The next ten years may see a major trend towards intelligent medical devices.

       Even seemingly cold medical devices can possess great wisdom. With artificial intelligenceKeeping pace with the AI era, the intelligent transformation of medical devices will become a major trend in the next 5 to 10 years. The production output value of Shanghai's medical device industry will double and exceed 100 billion, with over 100 listed companies. On the 14th, at the 81st China International Medical Equipment Fair (CMEF), held at the Shanghai National Exhibition and Convention Center, which boasts a 40-year history, industry insiders made professional judgments based on authoritative data.

At the end of last month, the National Medical Products Administration issued the "China Pharmaceutical Regulation Science Action Plan," which clearly states that in thenext 3 to 5 years, 3 to 5 pharmaceutical regulatory science research bases will be established, pioneering innovative regulatory science systems in nine major areas, including cell and gene therapy, drug-device combination products, and artificial intelligence medical devices.

From traditional moxibustion and imported colored contact lenses to rapidly evolving medical robots, how are medical devices defined today? Atthe "Regulatory Science of Medical Devices in the Intelligent Era" themed summit forum on the safety evaluation and innovative development of medical devices in China, Dr. Yuan Bin Hua, a member of the National Ministry of Education's Food and Drug Industry Vocational Education Teaching Steering Committee and a visiting researcher at the China Medical Device Policy Research and Safety Evaluation Center of Shanghai Health Medical College, believes that regardless of how it changes, a medical device simultaneously possesses five characteristics: it is for health purposes, it acts on the human body, it is different from drugs, its safety requires regulation, and its effectiveness needs to be determined.

Currently, the global medical device industry exhibits high growth and high concentration. Although China's medical device industry shows high growth, the ratio between the medical device and drug markets is still quite low, only0.4:1, far lower than the global level of 0.8:1. Of course, this also indicates that the potential for future development of China's medical device industry is enormous.

At present, China has initially formed medical device industrial clusters represented by the Yangtze River Delta, the Beijing-Tianjin-Hebei region, and the Pearl River Delta. Among them, Shanghai is also a major center in the industry. Lin Senyong, the person in charge of medical device supervision at the Shanghai Municipal Administration for Market Regulation, revealed that as of the first quarter of this year, the number of medical device manufacturing enterprises in Shanghai has reached926.

Looking at the year-on-year comparison, from2017 to 2018, the total output value of medical device production in Shanghai increased from 27.976 billion yuan to 35.028 billion yuan, an increase of 25.21%. In terms of import and export, although the export value is less than one-third of the import value, the export growth rate is higher than the import growth rate. In 2018, the city's medical device export delivery value reached 9.051 billion yuan, a year-on-year increase of 23.89%; while the import value of medical instruments and equipment was 33.449 billion yuan, a year-on-year increase of 17.26%.

Jiefang Daily·Shangguan News reporters learned that within the industry, an output value of 50 million yuan is a hurdle for medical device manufacturing enterprises. In 2018, the number of enterprises in Shanghai with an output value between 50 million and 100 million yuan was 41, while the number of enterprises with an output value exceeding 100 million yuan increased from 57 to 69, both showing an increase from the previous year. It is noteworthy that the proportion of the output value of leading enterprises with an output value exceeding 50 million yuan in the total output value of all enterprises in the city increased from 81.66% in 2017 to 86.85% in 2018, further increasing the industry concentration.

As the main initiator and implementer of the Shanghai medical device registration system, Lin Senyong said that in the future5 to 10 years, Shanghai will, through its pioneering implementation of the "Medical Device Registration System" in China, generate a manufacturing output value of over 100 billion yuan and nearly 100 listed companies. In the future, the trend in China's medical device industry will be: industry mergers and acquisitions and platformization, extending from device products to service products, achieving breakthroughs in single-point innovation of some products, and simultaneously developing intelligent internet-based medical devices.

It is foreseeable that a large number of high-performance medical devices, such as large-scale digital imaging equipment, surgical robots, molecular biology diagnostic products, personalized customized devices, and home medical devices, will be continuously applied and put on the market. Therefore, medical device supervision must also change its concepts, accelerate the reform of the review and approval system, explore effective supervision methods, and establish a scientific supervision system. However, Lin Senyong frankly admitted that currently, China's medical device management has not yet established a basic information platform, the application of big data is insufficient, precise supervision is not in place, and the supervision efficiency is not high.

As the first public medical device management undergraduate program in the country, the president of Shanghai Health Medical College, Professor Huang Gang, believes that if the current weak artificial intelligence is still assisting humans in operating and screening imaging devices, then strong artificial intelligence will eventually replace humans, but ultimately it will still be designed and controlled by humans. In terms of medical device safety supervision, the future working status of many devices will be7x24 hours, and artificial intelligence supervision, compared to manual supervision, can also achieve 7x24 hours, more diligent and tireless. Therefore, artificial intelligence will bring unprecedented convenience and efficiency to medical device regulatory science.