Recently, the 2019 Artificial Intelligence Medical Device Innovation Conference and Artificial Intelligence Medical Device Innovation Cooperation Platform Working Conference, hosted by the Artificial Intelligence Medical Device Innovation Cooperation Platform and the China Academy of Information and Communications Technology, supported by the Medical Device Technical Evaluation Center of the State Medical Products Administration (hereinafter referred to as the Device Review Center), and organized by the Hainan Provincial Drug Administration, Hainan Boao Lecheng International Medical Tourism Pilot Zone Administration and Hainan Ecological Software Park, was held in Boao Lecheng. With the theme of "Scientific and Technological Innovation Helps the High-quality Development of Medical Devices", the conference invited many industry experts to authoritatively interpret artificial intelligence medical devices and other related policies at home and abroad, and conducted in-depth discussions on the development trend of new technologies such as artificial intelligence and their application in the medical and health field.
Xu Jinghe, deputy director of the State Food and Drug Administration who attended the conference, said that in order to implement the Healthy China strategy, the State Council has issued a series of policies on strengthening the innovation supervision of drugs and medical devices in recent years to accelerate the construction of a healthy China. With the continuous integration and development of artificial intelligence technology and innovative industries, the medical device industry has gradually become a field where artificial intelligence technology is widely used, and artificial intelligence technology has inserted innovative wings for the development of the medical device industry. At present, artificial intelligence products in the field of medical devices in China are about to enter the stage of large-scale product transformation, in order to accelerate the research on key technologies for the safety supervision of artificial intelligence medical devices, the State Food and Drug Administration has included the safety and effectiveness evaluation research of artificial intelligence medical devices into the first batch of scientific research topics for drug supervision. At the same time, in order to effectively cope with the challenges brought by deep learning, the Device Review Center released the world's first technical review points for related products - "Key Points for Software Review of Deep Learning Assisted Decision Making Medical Devices", which comprehensively interprets the concerns of manufacturers and promotes and promotes the healthy development of China's artificial intelligence medical device field.
Participants believe that this meeting not only gave the industry a deep understanding of the research and development, review and approval of artificial intelligence medical devices, but also allowed more medical practitioners to further understand the special drug and device policies and many "pilot and pilot" achievements of the Boao Lecheng International Medical Tourism Pilot Zone. The combination of supervision and industry forces will accelerate the transformation and application of innovative achievements of artificial intelligence medical devices, help the high-quality development of medical devices in China, and bring more gospel to patients.
Policy blessing Innovation leads development
At present, the new generation of information technology represented by artificial intelligence, 5G, blockchain, cloud computing, and big data is accelerating the deep integration with various industries and reshaping the development pattern of traditional industries. Promoting the accelerated integration of artificial intelligence and the medical and health industry is an important measure to improve the level of medical and health modernization and meet the needs of the people's medical and health development, which is of great significance for accelerating the construction of a manufacturing power.
In April 2018, the General Office of the State Council issued the "Opinions on Promoting the Development of "Internet + Medical Health", proposing to promote "Internet +" artificial intelligence application services, develop a clinical diagnosis and treatment decision support system based on artificial intelligence, strengthen the integration, sharing and application of clinical and scientific research data, and support the research and development of medical and health-related artificial intelligence technology, medical robots, large-scale medical equipment, emergency rescue medical equipment, biological 3D printing technology and wearable devices.
In order to meet the development needs of the medical device industry and combine the actual supervision work, in October 2019, the State Food and Drug Administration issued an announcement that it decided to establish a focal point for standardization technology of artificial intelligence medical devices, a focal point for medical additive manufacturing technology for medical devices, and a focal point for standardization technology for medical electroacoustic equipment and medical devices.
The Ministry of Industry and Information Technology (MIIT), as the competent authority of China's information and communication industry and manufacturing industry, has taken many measures in recent years to promote the integration and development of artificial intelligence technology, medical and health services and medical devices, and achieved remarkable results. In December 2017, the Ministry of Industry and Information Technology issued the "Three-Year Action Plan for Promoting the Development of a New Generation of Artificial Intelligence Industry (2018-2020)", which particularly emphasizes the need to promote the industrialization of artificial intelligence technology and promote the integrated application of smart products in medical and other fields.
Liu Yulin, deputy director of the Information and Communication Development Department of the Ministry of Industry and Information Technology, introduced that the Ministry of Industry and Information Technology conscientiously implements the decision-making and deployment of the Party Central Committee and the State Council, and vigorously promotes the development and application of artificial intelligence technology. In recent years, the Ministry of Industry and Information Technology has issued a series of documents to actively promote the integrated application of 5G artificial intelligence, blockchain and other technologies and smart products in the field of health and health, which has strongly promoted the development of intelligent medical devices. In the next step, the Ministry of Industry and Information Technology will adhere to the concept of people-centered, innovation-led, and demand-driven, focus on relevant work, and promote the deep integration and development of information technology and medical devices.
Hainan Boao Lecheng International Medical Tourism Pilot Zone has been granted nine preferential policies with great openness, including "accelerating the approval of medical devices and drug imports", by the State Council. In September 2019, the National Development and Reform Commission, the National Health Commission, the State Administration of Traditional Chinese Medicine and the State Food and Drug Administration jointly issued the Implementation Plan on Supporting the Construction of the Boao Lecheng International Medical Tourism Pilot Zone, focusing on enterprise development and patient expectations on the basis of the "National Nine Articles". Further endow Lecheng with a series of breakthrough preferential policies to promote Lecheng into the "fast lane" of high-quality and high-standard development.
Shen Danyang, Vice Governor of Hainan Provincial People's Government, said that thanks to a series of breakthrough preferential policies granted by the state to the Boao Lecheng Pilot Zone, the Lecheng Pilot Zone has created more than 40 national firsts in terms of new international medical drugs, new equipment and new technologies, basically realizing the synchronization of drugs and medical equipment with the international advanced level.
Technological breakthrough Enterprises actively layout
Information technology has made continuous breakthroughs and has become the driving force for the high-quality development of the medical device industry. At present, the medical device industry at home and abroad is actively deploying in the field of AI. According to reports, China currently has artificial intelligence medical device products such as diabetic retinal eye disease diagnosis software and CT pulmonary nodule auxiliary diagnosis software that are being studied and declared.
In November 2018, Lepu (Beijing) Medical Device Co., Ltd. announced that the electrocardiogram artificial intelligence automatic analysis and diagnosis system "AI-ECGPlatform" independently developed by its wholly-owned subsidiary Shenzhen Kaiwo Electronics Co., Ltd. was approved by the US Food and Drug Administration (FDA) on November 19 of that year, becoming the first artificial intelligence ECG product approved by the FDA in China.
"Robotic AI technology is a key step in facilitating spinal surgery." Tian Wei, academician of the Chinese Academy of Engineering, introduced that robot-assisted technology solves the two major problems of hand-eye defects and surgical planning and execution, bringing orthopedics and spine surgery into a new revolution; 5G-onetomany (Editor's note: A physician or a medical team can help multiple places carry out medical activities at the same time, provide timely feedback, fully communicate, and transmit high-quality image data to multiple places in real time. The remote robotic surgery method is safe and reliable, so that the level of experts can be extended in a larger range, and it may be applied to communication, teaching, and remote operation surgery in the future, which is of great significance to the popularization of medical technology, remote surgery in dangerous environments and medical homogenization.
"In 2014, the fundus disease group of the ophthalmology branch of the Chinese Medical Association issued the "Guidelines for the Clinical Diagnosis and Treatment of Diabetic Retinopathy in China", which is the basis for our research and development. In 2016, we really embarked on a project of AI analysis of diabetic retinopathy; At the end of November of the same year, we discovered that a team from Google Inc. had also published an article on the application of deep learning algorithms to diabetic retinopathy analysis, theoretically proving that our product has an achievable basis. Lai Ming, deputy general manager of Shenzhen Silicon-based Intelligent Technology Co., Ltd., shared the practical experience of the artificial intelligence-based diabetic retinopathy analysis software developed by the company in the process of declaring innovative medical devices.
While enterprise research and development are in full swing, regulatory authorities are also actively exploring the path of AI medical device evaluation. In April 2019, the U.S. FDA published a discussion paper proposing a proposed regulatory framework for changes to independent software for artificial intelligence/machine learning (AI/ML) medical devices. In July 2019, China's Device Review Center issued a notice and released the "Key Points for the Review of Deep Learning Assisted Decision Making Medical Device Software", which takes deep learning assisted decision-making medical device software as the starting point, focuses on data quality control, algorithm generalization ability and clinical use risk of artificial intelligence medical devices, and clarifies the key points of the full life cycle review of artificial intelligence medical devices.
Orchestrate planning to accelerate app conversion
Relying on the help of technological development, policies and regulations, the enthusiasm of enterprises for research and development is increasing, and artificial intelligence medical device products continue to emerge. Up to now, three deep learning-assisted decision-making medical devices have passed the special approval channel for innovative medical devices and entered the technical review stage.
However, experts at the meeting also pointed out that the layout of China's artificial intelligence medical device development system research and development needs to be further optimized, and the intensity of collaborative innovation needs to be further increased; The thinking from learning and imitation to innovative research and development needs to be accelerated, the enthusiasm of enterprises to participate in the formulation of relevant rules and standards needs to be further stimulated, and the construction and development of relevant regulations, systems, standards also need to be further accelerated.
Liu Yulin suggested that the first is to establish and improve the standard and evaluation system, give full play to the guiding and leading role of standards in industrial development, and actively carry out research and formulation of intelligent medical device product and service standards. Promote relevant evaluation and verification, and gradually establish a medical artificial intelligence trust system. The second is to strengthen the capacity building of industrial infrastructure, strengthen top-level design, focus on the intelligent development of medical equipment, strengthen research and layout in key technology fields such as wearable devices, 5G + medical applications, medical and health cloud computing platforms, medical and health big data, and medical and health artificial intelligence, and develop technical products that meet user needs. The third is to promote collaborative innovation of intelligent medical applications, closely match the needs of the medical and health industry, strengthen information and communication enterprises, medical equipment enterprises, hospitals, pharmaceutical enterprises and other links, cross-industry technical exchange industry cooperation, and rely on relevant public service platforms to further promote industrial integration and application innovation, and promote the gradual maturity of the intelligent medical industry ecology. The fourth is to deepen international communication and cooperation, strengthen communication and coordination under the framework of the World Health Organization and other relevant United Nations agencies, promote mutual learning and mutual learning, guide relevant enterprises and institutions to strengthen international exchanges and cooperation in smart medical policy research standards, formulation of technology research and development application demonstrations, industry self-discipline and security guarantees, etc., and promote the healthy and coordinated development of the smart medical industry.
The Innovation Cooperation Platform for Artificial Intelligence Medical Devices (hereinafter referred to as the Innovation Cooperation Platform) is jointly initiated by the Center for Device Review and 14 units including the China Academy of Information and Communications Technology, aiming to actively respond to the new challenges brought by the rapid development of artificial intelligence to supervision and industry. Zhang Xueli, deputy secretary-general of the Innovation Cooperation Platform, introduced that the closed-door meeting of the Innovation Cooperation Platform held on December 27, 2019 not only revised the programmatic documents such as the standard operating specifications of the Innovation Cooperation Platform, but also established a medical data application technology research group with the Device Review Center as the leading unit and a medical artificial intelligence terminology standardization working group with the Chinese Society of Biomedical Engineering as the leading unit according to the latest situation, in order to further standardize the follow-up related work.
"In 2019, we mainly discussed the regulatory ideas on artificial intelligence medical devices, and in 2020, we hope to explore how to use artificial intelligence technology to achieve scientific supervision of medical devices. The Technical Regulation Group will continue to promote technical docking with other working groups to form a regulatory synergy. Peng Liang, deputy director of the review department of the instrument review center, introduced that the instrument review center will start the formulation of guiding principles for the evaluation of artificial intelligence medical devices in 2020 and study the construction of the guiding principles system for the evaluation of artificial intelligence medical devices.
"In 2020, the Clinical Evaluation Working Group of the Innovation Cooperation Platform will make efforts in three aspects: formulating clinical guidelines, investigating industry needs, and problem-oriented research." Liu Yinghui, deputy director of the Clinical Department of the Instrument Review Center, introduced that the clinical evaluation working group will make full use of the expert resources of the platform unit to carry out in-depth research on the products that are currently more concentrated, compile the technical guidelines for clinical evaluation of representative products such as diabetic retinopathy deep learning assisted decision-making software, clarify the review focus, and unify the review scale; Organize and carry out research work, comprehensively collect problems, and systematically sort out. At the same time, it tracks the research priorities and phased achievements of developed countries in the medical device industry, and carries out scientific research and achievement transformation in a problem-oriented manner.