On November 7, 2022, the National Health Commission, the State Administration of Traditional Chinese Medicine, and the National Health Commission jointly issued the “14th Five-Year Plan for National Health Informatization” (National Health Planning Document No. [2022] 30), which clearly proposed to “promote the integration and innovative development of digital health. Accelerate the development of digital health and the construction of new infrastructure, standardize and promote the in-depth application of a new generation of information technology in the health field, further optimize the allocation of resources and service supply, fill development gaps, improve service efficiency, and promote the transformation and upgrading of the health industry.” With the continuous development of society and economy, the demand for high-level medical health is also increasing, and safe, precise, minimally invasive, and efficient medical services have become the goals pursued by people. Such social demands are driving the rapid development of modern intelligent healthcare represented by medical robots. Medical robots mainly include surgical robots, rehabilitation robots, diagnostic robots, and hospital service robots. Currently, the ethical and legal issues surrounding medical robots are increasingly becoming important academic and practical topics.
1.Social Background of Medical Robot Development in China
Medical robots are a special field involving human life and health and have been listed as a strategic emerging industry by multiple countries. In the United States’ robotics development roadmap, medical health robots are one of the five key areas for development, indicating that robotic systems will be applied to various aspects of healthcare (from operating rooms to homes, from young people to the elderly, from the weak or disabled to the healthy, from routine surgeries to rehabilitation training without human intervention) to meet new medical health demands for precision/minimally invasive surgeries, functional compensation and rehabilitation, and elderly services. The robotics development plan in Europe explicitly states that the transformation brought by medical robots to the healthcare system is comparable to the impact of robotic technology on the industrial sector decades ago. Medical rehabilitation robots are an inevitable direction to address the aging population and growing demand for medical resources, and the medical robot industry will become an important engine for driving national economic growth in the new century.
Surgical robots can greatly improve the precision of surgeries, reduce surgical trauma and side effects, facilitate postoperative recovery, and lower patient surgical costs. At the same time, they enable remote areas with underdeveloped medical resources to enjoy more advanced medical standards, thereby improving the overall medical level of society. According to statistics from the World Health Organization, about 10% of the global population has different disabilities, and many countries have entered an aging society. The social service issues brought about by an aging population (medical care, rehabilitation, and nursing) have put immense pressure on economic and social development. With the continuous increase in the disabled and elderly population, relying on technological innovation to safeguard and improve their health has become a strategic demand for many countries. Researching and developing advanced medical robots to achieve functional compensation and reconstruction for patients with functional impairments or deficiencies is of significant social importance for promoting the development of elderly health services and disability assistance public welfare. Looking at the global level of healthcare services, there are currently relatively few healthcare institutions, facilities, and personnel providing health services, especially high-quality medical service resources, which are even scarcer. Many large comprehensive hospitals face numerous patients needing medical services daily, resulting in a heavy workload. Therefore, applying diagnostic robots and hospital service robots in healthcare can effectively alleviate the tense situation of medical personnel in China and worldwide.
China has also successively introduced relevant policies for the development of medical robots. In 2012, the Ministry of Science and Technology released the “12th Five-Year Plan for the Development of Service Robot Technology,” listing medical rehabilitation robots as a development goal and including some popular products such as minimally invasive surgical robots, vascular intervention robots, limb rehabilitation robots, cochlear implants, and intelligent prosthetics; in 2015, the State Council issued “Made in China 2025,” vigorously promoting breakthroughs in key areas and focusing on industrial robots, special robots, as well as service robots in healthcare, home services, and educational entertainment; in 2016, the State Council issued the “National Standardization System Construction Development Plan (2016-2020),” which emphasizes developing biomedical engineering, new medical materials, high-performance medical instruments and equipment, medical robots, home health monitoring and diagnostic devices, advanced life support equipment, and traditional Chinese medicine diagnostic devices; in 2016, the State Council issued “Guiding Opinions on Promoting the Healthy Development of the Pharmaceutical Industry,” accelerating the transformation and upgrading of medical devices and focusing on developing medical robots, health monitoring, telemedicine, and other high-performance diagnostic equipment.
On December 21, 2021, the Ministry of Industry and Information Technology and the National Development and Reform Commission, along with 15 other departments, officially issued the “14th Five-Year Plan for the Development of the Robotics Industry” (Ministry of Industry and Information Technology Document No. [2021] 206), proposing that by 2025, China will become a global source of innovation in robot technology, a gathering place for high-end manufacturing, and a new high ground for integrated applications. During the 14th Five-Year Plan period, breakthroughs in a number of core robot technologies and high-end products will be promoted, with overall performance indicators achieving international advanced levels, and the performance and reliability of key components reaching the level of comparable international products; the average annual growth rate of the robotics industry’s operating income will exceed 20%; a number of internationally competitive leading enterprises and a large number of highly innovative, growth-oriented specialized and new “little giant” enterprises will be formed, and 3-5 internationally influential industrial clusters will be established; the density of manufacturing robots will double.
2.Current Status of Medical Robots in China
After decades of rapid development, medical robots have been widely applied in neurosurgery, laparoscopic surgery, thoracic surgery, orthopedic surgery, vascular intervention, craniofacial surgery, rehabilitation, diagnosis, and hospital services. According to analysis, the global market value of medical robots was $2.7 billion in 2013, $3.3 billion in 2014, and is expected to increase to $4.6 billion by 2019, with a compound annual growth rate of 7% from 2014 to 2019, while the annual growth rate in the Asia-Pacific region during the same period is expected to be 13.4%.[1] Therefore, the current development of medical robots faces enormous market opportunities.
(1)Surgical Robots
Compared to traditional open surgery, the application of minimally invasive surgical robots can reduce the risks associated with surgery, offering advantages such as less surgical trauma, reduced pain, less intraoperative bleeding, and faster postoperative recovery, gaining widespread recognition in the field of surgery and increasingly favored by medical professionals and patients.[2-4] In 1987, Dr. Mouret from Lyon, France, successfully completed the world’s first laparoscopic cholecystectomy on a woman, marking the beginning of a rapid development period for minimally invasive surgical technology. Currently, various medical surgical robots have been successfully developed, among which the “da Vinci” surgical robot system is the most widely used medical surgical robot, achieving great success in urology, gynecology, cardiac surgery, and laparoscopic surgery. By the end of 2012, 2,132 “da Vinci” surgical robot systems had been applied in medical institutions worldwide. The “da Vinci” surgical robot system was developed by Intuitive Surgical, Inc. in the United States in 2001 and has received certification from the U.S. Food and Drug Administration (FDA). The system consists of three parts: a physician control platform, surgical robotic arms, and image processing equipment, as shown in Figure 1.
Figure 1 Da Vinci Surgical Robot
Although the development of surgical robots in China started relatively late, certain achievements have been made. In 2010, a laparoscopic minimally invasive surgical robot named “Miaoshou A” was jointly developed by Tianjin University, Nankai University, and Tianjin Medical University General Hospital, adopting a master-slave control method with feedback functions, enabling stereoscopic vision within the surgical space. In 2013, Harbin Institute of Technology, Nankai University, and the General Hospital of the People’s Liberation Army jointly developed a laparoscopic surgical robot system. This system consists of a physician control console, a surgical assistance system, and surgical execution mechanisms, capable of meeting the operational requirements such as tissue grasping, suturing, and knot tying, with good operability and a large operational space. Its high-end endoscope can magnify the operational space image by more than ten times, greatly improving the precision, safety, and convenience of surgeries. The single-port minimally invasive surgical robot researched by Shanghai Jiao Tong University and Harbin Institute of Technology integrates the end surgical micro-instruments with the endoscope based on a fixed-point motion mechanism, allowing the use of natural body passages or smaller incisions to reduce surgical harm to the body, although this system requires further research and verification before practical application.
Functional rehabilitation and assistive robots have gradually become important technical means for clinical rehabilitation treatment internationally. With the continuous development of robotic technology, rehabilitation robots have been gradually applied to the rehabilitation of patients with limited limb activity, mainly including rehabilitation robots, prosthetics, and exoskeleton rehabilitation robot systems. Numerous clinical trials have shown that rehabilitation robots can help long-term paralyzed stroke patients regain the ability to actively control their limbs to a certain extent. Patients can receive re-education through scientifically guided exercise learning methods with the help of rehabilitation robots to restore their motor functions. The LOKOMAT system, launched by a Swiss medical device company in collaboration with the University of Zurich, is the first exoskeleton-based lower limb gait correction device that assists neurological patients with gait training.
Assistive exoskeleton robots are wearable human-machine integrated mechanical devices that integrate humans and robots, allowing humans to command and control the robots, thereby assisting patients in standing and walking normally. The application of exoskeleton robots enables patients who have lost the ability to walk or have walking disabilities to stand and walk normally, significantly improving their physical function. The HAL series of wearable assistive robots developed by the Cybernics Laboratory at Tsukuba University in Japan can help the elderly and lower limb disabled individuals complete normal walking activities. The ReWalk lower limb assistive exoskeleton developed by Israeli medical technology company Elbit Systems consists of an electric leg brace, body sensors, and a backpack, requiring crutches to maintain body balance, and can help patients with lower body paralysis to stand, walk, and climb stairs. Although these limb function rehabilitation robot systems have achieved certain effects in clinical applications, they face issues such as complexity of operation, high costs, and lack of active rehabilitation functions, resulting in their limited application in clinical rehabilitation in China. Some research institutions and universities in China have also begun developing limb rehabilitation robots, achieving some technological breakthroughs, but there is still a distance to practical application with good results.
(3)Diagnostic Robots
Currently, there is a significant shortage of medical personnel in China, who also face heavy workloads, with varying levels of expertise across regions, leading to frequent delays in patients receiving effective diagnoses and treatments, exacerbating tensions in doctor-patient relationships. Therefore, developing various robots that can alleviate the burden on medical personnel and improve the accuracy of disease diagnosis is particularly necessary. For example, capsule robots, as miniature tools that can enter the human gastrointestinal tract for medical exploration and treatment, can assist medical personnel in disease diagnosis. The CoreTemp capsule robot developed by HQ Company in the United States was the first to be certified by the U.S. Food and Drug Administration and can monitor and record body temperature in real-time. The PillCam system developed by Israeli company Given Imaging received FDA certification in 2001, and its latest system can send high-definition color images at a speed of 14 frames per second, making it the most widely used capsule robot currently. The NaviCam developed by Chinese company Hanguang Optical Technology received a medical device registration certificate from the National Medical Products Administration in 2013 and uses magnetic field technology to achieve navigation and positioning of the robot.
Traditional Chinese medicine is a treasure of China’s medical culture and is receiving increasing attention worldwide. Therefore, combining traditional Chinese medicine with modern intelligent technology can also promote the improvement of medical standards in China and globally. Shanghai University of Traditional Chinese Medicine and Fudan University jointly developed an artificial intelligence robot for traditional Chinese medicine, which not only refines traditional diagnostic techniques such as face diagnosis, tongue diagnosis, and pulse diagnosis that originally relied on subjective judgment by doctors but also utilizes deep learning technology to analyze the accumulated experience of renowned traditional Chinese medicine practitioners, allowing the treasure of traditional Chinese medicine to be better passed down in the high-tech era. The intelligent robot for traditional Chinese medicine focuses on the “observation, listening, inquiry, and palpation” of traditional Chinese medicine, featuring distinct Chinese characteristics. Its main functions include face diagnosis, tongue diagnosis, inquiry, and pulse diagnosis. First, it collects facial and tongue images of the human body through the robot’s vision, and collects pulse data through robotic hands or wristbands, using advanced computer vision, machine learning, artificial intelligence, and deep learning algorithms to intelligently interpret the collected data, then combines it with inquiry information to infer the overall health constitution type of the human body based on traditional Chinese medicine theory, and finally provides personalized rehabilitation suggestions based on specific conditions, including health care principles, dietary prescriptions, lifestyle and health maintenance, acupoint pressing, traditional Chinese medicine practices, and music therapy, etc.[8]
(4)Hospital Service Robots
Hospital service robots are mainly designed to reduce the burden on medical personnel, capable of replacing them in completing simple, repetitive, or labor-intensive tasks, including hospital receptionist robots, transport robots, pharmacy robots, etc.[9-10] Recently, the National Health Service (NHS) in the UK has been testing a medical chatbot software, hoping to replace the current non-emergency hotline. It is reported that this software was developed by a British startup, Babylon, which will understand patients’ conditions through a question-and-answer format and then provide corresponding advice on whether to seek medical attention or to recover on their own.
In 2013, the RP-VITA remote medical robot, developed by iRobot Company and InTouch Health in the United States, received FDA certification. RP-VITA has autonomous navigation capabilities, allowing it to move autonomously based on remote instructions, avoid obstacles, and enter and exit elevators. So far, many commercial transport robots have been used in hospitals, primarily utilizing laser rangefinders for obstacle avoidance and using wireless communication to ride elevators for transporting blood, medications, surgical supplies, and tools, completing the delivery of food, medications, medical devices, and magazines. For example, the “Help Mate” robot developed by the American Transportation Association can operate 24 hours a day in hospitals to deliver food and medications. Unlike automated transport vehicles used in factories that travel along specific tracks, this robot moves autonomously based on sensors and motion planning algorithms, suitable for structured environments, and the system can handle sensor noise, errors, and positioning inaccuracies, detecting and avoiding obstacles. It has been reported that many hospitals have set up pharmacy robotic systems for dispensing medications. For instance, at the People’s Hospital in Yubei District, Chongqing, after handing over a traditional Chinese medicine prescription to pharmacy staff, medications can be obtained within one minute. Staff input the medication names, weights, and other information from the prescription into a computer, and corresponding medication bottles on the shelf immediately light up as prompts. Staff then pull down the bottles and scan the QR codes on the bottom with the robot’s scanner before placing the bottles into the robot’s slot, pressing a button to dispense the medication powder into bags. The hospital stated that one robot can reduce the workload of three people.
3.Governance Thinking of Medical Robots in China
Medical robots are the future direction of intelligent healthcare. To achieve the comprehensive application of medical robots, we must ensure the safety of medical robots technologically and solve the key technical challenges currently facing medical robots. Therefore, the following governance thinking for medical robots in China is proposed:
First, increase financial and tax support for medical robots.Optimize pilot projects for insurance compensation mechanisms for medical robot technology equipment, utilize government procurement to promote the application of innovative medical robot products. Implement tax policies such as additional deductions for research and development costs of medical robots. Promote investment in various medical robot industry funds to support eligible medical robot enterprises to go public. Encourage pilot cities for industry-finance cooperation to increase investment in medical robot enterprises and guide financial institutions to innovate service models.
Second, enhance the innovation capacity of the medical robot industry.Strengthen the tackling of core technologies, break through common technologies such as robot system development and operating systems, research frontier technologies such as bionic perception and cognition, and bio-electromechanical integration, and promote the integration and application of new technologies such as artificial intelligence, 5G, big data, and cloud computing with robotic technology. Focus on the demand in fields such as home services, public services, healthcare, elderly assistance, and special environment operations, gather advantageous resources, and prioritize the development and application of key products in industrial robots, service robots, and special robots.
Third, optimize the industrial organizational structure of medical robots.Cultivate and grow high-quality enterprises in the medical robot sector, promote the growth of enterprises into leading companies with ecological dominance and core competitiveness, and create a batch of specialized and new “little giant” enterprises and single-item champion enterprises. Promote strong, solid, and stable chains, support collaborative innovation among upstream and downstream of the medical robot industry chain, build advantageous and characteristic clusters, promote reasonable regional layouts, cultivate strong innovation capabilities and favorable industrial environments in clusters, and support clusters in focusing on niche areas to shape characteristic cluster brands.
Fourth, improve the talent guarantee system for medical robots..Support universities and research institutions in cultivating professional and interdisciplinary high-end talents in medical robots. Promote the construction of new engineering disciplines, encourage universities and enterprises to jointly carry out industry-academia cooperation projects, co-build modern medical robot industry colleges, and implement training models such as order-based training and modern apprenticeship to cultivate urgently needed talents for industrial development. Implement actions to enhance vocational skills for medical robots, supporting skill enhancement and job transition training for enterprise employees.
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References
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(This article was published in the “Proceedings of the 4th Conference on the Development Theory of Science and Technology Associations (2020)” by China Economic Publishing House in July 2021, with modifications made during publication.)
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Authors:
Ren Guozheng Researcher at the International Research Institute of Green Finance, Central University of Finance and Economics, Director of the Health Finance Laboratory (Resource Library), Team Leader
Wang Lei Research Assistant at the International Research Institute of Green Finance, Central University of Finance and Economics, Assistant of the Health Finance Laboratory (Preparatory), Doctoral Student at the Advanced and Precise Artificial Intelligence (Robotics) Laboratory, Beijing Institute of Technology