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Integrating resources and breaking through bottlenecks: AI medical devices are poised for a spring
Release time:
2025-03-12 09:43
How are medical artificial intelligence (AI) products approved? Many AI technology companies and investment institutions are desperately asking this question.
Recently, at the 2018 China Biopharmaceutical Industry High-Quality Development Forum "Medical Device High-end Technology and Industrialization Sub-forum" held in Beijing, industry experts, enterprise representatives, and regulatory representatives discussed new challenges in the medical device industry in the new era and the progress in the review and approval of innovative medical devices.
The forum revealed that the medical device technical review department is exploring, researching, and predicting the landing of AI products, making technical preparations to welcome the next generation of AI medical devices into the review process.
AI Medical Devices Encounter Bottlenecks
“Currently, AI performs well in academic papers, technology patents, social certifications, and capital investment, but it is difficult to achieve a substantial breakthrough in product application.” Fan Xiaodong, vice president of the China Medical Device Industry Association, frankly stated.
“As of June 2018, there were 4,925 AI companies globally, with China having 1,011, second only to the United States. In terms of specific cities, Beijing ranks first with 395 companies, while San Francisco is second with 287.” Fan Xiaodong stated that data from China Industry Information's "2017 Analysis of Future Development Trends of China's AI + Medical Imaging Industry" shows that domestic medical AI financing has increased year by year from 2014 to 2017, reaching a surprising 1.842 billion yuan in 2017. However, it has cooled down significantly this year, especially after March and April, and can be described as bleak.
In this regard, Fan Xiaodong believes that the development of medical AI technology innovation enterprises must overcome three major gaps: talent and technology, scenarios and products, and the market. In recent years, with the improvement of big data and computing power, medical AI has crossed the talent and technology gap, but is currently generally blocked by application-driven scenarios and mature products.
He indicated that most founders of dual-creation (innovation and entrepreneurship) companies currently engaged in AI did not have relevant education or experience in the medical field before, lacking basic professional knowledge and standard reserves of the medical device industry. This may lead to technology and products deviating from industry regulations and standards, failing to meet actual clinical needs, and thus being far from users and the market.
Creating a Platform to Solve Problems
How to break through the constraints and enable cutting-edge AI technology to be widely used in clinical practice and serve the vast number of medical patients? Recently, the Medical Device Technology Evaluation Center (hereinafter referred to as the "Evaluation Center") has also been trying to provide answers. “China Manufacturing 2025 clearly states the need to develop and support the artificial intelligence industry, and the review agency must play a role in this." said Sun Lei, director of the Evaluation Center.
“To date, no medical AI product has been submitted to the Evaluation Center and entered the review stage.” Sun Lei previously pointed out the true situation under the prosperous appearance of the medical AI field at the third China Pharmaceutical Regulatory Science Conference Medical Device Scientific Supervision Forum.
Relying solely on concepts to attract a large number of private equity and funds, ultimately evolving into capital market operations, has led to the current overheating of the medical AI industry. The cooling of financing in the first half of this year shows that capital parties have begun to rationally view the product transformation and commercial transformation issues in this field.
It is reported that the Evaluation Center previously conducted a survey of more than 100 technology companies and research institutions that are developing AI products. “According to the common statement of the companies, everyone is in the research and development stage. Most of the technical researchers and product developers of these AI products do not know how to transform these technologies into medical products to serve medical care.” Sun Lei stated that transforming AI technology into a medical health product is not a simple matter.
To this end, the Evaluation Center cooperated with the Chinese Society for Biomedical Engineering to establish an open AI medical device research platform, including well-known research institutions, enterprise representatives, and experts involved in research and development.
Conducting technological research and development based on the clear characteristics of medical products, and submitting for review based on the clear key points of medical device technical review, have become the two major visions of the research platform's early guidance role. Sun Lei frankly stated, “First, we want to use this research platform to help companies solve the problem of how to design and develop AI products to meet the basic requirements of medical health products. Second, through joint research by all parties, we can form review requirements for AI products. In this way, when a medical device product enters the review and approval stage, both the company and the review personnel are very clear about all the guiding principles and review key points, which can not only greatly improve the efficiency of the review process, but also save the company's R&D costs.”
He Weigang, director of the second department of the Evaluation Center, also stated: “Based on this research platform, we can integrate various advantages resources to carry out relevant research work.”
“If the above two points can be achieved, the AI medical device research platform will make a huge contribution to the application of domestic AI industrial technology in the health field.” Sun Lei placed high hopes on the platform.
Win-Win Cooperation Through Positive Interaction
“It is undeniable that AI technology has a profound impact on the medical device industry and is also a development direction that everyone is concerned about, so we must have corresponding predictions, keep up with the development of core technologies in medical devices to carry out forward-looking research, and make technical preparations before product listing.” He Weigang stated.
It is reported that at the end of 2017, the Evaluation Center took the lead in establishing an AI research working group. Currently, the working group has identified seven key research areas for medical AI: datasets, algorithm evaluation, clinical evaluation, verification and confirmation, analysis of the listing of relevant AI products abroad, data security, and registration changes. On September 12, the working group discussed the key points of review of deep learning-assisted decision-making medical software and formed a draft of general review key points.
AI medical devices are different from traditional medical device products. If we want to rely on a predetermined review standard to verify the risks of all AI medical products, we may ignore the product's own characteristics and technical key points. In this regard, He Weigang stated that the ideal state is for reviewers to pay attention to the technical key points and product characteristics from the product's research and development stage. The AI medical device research platform will help further improve the technical level of review.
It is introduced that the Evaluation Center has currently established cooperative relationships with the Institute of Automation, Chinese Academy of Sciences, Zhejiang University, Tsinghua University, and other universities, as well as the China Academy of Information and Communications Technology, Ministry of Industry and Information Technology, and clinical experts from medical institutions. At the same time, leveraging the advantages of the AI medical device research platform to connect with companies, further research is conducted on specific products to form specific review key points and technical requirements. More importantly, in-depth research is conducted on the technical difficulties of different products.
“This is a win-win cooperation with positive interaction.” He Weigang stated that the so-called full life cycle supervision requires that enterprises carry out research and development, design, and verification and confirmation in accordance with the relevant technical and regulatory requirements of medical devices to ensure their safety and effectiveness. The establishment of the AI medical device research platform allows the review department to provide targeted review opinions to companies, helping companies improve technology transformation efficiency; while reviewers can deepen their understanding of product technology through communication with companies, which can also help regulators improve their supervision level. (Reporter Zhang XiaoCen)
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