articles

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 […]

Today, I’d like to begin this blog with a simple question.  What does “the best user experience” mean to you?  If an answer came to mind right away, it’s probably because that experience moved you so deeply that it engraved itself into your memory. And yet, the more powerful an experience is, the harder it often becomes to explain why it […]

As a UX researcher, I’m trained to observe the subtle ways people interact with the world. Within the last few years, a fascinating pattern has emerged among my peers, friends, and in my own digital life. It’s a four-letter code that has become a new kind of language: MBTI*.  * Short for the Myers-Briggs Type Indicator, a self-reported questionnaire that assigns people to one of 16 […]

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 […]

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 […]

Introduction  As UX researchers, we depend on real people to understand their needs, frustrations, and emotional journeys.  But what if we could simulate those people instead?  With generative AI evolving so quickly, there’s been growing interest in using “synthetic users”, meaning AI-generated personas that respond to research prompts as if they were real. These virtual […]

Japan has a long history of taking ideas from other cultures and refining them into something uniquely Japanese. Toilets are no exception. They’ve been transformed into high-tech marvels, complete with heated seats, bidets, dryers, self-cleaning functions, sound masking, all integrated into a compact Washlet.   But here’s the twist. For something so advanced, there are countless […]

Empty space, leaving things out, can speak more strongly than putting them in, and I think that’s very Japanese. — Hiroe Swen (Ceramic Artist) Ma (間), meaning gap, pause, or space, is a spiritual concept of emptiness deeply rooted in Japanese art and culture. It represents the beauty found in the space between things and […]

Studying abroad, I stumbled upon an app that quickly became a daily essential: Too Good To Go. This wildly popular European platform transforms leftover food from cafes and restaurants into “magic bags”, at a wallet-friendly price. Every time I placed an order, I’d find myself eagerly heading to the venue, wondering what goodies awaited me […]

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. […]