2025.10.15

Challenges and Opportunities for the Use of RWE for Medical Devices in Japan

We were very please to present a review of the challenges and opportunities for the use of real-world evidence (RWE) for medical devices in Japan at the ISPOR Real-World Evidence Summit in Tokyo in late September 2025. This is a hot topic in our industry now given that medical devices are often approved based on limited data compared to pharmaceuticals, which can make the assessment of their value challenging.

Our poster was titled, "A Review of the Challenges and Opportunities for the Use of Real-World Evidence for Medical Devices in Japan". In hindsight, however, the title probably should have been "A Review of Opportunities and Challenges...", in that order, because Japan has a great infrastructure for data these days and it seems like more and more examples of the use of RWE to support medical device submissions can be found. However, challenges remain, such as difficulty with setting up and managing registries across multiple facilities and a lack of unique device identifiers (UDI) in insurance claims databases to examine the benefit of specific products (as opposed to different types of products).

For more information on the opportunities and challenges for the use of RWE for medical devices in Japan, please visit the ISPOR website here and view the poster that we presented in collaboration with Ark Medical Solutions, a Japan-based CRO. You can also access the publications we referenced on the site here.

Despite the challenges with preparing RWE for medical devices, we were very pleased to see strong representation from medtech companies at the ISPOR RWE Summit, including numerous medtech-focused poster presentations and sessions. There were great presentations by researchers from Smith+Nephew, Medtronic, Boston Scientific, ZOLL Medical Corporation, BD, etc. So, it's clear that RWE is a vital topic for medical devices and diagnostics! Most of those posters can be found on the ISPOR site here. In particular, the poster by Smith+Nephew, which utilized a novel database to examine cumulative revision rates overall and between unicompartmental knee arthroplasty (UKA) with robotic assistance and manual instrumentation, was rather interesting as it exemplifies a very meaningful collaboration between the industry and the academia and providers to establish a new multicenter data source.

Please drop us a line if you would like to discuss the use of RWE in Japan or if you need support with designing and conducting a RWE study for a medical devices or IVD in Japan. Please also let us know if you will be at the ISPOR Europe meeting in November so that we can meet up in person.

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