Cracking the Da Vinci code: the localization of endoscopic surgical robots goes further

The localization of endoscopic surgical robots has gone further.

On April 1, Professor Sun Dawei's team from the Department of Obstetrics and Gynecology of Peking Union Medical College Hospital completed the first multi-arm pure single-hole gynecological registered clinical operation in China with a surgically sharp single-hole surgical robot. It is reported that the full-link master-slave operation delay of the device is less than 50 milliseconds, and it can achieve 1,000 sub-millimeter-level surgical precision control per second, and the main technical indicators are up to or better than the existing single-hole endoscopic surgical robot products in the market.

A month ago, the team of Professor Zhao Ren of Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine "harnessed" the surgical robot with complete independent intellectual property rights and successfully completed the first radical treatment of sigmoid colon cancer.

"Looking at the global single-hole endoscopic robot market, only the Da Vinci SP single-hole surgical robot has been approved for listing, but due to its industrial and technological advancement, it is currently restricted from exporting to China." A few days ago, Xu Kai, founder of Beijing Shurui Technology Co., Ltd., said in an interview with the "China Times" reporter, "The successful treatment of China's first radical treatment of sigmoid colon cancer marks that the domestic single-hole surgical robot has opened up a new surgical application field after urology." ”

So far, the domestic single-hole robot equipment has realized the coverage of departments from gynecology, general surgery to urinary indications. In addition to the "sharp" single-hole endoscopic surgical robot, the dragonfly eye three-dimensional electronic laparoscope developed by another domestic company is also accelerating the promotion of product listing, while Jingfeng Medical Porous and Single-hole Endoscopic Surgical Robot and Kangduo Robot are in the clinical trial stage, and are expected to be listed and commercialized in the past two years.

But the localization of endoscopic surgical robots still has a long way to go.

In the field of endoscopic surgical robotics, Intuitive Surgical, Inc. Due to the first-mover advantages such as long time to market and wide use area, da Vinci Surgical System occupies a global monopoly position. Xu Kai said frankly: "With a price of 30 million per machine and a consumable cost of 70 million, surgical robots have become Chinese high-end medical services that are prohibitive. ”

Behind the sky-high price, the mainland surgical robot has long relied on imports, the cost remains high, and the disaster of localization jumps on the paper.

demand

The rising market size of the surgical robot field year by year has aroused concern.

According to comprehensive data from Frost & Sullivan and China Business Industry Research Institute, the global surgical robot market size increased from $3.581 billion in 2016 to $8.321 billion in 2020, with a compound annual growth rate of 22.6%, and it is expected that the market will continue to grow rapidly and may reach $15.574 billion in 2022.

It is understood that the surgical robot is designed to complete a variety of complex minimally invasive surgeries, and the endoscopic surgical robot is a representative of the application field of surgical robots, which can be applied to a wide range of surgical operations, including urology, gynecology, general surgery, etc. (accounting for more than 90%).

The endoscopic surgical robot adopts the control mode of master-slave remote control operation, and consists of a surgeon's console, a patient-side surgical cart and a three-dimensional high-definition imaging system. It has significant advantages such as minimally invasive, fine, flexible, and filtration, which can greatly expand the surgical capabilities of surgeons and effectively solve various problems faced by traditional surgery.

In China, endoscopic surgical robots have great potential for demand growth.

According to the statistics of the Prospective Research Institute, despite the negative impact of the new crown epidemic in 2020, the number of domestic laparoscopic surgical robot surgery cases still remained on the rise, reaching 47,400 cases. According to the estimate of frost & Sullivan website in August last year, the number of domestic endoscopic surgery robot surgery cases in 2021 reached 87,500 cases. According to this data, only in 2021 a year growth of 84.6%, the website is expected to continue steady growth in the past three years, thanks to the outbreak of stock installed capacity, 2021-2026 domestic RAS surgery volume is expected to increase to 681,000 cases with a compound of 56%.

"According to the 2021 reports of major hospitals, the number of units that want to purchase endoscopic surgical robots is 1400 units." A person familiar with the matter revealed to the "China Times" reporter.

By the end of 2021, only 219 laparoscopic surgical robots have been installed in China, and the surgical penetration rate is only 0.5%, of which the proportion of da Vinci laparoscopic surgical robots used in all tertiary hospitals in China is less than 10%. In contrast, 3727 units have been installed in the United States in 2020, and the surgical penetration rate has reached 13.3%. The average number of surgeries performed by a single laparoscopic surgical robot in China averaged 299 cases per year in 2018-2020, compared with an average of 240 surgeries per year in the United States, a gap due to the limited supply and high price of endoscopic surgical robots in China.

According to the financial report of intuitive surgery, by the end of 2021, the global installed capacity of da Vinci surgical robot system has reached 6730 units, distributed in 67 countries, with an annual operation volume of 1.24 million cases, occupying 82.9% of the global market share of surgical robots. Other major competitors include Medtronic, Johnson & Johnson, Stryker and others.

"Da Vinci surgical robots are expensive, with a sales price of 30 million yuan, and can form 70 million consumables sales in the future." Xu Kai said.

The only domestic listed endoscopic surgical robots are da Vinci Si and Da Vinci Xi surgical systems, and domestic "Magic Hand S" surgical systems. According to incomplete statistics, by the end of 2021, there will be a total of 219 da Vinci surgical robots nationwide, and more than 250,000 operations have been completed nationwide.

Break the game

"Da Vinci surgical robots have 4,000-5,000 patents worldwide, and litigation issues caused by intellectual property rights may form a compensation for infringement of each unit of 100 million yuan." Xu Kai analyzed, "This is inseparable from the 20-year patent period of the product and the strict infringement punishment. ”

In 1996, Intuitive Surgery launched the first surgical robot product for humans, and in 1999 it was certified by the FDA (United States Food and Drug Administration) for marketing. The company's Da Vinci surgical robot system adapts to a wide range of departments (including cardiac surgery, thoracic surgery, urology, gynecology, general surgery, pediatric surgery, vascular surgery, otolaryngology, etc.). Because of its first-mover advantage, da Vinci surgical robots occupy a global monopoly position.

Xu Kai said, "The equipment and consumables of surgical robots often come from the same company. This is because the chip on the consumables can be bound to the device, thus forming a closed loop of the consumables ecology. Each of these links has basically been patented by Leonardo da Vinci, and intuitive surgery currently enjoys more than 700 authorized patents in China, subdivided into 11 major fields. ”

Undoubtedly, the patent right has become a roadblock for domestic surgical robots to enter the market. How to break the monopoly of multinational giants? How to improve the supply of surgical robots and achieve a breakthrough in the market share of domestic brands? A series of problems lie ahead of the industry's managers and operators.

According to Xu Kai, on the eve of the finalization of Shurui products, a third-party lawyer team of more than 10 groups has been hired to carry out a three-month self-examination of product infringement, and after reaching the conclusion that there is no risk, it is used as a sign of the formal finalization of the product.

The state is also continuing to introduce favorable policies to help the development of the endoscopic surgical robot industry. As early as 2015, the "Made in China 2025" (National Action Plan) mentioned the key development of medical robot equipment; the "Medical Equipment Industry Development Plan (2021-2025)" draft for comments more clearly pointed out that it is necessary to improve the performance quality of equipment such as endoscopic surgical robots, orthopedic surgical robots, and neurosurgery robots, and encourage local governments to include robot-assisted surgery in the scope of medical insurance reimbursement, which has an important driving effect on the development of domestic surgical robots.

A large number of enterprises rely on the combination of imitation and innovation research and development, trying to pry open the localization shackles of surgical robots. By the end of 2021, there are a total of 94 domestic surgical machine enterprises, mainly distributed in 5 cities such as Beijing, Shenzhen, Hangzhou, Suzhou and Shanghai, of which Beijing has the highest concentration of enterprises.

In this multi-arm pure single-hole gynecological registered clinical operation, the extracorporeal positioning arm of the surgical sharp single-hole endoscopic surgical robot can remain stationary during the operation and rely on the in vivo snake-like surgical tool to complete the surgical action, avoiding the risk of "fighting" during the operation that is inherent in the operation similar to the da Vinci porous surgical robot.

In Xu Kai's view, once the clinical effect is verified, surgical robots are likely to quickly form a domestic alternative track, provided that the operational performance of domestic products can be comparable to foreign countries.

"As long as surgical robot products can complete surgical treatment in a meticulous manner and achieve patient benefits without discount, most hospitals may prefer to choose products with high quality and low price." Therefore, domestic brands have achieved a cost-effective advantage by virtue of their 30%-50% cheaper prices. Xu Kaida, for example, said, "This logic can be equated with the purchase of tickets in life, under the premise of similar safety, convenience and service level, airline brands are often not so important." ”

Editor-in-Charge: Wang Yu Editor-in-Chief: Chen Yanpeng