Release date: 2016-11-01 October 29-30, 2016, hosted by the World Medical Robot Association (MRS), the World Medical Robotics Conference hosted by the ROBO Medical Robotics Institute was held in Shenzhen, China. According to BCG Boston Consulting Data, as of January 2016, the global medical robot industry's annual revenue reached 7.47 billion US dollars. It is expected that the compound growth rate will stabilize at 15.4% in the next five years; the future will form a trillion industry chain. A text to understand medical robots and their industrial development This section is selected from Lei Feng. It is a speech given by Prof. Sun Lining at the pre-conference meeting of the 2016 World Medical Robot Conference. The report titled: "Medical Robots and Their Industry Development". Sun Lining is the director of ROBO Medical Robot Research Institute, the deputy director of the State Key Laboratory of Robotics and Systems (Harbin Institute of Technology), the recipient of the National Outstanding Youth Fund, the Distinguished Professor of the Yangtze River Scholars Award Program, and the leading talent of the National People's Program. The application of robots is indispensable for medical treatment. Even many people think that the popularity of medical robots will be more rapid than that of home robots, because the use environment is more controllable and the benefits are more obvious. So what kind of development of medical robots, what kind of trend will there be, and what kind of challenges will it face? At present, medical robots have important strategic positions not only in China but also abroad, and are supported by policies. In the domestic "Made in China 2025" white paper, it is pointed out that it will focus on the development of high-performance Medical Equipment such as imaging equipment and medical robots; "Robot Industry Development Plan (2016-2020)" also lists surgical robots as ten in robots. Large iconic product. In the international market, according to Boston Consulting's forecast, the annual revenue of medical robots is 4 billion US dollars, and will reach 11.4 billion US dollars in 2020; while the medical robot company's intuitive surgery revenue in 2014 reached 2.1 billion US dollars. As shown in the following figure, the current medical robots mainly involve robots, micro-nano, 3D and information, covering the fields of diagnosis and monitoring, telemedicine and rehabilitation. As for why there is such a large and speed of development and market, Sun Lining pointed out that because of the high performance and high added value of medical robots compared to industrial robots. At present, the most famous Da Vinci system is worth about 20 million, while industrial robots are generally only 200,000 yuan. What is a medical robot? So how do you define the meaning of a medical robot? Sun Lining believes that it should be a medical device, but it is different from medical devices. It can assist doctors, expand the doctor's ability, and the level of intelligence will continue to grow, while also meeting the following three aspects: medical, clinical adaptability and good interactivity. In this way, medical robots are completely different from traditional instruments. In providing such functions, medical robots are mainly divided into the following categories: Surgical robot radiotherapy robot rehabilitation and helpless robots hospital non-therapeutic robots and robotic medical equipment Major medical robots abroad Main domestic medical robot For the time being, surgical robots account for the highest proportion, more than 60%; followed by radioactive mobile robots, accounting for about 20%. Thanks to the rapid growth of medical robots, commercial robots will replace military robots as the second largest robot market in the future (thinking questions: Who is the first?), with a market capitalization of $17 billion. A case: Da Vinci robot The most successful medical robot is the Da Vinci surgical robot. Since its inception in 1995, the company has been said to have been at the forefront of medical robots. Therefore, Sun Lining also regards it as a case of centennial development in this field. Overall, the century-old history of medical robots began in 1901 and gradually evolved toward automation after 1987. In 2000, Da Vinci's minimally invasive laparoscopic surgery system passed FDA certification and has since grown strongly. The original Da Vinci robot sold for 31 million yuan. Now it has already cut prices, but it is still expensive. There are more than 3,700 units in the world and 2,344 units in the United States. During the speech, Sun Lining also showed the process of Da Vinci robots performing surgery. The robots are flexible in the human body, and they are threaded like needles. At present, medical robots have been widely recognized. The search for Da Vinci robots can also be seen from the capital market. The affiliated company's intuition surgery was only $8 at the time of listing, but it reached $623 in 2016. Trends and challenges in the development of medical robots It can be seen from the Da Vinci robot that the medical robot is a high-tech high-output value, with high technical threshold, long development cycle, high risk, and multi-disciplinary characteristics. Therefore, Sun Lining believes that there is a need for a long-term mechanism for “government, industry, research and researchâ€, and domestic medical robots can be better developed. Specifically, its trends and challenges include the following parties. Medical-worker combination Internet companies like to talk about "user experience", medical robots are also suitable for this, but the users here refer to doctors, they are using robots for surgery, the role is very important. Sun Lining believes that the main process of medical-worker integration is as follows (see above): the functional requirements, safety requirements and surgical methods and procedures are proposed by the doctor; then the technicians specify the requirements, determine the design input, plan the implementation, and form the project. Language; then the two sides combine the program argument, constantly modifying and iterating. After the plan is made, technical tests, doctor tests and evaluation changes are also required. Sun Lining mentioned that the development of medical robots often takes several years, and the whole process is “very tiredâ€. But it is from here that he realizes the importance of needing a doctor. Development trend: technological innovation Sun Lining believes that the future of medical robots must be the smaller the wound, the better, to be simple, safe, integrated, and suitable for doctors to operate. The development of Da Vinci robots has also experienced twists and turns. In the early days, the main console (main operator) was used, equipped with an arm system, but in the future it will be directly controlled, so that master-slave integration, smaller and more convenient. Specifically, the master-slave integration will face the problems in the following figure. It will require smaller and more flexible instruments and requires advanced design and manufacturing. And when the doctor directly controls, the human hand will vibrate, how can this be solved? These are all issues that need to be considered, and there is no clear answer yet. The second development he mentioned was from minimally invasive to more minimally invasive, as well as from minimally invasive porous to minimally invasive single-hole robots. In this area, there are intuition surgery, Titan Corporation of Canada, and Shanghai Jiaotong University in China. The problems faced here are mainly reflected in two aspects: First, the size of the robot is too large, because the discrete joints restrict the size of the system; the second is the lack of integration, which restricts the integration of multi-degree-of-freedom end devices. There are also flexible robots that are also worthy of attention. The structure of the human body is complex, limited by the small space in the body, and the operation of the flexible robot is more convenient. Standard setting and supervision Finally, Sun Lining talked about the standardization and supervision of medical robots. Due to its seriousness, the application process of medical robots must be very complicated. After the publication of the "Measures for the Administration of Medical Device Registration" in 2014, the supervision mode of product registration and post-production license also paved the way for the popularization of medical robots. In the theme of the conference, Professor Hannes Bleuler, director of the Robotics Laboratory of the Lausanne Institute of Technology in Switzerland (EPFL), academician of the Swiss Academy of Technical Sciences (SATW) and IEEE top journal reviewer, pointed out the single-hole surgical robot. It is the development and clinical application of the next generation of surgical robots. Although it is difficult, the market potential is huge, and surgical robots will become the standard for every operating room. In addition, the remote control technology of the robot in the medical field will effectively solve the problems encountered in telemedicine and reduce the geographical differences between urban and rural areas. At the meeting, Huang Jian, director of the Department of Urology of Sun Yat-sen Memorial Hospital of Sun Yat-Sen University and the deputy director of the Urology Branch of the Chinese Medical Association, said that medical robots have developed rapidly in China. As of October 28, 59 machines were installed nationwide and 35,273 cases were completed. Among them, urological surgery accounts for more than 2/5. Robotic surgery is the future direction of modern surgery, but there are still many shortcomings. Why introduce robots for surgery? Huang Jian believes that traditional open surgery is traumatic to patients and it is difficult to expose deep organs; laparoscopic surgical instruments are limited in flexibility and the operators are prone to occupational fatigue. In this case, it is necessary to introduce a robot that can perform very complicated minimally invasive surgery, touch some hard-to-reach body parts, and avoid the vibration caused by the fatigue of the doctor. "Currently, the reason why the Da Vinci robot developed in the United States is doing well is mainly because it is 'right to see, is enough, and is stable.'" Huang Jian said. Despite this, in Huang Jian's view, the Da Vinci surgical robot is still only imitating the surgeon's hand, there are still many shortcomings, such as stupid, blunt, rough, less, and away. Stupid, it is said that it is only a mechanical arm, just like a puppet, need a doctor to control; blunt, mainly refers to no touch, different from the human hand, can not distinguish whether it is normal tissue or tumor; thick, that is, the wound is very traumatic, For laparoscopic surgery, a 3-5 mm hole can be entered, and the robot is now 8 mm; less, Da Vinci now has only 3 robot arms, and the number of devices that can be converted is limited. "The most important thing is that the surgeon and the patient and assistant are separated. The remote control operation is very good for military and aerospace. But the surgery is usually done, the doctor is in Shenzhen, the patient is in Beijing, the patient will feel very unsafe, and 10,000 In the operation, the network is broken, or other unexpected situations occur, but it is a risk." Huang Jian stressed. Huang Jian hopes that the new generation of surgical robots can “have thoughts, see through, feel, small size, and many hands and feetâ€. It has human thinking and memory ability, and can develop surgical plans, surgical procedures and methods during the operation. Remind for dangerous operations, truly flexible, sensitive, minimally invasive and intelligent. Xu Ning: "Practice of Medical Equipment from R&D to Production" Selected from Lei Feng.com, Xu Ning, senior consultant of ROBO Research Institute, with 27 years of experience in Chinese and foreign medical device products. Before the official speech, Xu Ning first made the following opening statement: “I have seen too many medical device projects for many years, that is, the medical surgery robots we are talking about today, the number of medical robots that can go from the laboratory to the clinic is very limited, and ultimately there are fewer markets. The medical robots must be experimented. It is a long road to go to the market, and there are so many things to consider. Today I will share my views on this aspect from an industrial perspective." In the whole process of sharing later, Xu Ning mainly elaborated on the following four aspects: The basic link in the development of medical device products Xu Ning said that the mainstream development process of medical device robots at home and abroad is basically similar. From research and development, production to marketing, the whole can be divided into the following parts: 1. Conceptual assessment of innovative research 2. Experimental or experimental prototype of preliminary research conclusions 3. Clinical research, marketing approval 4. Production 5. Listing 6. After sales service Key points for evaluation of medical device products Regarding the review and evaluation of medical device products, Xu Ning gave a very high priority. He said: “First of all, we must ensure the composition of the evaluation team. There must be not only software, hardware and system integration R&D personnel, market personnel and production representatives, but also experts in laws and regulations, certification and licensing, and patent application. ." Xu Ning said that most of the medical devices are now improved and re-created based on existing products. The industry has rarely seen those truly innovative results from 0 to 1. Under this circumstance, before actually starting to develop and produce products, it is necessary to conduct a very detailed analysis of the domestic and foreign markets, conduct multi-party research on core technologies and patents, and ensure the use of patents and production licenses. Nothing is wrong. In addition, many people are now saying that they want to be the best medical robot brand, to be the industry first, and to have an IPO to go public after a few years. Xu Ning believes that having this ideal is good, but first of all, it is necessary to clarify the market positioning of the product, and the development strategy of the enterprise should be clear. Take the Da Vinci robot as an example. In 2013, their R&D investment was 167 million US dollars, 178 million in 2014 and 197 million in 2015, showing an increasing trend year by year. However, their products have passed the review and approval of relevant US departments in 2000, and it has been 16 years now. Xu Ning said: "For the products that have already been listed, there is still continuous research and development, and the input is getting stronger and stronger. This is a comprehensive analysis and understanding of the products we make, we can't simply see Others. Scientific research results, not to look at the development strategies behind others." Always have awe of customer needs and the market Nowadays, most people who make products know that they should be guided by the needs of customers and the market, but in fact only a small number of people can really do it. Xu Ning shared his experience for us. Xu Ning said that you can't blindly listen to the needs of customers. Customers want this today, and tomorrow they want that. Their real needs may not even be clear to them. I can't listen to the R&D staff, and I can't listen to it from the Internet or other ways. Instead, we must do adequate market research, pay attention to the way of research and coverage, pay attention to the representativeness of the research object, and pay attention to the feelings of patients and doctors. Xu Ning stressed that because medical robots are discussed here, special attention should be paid to the specific surgical procedures and methods. It should be coordinated according to the doctor's existing practice, and do not intend to change the doctor's existing habits, and do not attempt to change the entire market. In addition, Xu Ning reminds everyone to pay attention to the power of the “template marketâ€. For example, if a manufacturer puts a medical robot in a famous hospital as a pilot, then with the passage of time and the increase in the number of robotic practices, the demonstration effect will be very powerful, even more than a few million or even tens of millions to promote. It is much more useful. Other questions regarding production and implementation In terms of production and execution, Xu Ning started from his many years of experience in many domestic and foreign medical companies, and shared key issues that he thought need attention. In terms of factory production, Xu Ning said: “From the R&D project stage, we have to have a clear understanding that the robot is going to go from the factory to the market, not from the laboratory.†Under this premise, Xu Ning believes that from the time of research and development, it is necessary to consider the problem of materials, the qualification of suppliers, the quality control of parts, the maturity of production technology, the problem of mass production capacity, and the production of products. How to detect afterwards, how to ensure quality and safety. Xu Ning said that in order to go to the market, robots must comply with a series of certification standards, specifications and licenses. Therefore, detailed research on these contents is required before the project is established. For example, at present, the US FDA approved that there are only a few hundred kinds of clinical operations that robots can carry out. If the final production shows that the robot is not in this category, it will waste resources. In addition, Xu Ning also shared the industry's "secret" about medical equipment maintenance. He said that at present, most medical device companies, at least 30% of their total revenue comes from after-sales maintenance, not new sales. This means that if manufacturers want to be profitable and want to survive, they must consider how to modularize and how to repair and maintain them from the research and development stage. This puts higher requirements on R&D. Finally, in the special discussion session, Xu Ning put forward his own views on the medical robot industry from the laboratory to the market. He said: "We should find some specific surgical categories as a breakthrough point, so that the surgical robot is a senior assistant to the doctor, rather than completely replacing the doctor. This is a practical development direction. This method is less risky and easier to control. On the one hand, it has fully utilized the advantages of surgical robots, which has reduced the doctor's fatigue and the chance of mistakes. On the other hand, it has laid a solid foundation for the future development of surgical robots." The development and industrialization of medical robots must follow the seven-point principle This part is selected from the arterial network The birth process of medical devices is product innovation research, experiment, clinical research, production, and marketing. Xu Ning, senior consultant of ROBO Medical Robot Research Institute and former vice president of GEHealth China, said at the pre-conference of the 2016 World Medical Robot Conference that the research and development and industrialization of domestic medical robots should also be introduced, learned, repeated, copied, improved, and The road to innovation. At the same time, we must pay attention to the protection of effective patents and commercial technology secrets on this road, pay attention to meet the needs of the market, pay attention to safety, consider the product's productivity, and effectively manage talents. Protection of effective patents and trade technology secrets When the company is researching robots, it will involve many core technologies, including mechanical arm forces, core algorithms, softness, degrees of freedom, and 3D systems. Companies should make great efforts to study, especially the cooperation between us and foreign countries through capital purchases and technology shareholdings. We must also study the patent issues. If the research is not thorough, we will not even have basic legal guarantees. Trade secrets and patents are often linked together. Sometimes a patent does not directly tell you its value, and trade secrets will clearly reveal the business value and be more intuitive. Large companies in the market, especially the United States, like Apple, Da Vinci, etc., make trade secret protection a top priority. This makes sense. There have been many lessons about this kind of thing in my country. Pay attention to meeting the needs and laws of the market The research and development of medical robot innovation company products should be guided by the specific needs of the market and customers, avoiding the development of a product that deviates from the direction. However, many people have misunderstandings. The market demand is not only a request from today's customers to satisfy it, but another customer will propose another demand tomorrow, and will satisfy it. It is to add the experience of the engineer, the engineer's imagination of the product in the laboratory, and then collect the information on the Internet, and gather a lot of words. In addition, medical robots are applied to patients and consider the patient's experience. Doctors are users of medical robots. Innovative companies are looking for doctors to interview, and they are not only looking for doctors in these top three hospitals in Beishangguang. We also need to consider the opinions of remote doctors and community service center medical staff in the west. Design products from multiple dimensions, don't build cars behind closed doors, and don't listen to partial beliefs. The company wants to retain the awe of the market. Our products are for doctors, don't always think about subverting anything. In the production process, we must consider consumables, costs, and proportion of after-sales maintenance revenue. Mature robot companies generally account for about 30% of maintenance and 50% of high. So consider these issues when designing your product. The most difficult technical difficulty for robots to enter the medical field is safety, which is to ensure the safety of the doctor and the safety of the patient. From the original open surgery to the endoscopic surgery, the current robotic surgery, for a surgeon, from the direct view, from the mirror to the current robot. The biggest challenge for doctors is the lack of sense, including loss of vision, loss of touch, and loss of perception. This challenge caused some medical incidents, but it was not reported. The current mainstream solution is to use inverse feedback, but this method requires high technology, especially sensor technology. It requires the sensor to be accurate enough to be small enough to enter the body. As well as the requirements of temperature, humidity and other parameters, coupled with cost issues, the overall implementation is very difficult, and is still in the research stage. But don't be too discouraged. Medical robots are similar to aircraft tower guidance technology. The probability of robotic medical accidents is similar to or even lower than the probability of plane crash, so everyone should relax. Consider the product's productivity The ultimate goal of the establishment of the company is to make profits. While pursuing the perfection of the product, we must also consider the parts, operability, and productivity of the product, and whether the production process can be verified and transferred. It is one production per year, or one production per year. This is a great challenge for the factory and it is also about the survival of the company. The most obvious example is the hammer mobile phone. In the past, the hammer mobile phone pursued the design, did not consider the industrial production problem, resulting in insufficient production capacity and not achieving profitability. Recently, the new hammer release, taking into account this problem, while considering the quality while considering the industrialization, the effect has improved. In short, the control of the quality of components, as well as the requirements for product stability, is the biggest bottleneck in the scale of medical robots in China. Now that localized medical robots can achieve their goals, we still have a long way to go. Rational configuration of team members Leading figures have to figure out the issue of responsibility. For example, if the person in charge of the project is a university professor and the university professor is also the head of many projects, it is very difficult for him to put all his time and energy into the improvement of a project and a component. The ability of technicians is limited. At present, due to historical issues, most of China's excellent engineering and technical personnel are around 50 years old. It is very difficult for the company to find an employee with the skills of artisans and craftsmen. Although the country is now aware of this problem and is cultivating it, there is still a fault of talent. Therefore, the company must train the backbone of the technology people from time to time. The R&D team is well configured. A medical robot is designed in the fields of medicine, mechanics, machine science, computer science, etc., and the company must be properly configured. The current mature medical robot company Da Vinci has more than 1,700 employees. One in ten people in his research institute are doing the same thing. This kind of concentration, although high investment, speeds up research and development. Many companies are now experiencing difficulties in doing overseas mergers and acquisitions and introducing advanced technology from overseas. In particular, the difficulties encountered by the technology we purchased or the technology of the holding company to cooperate with foreign countries are difficult to imagine. It is because of different management methods, behavioral habits and cultural mechanisms at home and abroad. Therefore, before overseas companies cooperate, they must first study the culture of each side of the company and try to reduce the problem. Funds must also be configured When making a company budget, reduce the deviation as much as possible, and reserve reserve funds. At the same time, try to make the funds for the special funds, do not distract. For the patent application, equipment purchase, pre-clinical, clinical trial, license management, production site construction, factory production transfer verification process, market promotion and other stages must be a reasonable allocation of funds. Made in China does not have to choose the bottom cost The production costs of medical robot enterprises include: raw materials, talents, labor, factory sites, product quality, marketing promotion, sales, after-sales maintenance and other links. Every step of his cost is a standard. In order to save costs, if the products use domestically produced parts, most of the time will affect the quality of the products. If you reduce the investment of talents, it will reduce efficiency and extend the cycle. Reducing marketing promotion costs will not achieve the desired results. Therefore, Chinese manufacturing should not only consider reducing costs. The cost is reduced and the effect often falls short of expectations. Source: Lei Feng Network Art Network Technology Daily Medical Valley related information synthesis Anesthesia Medical Co., Ltd. , https://www.honestymed.com
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