Human Factors Engineering

Mitigating Risk by Design

Designing safe and effective healthcare products requires expertise in risk management and a deep understanding of human behavior, patient needs, and clinical environments. We partner with healthcare leaders around the world to ensure that their products meet the human factors requirements of the regulatory bodies that govern global healthcare markets.


We’ve conducted hundreds of successful formative and summative usability studies for drug delivery and medical devices, engaging thousands of patients, caregivers and healthcare professionals across a diverse range therapeutic areas and geographies.


Our global human factors team strictly adheres to International Standards like IEC 62366 and guidance from regulatory agencies such as the FDA, MHRA, the European Union (MDD/MDR), and PMDA. We maintain an active dialogue with key regulatory bodies, industry leaders, and international organizations like AAMI to ensure our team is up to date on current and forthcoming standards and regulations worldwide.


While we’re experts at identifying and mitigating risk, we recognize that the benefits of human factors extend far beyond risk management alone. We integrate formative usability studies into the design and development process and use them as an opportunity to iteratively identify and design improvements for our partners’ products.


Usability Plan
User + Environmental Assessment
Use Specifications
Risk Analysis + FMEA
Formative Human Factors Testing
Summative (Validation) Human Factors Testing
Final HFE/UE Report for Regulatory Submission
Instructions for Use (IFU)
Quick Reference Guide (QRG)
Multimedia Training Materials
Formative Usability Evaluations
User Acceptability Studies
Packaging + Labeling