Recruiting Participants for Medical Device Usability Evaluations in Japan: A Practical Guide for PMDA Submissions
As UX researchers specializing in medical devices, we often receive questions from manufacturers outside Japan who are looking to enter the Japanese market. One of the most common is: “How should we recruit participants for a usability evaluation in Japan?” While you might be familiar with established practices for usability testing in the U.S. and Europe, […]
Sample Size and Test Environment Requirements for PMDA HFE Submission: A Practical Guide for Validation Studies in Japan
PMDA’s overall HFE mindset is aligned with international regulatory frameworks, but expectations in certain areas can differ. In particular, PMDA takes a distinct approach to topics such as sample size determination and test environment considerations. This guide outlines key points based on the implementation of JIS T 62366-1:2022 and current PMDA expectations. Sample Size PMDA does not […]
Human Factors for Medical Devices in Japan: What Global Manufacturers Need to Know
As Human Factors Engineering (HFE), commonly referred to as Usability Engineering (UE) in Japan and the EU, becomes a core pillar of safe and effective medical device design worldwide, international manufacturers may find themselves asking, “How is usability evaluated in Japan?” In the US, the FDA requires a formal HFE/UE report* for most Class II […]
Beyond Clicks: How Behavioral Science Transforms Health Apps
Have you ever committed to losing weight, downloaded a health app, and then quit after a few days? You’re not alone, and you’re not to blame. In a world saturated with digital innovations, countless apps and services are designed to support healthier living. Yet changing health behavior remains difficult. It requires not only adopting new […]