Medical devices areAIOne of the important areas of application, with innovative products emerging continuously. From the perspective of the medical device industry, currentlyAI+What are the key directions of investment in medical product research and development? Where does the R&D funding mainly come from? What is the return on investment? Looking at specific sub-sectors, which areas are experiencing fierce competition, and which ones are relatively blue oceans?AIIn the field of medical devices, practical applications are gradually shifting from scenario exploration to commercialization transformation. How do you view this?AIWhat are the current dilemmas of high R&D investment in medical products and difficulties in commercialization? What are the solutions for the future?2020First medical record of the yearAIThree types of certificates start,AIThe supervision of medical equipment is constantly developing. In the future, where else do we need to further improve it?
Frost & SullivanFrost & SullivanXu Chao, project manager of the Life Sciences Business Unit of Frost & Sullivan Greater China, was interviewed by China Securities Journal to discuss the “AI+Medical & rdquo; industry development.
China Securities Journal
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Q: From the perspective of the medical device industry, currentlyAI+What are the key directions of investment in medical product research and development? Where does the R&D funding mainly come from? What is the return on investment? Looking at specific sub-sectors, which areas have fierce competition and which ones are relatively blue oceans?
Currently, clinical needs are developing towards precision, minimally invasive techniques, intelligence, and remoteization. Consequently, medical devices andAIThe integration of technologies is also becoming increasingly close-knit,AITechnology has been widely applied in various sub-sectors of medical devices.AI+The investment focus on medical product research and development is mainly concentrated in auxiliary diagnosis and imaging recognition, intelligent medical devices, personalized medicine, etc. Driven by the increasing maturity of technology and the improvement of policy systems, medical devicesAIThe application of the track is gradually moving from the initial development stage to a deeper implementation phase.
At the same time, rapid development cannot be separated from the continuous attention and vitality injected into the medical device sector by primary or secondary markets.2021In [year], Eagle Vision Technology made a splash at the Hong Kong Stock Exchange, becoming a healthcareAIThe first stock listed.
Looking at the sub-sectors,AIMedical imaging has become a popular application area in recent years. Pulmonary nodules and fundus screening are two disease areas that companies are widely deploying in at present. In addition, the era of robotics is subverting various traditional surgeries and presenting trends such as informatization, intelligence, and minimally invasive techniques.AIThe surgical robot industry is also developing rapidly. Currently, the main technical bottlenecks are insufficient data volume and algorithmic interpretability, which affect the promotion scope and application effectiveness of artificial intelligence in the medical device industry. Products and related enterprises that can break through these bottlenecks in the future will bring new development momentum to the industry.
Q: AIIn the field of medical devices, practical applications are gradually shifting from scenario exploration to commercialization. What's your view?AIWhat are the current dilemmas of high R&D investment in medical products and difficulties in commercialization? What solutions do you think there are for the future?
AIThe practical application in the field of medical devices is shifting from scenario exploration to commercialization, which is a positive trend that demonstrates its market potential and practical value. However, at presentAIMedical products indeed face the dilemma of high R&D investment and difficult commercialization, mainly due to various factors such as technological maturity, business model, and regulatory policies.
Firstly, from the perspective of business model,AIThe research, development, and commercialization of medical products require the construction of a complete industrial chain, including upstream data collection, processing, and analysis, midstream algorithm model development and optimization, as well as downstream medical service provision and market promotion. In this process, each link needs to cooperate closely to form an effective business model.
Secondly, technological breakthroughs are also key to solving the challenges of commercialization. Currently,AIMedical products need further improvement in terms of algorithm accuracy, stability, and reliability.
In addition, data security and privacy protection are alsoAIAn important consideration in the development of medical technology. Strengthen research and application of data governance and privacy protection technologies to ensure the security and compliance of patient data.
Furthermore, regulatory policies also have an impactAIAn important factor in the commercialization and implementation of medical products. WithAIWith the rapid development of technology, regulatory authorities need to formulate and improve corresponding laws, regulations, standards, and norms toAIThe commercialization of medical products provides strong institutional support.
Q: from2020First medical record of the yearAIThree types of certificates start,AIThe supervision of medical equipment is constantly developing. In the future, where else do we need to further improve it?
since2020year1In the month, Keya Medical obtained Class III medical device certification, marking ChinaAIMedical devices have entered the commercialization stage. As regulatory pathways become increasingly clear, the number of approvals for Class III certificates will increase. As of2023year6month30day, already63The product has successfully obtained Class 3 certificates. More and moreIIIThe approval of the class certificate also means that the industry's focus is shifting from research and development to commercial implementation.
In recent yearsAIThe regulatory mechanism for medical devices has made remarkable progress, but there is still room for continuous improvement in several areas. For instance, classification management and risk grading strategies can be implemented to clarify the scope of use and limitations for different types of large models.2022The "Guiding Principles for the Registration and Review of Artificial Intelligence Medical Devices" (hereinafter referred to as the "Principles") promulgated in [year]AIThe specific positioning and uses of medical device products have been carefully divided and supplemented with explanations, providing clear guidance for supervision. In terms of data sources, the 'Principles' detail three types of data sources, all of which share the common characteristic of being objective data used for medical purposes. To ensure the accuracy and reliability of data, it is necessary to strengthen the review of training data sources and quality, clarify compliance requirements for data collection and use, thereby effectively preventing data abuse and privacy leaks. In addition, an accountability system for medical large models can be explored to ensure clear and traceable responsibilities. Through the implementation of these measures, we will be able to further improve.AIThe regulatory mechanism for medical devices ensures their safety and effective service to public health.
*This interview has been published in 'China Securities Journal', with reporter Li Mengyang and the original title being ' "AI+Medical ”Rising Tides Medical device companies explore commercial models >>
