China's surgical robotics sector has leaped from "technology following" to "globally pioneering," ushing in a new breakthrough. The National Medical Products Administration of China (NMPA) has recently approved the market launch of the "thoracic and abdominal endoscopic surgery system" with remote application capabilities (hereinafter referred to as the "remote surgical robot") developed by Shanghai MicroPort MedBot (Group) Co., Ltd. (hereinafter referred to as "MicroPort MedBot").
This is the world's first 5G remote surgical robot approved for market launch.
The product is approved for remote surgery in urology, general surgery, gynecology, and thoracic pulmonary surgery under 5G networks, wired networks, and 5G-wired hybrid networking. This means that the product not only overcomes geographic barriers but also avoids dependence on dedicated lines or single communication providers, solving the problems of high operational and maintenance costs and difficulty in large-scale application of remote surgical procedures, providing a new pathway for the balanced distribution of medical resources.
"We are extremely excited at the product's approval. In the future, specialists in Beijing and Shanghai, from their local hospitals, can operate on non-local patients," said He Chao, President of MicroPort MedBot, delightedly. The product certification is a milestone in the company's R&D work, further firming the company's confidence in strengthening cutting-edge innovation.
Major technological breakthrough
In recent years, the industry has actively researched surgical robot applications based on remote technology, which has been frequently covered by the media. Then, what breakthrough developments have this remote surgical robot achieved?
"Before this product, remote surgical robots in China mostly conducted surgery in the form of project research, with no products formally approved for market launch. This product is the first to receive approval after verification through non-clinical research, clinical trials, and other validations," introduced Yang Pengfei, Head of Evaluation Department II at the Center for Medical Device Evaluation, NMPA (CMDE).
The key bottleneck lies in the extremely high network stability and extremely low latency required for remote surgery. He Chao explained that when remote surgery is being conducted, the data signal transmission of surgical robots must ensure low latency and high quality to enable doctors to perform precise surgical procedures from thousands of miles away. Previously, conventional networks could not support this, and dedicated fiber optic networks were required. However, fiber optic could cost as high as several million yuan, with annual maintenance costs of hundreds of thousands of yuan.
China has overcome this bottleneck through sustained efforts from multiple parties. The newly approved product is compatible with various communication networks including 5G and wired networks and supports network hybrid communication across operators and media, significantly reducing application costs and facilitating clinical use.
The technological breakthrough of the product benefits from the implementation of new-generation communication technologies represented by 5G, and is inseparable from the research efforts of regulators and enterprises.
To stay ahead of innovation, CMDE actively began research related to remote medical devices as early as 2020 to accomplish technical reserves for evaluation. In 2021, when the NMPA launched the second batch of key projects of the Action Plan for Drug Regulatory Science in China, CMDE actively applied for and successfully obtained approval for the project "Safety and Effectiveness Evaluation Research of Medical Device Products Based on Remote/Wireless Transmission Technology" and subsequently conducted in-depth research on remote transmission technology for products such as surgical robots, organized various forces to collaborate on problem-solving, and studied relevant evaluation points.
MicroPort MedBot, as one of the representatives actively exploring remote medical application scenarios, began developing surgical robots in 2014 and started researching the remote transmission functions and commercial applications of surgical robots in 2020.
"The conduct of the CMDE project has benefited us a lot. Through participation in project discussions, we could preliminarily understand the technical requirements of drug regulators for remote surgical robots and communicate about problems encountered during product development," introduced Li Jingwen, Director of Registration and Regulatory Affairs at MicroPort MedBot. After an exchange of ideas with CMDE in 2022, the company conducted product testing under more stringent network conditions and further optimized product design.
The biggest difficulty in the R&D was how to adequately control risks brought by network instability. To address this, the company's R&D personnel designed a remote surgery technical support system consisting of corresponding network monitoring measures, low-latency ultra-compression image technology, dynamic communication network optimization strategies, etc., continued to overcome R&D challenges, and constantly improved product maturity.
Adequate control of product risks
In December 2023, based on its previously approved product, MicroPort MedBot formally submitted a registration application for the product's remote application. As the first surgical robot in China to apply for registration of remote surgical application, how should it be evaluated?
Given the product's particularity, CMDE chose to deploy elites experienced in surgical robot evaluation to form the evaluation team.
"The main difference between remote surgical robots and conventional surgical robots lies in the newly added remote communication function, which is also its greatest source of risk. So, we were more cautious in evaluation, considering influencing factors as comprehensively as possible," said lead evaluator Cao Yue.
The evaluation work progressed steadily. In April 2024, in response to the risks of remote surgery, according to the product's clinical positioning and applications, CMDE issued a notice on supplements and corrections to the company, requiring further supplementation and improvement, after thorough communication with experts from various parties regarding risks and benefits.
It is learned that during remote surgery, low-latency, high-quality image transmission can help remote doctors promptly adjust intraoperative procedures to ensure patient safety. Therefore, CMDE required the company to prove the safety and effectiveness of the application product with more clinical trial data.
The comprehensive consideration in the evaluation link is also reflected in some details. Lead evaluator Wang Yawen stated, "We specifically reminded the company to include the monitoring of intraoperative latency and packet loss probability, image quality, alarm frequency, switching frequency between remote and local backends, and other matters that might affect patient safety as evaluation indicators in clinical trials."
"Adequate control of risks" is one of the most frequently mentioned phrases in communications between CMDE and the company.
According to Li Jingwen, during the supplements and corrections stage, MicroPort MedBot engaged in thorough discussions with CMDE on how to design specific clinical trials. Ultimately, the company conducted multi-department clinical trials according to requirements and relevant evaluation points, which secured "hard data" for product approval.
"From a safety perspective, CMDE considered many aspects, which continued to deepen our understanding of the product," stated He Chao. During the product evaluation process, CMDE provided comprehensive guidance to the company from dimensions including standards discussion, technical guidance, and expert demonstration to strengthen product compliance and help the company continuously break through technical bottlenecks.
Remote functions confirmed through research
How can the network transmission quality, emergency support, and other software and hardware functions of remote surgical robots be verified? MicroPort MedBot worked hard to solve this challenge under CMDE's guidance in the later stages of product development.
The verification work required verifying not only the product's functions and performance under network fluctuation conditions but also the impact of various network parameters on product performance. Detailed communication helped the company take fewer detours when clarifying testing requirements.
"When we consulted with CMDE, the evaluators fully communicated with us about details such as the principles and objects of product network environment monitoring and the testing methods, which ensured that the product's network parameter monitoring and corresponding over-limit feedback were rigorous and reliable," Li Jingwen introduced.
To meet testing and verification needs, MicroPort MedBot turned to the remote medical technology team at the China Academy of Information and Communications Technology (CAICT).
CAICT's testing implementation also faced numerous technical challenges. For example, testing needed to consider both system connectivity and control independence because the product's local end and remote end need to be mutually independent with highly coordinated functions. Furthermore, with no mature international experience to follow, how to scientifically simulate real remote surgery usage scenarios and accurately collect and evaluate key network performance indicators was also a challenge.
Li Man, Director of the Biotechnology Department at CAICT's Cloud Computing and Big Data Research Institute, introduced that to solve testing challenges, CAICT went through multiple rounds of technical communication and solution demonstration with CMDE and the company, ultimately constructing a technical path for remote surgical robot testing. CAICT reproduced complex scenarios including end-to-end remote communication, network degradation, and cross-operator and cross-regional connections by building a full-featured dual-end testing platform with adjustable parameters for remote data communication network connectivity, to verify the safety and effectiveness of multiple functions and performance aspects of the product, covering safety assurance, remote control, and transmission.
"We were very cautious, with several months spent on researching the testing environment and completing testing work and testing reports," Li Man recalled the work state back then. It is learned that both the product's network adaptability and the conformance of product functions and performance were demonstrated.
MicroPort MedBot finally received the remote surgical robot registration certificate in April this year after obtaining the test report and completing clinical trials and other research. This world's first 5G remote surgical robot is another epitome of "intelligent manufacturing in China" and became one of the significant milestones demonstrating new strides in China's high-end medical devices industry.
Source: www.cnpharm.com
This is the world's first 5G remote surgical robot approved for market launch.
The product is approved for remote surgery in urology, general surgery, gynecology, and thoracic pulmonary surgery under 5G networks, wired networks, and 5G-wired hybrid networking. This means that the product not only overcomes geographic barriers but also avoids dependence on dedicated lines or single communication providers, solving the problems of high operational and maintenance costs and difficulty in large-scale application of remote surgical procedures, providing a new pathway for the balanced distribution of medical resources.
"We are extremely excited at the product's approval. In the future, specialists in Beijing and Shanghai, from their local hospitals, can operate on non-local patients," said He Chao, President of MicroPort MedBot, delightedly. The product certification is a milestone in the company's R&D work, further firming the company's confidence in strengthening cutting-edge innovation.
Major technological breakthrough
In recent years, the industry has actively researched surgical robot applications based on remote technology, which has been frequently covered by the media. Then, what breakthrough developments have this remote surgical robot achieved?
"Before this product, remote surgical robots in China mostly conducted surgery in the form of project research, with no products formally approved for market launch. This product is the first to receive approval after verification through non-clinical research, clinical trials, and other validations," introduced Yang Pengfei, Head of Evaluation Department II at the Center for Medical Device Evaluation, NMPA (CMDE).
The key bottleneck lies in the extremely high network stability and extremely low latency required for remote surgery. He Chao explained that when remote surgery is being conducted, the data signal transmission of surgical robots must ensure low latency and high quality to enable doctors to perform precise surgical procedures from thousands of miles away. Previously, conventional networks could not support this, and dedicated fiber optic networks were required. However, fiber optic could cost as high as several million yuan, with annual maintenance costs of hundreds of thousands of yuan.
China has overcome this bottleneck through sustained efforts from multiple parties. The newly approved product is compatible with various communication networks including 5G and wired networks and supports network hybrid communication across operators and media, significantly reducing application costs and facilitating clinical use.
The technological breakthrough of the product benefits from the implementation of new-generation communication technologies represented by 5G, and is inseparable from the research efforts of regulators and enterprises.
To stay ahead of innovation, CMDE actively began research related to remote medical devices as early as 2020 to accomplish technical reserves for evaluation. In 2021, when the NMPA launched the second batch of key projects of the Action Plan for Drug Regulatory Science in China, CMDE actively applied for and successfully obtained approval for the project "Safety and Effectiveness Evaluation Research of Medical Device Products Based on Remote/Wireless Transmission Technology" and subsequently conducted in-depth research on remote transmission technology for products such as surgical robots, organized various forces to collaborate on problem-solving, and studied relevant evaluation points.
MicroPort MedBot, as one of the representatives actively exploring remote medical application scenarios, began developing surgical robots in 2014 and started researching the remote transmission functions and commercial applications of surgical robots in 2020.
"The conduct of the CMDE project has benefited us a lot. Through participation in project discussions, we could preliminarily understand the technical requirements of drug regulators for remote surgical robots and communicate about problems encountered during product development," introduced Li Jingwen, Director of Registration and Regulatory Affairs at MicroPort MedBot. After an exchange of ideas with CMDE in 2022, the company conducted product testing under more stringent network conditions and further optimized product design.
The biggest difficulty in the R&D was how to adequately control risks brought by network instability. To address this, the company's R&D personnel designed a remote surgery technical support system consisting of corresponding network monitoring measures, low-latency ultra-compression image technology, dynamic communication network optimization strategies, etc., continued to overcome R&D challenges, and constantly improved product maturity.
Adequate control of product risks
In December 2023, based on its previously approved product, MicroPort MedBot formally submitted a registration application for the product's remote application. As the first surgical robot in China to apply for registration of remote surgical application, how should it be evaluated?
Given the product's particularity, CMDE chose to deploy elites experienced in surgical robot evaluation to form the evaluation team.
"The main difference between remote surgical robots and conventional surgical robots lies in the newly added remote communication function, which is also its greatest source of risk. So, we were more cautious in evaluation, considering influencing factors as comprehensively as possible," said lead evaluator Cao Yue.
The evaluation work progressed steadily. In April 2024, in response to the risks of remote surgery, according to the product's clinical positioning and applications, CMDE issued a notice on supplements and corrections to the company, requiring further supplementation and improvement, after thorough communication with experts from various parties regarding risks and benefits.
It is learned that during remote surgery, low-latency, high-quality image transmission can help remote doctors promptly adjust intraoperative procedures to ensure patient safety. Therefore, CMDE required the company to prove the safety and effectiveness of the application product with more clinical trial data.
The comprehensive consideration in the evaluation link is also reflected in some details. Lead evaluator Wang Yawen stated, "We specifically reminded the company to include the monitoring of intraoperative latency and packet loss probability, image quality, alarm frequency, switching frequency between remote and local backends, and other matters that might affect patient safety as evaluation indicators in clinical trials."
"Adequate control of risks" is one of the most frequently mentioned phrases in communications between CMDE and the company.
According to Li Jingwen, during the supplements and corrections stage, MicroPort MedBot engaged in thorough discussions with CMDE on how to design specific clinical trials. Ultimately, the company conducted multi-department clinical trials according to requirements and relevant evaluation points, which secured "hard data" for product approval.
"From a safety perspective, CMDE considered many aspects, which continued to deepen our understanding of the product," stated He Chao. During the product evaluation process, CMDE provided comprehensive guidance to the company from dimensions including standards discussion, technical guidance, and expert demonstration to strengthen product compliance and help the company continuously break through technical bottlenecks.
Remote functions confirmed through research
How can the network transmission quality, emergency support, and other software and hardware functions of remote surgical robots be verified? MicroPort MedBot worked hard to solve this challenge under CMDE's guidance in the later stages of product development.
The verification work required verifying not only the product's functions and performance under network fluctuation conditions but also the impact of various network parameters on product performance. Detailed communication helped the company take fewer detours when clarifying testing requirements.
"When we consulted with CMDE, the evaluators fully communicated with us about details such as the principles and objects of product network environment monitoring and the testing methods, which ensured that the product's network parameter monitoring and corresponding over-limit feedback were rigorous and reliable," Li Jingwen introduced.
To meet testing and verification needs, MicroPort MedBot turned to the remote medical technology team at the China Academy of Information and Communications Technology (CAICT).
CAICT's testing implementation also faced numerous technical challenges. For example, testing needed to consider both system connectivity and control independence because the product's local end and remote end need to be mutually independent with highly coordinated functions. Furthermore, with no mature international experience to follow, how to scientifically simulate real remote surgery usage scenarios and accurately collect and evaluate key network performance indicators was also a challenge.
Li Man, Director of the Biotechnology Department at CAICT's Cloud Computing and Big Data Research Institute, introduced that to solve testing challenges, CAICT went through multiple rounds of technical communication and solution demonstration with CMDE and the company, ultimately constructing a technical path for remote surgical robot testing. CAICT reproduced complex scenarios including end-to-end remote communication, network degradation, and cross-operator and cross-regional connections by building a full-featured dual-end testing platform with adjustable parameters for remote data communication network connectivity, to verify the safety and effectiveness of multiple functions and performance aspects of the product, covering safety assurance, remote control, and transmission.
"We were very cautious, with several months spent on researching the testing environment and completing testing work and testing reports," Li Man recalled the work state back then. It is learned that both the product's network adaptability and the conformance of product functions and performance were demonstrated.
MicroPort MedBot finally received the remote surgical robot registration certificate in April this year after obtaining the test report and completing clinical trials and other research. This world's first 5G remote surgical robot is another epitome of "intelligent manufacturing in China" and became one of the significant milestones demonstrating new strides in China's high-end medical devices industry.
Source: www.cnpharm.com