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 […]
For International Manufacturers: Key Usability Points for Japanese PMDA Submissions
What is Required to Market a Medical Device in Japan? If your company is planning to introduce a medical device to the Japanese market, you may be asking questions such as: In recent years, the PMDA has placed a clearer and stricter emphasis on usability engineering. They now require manufacturers to demonstrate compliance with JIS T 62366-1:2022, which […]
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 […]
Emerging Digital Healthcare Services in Japan: A Market Overview
Many people view Japan as a country with a strong focus on health, from its lifestyle to its cuisine. However, when it comes to the digital aspect of healthcare, Japan lags behind. Meanwhile, in the United States, digital technology has rapidly advanced, offering a variety of services like remote monitoring, telehealth, fitness, and wellness apps. […]
How to Recruit for Success in Japanese Medical Research
In the realm of healthcare research, Japan is a unique and challenging market. At Uism, we’ve been at the forefront of bridging the gap for international healthcare companies, and are proud of our track record of diverse projects in the healthcare domain. From conducting concept evaluations with medical professionals and patients, to validation testing of […]