"Humanity will eventually enter the era of artificial intelligence." Although this judgment has almost become a social consensus, people have always been cautious about the application of AI in the medical field.
In a certain way, a question about "after the large-scale listing of medical robots, will surgeons be replaced?" The question was answered by 19, most of whom believed that robots could not replace doctors; some people thought that they would not do so now, but might in the future; and a small number of people said that medical robots may not be able to replace the "main knife" doctor now, but may replace the "assistant" doctor.
The latter is in line with the views of Tian Wei, academician of the Chinese Academy of Engineering and chairman of the Medical Robot Engineering and Clinical Application Branch of the Chinese Society of Biomedical Engineering: "The future of medical robots has two very important points, one is that we must take the interests of patients as the center; the other is not to replace doctors, but to provide new help to doctors."
However, if it is only to play a role in artificial assistance, then for the hospital, it is often millions of yuan or even tens of millions of yuan to buy a single machine; for patients, is it worth the "boot fee" of tens of thousands of yuan for a surgery?
In the past year, the stock price of Tianzhihang, a leading domestic orthopedic surgical robot, has suffered a waterfall decline, and the current market value has fallen by nearly 90% compared with the highest point. Minimally Invasive Robot, a subsidiary of Minimally Invasive Medical, which owns surgical robot products in the fields of endoscopy, orthopedics and pan-blood vessels, has also shown a downward trend in fluctuations since it landed on the Hong Kong stock market in November 2021.
Capital markets are gradually losing confidence in orthopedic surgical robots.
Recently, a letter document on soliciting the price of "orthopedic surgical robots" auxiliary operations has spread in the industry, which has triggered heated discussions, and questions about the value of orthopedic surgical robots have been pushed to the peak.
"Now the cost of surgery is very low, artificial joint replacement such an advanced operation, the price is less than 3,000 yuan, if on the basis of this price is proportionally charged, as the robot start-up cost, I think there are only two words to describe, that is, 'absurd'." 」 An orthopedic expert at a third-class hospital in Beijing told the health community.
Under the value and price dispute, where will the orthopedic surgical robot industry go?
"The development of minimally invasive technologies such as endoscopy in China tells us that we must not rest on our laurels." Lin Jin, chief physician of the Department of Orthopedics of Peking Union Medical College Hospital, told the health community that the surgical robot, as a new generation of medical devices, is the best interpretation of the current concept of translational medicine and precision medicine, and its development and clinical popularization and application will surely become part of the future intelligent medical model.
$20,000 and not an "economical" option?
China's first robot-assisted total knee artificial joint replacement surgery occurred on January 6, 2020, a 66-year-old patient with severe knee pain, deformation, and osteoarthritis for more than 20 years underwent the operation at Peking Union Medical College Hospital, an orthopedic surgical robot independently developed by the mainland.
First, the patient's three-dimensional image scan image data of the patient's affected limb is synchronously transmitted to the robot's "brain" - the computer system, and then, the doctor plans the surgical plan on the computer system screen, and then, the robot's robotic arm is based on the surgical plan, accurately positioned to the expected surgical position through the optical tracker, and in accordance with the planned path, the doctor cooperates with the doctor to perform osteotomy operations, and then the doctor installs an artificial joint prosthesis.
"Surgical robots elevate and extend the doctor's brain, eyes, and hands." Lin Jin, the main surgeon of this operation, told the health community that the robot can help doctors achieve accurate positioning, the positioning of osteotomy, the location of the prosthesis placement, can be completed according to the pre-set plan, and will not have too much invasion of bones and soft tissues, less surgical trauma, less bleeding, safe process, and fast patient recovery.
Lin Jin, chief physician of the Department of Orthopedics of Peking Union Medical College Hospital, performed osteotomy with the assistance of orthopedic surgical robots
However, in China, there are not many cases of robot-assisted orthopedic surgery like this.
From the perspective of application scenarios, orthopedic surgical robots are mainly used in joint replacement surgery (knee joint or hip joint), spine surgery, and fracture reduction in trauma (mostly in research). According to Frost & Sullivan's data, the number of robotic-assisted joint replacement surgeries in China in 2020 was only 243, with a penetration rate of less than 0.1%, while the number of robotic-assisted joint replacement surgeries in the United States in the same period was as high as 100,000, with a penetration rate of 7.6%.
According to its prospectus, as of the end of 2019, its orthopedic surgical robot products have been put into clinical use in 74 medical institutions in China, with a total of 5371 cases of spine surgery. However, the frequency of use of a single machine is not high, according to guosheng securities statistics, from 2016 to 2019, the average frequency of use of a single orthopedic robot of Tianzhihang in the hospital was only 12 cases, 47 cases, 64 cases and 73 cases, respectively.
Why is it that the orthopedic surgical robots with certain advantages are not well promoted and applied in China?
Some doctors pointed out that at present, the orthopedic spine surgery robot only helps the doctor locate and provide a guide needle insertion path, which solves the secondary contradiction in the operation, rather than the main contradictions such as orthopedics and decompression, which is not "sending charcoal in the snow", at least for now it is only the "icing on the cake".
But this "flower" is expensive.
The cost of a surgery usually includes the cost of surgery, anesthesia, blood transfusion, medicine, consumables, etc. According to statistics, at present, robot-assisted orthopedic surgery has been included in the clinical fee directory in 18 provinces/cities such as Beijing, Tianjin, Jilin, Anhui, Hebei and Shandong, and in the settlement of patient surgery, the use fee of orthopedic surgical navigation and positioning robot (that is, "boot fee") is charged separately as a new item.
According to the "Specifications for the First Batch of New Medical Service Price Items in 2019" published by the Beijing Municipal Health Commission on its official website, in 2019, robot-assisted orthopedic surgery was charged 39,000 yuan in Beijing Haidian Hospital and Weeping Yangliu Hospital.
According to Guosheng Securities data, in 2020, Beijing Jishuitan Hospital will charge 18,000 yuan to 45,000 yuan for robot-assisted orthopedic surgery according to the complexity of surgery; the third people's hospital of Jinan City and Yantaishan Hospital of Yantai City will charge robot-assisted surgery, according to the operation situation, which is about 0.7 million yuan to 15,000 yuan.
According to a chief physician of the Department of Orthopedics of a large tertiary general hospital in Beijing, after the introduction of orthopedic surgical robots in the hospital in 2019, the initial pricing of the use of robot-assisted spine surgery fees was 44,000 yuan, and then the cost was adjusted to 22,000 yuan, 33,000 yuan and 44,000 yuan according to the complexity of the operation.
"In fact, before and after the price adjustment, there was no significant change in the number of robotic spinal surgeries in hospitals." The chief physician said that in the case of patients paying their own expenses, there are not many patients who are willing to increase the payment of more than 20,000 yuan for the use of robots.
In terms of surgical cost alone, robot-assisted orthopedic surgery does not seem to be an "economical" option for patients. However, if you look at the overall cost of treatment, it may not be "economical".
"Traditional surgery requires the implantation of a metal bone plate system in the patient's body, which is expensive, and the use of robot-assisted surgery, in most cases, only needs to implant a few screws in the patient's body, which will greatly reduce the patient's cost." Wu Xinbao, vice president of Beijing Jishuitan Hospital and executive deputy director of the Beijing Institute of Trauma and Orthopedics, told the health community.
"High or low?"
The Beijing Municipal Medical Insurance Bureau, together with the Municipal Health Commission and the Municipal Human Resources and Social Security Bureau, issued a document in August 2021, stipulating that from October 23, 2021, robot-assisted orthopedic surgery will enter the Beijing Class A medical insurance payment directory (100% reimbursable), and the project price will be set at 8,000 yuan / time; one-time robot-specific equipment will be paid by Beijing Class B medical insurance (70% reimbursable).
After the inclusion of medical insurance, has the operating rate of orthopedic surgical robots in hospitals increased?
The chief physician told the health community that the number of robotic-assisted spinal surgeries had changed "not significantly".
"Compared with the patient's willingness to choose, the doctor's willingness to use is the key to affecting the robot's availability." The chief physician believes that the orthopedic surgical robots currently used in clinical practice have not yet reached the goals expected by doctors, and have not yet played a good auxiliary role in complex and difficult spine surgery.
For spinal surgery, on the one hand, surgical planning still needs to be completed by doctors; on the other hand, the three-dimensional image scanning function of the robot is not real-time, and the position of the patient during the operation may change, resulting in a certain difference from the preoperative CT scan results, which in turn affects the accuracy of the positioning of the robotic arm. For experienced doctors, screws can be implanted into patients with greater precision, even without robot assistance.
"Now the state of the orthopedic surgical robot, I feel that it is a bit of a state of "high or low", complex surgery can not use robots, can use robot surgery, relatively simple." 」 The chief physician further added that before using the surgical robot, it takes a certain amount of time to dock and debug the system, which increases the time cost of the operation.
However, some experts have expressed support for surgical robots.
"People always have a nap time, people always have a time to shiver, even high-level experts have it, this is a weakness of people, but machines will not." 」 Wu Xinbao frankly said that the robot currently put into clinical use is indeed not fully functional, mainly used for "positioning", "aiming" and other functions, and it is not yet possible to complete more complex functional requirements such as assisted fracture reduction, but the changes brought by the robot are subversive, if it is abandoned because of its initial function is more basic, it is actually killing the future.
Lin Jin told the health community that he has basically stopped doing traditional joint replacement surgery. "There is a significant difference between the precision of humans and the accuracy of robots, and if there are better ways to operate, why are there still ancient methods?" 」
Reduce the fatigue and trembling of the surgeon, reduce the number and time of the doctor's fluoroscopy during the operation, reduce the radiation dose of the doctor and the patient, improve the accuracy and precision of the operating instruments ... The advantages of robotic-assisted surgery are clear, but it may be difficult to determine which is more preferred than traditional surgery.
The willingness of patients, the willingness of doctors, the functional level of robots, and the "start-up fee" are all influencing the popular application of surgical robots.
The industry has different views on this, but there is a consensus on the value of orthopedic surgical robots - surgical robots are a very necessary tool to achieve precision medicine, especially for promoting the development of medical homogenization, which is of great significance.
"Through robot assistance, hospitals of different levels and doctors of different levels can achieve homogeneous treatment effects." Ordinary doctors can do more difficult and complex surgeries; experienced doctors can use robots to make the operation more accurate, safer and less labor-saving." The aforementioned chief physician also said.
Wu Xinbao also pointed out: "From the beginning of the design, the positioning of the orthopedic surgical robot is equivalent to that of the top orthopedic expert, even if a resident doctor, as long as he understands the anatomy, he can complete the same surgical operation as the top expert with the assistance of the robot."
"In the future, surgical robots are more suitable for hospitals at the second level or even below, as long as the robot-related training is carried out and the standard operation is carried out, the doctors in the low-level hospitals can also achieve reliable surgical results." Lin Jin said that surgical robots can help shorten the learning curve for doctors.
He believes that in the past, young orthopedic surgeons needed dozens or hundreds of surgeries to grow up as the main knife, but with the assistance of robots, less than 10 surgeries, doctors can be independent, provided that doctors have a certain surgical foundation and orthopedic experience.
In the mainland, high-quality medical resources are mainly concentrated in large cities such as Beijing, Shanghai, Guangzhou, and Shenzhen, and the capacity of primary medical services is relatively weak. According to the data of the National Health Commission, as of the end of 2020, the total number of hospitals in the country was 35394, of which 2996 were tertiary hospitals (including 1580 tertiary first-class hospitals), 10404 second-level hospitals, 12252 first-level hospitals, and 9742 unspecified hospitals. How to quickly improve the medical technology level of grass-roots doctors and how to allow patients in remote areas to enjoy the diagnosis and treatment services of large hospitals are the problems facing China at this stage.
"With the help of surgical robots and 5G network technology, top experts in Beijing and Shanghai can remotely guide doctors in remote hospitals to perform surgeries, plan surgical plans for them, and truly realize that patients can 'not leave the province for serious illnesses' while receiving homogeneous high-level treatment." Wu Xinbao said.
Boot fee pricing "broken bones"?
In September 2021, the person in charge of Tianzhihang optimistically told investors: "It is of benchmarking significance for robot-assisted orthopedic surgery to enter Beijing medical insurance, and the subsequent entry into other regional medical insurance will gradually accelerate."
However, things did not go as smoothly as expected. Faster than the acceleration of health insurance is the pricing adjustment.
In early March 2022, a note-writing document soliciting prices for assisted operations by orthopedic "surgical robots" was uploaded on the Internet. According to the document, the state plans to make a major adjustment to the cost of robot-assisted orthopedic surgery before the national collection of artificial vertebral body is launched to ensure that the quality and price of medical services and charges are consistent.
The document divides the fees charged for orthopedic surgical robots as follows:
If the surgical robot only has and plays the function of navigation and positioning, the proportion of each surgical surcharge shall not exceed 40%, and the core surgical price shall be more than 5,000 yuan per case, and the additional charging standard shall be capped at 2,000 yuan per time.
Where surgical robots complete or participate in completing part of the surgical operation under the control of medical personnel, the proportion of additional charges shall not exceed 80%.
Surgical robots that complete or participate in the completion of all surgical operations under the control of medical personnel, as well as remote surgical operations, may appropriately relax the proportion of additional charges.
The surcharge includes navigation and positioning kits (including but not limited to bases, trackers, connectors, calibrators, guide tubes, sleeves, retainers, etc.), as well as other consumables consumed during the use of the "surgical robot".
At this stage, most of the domestic orthopedic surgical robots are only playing a role in navigation and positioning, if the reference standard 1) charges, including navigation and positioning kits and other consumables consumed during the use of surgical robots, each case of robot-assisted orthopedic surgery, will only be able to charge up to 2,000 yuan on the basis of traditional surgery.
"Hospitals should consider the balance of payments, the price of an orthopedic surgical robot is generally more than 10 million yuan, if the 'start-up fee' is priced too low, it will be difficult for the hospital to recover the cost, and there will be no more incentive to introduce robots." The chief physician said.
"At present, the industry level of China's orthopedic surgical robots has led the international momentum, but if the charging standard is so fixed, the blow to the industry will be devastating." Wu Xinbao stressed that the market pays attention to practical benefits, and if the product is not purchased, there will be no one to carry out further research and development.
"Orthopedic surgical robot is a high-tech medical device product that integrates basic and clinical medicine, ergonomics, mechanical and electrical engineering and computer science, etc., and its research and development investment, material cost, manpower and material consumption, etc., it is difficult to imagine that this pricing can cover." Lin Jin said.
On March 30, further clear news came that the National Medical Insurance Bureau and the National Health Commission jointly issued the "Opinions on the Centralized Procurement and Use of Supporting Measures for the Centralized Procurement and Use of High-value Medical Consumables (Artificial Joints) organized by the State" (Medical Insurance Office [2022] No. 4) (hereinafter referred to as the "Opinions").
According to the "Opinions", where public medical institutions use intelligent systems such as "surgical robots" to assist in surgical operations, according to the actual functions of the intelligent system, a certain proportion of the "artificial joint replacement" project price is added, and no separate charging items are set up.
"Now the cost of surgery is very low, artificial joint replacement such an advanced operation, the price is less than 3,000 yuan, if on the basis of this price is proportionally charged, as the robot start-up cost, I think there are only two words to describe, that is, 'absurd'." 」 An orthopedic expert from a third-class hospital in Beijing said.
Although the advantages are not prominent at this stage, the state should give policy support in terms of fees
Orthopedics is often referred to as the "surgical boss", but in the application of surgical robots, it is not the first.
Since the beginning of the 21st century, the use of robotic systems in surgery has greatly increased. General surgery, urology, gynecology, etc., have gone to the forefront of minimally invasive robotic surgery with the help of endoscopic robotic systems, and even put robotic surgery in the standardized training of residents.
And many Chinese orthopedic doctors are still freehand nails, steel plates, joint changes and endoscopic minimally invasive surgery, decades have passed, may only be that the steel plate has changed a new model, nails have changed a new style, joints have changed a new interface, minimally invasive out of some new surgical methods.
"For a long time in the past, there were only some small advances and changes in the surgical methods, concepts, materials, instruments, etc. of joint replacement, but there were no real revolutionary changes until the emergence of 'artificial intelligence'." Lin Jin said.
In Lin Jin's view, surgical robots are not only a trend, but also an inevitable development trend, so we should understand it, face it squarely, and adapt to it - we have entered a new era of intelligent surgery.
After more than 30 years of development, a number of commercially used surgical robots have been developed worldwide, covering spine surgery, joint surgery, trauma and orthopedics and other fields. Foreign companies that lay out the orthopedic surgical robot track include Stryker, Medtronic, Johnson & Johnson, Zimmer Bangmei, Xerox and so on. Mainland China started late, but in recent years has developed rapidly, and a number of domestic companies have entered the field, such as Tianzhihang, Hehua Ruibo, Minimally Invasive Medical, Weigao Group, Rosenbot, etc.
Closed reduction of pelvic fractures is recognized as the most difficult surgical operation in trauma orthopedics, if the limb fracture is likened to "chopsticks broken", then the pelvic fracture is like "bowl broken", and the reduction is extremely difficult.
The United States, Japan, Germany and other countries have successively carried out the research and development of pelvic fracture reduction robots, but so far there is still no system that can enter clinical application.
In December 2021, the world's first intelligent fracture reduction robot successfully completed 22 cases of scientific research clinical trials in Beijing Jishuitan Hospital, marking that the technical strength of orthopedic surgical robots in mainland China has reached the international leading level.
"Traditional pelvic fracture reduction surgery mainly relies on the experience of doctors; with the assistance of multi-person traction, the reduction is closed by the practitioner's bare hands, which is not only time-consuming and labor-intensive, but also difficult to ensure the reduction effect." Wu Xinbao said.
The pelvic fracture reduction robot completely subverts the traditional "end-to-end" reduction concept, through the preoperative CT three-dimensional reconstruction, the robot system will intelligently plan the optimal fracture reduction posture. During the operation, under the real-time 3D navigation and force position coordination control, the robot can accurately and safely complete the automatic reduction of pelvic fractures.
From the need for doctors to plan surgical plans, to artificial intelligence automatic surgical planning; from static 3D navigation to real-time dynamic 3D navigation; from simple navigation and positioning, to force coordination control and automatic reduction, orthopedic surgical robots are gradually "evolving" into the first assistant of surgery that doctors expect.
The internationally renowned academic journal "Science" magazine sub-journal "Science Robot" divides the degree of automation of medical robots into 6 stages: no automation, robot assistance, task automation, conditional automation, high automation, and full automation. At present, most of the orthopedic surgical robots on the market are in the "robot-assisted" stage, and there is no doubt that automation is the future development trend.
"Maybe the advantages shown by orthopedic robots at this stage are not so prominent, but it brings a qualitative leap, and there will be very good prospects for the future." Lin Jin believes that the state should support the development of innovative enterprises from various aspects such as medical insurance policies, price policies, and access policies, and hospitals also have the responsibility and responsibility to introduce cutting-edge equipment, especially large public hospitals should play a leading role in the industry.
"Surgical robots subvert the traditional concept of treatment, embodying 'high-tech to help healthier treatment', its value is unlimited, in the early stage of industrial development, the state should give certain policy support in terms of fees." Wu Xinbao said.
The future has come, and time will tell us the real answer.
Exhibit: Health Community
Author: Shen Mengxia
Producer: Zheng Yujun