Presentation (CTI)

OBJECTIVES: To review the challenges and opportunities for the use of real-world evidence (RWE) for medical devices (hereafter “devices”) in Japan.
METHODS: A targeted review was performed to identify literature on the challenges and opportunities for the use of RWE and specific examples of its use for devices in Japan from 2017, after key guidance was issued, to 2024. Full-text studies were identified using PubMed (MEDLINE) and the Japan-based CiNii database. Additional studies were also identified through a grey literature search of other publicly available sources. The challenges and opportunities for RWE generation for devices are summarized in the context of the evolving landscape for RWE in Japan. Specific use cases are also presented for the use of RWE for devices in Japan.
RESULTS: Several issues were identified concerning the use of RWE for devices including some that may be unique to Japan. Examples include lack of clarity among device manufacturers in Japan about how RWE can be leveraged, bias due to variability in device performance across different healthcare facilities or departments, and a short period during which new devices can be identified in claims databases. On the other hand, opportunities such as expansion of the availability of real-world data (RWD) for devices in Japan, including device-generated data, and the leveraging of RWD for post-marketing evidence are noted. Specific cases were identified whereby RWE was used for devices in Japan for marketing approval, post-marketing surveillance, and to support reimbursement decisions. Sources of data included claims databases, registries, electronic medical records, and device-generated data.
CONCLUSIONS: Despite an expansion in the availability of RWD for Japan some challenges exist in its application for devices - some of which are unique to Japan. However, there are clear opportunities and numerous success cases for the use of RWE for devices in Japan.