What We Do

We build and run human factors and usability engineering programs for medical device, drug delivery, and AI-enabled product companies — from early-stage research through FDA/EMA-ready validation.

Our services:

• Human Factors Consulting

• Human Factors Strategy & Planning

• Formative and Summative Usability Studies

• Use-Related Risk Analysis (URRA) & Patient Safety Risk Analysis

• User and Usability Research

• Data Services (biometric, anthropometric, and behavioral data collection)

• Team Building — hiring, procedures, and templates to stand up an in-house HF function from the ground up

Why It Matters Now

With evolving FDA and EMA requirements, human factors and usability engineering are more critical than ever. Don't get surprised at end-stage validation or during filing. We identify use-related risks early and flag where design, labeling, or training changes are needed — before they cost you a submission delay or rejection.