The global surgical robot market has a history of more than 30 years, and at present, it has basically formed master-slave control robots such as laparoscopic, panvascular, and natural orifice surgical robots; and navigation surgical robots, such as spinal nail (needle) navigation, joint replacement navigation, puncture surgical robots diversified development pattern.
"Surgical robot" also has many classifications from the physical form, and the current name is also a bit confusing, including all kinds of auxiliary operation equipment, platforms, systems or tools with similar names, but from the perspective of clinical participation and actual functions, with reference to domestic and foreign definitions, as well as the latest division of the state and local medical security bureaus, it can be roughly divided into several:
1. Surgical planning assistance: the auxiliary operating system of the surgical robot that only plays the function of surgical planning;
2. Surgical navigation and positioning assistance: an auxiliary operating system for surgical robots that only have and play the function of navigation and positioning;
3. Surgical part step assistance: RA equipment/system (auxiliary surgical equipment and auxiliary surgical system using robot technology) that only completes or participates in some core operation steps (including remote surgical operation) to achieve the surgical goal under the control of medical staff;
4. Surgical whole-process assistance: RA equipment/system (auxiliary surgical equipment and auxiliary surgical system using robot technology) that completes or participates in all core operation steps (including remote surgical operation) to achieve surgical goals under the control of medical staff.
In the field of laparoscopy, "da Vinci" is unique with the powerful function of full-process assistance and the sustainable "special consumables" business model. In the field of orthopedics, although there are many flowers and many players, the current generation is all navigation and positioning products, such as Mazor X, ExcelsiusGPS, Dimensity, etc. At present, only the "Newton" full-process orthopedic endoscopic minimally invasive surgical robot of Gerui Technology can assist in the execution of orthopedic minimally invasive surgery in the whole process, and through clinical and technological innovation, a new next-generation product has been formed.
Gerui Technology "Newton" full-process orthopedic endoscopic minimally invasive surgical robot platform
Unlike laparoscopic surgery, minimally invasive orthopedic surgery has a more complex procedure and a smaller range of operations. The whole process includes: 1. high-precision 3D image digital acquisition and reconstruction; 2. intelligent surgical planning; 3. establishment and expansion of surgical channels; 4. refined surgical operation; 5. postoperative evaluation and examination; 6. remote surgery and virtual reality interaction. The "Newton" surgical robot can deeply participate in every link of surgery, making the imagination of the digital and intelligent operating room a reality.
The spine navigation surgery robot can accurately navigate and position, assist doctors to manually place needles or nails, and complete some tasks in fusion surgery
Image source: Handan, Palm
Joint replacement navigation surgical robot is navigation through image planning,
The assistant doctor completes some of the critical surgical steps with a handheld tool at the bedside
Sorting out the development context of the orthopedic surgical robot industry, we can clearly see the process of product and clinical upgrade iteration, and the clinical and market are looking forward to the popularization of orthopedic minimally invasive surgical robots like "Newton" as soon as possible.
01
In the era of navigation robots, there are many giants
Before the birth of "Newton", it was 20 years of exploration and attempts by the previous generation of pioneers, and a product was continuously introduced to the market, although it was still navigation technology, but clinical innovation and commercialization were remarkable. At present, the more representative products are as follows:
1.Mazor Spine Assit to Mazor X, navigation technology is constantly optimized
Mazor is the pioneer of spine navigation robots in the world, which has undergone three iterations of technology.
In December 2018, Medtronic acquired Mazor Robotics for $1.64 billion, officially entering the surgical robot industry. In 2004, the first generation of Mazor spine robot Spine Assit obtained CE and FDA certification, and was the first to perform preoperative planning through CT imaging; In 2011, the second generation product Renaissance was born, which can realize intraoperative 2D and 3D navigation; In 2016, the third generation of the Mazor X was launched.
Since the emergence of the first generation of Mazor spine robots, Mazor series products have nearly 20 years of clinical application experience, accumulating a large amount of clinical data, laying the foundation for the continuous optimization of navigation technology.
Medtronic Mazor X spine navigation robot
2. From "GD-A" to "Dimensity II", the earliest spine navigation surgical robot in China
In China, TINAVI has successively developed "GD-A" and "GD-2000/GD-S" two generations of orthopedic surgical robots, and the main products are the third-generation orthopedic navigation and positioning robots "Dimensity" and "Dimensity II" series, which can be used for trauma surgery and full-segment spine surgery in the pelvis, acetabulum, limbs and other parts. It is reported that the installed capacity of TINAVI orthopedic robots has exceeded 150 units, and the number of surgeries has exceeded 30,000, covering 150+ medical institutions.
TINAVI Orthopedic Navigation Robot "Dimensity II"
3.Globus creates a closed-loop business model in the field of spinal navigation
Globus Medical is seen as a strong competitor to Medtronic. In 2017, the company launched ExcelsiusGPS, a spine navigation surgical robotic platform, and in 2021, it launched the Excelsius 3D intelligent intraoperative 3-in-1 imaging platform, which combine to improve implant placement accuracy, reduce radiation exposure, and shorten surgical time.
ExcelsiusGPS navigation robot (left)
and Excelsius 3D C-arm platform (right)
With the successful closed-loop business model of "intraoperative imaging + surgical robot + consumables", Globus Medical has developed rapidly, with total sales of US$1.023 billion and a market value of approximately US$6 billion in 2022.
4. MAKO, a rapidly developing joint replacement navigation surgical robot
Launched in the U.S. in 2006, the Mako surgical robot integrates tools and consumables through robotic navigation technology to assist doctors with total hip replacement, total knee replacement, and unicondyle arthroplasty during some of the most important surgical steps. On March 8, 2023, orthopedic giant Stryker released Mako's total knee replacement surgery robot Mako Total Knee 2.0. Up to now, the total number of Mako surgical robots in the world has exceeded 1 million, and the global installed capacity is about 1,500 units.
Mako joint replacement surgical robot
After years of market education, domestic doctors and the entire medical system have a basic understanding of the orthopedic surgical robot system, and the acceptance of such products is gradually increasing, and they are also looking forward to greater progress in clinical innovation. The future development is roughly in two directions: one is to simplify specialization, such as simplification into a low-cost fast navigation device; The other is a high-value platform towards full-process assistance, from preliminary navigation and positioning, to navigation and local auxiliary operations, and further evolved to the real orthopedic "Da Vinci" - a full-process orthopedic minimally invasive surgical robot, and the "Newton" platform of Gerui Technology came into being.
02
The call of the clinic and the market:
Full-process assisted surgical robots are king
When companies were still looking forward to the bright future of navigation robots, a basin of cold water was poured down. In 2022, the National Health Insurance Administration and the Hunan Provincial Medical Insurance Bureau successively issued documents to control the price of robotic surgery, aiming to return surgical robots to clinical value and guide higher value innovation while collecting consumables. For a while, the enterprises fell into a state of anxiety.
In China, the Medical Insurance Bureau acts as the "payer" of actual medical expenses, and such guidance is actually the voice of many medical workers and patients. At present, many surgical robots can only participate in certain aspects of surgery, such as navigation and positioning or needle placement, which cannot cover the whole process, and the clinical value is limited. In many academic seminars on minimally invasive orthopedics, such as the recent "11th Lingnan Spine Minimally Invasive Summit Forum", senior clinical experts in the industry such as Professor Zhou Yue and Professor Chen Bolai have put forward greater expectations for the future of orthopedic robots. According to the feedback of clinical, market and regulatory authorities, the orthopedic robot platform will gradually move from navigation and positioning to full-process assistance.
In this regard, refer to the da Vinci surgical robot. The first da Vinci robot was born in 1999 and approved by the FDA in 2000, and in the past 20 years, the da Vinci robot has been iterated four times, which can assist doctors in the whole process of general surgery, urology, cardiovascular surgery and other fields. By the end of last year, the total installed capacity of da Vinci system in the world had reached 7,544 units, and the installed capacity in mainland China exceeded 300 units, making it the most successful surgical robot for clinical application and commercialization.
Similarly, Gerui Technology integrates a number of advanced technologies into the "Newton" full-process surgical robot platform to meet the needs of accurate assistance in the whole clinical process, and at the same time realize a completely closed-loop business model. 3D composite image positioning technology can help doctors accurately plan the surgical path before surgery, and provide real-time image guidance during surgery, avoiding high doses of radiation caused by repeated fluoroscopy; High-precision motion control technology can ensure that the robotic arm accurately reaches the target position, and the error can reach submillimeter; Combined with metaverse technology, it realistically reproduces the three-dimensional structure of the human body and helps doctors carry out remote surgery. When allowing doctors to flexibly operate the robotic arm, they can also accurately control the contact force between the end of the device and the human body to avoid accidents.
The cost-effective 6-in-1 solution and the internal circulation service model of the dedicated consumables system ensure that the cost of surgery is affordable and can continue to deliver value to the entire medical system. From minimally invasive spine to minimally invasive nerve, and even minimally invasive joint, the extended application prospects of the "Newton" platform are very broad.
Gerui Technology "Newton" has completed the innovation and upgrading of the current generation of orthopedic robot products and business model upgrades. Returning to the essence of medical treatment and promoting the development of minimally invasive orthopedics can better solve clinical problems and improve the quality of medical services.
03
Surgical robots as a whole ushered in a golden period of development
The 2023 Government Work Report proposes to promote the expansion and sinking of high-quality medical resources and the balanced layout of regions. In recent years, with the development of 5G communication, artificial intelligence and human-computer interaction technology, surgical robots have become an important force to help the redistribution of medical resources.
Orthopedic surgical robots can complete fine surgical operations with high-sensitivity, high-precision, high-stability robotic arms and precision surgical instruments, narrow the gap between the surgical effects of doctors with different experience and seniority, and promote the homogenization and standardization of diagnosis and treatment, which is urgently needed by the medical system.
The huge patient population and demand for diagnosis and treatment are also driving the development of the industry. According to the United Nations standards, more than 14% of the population over 65 years old is an aging society, and by the end of 2022, the mainland population aged 65 and above has reached 210 million, accounting for 14.9% of the country's total population, which is a veritable aging country.
In terms of policy, the signal of the state to encourage the development of innovative medical devices is very clear. The Regulations on the Supervision and Administration of Medical Devices, which came into effect on June 1, 2021, mention that medical device innovation will be included in the development focus, and innovative medical devices will be given priority review and approval; In September 2022, the Health Insurance Bureau said in response to a question from NPC deputies that innovative medical devices would not be included in collective procurement for the time being.
In addition, from January 1, 2023, the "Import and Export Tariff Rules of the People's Republic of China (2023)" will add a new sub-heading of surgical robots, and the import of surgical robots in countries and regions where the most-favored-nation treatment clause applies will achieve zero import tariffs. It is not difficult to see that the country has fully recognized the value of surgical robots, but this also means that the industry competition will be more intense, and enterprises need to take advantage of differentiation and open up more market space.
The founding team of Gerui Technology has focused on the fields of orthopedics, vascular intervention and tumor intervention for more than 20 years, with rich product development from 0 to 100 and successful commercialization experience worldwide. Relying on digital and platform-based core technologies and in-depth understanding of clinical practice, Gerui Technology will continue to expand the depth and breadth of product layout, innovate surgical methods, and cover more clinical application scenarios.
"Newton" surgical robot will first be applied to the minimally invasive treatment of spinal degenerative diseases, such as lumbar disc herniation, lumbar spinal stenosis, vertebral compression fracture, spinal hemangioma, etc., and can also be extended to microscopic fusion surgery, which can assist in the implantation of new consumables for treatment. Subsequently, it can be further extended to neurosurgery minimally invasive, joint minimally invasive and other fields. Based on the reusable "Newton" technology platform, the product line of Gerui Technology will also be extended to vascular intervention, tumor intervention and other fields, covering high-incidence species in mainland China and even the world one by one, to meet the most urgent clinical needs.
Standing on the shoulders of giants, "Newton" surgical robots have emerged, and the future will lead the golden age of surgical robot development with more independent innovative technologies.