On October 8, the General Office of the Ministry of Industry and Information Technology and the Comprehensive Department of the State Food and Drug Administration released the list of winning units of the artificial intelligence medical device innovation task, and four Chinese medicine device enterprises were shortlisted, and the innovation and development of Chinese medicine devices showed new vitality.

  In recent years, traditional Chinese medicine instruments and equipment have received continuous attention. Since 2016, China has issued a series of policies to encourage the use of modern science and technology to research and develop medical devices and equipment with traditional Chinese medicine characteristics, laying a solid institutional foundation for the development of traditional Chinese medicine devices.

  At the same time, with the acceleration of the aging process of the population and the increasing demand for health care, the market is expected to be higher for the traditional Chinese medicine equipment industry. Driven by technological breakthroughs in the field of basic science and market transformation needs, the Chinese medicine device industry has ushered in rapid development, and the number of production enterprises and the number of registered (record) products have achieved double growth. However, it can not be ignored that the traditional Chinese medicine equipment industry urgently needs to step up to complement the innovation "short board".

01Supportive policy

    Leading the industry to speed up development

  Policy innovation is the "booster" for accelerating industrial development.

  As early as February 2016, The State Council issued the Outline of the Strategic Plan for the Development of Traditional Chinese Medicine (2016-2030) (hereinafter referred to as the Outline of the Plan). The Outline of the Plan elevated the development of traditional Chinese medicine to a national strategy, clarified the development direction and work priorities of traditional Chinese medicine in China from 2016 to 2030, and painted a beautiful blueprint for the inheritance and innovation of traditional Chinese medicine in the new era. The Outline of the Plan specifically mentions that it is necessary to comprehensively use modern scientific and technological means to develop a number of diagnosis and treatment instruments and equipment based on traditional Chinese medicine theory.

  Since then, along the spirit of the "Planning Outline", China's relevant departments have issued a series of policy documents to support the innovation and development of the traditional Chinese medicine equipment industry.

  In August 2018, the State Administration of Traditional Chinese Medicine and the Ministry of Science and Technology jointly issued the Guiding Opinions on Strengthening Scientific and Technological Innovation in Traditional Chinese Medicine Health Services, proposing to enrich the variety of traditional Chinese medicine health service products and expand the service field through scientific and technological innovation; Focusing on the improvement of traditional Chinese medicine health care, diagnosis and rehabilitation ability, with the guidance of traditional Chinese medicine theory, the research and development of traditional Chinese medicine medical devices and related auxiliary appliances are carried out.

  In October 2019, the "Opinions of the CPC Central Committee and The State Council on Promoting the Inheritance and Innovation of Traditional Chinese Medicine" was officially issued, putting forward six opinions to "take the pulse and open the way" for the development of traditional Chinese medicine. The guideline proposes to accelerate the promotion of traditional Chinese medicine research and innovation, and develop a number of advanced traditional Chinese medicine instruments and traditional Chinese medicine pharmaceutical equipment.

  In December 2021, ten departments including the Ministry of Industry and Information Technology, the National Health Commission, and the State Food and Drug Administration jointly issued the "14th Five-Year Plan" for the Development of Medical Equipment Industry (hereinafter referred to as the "Development Plan"). The "Development Plan" lists "TCM diagnosis and treatment equipment" as a key development area, proposing to give full play to the unique advantages of TCM in disease prevention, treatment, health care and rehabilitation, and under the guidance of TCM theory, deeply explore the original resources of TCM, and develop TCM characteristic equipment integrating big data, artificial intelligence, wearable and other new technologies. Focus on the development of pulse diagnosis, tongue diagnosis, acupuncture, moxibustion therapy, rehabilitation and other traditional Chinese medicine equipment.

  In addition, large-scale equipment renewal has also effectively stimulated the development of the Chinese medicine equipment industry.

  This year, China ushered in a new wave of large-scale equipment renewal, and the replacement of traditional Chinese medicine instruments is also one of them. At the end of May this year, the National Development and Reform Commission and other four departments jointly issued the "implementation plan to promote the renewal of equipment in the medical and health field" mentioned that support county-level hospitals to be equipped with traditional Chinese medicine electrical, magnetic, thermal and other characteristics of diagnosis and treatment equipment, strengthen the emergency, critical, traditional Chinese geriatric medicine, rehabilitation, hospice and other specialized capacity building; Strengthen the upgrading of information equipment related to TCM hospitals; Encourage the transformation of urban secondary hospitals to replace intelligent medical equipment such as rehabilitation nursing, monitoring, and TCM diagnosis and treatment; We will promote the application of remote diagnosis, remote treatment and remote teaching systems, develop and apply smart TCM diagnosis and treatment equipment such as pulse diagnosis and rehabilitation, and improve the efficiency and quality of medical services. The implementation of the program has effectively promoted the replacement of traditional Chinese medicine instruments and released greater market space.

02Industry status

    Insufficient innovation in aggregate growth

  With the continuous release of policy dividends, the inheritance and innovation of traditional Chinese medicine is changing from a "beautiful blueprint" to a "vivid reality", and the traditional Chinese medicine equipment industry has also entered the "fast lane" of development - the number of production enterprises and the number of product registration (filing) have shown a growth trend. However, it is unavoidable that the "short board" of traditional Chinese medicine instrument innovation needs to be replenished.

The number of production enterprises is increasing year by year, concentrated in the middle and eastern regions of China

  In recent years, driven by favorable national policies and the rapid development of the elderly rehabilitation industry, the number of Chinese traditional medicine equipment enterprises has shown an increasing trend year by year.

  According to the State Food and Drug Administration medical device manufacturers license/record information statistics show that as of the first half of this year, China has a total of 2,555 TCM device manufacturers, with a compound annual growth rate of 29.81%. Among them, the number of enterprises producing Class I traditional Chinese medicine devices grew fastest, from 662 in 2019 to 2,320 in the first half of this year, with a compound annual growth rate of 33.65% (see Figure 1).

  From the perspective of geographical distribution, traditional Chinese medicine equipment enterprises are mainly distributed in the central and eastern regions of China, and the number of enterprises in Shandong, Henan and Guangdong provinces ranks among the top three, respectively, 501, 304 and 264.

  The compound annual growth rate of the number of product registrations (filings) exceeded 30%, mainly for traditional Chinese medicine equipment products

  In recent years, a large number of new products of TCM instruments have emerged in China. According to statistics, as of the first half of this year, the number of Chinese medicine device registration (record) products reached 4,861, with a compound annual growth rate of 30.67%. Among them, there were 3,891 Class I registered products, 970 Class II registered products (see Figure 2), and no Class III products were approved.

  From the perspective of product registration (filing) categories, the current research and development and production activities of traditional Chinese medicine instruments mainly focus on various kinds of traditional Chinese medicine instruments, such as cupping instruments, scraping instruments, traditional Chinese medicine needles, etc. Taking the registration (filing) of first-class products as an example, the total number was 4861, of which 4360 were traditional Chinese medicine instruments, accounting for 89.70%; There were 442 TCM treatment equipment, accounting for 9.09%; There were 59 TCM diagnostic devices, accounting for 1.21% (see Figure 3 for details). From the perspective of the proportion of the number of registration (filing) of the second-class products of traditional Chinese medicine instruments, acupressure stimulation devices, cupping devices, gua sha devices, etc., are the main products for the registration (filing) of various production enterprises. Among them, the number of registration (filing) certificates of acupressure stimulation devices is the largest, with a total of 2680 (see Figure 4).

  From the perspective of the development trend of product registration (filing), many products have gradually become the focus of enterprise research and development and production, and the growth rate of the number of registration (filing) certificates is amazing. For example, TCM dermal needles are one of the popular categories of enterprise layout, and the number of product registration (filing) certificates has grown rapidly from 6 in 2019 to 125 in the first half of this year, with a compound annual growth rate of 108.78%; Acupoint magnetic therapy equipment, acupoint pressure stimulation equipment and other products registration (filing) growth rate is also very obvious, the compound annual growth rate has exceeded 30%.

  Product innovation research and development capabilities need to be improved

  It is not difficult to see from the above data that the development of traditional Chinese medicine equipment industry has made significant progress, but it is still relatively weak in product innovation and research and development. According to statistics, from 2019 to the first half of this year, a total of 5 products applied for innovation approval, and finally only 3 products were approved for listing, respectively: Hunan Qi He Medical Technology Co., LTD. 's TCM odor conveying device (approved on February 4, 2021, Class II), Zhongke Shangyi Health Technology (Beijing) Co., LTD. (hereinafter referred to as Zhongke Shangyi)' s meridian conditioning instrument (approved on May 31, 2023), Class II), Hangzhou Hercules Medical Equipment Co., LTD., percutaneous and acupoint therapy instrument (approved on May 31, 2023, Class II).

  Fortunately, on October 8, the General Office of the Ministry of Industry and Information Technology and the Comprehensive Department of the State Food and Drug Administration released the list of winning units of the artificial intelligence medical device innovation task, in the direction of intelligent traditional Chinese medicine diagnosis and treatment products, The multi-modal intelligent Chinese medicine four-diagnosis auxiliary diagnosis system of Yimai Artificial Intelligence Medical Technology (Tianjin) Co., LTD., the intelligent meridian diagnosis and treatment system of Zhongke Shangyi (Meridian diagnosis and treatment robot), the intelligent tongue and facial pulse collection and analysis system of Tianjin Huiyigu Technology Co., LTD., and the intelligent tongue diagnosis instrument of Sichuan Bo Ruike Information Technology Co., LTD., were successfully selected. It is reported that in the next step, the local industrial and information technology authorities and drug regulatory departments will increase the support of funds, projects and policies for the winning units, and encourage the shortlisted units to further strengthen the innovation of artificial intelligence technology in the field of medical devices.

03Future trend

    Intelligence is the direction of development

  From the industry data, we can get a glimpse of the development status of the Chinese medicine equipment industry: the overall development momentum is good, the market performance prospects can be expected, and the industry innovation "short board" needs to be filled.

  As mentioned above, the number of TCM device manufacturers and the number of registered (filed) products show an increasing trend year by year and maintain a good momentum of development. However, looking at the entire medical device industry, according to statistics, as of September 30 this year, the total number of Chinese medical device enterprises accounted for only about 6.86% of the total number of medical device manufacturers in the country, and the number of products accounted for only about 1.43% of the national medical device products, and the industrial scale was relatively small.

  At the same time, the current TCM device registration (filing) product category is relatively simple, and the trend of scientific and technological content and technical added value is not high. Diagnostic medical devices are one of the subdivisions that companies focus on, mainly because the current level of science and technology can electronically process the information contained in the four diagnoses of "looking, smelling, asking and cutting". The approval of this kind of Chinese medicine equipment can help doctors analyze and monitor human body function, improve the accuracy and reliability of diagnosis, and has great development space and potential.

  In terms of R&D and innovation, the TCM device industry is still in its infancy, and some enterprises try to use AI, 5G, Internet +, big data technology, etc., to develop medical device products with TCM characteristics, and strive to develop in the direction of intelligence, standardization, and industrialization.

  Zhongke Shang Yi approved innovative medical device meridian conditioning instrument is based on artificial intelligence technology research and development and production of precision conditioning equipment, which is China's first approved Chinese medicine industry treatment innovative medical device products. The device integrates the traditional Chinese acupuncture point therapy and human three-dimensional space positioning, patent image algorithm, panoramic AI vision, flexible robot and force perception and other advanced intelligent technologies, which can quickly extract the path of human meridian points, complete prescription planning, drive the multi-physical conditioning head to simulate the operation of human hands through the meridian, and then dredge the meridian, regulate the human body function, and complete the physical conditioning process of traditional Chinese meridian.

  In addition, there are a number of Chinese medicine equipment enterprises such as Eagle Eye Wisdom Chinese Medicine, focusing on the organic combination of Chinese medicine theory and modern science and technology, through infrared thermal imaging and other technologies, for the early prediction of chronic diseases, prediction, early warning, prevention of non-invasive functional detection and evaluation means, but also for cardiovascular and cerebrovascular and other chronic diseases early screening.

  Traditional Chinese medicine meets artificial intelligence and is colliding with more "innovation sparks".

  It can be said that in today's era of rapid development of science and technology, any industrial production can not be separated from big data, artificial intelligence empowerment, the future development of traditional Chinese medicine instruments and equipment is also the same, intelligence will be the main development direction. At present, most of the listed Chinese medicine intelligent equipment is passive input equipment, lack of independent learning ability, the future Chinese medicine medical enterprises should focus on improving the independent learning of equipment and the ability to analyze ancient books and medical records, establish a continuous feedback mechanism, and strive to enable accurate diagnosis and treatment. In order to achieve this goal, it is suggested that Chinese medicine equipment enterprises closely follow the industrial policy guidelines, deepen the "industry-universityresearch" cooperation, insist on playing the main role of enterprise innovation, strengthen the collaborative innovation with medical institutions, universities, research institutes, increase scientific research investment through the declaration of invention patents and high-tech enterprises and other forms, improve the level of enterprise R & D innovation, and prepare for the development of innovative Chinese medicine equipment products.