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Increased policy support makes the prospect of AI medical devices promising
Release time:
2025-03-12 09:43
In reviewing the popular terminology of the medical device industry in 2018, "Artificial Intelligence (AI)" ranks as one of the top terms. Whether at the China International Medical Device Fair (Spring) or the first China International Import Expo, AI has been a hot topic and highlight of the exhibitions, receiving widespread attention. However, it is undeniable that the application and promotion of AI medical products face numerous practical problems.
Recently, at the "Medical Artificial Intelligence Data Governance and Standardization Conference" held in Beijing by the Chinese Society of Biomedical Engineering, in addition to looking forward to the application prospects of AI, the guests also conducted rational analysis and discussions on practical issues such as laws and regulations, standards systems, and quality evaluation.
"AI will cause significant changes in traditional medical diagnosis, medical services, and health management. To adapt to these changes, close cooperation between policies, regulations, and regulatory mechanisms is needed." Professor Zhang Bo, an academician of the Chinese Academy of Sciences and dean of the Tsinghua University Institute for Artificial Intelligence, pointed out in his speech that there is a need to re-establish a trustworthy, reliable, high-quality, and efficient human-computer collaborative medical system.
Current Situation
Performance Still Falls Short of Human Level
When AI was born in 1956, a symbolic reasoning model based on knowledge and experience was proposed, and medical diagnosis was one of the earliest fields in which this model was applied.
In the early 1970s, to standardize the use of antibiotics, a research team at Stanford University spent five or six years developing the MYCIN system. In the 1980s, some clinical institutions in Beijing also developed computer diagnostic systems for diseases such as hepatitis and acute abdominal disease. However, these systems were not widely adopted. Why is that?
"The MYCIN system failed to be applied because there was no legal basis for machines to diagnose illnesses. Furthermore, from a technical perspective, some of the diagnostic systems launched domestically in the 1980s were based on knowledge-driven methods, with medical knowledge coming from experts. Because expert knowledge is difficult to obtain, and is scarce and expensive, it was difficult at the time to construct systems on a practical application scale." Zhang Bo explained.
With the popularization and application of the internet, the medical field has unprecedented big data, and deep learning models based on big data in AI have emerged and been widely used. However, in terms of certain performance aspects, AI medical applications are still far from human capabilities.
Zhang Bo pointed out that systems based on deep learning have issues such as unexplainability and vulnerability, making it difficult to gain the trust of clinicians, thus hindering their widespread promotion and application. At the same time, deep learning based on big data often uses low-quality data. Coupled with the "black box" learning method, although AI systems outperform humans in individual indicators, they are far from human levels in other performance aspects such as robustness and explainability.
"To solve these problems, we need to strengthen research on one hand; and on the other hand, we need to formulate a complete set of laws, regulations, standards, and regulatory measures." said Zhang Bo.
"AI medical products will bring new challenges to the existing medical legal system. Whether it is risk prevention, codes of conduct, or legal entities, while promoting the development of AI medical products, it is necessary to conduct in-depth discussions on their potential risks and legal liability." Cao Yanlin, director of the Institute of Medical Information, Chinese Academy of Medical Sciences, stated that the 2016 AlphaGo victory over Lee Sedol marked the fall of what was considered an intellectual stronghold in board games. This event further catalyzed widespread and continued social attention to AI. Especially in the past two years, with technology companies such as Baidu, Tencent, and iFlytek making efforts in the AI field, AI has become a key focus of governments and research institutions.
Progress
Standardization Work Proceeds Orderly
"AI medical devices in China have entered a critical period of product transformation, and the quality evaluation standards and regulations for AI products are being rapidly researched and established." Ren Haiping, director of the Opto-mechatronics Laboratory of the China National Institute for Food and Drug Control (hereinafter referred to as "CNIFDC"), told reporters.
Zhong Daidi, professor at Chongqing University and chairman of the International Standard Committee for Personal Health Devices, stated that due to the special nature of medical devices, the application of AI products and technologies in the medical field must operate within the industry policy framework of medical device supervision and management, following the requirements of the medical device industry for safety, effectiveness, and ease of use. These all need to be implemented through technical standards and supporting policies.
Zhong Daidi further stated that globally, the traditional classification of "decision support" products can no longer meet the needs of industrial development. Relevant standards for AI products in the medical field in various countries are still blank and urgently require the establishment of specialized standard systems to provide support for various stakeholders. Standardization work plays a fundamental, supportive, and leading role in the development of medical AI industries.
Reporters learned that, as a national-level medical device testing center, the CNIFDC began to deploy the quality evaluation research of AI medical devices in 2016. Currently, the CNIFDC undertakes the registration and testing of dozens of AI medical devices nationwide. Based on this, in September 2018, the National Medical Products Administration approved the CNIFDC as the national centralized management unit for artificial intelligence medical device standardization, and the establishment of an expert group is nearing completion. In December 2018, the CNIFDC was approved by the IEEE Standards Association to serve as the convening unit of the Artificial Intelligence Medical Device Working Group, and two international standard proposal projects have been approved.
"China's standardization work for AI medical devices is about to start simultaneously on both domestic and international stages, and it will certainly play a supporting and guiding role in review and approval and industry development." said Ren Haiping.
Prospects
Medical Devices Enter a Period of Innovative Opportunities
Despite numerous practical problems and challenges, AI has great potential in the medical field, a point widely recognized by experts and industry professionals.
Cao Yanlin pointed out that AI medical technology can help patients conduct preliminary self-analysis and evaluation of their health status before seeking medical attention, assist physicians in managing patient information and improving service levels, help hospitals guide and manage patient visits, conduct drug and medical device research and development, alleviate the shortage of medical HR, restructure medical service models, and ultimately may restructure the health care system.
Zhao Yi Wu, chairman of Beijing Natong Technology Group Co., Ltd., analyzed that compared to the field of medical diagnostic analysis, AI's development in treatment, especially surgical procedures, has remained lukewarm due to safety and ethical factors. However, in the past year, with the in-depth development of algorithm research and the expansion of applicable fields, AI applications in surgical procedures have given rise to the concept of precision surgery, which is also a powerful supplement to precision medicine.
He said that in the face of new market space and new field expansion, whether or not AI medical companies can change their R&D thinking, strengthen their industry understanding, standardize medical practices, and encourage cross-domain cooperation to open up new territory in the field of surgical procedures is the greatest challenge and opportunity facing them.
Wang Defeng, associate professor at the Chinese University of Hong Kong, also stated that with the issuance of the "New Generation Artificial Intelligence Development Plan" and "Made in China 2025", innovation and research and development of high-performance diagnostic equipment have been elevated to an unprecedented level of importance.
The future of medical devices will undoubtedly be intelligent, and research and development investment will move in this direction. Medical robots are the ultimate direction of intelligent medical devices, and their share of the medical device market will continue to grow. Wang Defeng further stated that the combination of AI and robots must be analyzed on a case-by-case basis to form "specialty-customized" medical robots. The application of AI technology to perform multi-modal, high-precision automatic fusion of image data is an important cornerstone for combining cutting-edge technology with intelligent robot application scenarios.
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