Blog

Human Factors Research We help identify use-related risks early, improve designs with confidence, and build evidence to support PMDA review when needed. Learn More

Read More →

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, […]

Read More →
Medical device usability testing session in a simulated clinical environment with researchers observing a healthcare professional interacting with monitoring equipment

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 […]

Read More →
Healthcare professional conducting simulated usability testing with a patient mannequin in a conference room environment for PMDA human factors engineering validation in Japan

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 […]

Read More →
Laptop and notebook on a desk with a Tokyo skyline silhouette in the background, representing UX research and fieldwork in Japan.

Fieldwork in Japan 101: A Practical Guide for Overseas Research Teams 

Fieldwork in Japan often looks straightforward on paper, but projects can quietly lose quality through mistranslated stimuli, over-tight recruitment criteria, or session designs that ignore local communication patterns. Executing high-quality user research in Japan requires careful planning and awareness of local operational and cultural factors. This guide outlines our proven workflow across three phases:  Pre-Fieldwork Preparation […]

Read More →
夕食で使われた囲炉裏。燃え盛る炎の上に黒い鉄鍋が吊るされており、食事への期待感が高まる様子。

Why One Stay at a Traditional Japanese Inn Became an Unforgettable User Experience 

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 […]

Read More →
「MBTI」と書かれた木製ブロックを並べている画像。「M」の上には自己分析する人の、「B」の上には対話する人のピクトグラムが描かれ、MBTIが自己理解と関係構築のツールであることを象徴している。

The UX of MBTI: Why Gen Z is Building a New Protocol for Connection 

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 […]

Read More →
An illustration of philosopher René Descartes in a classic thinking pose. Beside him is the title of the article: "I Think, Therefore I Test: What Descartes Can Teach Us About UX."

I Think, Therefore I Test: What Descartes Can Teach Us About UX 

What can a 17th-century philosopher teach us about UX? Surprisingly, quite a lot. One of the most famous phrases in philosophy comes from René Descartes:  “I think, therefore I am.”  For him, this wasn’t just proof of existence. It was the starting point of an intellectual journey to find absolute certainty through radical skepticism. Centuries later, this […]

Read More →
An illustration of philosopher René Descartes in a classic thinking pose. Beside him is the title of the article: "I Think, Therefore I Test: What Descartes Can Teach Us About UX."

I Think, Therefore I Test: What Descartes Can Teach Us About UX 

What can a 17th-century philosopher teach us about UX? Surprisingly, quite a lot. One of the most famous phrases in philosophy comes from René Descartes:  “I think, therefore I am.”  For him, this wasn’t just proof of existence. It was the starting point of an intellectual journey to find absolute certainty through radical skepticism. Centuries later, this […]

Read More →

Posts pagination