In a recent survey of front-line practitioners in the ultrasonic scalpel industry, the most common answer was that the industry is going through a period of pain. The general consensus is that domestic brands will undergo a major reshuffle this year and next. Zhang Tao, founder of Ansukang, believes that from the first domestic ultrasonic scalpel certification in 2013 to 2023, it took about ten years for domestic brands to develop from scratch. Next, domestic brands are moving towards a new stage from existence to excellence.

Half sea water, half fireworks. Judging from the data on paper, the domestic ultrasonic scalpel market will see rapid growth in sales in 2023. According to data recently released by a market research institution, domestic ultrasonic scalpels (excluding the blade) are increasing rapidly and have reversed the import monopoly. But when Artery.com used data to explore the drivers of growth from front-line personnel in the industry, industry insiders bluntly said that the real temperature of the market is not as eye-catching as the data.
According to feedback from many parties, after more than ten years of catching up, domestic ultrasonic scalpel companies are facing real challenges and solving key problems.
What are these real challenges, real problems? What kind of differentiation is the domestic ultrasonic scalpel industry experiencing? How will it evolve in the future? In response to this, Arterial Network combined relevant data and industry front-line observations to get a glimpse of the answer to the question.

Ten billion market, two camps. As high-frequency energy surgical instruments, ultrasonic scalpels appeared in the 1950s and began to be used clinically in the 1980s, gradually replacing mechanical scalpels and electric scalpels. It has been in development for 70 years. According to different working principles, ultrasonic scalpels are divided into two types: suction-type ultrasonic scalpels and cutting-type ultrasonic scalpels. Clinically, cutting ultrasonic scalpels are the most common. The core is to use the ultrasonic effect of the blade and high-frequency mechanical vibration to cut and separate tissues. Doctors can operate with a small field of view and are mostly used in laparoscopic surgeries. The ultrasonic scalpel can complete tissue cutting and coagulation simultaneously and reduce thermal damage. Suction-type ultrasonic scalpel uses high-energy ultrasonic oscillation to crush the target tissue, emulsifies it with irrigation fluid, and removes the diseased tissue through negative pressure suction. The suction-type ultrasonic scalpel has the best effect on tissues with high water content and low collagen content, such as the brain, liver and other organs, but has little effect on tissues with high collagen content, such as blood vessels and fascia. In terms of application scenarios, ultrasonic scalpel has covered more than a dozen departments including plastic surgery, gynecology, urology, thoracic surgery, hepatobiliary surgery, gastrointestinal surgery, head and neck surgery, otolaryngology surgery, and pediatric surgery, including uterine fibroid surgery, Abdominal aortic aneurysm repair, rectal tumor resection, appendix surgery, hemorrhoidectomy, adrenalectomy and dozens of other surgical operations.

With its important role in clinical practice, the market size of ultrasonic scalpel in my country continues to rise. According to the "China Energy Surgical Devices Report" released by Danke Research Institute, the growth rate of China's ultrasonic scalpel market is much higher than that of the global market. The market size will exceed 12.5 billion yuan in 2021, with an estimated compound annual growth rate from 2020 to 2025. is 24.9%. "In the ultrasonic scalpel industry, Johnson & Johnson is the leading company, and its products have always been considered the 'gold standard.' Most of the products on the market are imitated and innovated based on this 'gold standard.'" Founder of Ansu Kang Zhang Tao told Arterial.com, "But we believe that strictly following Johnson & Johnson's standards will actually easily restrict the innovation of enterprises. Based on this, we are trying new paths."

After sorting out, we found that from the perspective of product design, the current ultrasonic scalpel industry has been divided into two camps. The first type is the ultrasonic scalpel with host machine, represented by companies such as Johnson & Johnson, Jianxin Medical, Houkai Medical, Sanowei, Anhe Galil, Mindray, Enokang, etc. Taking Johnson & Johnson's products as an example, the ultrasonic scalpel consists of a main unit, a transducer handle, an ultrasonic scalpel head and a foot pedal. This path is currently the mainstream of the industry and is also the direction in which the industry will accumulate more accumulation. The other type is host-less ultrasonic scalpel, represented by companies such as Covidien and Ansukang. Specifically, the design of the hostless ultrasonic scalpel eliminates the need for an independent host and integrates all functions into the handle of the ultrasonic scalpel. This design can reduce hospital procurement costs and simplify operating procedures in application scenarios.

"At present, each manufacturer has certain differences in the definition of this system, but we believe that the ultrasonic system cannot be separated to look at different components separately." According to Zhang Tao, founder of Ansukang, the full name of ultrasonic scalpel is ultrasonic soft tissue cutting. Hemostatic system, or ultrasonic soft tissue surgery system. The common characteristics behind these terms are: first, it is based on ultrasonic technology; second, it is a system, not a component or a part; third, it is an interdisciplinary product at the intersection of mechanics, electronics and ultrasound. “If we look at the products in isolation, it is actually easy to limit the innovation of the company.” But no matter what technical route they take, industry insiders interviewed believe that for ultrasonic scalpel innovative companies, the core is still to return to clinical value. , and returning to mass production - this is the key to whether the company can successfully adopt the business model.

"Recently, the field of ultrasonic surgery has changed a lot, and many companies have 'died'. There are two main reasons for this. First, there are many technical challenges, resulting in many shortcomings in practical applications; second, there is no industrialization There are huge problems in the supply chain due to mass production,” said an industry source who did not want to be named.

Technically, compared with imported brands, some domestic ultrasonic scalpels have problems such as host failure, unstable frequency impedance fluctuations of the transducer, and blade failure. Taking the cutter head as an example, the breakage rate of domestic ultrasonic knives is higher than that of foreign competing products. This has an important relationship with the processing capabilities and the company's technology development process. In addition, as an important component of ultrasonic scalpel, the transducer is known as the "eyes" of the ultrasound system. Currently, there are not many domestic brands that can make breakthroughs in transducers. According to industry sources, there are currently no more than three domestic manufacturers that can implement original research and development of transducers. At the same time, most domestic manufacturers are still in the stage of R&D and production of ultrasonic blades, and there are not many companies focusing on overall R&D. "In the field of ultrasonic scalpels, Johnson & Johnson has advantages in many aspects such as host machine, transducer and blade head, and its comprehensive strength is very strong." Feng Qingyu, chairman of Jianxin Medical, said, "I think it is difficult for domestic brands to compete with Johnson & Johnson The reason is that the ultrasonic scalpel system is too complex and involves too many disciplines, and entrepreneurial companies lack discipline construction. This is the real technical threshold, especially in terms of stability and consistency after mass shipments. There is a huge gap. This is also the real dilemma faced by domestic ultrasonic scalpel products.”

In terms of industrialization, the supply chain of the ultrasonic knife industry is an important factor that hinders the further development of domestic brands. Especially when it comes to the implementation of knife heads, domestic processing and manufacturing are still facing chaos. In this regard, Feng Qingyu shared an example: Previously, Yichao Medical, a subsidiary of Jianxin Medical, had cooperated with a small factory. It originally ordered 6 mm titanium rods for processing, but the goods sent back by the manufacturer still had 5.5 mm. mm. "This error will cause the cross section of the tool tip to change when processing the tool tip. Although it does not have much impact on the surface, it will affect the frequency of vibration when used." Therefore, if the supply chain problem is not solved, the product Quality control becomes a problem, which will ultimately make it difficult for companies to deliver large quantities of goods. It is not difficult to find that domestically produced ultrasonic scalpels are firstly limited by the intersection of disciplines and difficult to do well; secondly, they are limited by the supply chain and difficult to mass produce on a large scale. In addition, Zhang Tao, founder of Ansukang, believes that the current gap between domestic brands and leading multinational companies is still reflected in three aspects: first, product design concept, second, processing technology, and third, quality control. "On an overall level, product design is a series of important factors that determine the later quality, cost, performance, etc. of the product. There are many things to consider in product design. Once there is a problem in the design, we can only work hard to make up for it later, but we cannot eradicate it. Processing technology and quality control are twins. If there is a problem in either aspect, good products will not be produced. "Behind the challenge is an opportunity.

During the period of pain in the industry, many domestic innovative brands began to make efforts to solve the above-mentioned problems. On the technology research and development side, brands are paying more and more attention to the construction of composite teams. For example, Jianxin Medical currently has a professional R&D team covering multiple disciplines such as acoustics, optics, electricity, and mechanics, as well as a leading domestic acoustic core component design team. Another example is Sanowei, which was founded in 2015. The company has a R&D center in Beijing that includes more than 10 laboratories including electronics, mechanics, optics, acoustics, robotics, animal tissue, and reliability, involving multi-disciplinary R&D engineers. . On the supply chain side, Jianxin Medical’s plan is to conduct diversified cooperation with a number of internationally renowned companies and listed companies to build a strong R&D, production, operation and supply chain management system, including cooperation with leading international processing and manufacturing companies to build high-end medical devices R&D and production manufacturing center to achieve real product implementation.

At present, Jianxin Medical has jointly established a "high-end medical device R&D and manufacturing center" with Fulian Yukang Medical Technology (Shenzhen) Co., Ltd., a subsidiary of Foxconn Industrial Internet Co., Ltd., through a "full-stack" R&D and manufacturing model, collaborative Innovation, providing original "product-level" solutions to the world. Houkai Medical, headquartered in Wenjiang, has established a research and development center and manufacturing base for new products and projects in Chengdu. It is understood that the first-phase production capacity of its manufacturing base will reach 600,000 sets/year, and the second-phase production capacity will reach 1.5 million sets/year. "In the future, if the entire industry wants to form the ability to compete with multinational companies, it must solve quality problems. Product performance, quality, stability, and consistency must be good enough." said Zhang Tao, founder of Ansukang. Feng Qingyu, chairman of Jianxin Medical, also believes: "China does not lack innovation. What it lacks is good products. What it lacks is good products that are stable, consistent, safe and effective." There is no doubt that after the great waves, the Chinese ultrasonic scalpel brands that face the challenge will usher in greater development.

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