
Shuimu Dongfang has an in-house multidisciplinary team of professionals,Over 60% Hold Master’s or Doctoral Degrees, with members’ backgrounds spanning multiple disciplines including engineering, artificial intelligence, and clinical medicine,More than half of the management team have international backgrounds, and all core members possess many years of experience in the medical device industry.Managing Director Wang Binbin oversaw the entire process of Tinavi’s orthopedic surgical robot, from research and development to market launch, bringing extensive experience in technical R&D, product commercialization, and team management. The company’s vice president and its R&D team previously held positions at leading medical robotics firms such as Tinavi, as well as at global giants in medical imaging equipment.
Meanwhile, Shuimu Dongfang has served numerous industry leaders, innovative enterprises, and research teams, accumulating extensive professional service experience and implementing standardized internal service process management. Over the years, Shuimu Dongfang has also built profound technical expertise in the R&D of high-end medical devices, such as medical robots and medical imaging equipment. It has established a specialized internal technology platform and leverages abundant resources, including domestic and international academicians, clinical experts, and upstream and downstream enterprises, enabling it to respond rapidly to market demands.
As multiple innovative projects advance smoothly, Shuimu Dongfang’s core business has transitioned to specialized services centered on high-end medical device CDMO.
Over the next 3–5 years, the company will adopt a “CDMO+X” service model, with CDMO services as its core, while empowering the development of innovative medical devices through multi-dimensional support in investment and financing, clinical resource matchmaking, and market promotion.In the development of high-end medical devices, R&D and production focused on cost reduction and efficiency improvement are priorities; however, addressing the needs at different stages of development through multi-party resource collaboration and building a healthy ecosystem for sustainable growth is the key.
Shuimu Dongfang’s CDMO services constitute a critical component of its medical robotics innovation and commercialization ecosystem, enhancing conversion efficiency. In turn, the medical robotics innovation and commercialization business can channel client resources to the CDMO division, fostering collaborations at various stages of innovative project development.
Meanwhile, Beijing Medical Robotics Industry Innovation Center will continue to strengthen its influence in niche sectors such as medical robotics, medical imaging, and in vitro diagnostic reagents, with a focus on serving the stages of customized product development and clinical translation, while establishing collaborations with leading enterprises.
In terms of regional service capabilities, with its headquarters rooted in Beijing and in addition to the Haidian platform, Shuimu Dongfang established the Southern Platform for high-end medical device CDMO in Yizhuang this August. This platform covers clinical trials for high-end medical devices, high-end implantable and interventional products, and innovative IVD services, while also incorporating functional modules such as innovative medical device services and clinical training. Meanwhile, the company plans to establish sub-centers in Chongqing, Shanghai, Shenzhen, and other locations to align with local advantageous industrial development and strengthen its influence across the national market.
Furthermore, multiple industrial parks across China are currently building one-stop innovation and commercialization platforms that incorporate CDMO services. The Company can also undertake the managed operations of these services to connect with more enterprises and expand its industry influence.
As the medical device sector rapidly develops and the device CDMO industry becomes increasingly consolidated, Shuimu Dongfang will continue to strengthen its core capabilities in R&D, manufacturing, and marketing. By partnering with more industry leaders and startups, we aim to accelerate the commercialization of high-end medical devices and promote orderly industry growth, ultimately benefiting a broad patient population.