China's Formed Medical Robotics Products Face Marketization Challenges: Eight Key Research Directions Identified

China’s medical device industry started relatively late, with the development of medical robots primarily concentrated in universities and research institutes, resulting in significant differences and gaps compared to European and American enterprises. At the 2016 World Medical Robot Conference, Professor Sun Lining, Director of the ROBO Institute of Medical Robotics and Deputy Director of the State Key Laboratory of Robotics and Systems (Harbin Institute of Technology), introduced the current status of Chinese medical robots, represented by Tinavi Medical Technologies, which leverages technological advancements from Beihang University. From an academic perspective, he proposed key research directions and development recommendations for China’s medical robot industry.

Tianzhihang, leveraging technological advancements from Beihang University, has obtained registration certification for its medical robot products, instilling confidence in domestically produced robots. Other research institutions, such as the Chinese Academy of Sciences and Harbin Institute of Technology, have followed suit by launching their own products.

Beijing Tinavi Medical Technology Co., Ltd. (TINAVI): TINAVI obtained China’s first medical robot product registration certificate (Guo Shi Yao Jian Xie Zhun Zi [2010] No. 3540188), becoming the fifth company globally to receive a medical robot registration license, following ISI Corporation (USA), ISS Corporation (USA), Medical Robotics (Sweden), and Mazor Robotics (Israel).

Currently, Tinavi’s main products include: the GD-2000 Orthopedic Surgical Robot Navigation and Positioning System, Neurosurgical Navigation System, GD-A Orthopedic Surgical Robot Navigation and Positioning System, TC-6 Intelligent Surgical Platform, Remote Surgical Service Platform, and Technology Achievement Transformation Platform. In 2010, Tinavi completed its joint-stock reform and established Beijing Tinavi Medical Technologies Co., Ltd. On November 20, 2015, it was listed on the National Equities Exchange and Quotations (NEEQ), with a market capitalization of RMB 234 million.

Beihang University Institute of Robotics: Founded in 1987 by Academician Zhang Qixian, the Institute of Robotics is a research entity integrating teaching, scientific research, and development. Its current medical and service robotics products include: a miniaturized modular orthopedic robotic system, a spinal grinding navigation and robotic system, a curtain wall cleaning robot, a digital operating table, an integrated bed-chair system, and a stereotactic brain robot.

The neurosurgical robot jointly developed by Beihang University and the Navy General Hospital has received certification from the China Food and Drug Administration (CFDA) and has been used in thousands of clinical surgeries.

In September 2013, the Shenzhen Institute of Advanced Technology, Chinese Academy of Sciences (CAS), developed a spinal surgery robot capable of integrating with existing infrared tracking and positioning systems to achieve accurate, real-time localization of surgical instruments during procedures.

The Hong Kong Polytechnic University has successfully developed the world’s first motor-integrated robotic system dedicated to surgical procedures (NSRS, Novel Surgical Robotic System). This research leverages the clinical surgical expertise of the Li Ka Shing Faculty of Medicine at the University of Hong Kong and has been successfully tested in animal trials. The technology is expected to enter clinical testing within two years, with a market launch as early as 2019.

Although the da Vinci Surgical System has been highly successful, it faces two prominent challenges. First, the lack of haptic feedback during surgical procedures deprives surgeons of sensory input, thereby reducing their sense of security and control. Second, the da Vinci system predominantly utilizes a multi-port approach; while this results in shorter postoperative recovery times compared to conventional open surgery, there remains significant room for improvement.

Addressing the limitations of the da Vinci Surgical System, the NSRS can access the human body via a single incision or natural orifice (incision-free), with capabilities covering various abdominal and pelvic surgeries. By integrating micro-motors within the robotic arms in close proximity to the end effectors (surgical instruments), the system not only executes high-precision movements but also provides highly sensitive haptic and force feedback.

In summary, we have found that China has indeed developed numerous medical robots; however, unlike in Europe and the United States, these innovations have not achieved widespread market commercialization, with many results remaining confined to laboratories. Tinavi Medical Technologies has set an exemplary model for many research institutes.

There are many common key technologies in the current development of medical robots, with a particular focus on issues represented by surgical robots. In this regard, Professor Sun Lining has identified eight key research directions.

First, the processing of surgical images, including 3D reconstruction and registration, facilitates precise localization for surgeons during procedures through the generation of three-dimensional images.

Second, lesion planning and navigation for surgical robots can improve surgical precision.

Third, to achieve the dual objectives of high-precision operations for future development and minimally invasive procedures, it is essential to develop novel mechanical structures. Unlike industrial robots, medical robots must be precise, compact, and durable.

Fourth, new materials enable the on-site 3D printing of organs, including transplantable hearts.

Fifth, to enhance the precision and safety of surgery, intelligent control and multi-information fusion are employed during the procedure. A lack of information can hinder surgical maneuvers and compromise safety. Such information includes various data on the interaction between surgical tools and organs, imaging and tissue characteristics, and extracted physiological parameters. The integration of these multimodal data ensures smoother surgical execution.

Sixth, biological modeling. Research models of bone, skin, and tissue during resection procedures to optimize various parameters throughout the surgical process, thereby assisting physicians in selecting optimal surgical plans.

Seventh, human-robot interaction: how to enable seamless integration between surgeons and robotic systems to enhance surgical operability, with greater convenience facilitating clinical adoption by physicians.

Finally, future intelligent prosthetics and exoskeletons will draw on multiple information sources—including electroencephalography (EEG), electromyography (EMG), and other human limb signals—as well as mapping human motion data to robotic movements. These advancements will provide robust technical support for the deployment and use of robotic systems.

Medical robotics entails high entry barriers, multidisciplinary integration, long development cycles, and complex systems engineering. Achieving industrialization involves numerous social and capital-related challenges. As a category of high-end medical devices, it has unique requirements in regulatory registration and clinical evaluation. Therefore, to advance the development of medical robots in China, it is essential to leverage the strengths of all stakeholders and build a diversified, collaborative ecosystem that integrates talent, technology, and capital, while engaging industry, government, hospitals, physicians, as well as testing and standards organizations.

Specifically, with government support, a platform is being established to enable research institutes to share data and outcomes. This platform will transform the previous model of isolated development among individual research departments, prevent the premature failure of most studies before they reach industrialization, and reduce resource waste.

By leveraging such a platform to incubate projects and allocate various resources during the incubation process—particularly by facilitating capital matching—industrialization can be accelerated. Furthermore, through government efforts to engage hospitals and physicians in establishing medical testing standards, the essential conditions for achieving industrialization will be met.

On the other hand, in the integration of medicine and engineering, medical robots are ultimately operated by physicians, who, along with hospitals, play a decisive role in this process. Sun Lining suggests that hospitals selected should be large, demonstrative institutions, and physicians chosen should be those interested in this field and possessing certain influence and persuasiveness within the industry, thereby facilitating the mobilization of relevant resources. Regarding functionality, safety, surgical procedures, and technical issues, these physicians can articulate the primary product requirements to designers.

Only by communicating with physicians to understand their needs and workflows can designers develop surgical robots that are truly suitable for clinical use; otherwise, the effort risks becoming an exercise in isolation, detached from real-world practice.