专访安永吴晓颖：未来3-5年，AI将重塑医械产业格局

Core Insights - The rapid evolution of artificial intelligence (AI), particularly generative technology, is transforming the healthcare industry, especially in the medical device sector, which is characterized by high technical barriers and complex supply chains [1][2] - The industry is undergoing structural changes driven by policy reforms, increasing demands for efficiency and quality from hospitals and doctors, and a shift from product competition to comprehensive solutions that emphasize technological innovation and clinical value [1][2] Policy Developments - The National Medical Products Administration (NMPA) released guidelines for the registration and review of AI medical devices in 2022, followed by more detailed regulations in 2023 regarding AI-assisted detection devices [2] - In early 2025, the State Council will issue opinions to deepen regulatory reforms in the pharmaceutical and medical device sectors, emphasizing the establishment of standardization organizations for cutting-edge medical devices like AI and medical robots [2] AI Applications in Medical Devices - AI is increasingly seen as a key driver for cost reduction and efficiency enhancement in the medical device industry, particularly in the context of centralized procurement and payment reforms [5] - Generative AI can optimize device design and automate data processing, significantly reducing research and development cycles and operational costs [5][6] Potential Application Scenarios - The most promising application for generative AI in the medical device sector is in generating imaging reports, as it allows for standardized data processing and quantifiable efficiency improvements [6] - Internal business intelligence (BI) applications of AI can help medical device companies quickly analyze performance data and address business challenges [6] Challenges to Implementation - Medical device companies face significant challenges in data governance, privacy protection, and cross-institutional collaboration due to the sensitive and fragmented nature of medical data [7][8] - Establishing effective data-sharing mechanisms and robust data governance frameworks is crucial for overcoming these challenges and enabling AI deployment [8][9] Strategic AI Integration - Companies should view AI as a systemic initiative rather than a standalone project, ensuring that all relevant departments are involved in the AI implementation process [9][10] - Compliance should be integrated into the AI development process from the outset, ensuring that all aspects of data handling and algorithm validation are designed with regulatory requirements in mind [10] Future Outlook - Generative AI is expected to evolve from being an auxiliary tool to a core capability within the medical device industry, fundamentally reshaping business models and competitive dynamics [12][13] - Companies that effectively integrate AI into their operations and maintain a strong understanding of clinical needs will likely emerge as leaders in the industry [13]