The first FDA certification, entering overseas markets... Domestic surgical robots are breaking through

Source: [People's Daily Health Client]

Shanghai MicroPort Medical Robotics (Group) Co., Ltd. announced that its independently developed Honghu orthopedic surgical robot has obtained the U.S. FDA's 510(k) certification, becoming the first and only Chinese surgical robot to obtain FDA certification.

The industry believes that domestic surgical robots are breaking through here and looking for the "Chinese opportunity" to enter the world market.

On the road of R&D, "frustration" is common

A group photo of the core technical personnel of minimally invasive robots. Photo provided by the interviewee

From 2015, when the Honghu orthopedic robot started feasibility research, to 2022, when it was approved for marketing by the National Medical Products Administration, He Chao, president of MicroPort Robotics Group, said frankly that "frustration" has always been the main theme during the R&D stage. Because R&D is difficult, robots are known as "the jewel in the crown of the manufacturing industry", and medical-grade surgical robots are more difficult to develop than traditional industrial surgical robots.

He Chao told the People's Daily Health Client reporter that one of the biggest difficulties with surgical robots is that their technical level is far higher than that of traditional industrial robots and requires a higher level of technology than industrial robots.

Problems such as "bottleneck" technology and solving core components are all encountered in the development of surgical robots in China. Surgical robot components need to be as sophisticated as aerospace grade, but traditional domestic industrial robots cannot meet the requirements. He Chao said, "At that time, since we couldn't buy them, we chose to make breakthroughs ourselves. We tackled each sub-project and underlying technology of optics, motion, algorithm, mechanics, and electronics one by one."

This is difficult, but minimally invasive robots achieve one or two important breakthroughs every year, which has supported the team to gradually reach where it is today.

In 2017, Minimally Invasive Robotics, together with domestic universities and research institutes, successfully applied for the first joint surgery robot project supported by a major national project. On May 21, 2020, Honghu passed the special review application for innovative medical devices of the National Medical Products Administration and entered the "green channel". On June 30, 2020, Honghu completed the first human clinical trial. In July 2021, Honghu completed the registration clinical trial and submitted the registration application to the National Medical Products Administration...

"When it comes to technology, it's often difficult to make breakthroughs, and you start to doubt your life or even everything. But as long as you take one more step forward and pass that point, everything will become clear," said He Chao. "We believe that the Chinese can make their own high-end surgical robots. Throughout the research and development process, our entire industry is also improving."

What is more meaningful to the development of the industry is that Minimally Invasive Robotics has also taken the lead in formulating the first national standard for surgical robots in my country. He Chao introduced: "At present, Minimally Invasive Robotics' testing methods for surgical robots and indicators of key components have been applied to the formulation of industry standards for domestic surgical robots. To some extent, the work we have done in the early stage has now become the trend of the most cutting-edge technology in this field, driving the entire domestic surgical robot industry to strive for higher standards, which makes us very proud."

Surgical robots solve clinical problems and benefit patients who have difficulty seeing a doctor

A doctor operating the Honghu® orthopedic surgical robot. Photo provided by the interviewee

"Its clinical value is to make joint replacement surgery intelligent, surgical results precise, and surgical procedures standardized." He Chao told the reporter of People's Daily Health Client that the Honghu orthopedic surgical robot uses digital methods to empower doctors' "hands" (robotic arms), "eyes" (navigation) and "brain" (intelligent planning). It has the advantages of simple operation and short learning curve. It can effectively solve the clinical pain points of traditional surgery that relies too much on the operator's experience and cannot achieve standardized and repeatable operations.

"Perhaps 15%-20% of patients will feel uncomfortable after the operation. The fundamental reason is that traditional doctors perform the operation with their bare hands, which results in an angle deviation of three degrees or higher, and the replaced joint does not fit the human tissue well." He Chao introduced that such deviation will cause unbalanced force on the lower limbs of the human body.

Since this type of surgery involves a large number of patients, fatigue can also affect the accuracy of the doctor. The intervention of surgical robots can effectively solve these problems. From the data, the accuracy of the Honghu surgical robot is controlled within one degree or even zero degrees, which is completely consistent, so that the patient's force is very balanced. However, to achieve such accuracy, the minimally invasive robot team led by He Chao has been working on scientific research for a full 7 years.

He Chao introduced that, with the help of 5G technology, the Honghu surgical robot can also enable doctors in tertiary hospitals to perform surgery remotely. "Previously, imported robots were too expensive and difficult to promote. Domestic surgical robots have reduced the cost of domestic hospitals and are relatively easier to promote than imported equipment."

He Chao gave an example, "We brought the Honghu orthopedic surgical robot to Yunnan, so that local patients can enjoy the services of advanced surgical robots. Most of the patients in Yunnan are between 50 and 70 years old, and they all suffer from knee pain all year round, and some severe cases have suffered for more than 20 years."

In March 2022, Yang Bing, director of the Department of Orthopedics at Qujing Second People's Hospital, successfully completed a total knee replacement surgery with the assistance of the "Honghu®" orthopedic robot; Nujiang Prefecture People's Hospital successfully completed four robot-assisted total knee replacement surgeries; Zhaotong Second People's Hospital successfully completed two robot-assisted total knee replacement surgeries...

Domestic surgical robots enter overseas markets

According to statistics from Frost & Sullivan, the global surgical robot market will grow from 3 billion to 8.32 billion from 2015 to 2020, and the orthopedic surgical robot market is expected to reach 4.69 billion US dollars in 2026. With the rapid improvement of the overall strength of my country's robotics industry, the voice of domestic robotics companies in the international market has gradually increased, and the "China opportunity" to enter the overseas market has emerged.

What makes Professor Li Huiwu, deputy director of the Department of Orthopedics at the Ninth People's Hospital affiliated to Shanghai Jiao Tong University School of Medicine, happy is that Honghu, as a truly domestically developed orthopedic surgical robot, is "keeping pace" with the products of several major orthopedic surgical robot companies in the world.

He Chao introduced that because the Honghu robot is original and has independent patents, there will be no intellectual property issues when entering the US market.

At present, from the perspective of the development of domestic surgical robots, the best embodiment of market recognition, cost-effective and highly functional robot star products are concentrated "going overseas" and have become the common choice of many innovative companies. For example, Geek+ promotes the landing of warehouse robot products in Europe, and Juxing has established a cooperative relationship with Mitsubishi to promote AMR automated warehouse solutions in the Japanese market...

He Chao introduced that minimally invasive robots will leverage domestic innovation advantages and establish brands and factories in the United States. By solving the pain points of clinical needs of American doctors, it will gain recognition from the local market and create a "Chinese brand" of surgical robots.

Editor: Liu Meiyan

Editor-in-Chief: Xu Tingting

Proofreading: Li Xin

This article comes from the People's Daily Health Client and only represents the author's views. The National Party Media Information Public Platform provides information release and dissemination services.

ID: jrtt