Medical Equipment

The government’s “Basic Policy on Economic and Fiscal Management and Reform 2026” sets out a policy, aimed at realizing high-quality social security for all generations, of shifting the healthcare and long-term care delivery system from a hospital-centered model to a community-based model, deepening the community-based integrated care system, improving service quality and productivity through the use of DX, AI and other technologies, and promoting “proactive preventive healthcare.” In addition, Japan’s Growth Strategy and the Public-Private Investment Roadmap position drug discovery and advanced medicine as growth sectors and promote public-private investment spanning from research and development to real-world implementation. These policies must be translated into improved patient access to innovative technologies and tangible results in clinical settings.

With regard to preventive healthcare, the Ministry of Health, Labour and Welfare’s “U.E.N.O. Plan: MHLW Measures for Proactive Preventive Healthcare” sets out health promotion through proactive intervention by government, insurers and others, in addition to improving health literacy. It is important to promote evidence-based health checkups and screenings, while ensuring that their results reliably lead to any necessary follow-up examinations and treatment, so as to achieve early detection of and early intervention in disease and to prevent disease progression. By leveraging medical devices, IVDs, AI and other technologies to advance disease risk assessment, early detection and support for appropriate healthcare-seeking in an integrated manner, it is expected that we can contribute to extending healthy life expectancy and enabling continued social participation.

To enhance the effectiveness of these initiatives, it is necessary to securely link and utilize data from health checkups, medical care, long-term care and other sources, and to visualize and optimize the entire course from prevention to diagnosis, treatment and the patient’s subsequent life. Through Patient Journey analysis using real-world data (RWD) and the implementation of DX solutions, it is possible to identify delays in seeking care or transitioning to treatment, avoidable tests and procedures, and regional differences in care pathways, thereby pinpointing issues in the care process and leading to improved and optimized collaboration across professions and facilities. It is also important to verify the effects of introducing technologies across the entire care pathway, considering not only the performance of individual tests and procedures but also patient burden, time to treatment initiation, health status and healthcare resource utilization, and to link these findings to the realization of a sustainable healthcare delivery system.

In the real-world implementation of AI, Software as a Medical Device (SaMD) and similar technologies, it is essential to adopt the perspective of delivering patient benefits, such as rapid diagnosis and treatment and ensured access to necessary care, by reducing the workload of healthcare professionals. This requires mechanisms that appropriately evaluate clinical value and contributions to the healthcare delivery system, transparency and predictability in regulatory approval and insurance reimbursement, and an environment that supports continuous verification based on post-introduction data. Furthermore, through such continuous verification, care offering little patient benefit should be reviewed and the freed-up healthcare resources redirected to effective prevention and innovative diagnosis and treatment, with the aim of simultaneously improving the quality of care and optimizing healthcare expenditure.

At the same time, a stable supply of medical devices and IVDs is an indispensable condition for ensuring the continuity of healthcare. To respond to rising raw material and logistics costs, exchange rate fluctuations, geopolitical risks and other factors, it is necessary to strengthen the resilience of international supply chains and to establish systems that support supply structures, including quality maintenance, servicing and human resource development. In addition, in the utilization of medical information and the dissemination of digital technologies, it is important to ensure personal data protection, cybersecurity and interoperability, and to create an environment in which international expertise and technologies can be leveraged.

Promoting healthcare DX has become an urgent priority for building a sustainable healthcare delivery system. The EBC Medical Devices & IVD Committee regards the promotion of DX in Japan’s healthcare delivery system as one of its key priorities, and since 2021 has operated a Digital Health Task Force guided by the basic policy of “promoting DX premised on ensuring appropriate cybersecurity (CS).” In 2026, the Committee further expanded its scope of activities, establishing and operating multiple working groups related to DX.

The EBC Medical Devices & IVD Committee will continue to advance evidence-based policy recommendations, drawing on knowledge of technologies and systems in Europe and other overseas regions, the expertise of its member companies, dialogue with government, academic societies and clinical settings, and collaboration with related domestic organizations. Through prevention and early diagnosis, the development and real-world implementation of highly effective DX solutions, innovation assessment based on patient benefit, the utilization of medical data, and ensuring a stable supply, the Committee will enhance the quality and sustainability of Japanese healthcare, promote value creation for clinical settings and appropriate investment in innovation, and contribute to fostering international cooperation.