Utilizing User-Informed Insights and Human-Centered Design

Our human factors engineering and usability engineering (HFE/UE) support and testing services are based on deep expertise in risk management and an extensive understanding of human behavior, patient needs, and clinical environments.

Working with healthcare leaders around the world, we ensure their products meet the human factors requirements of the regulatory bodies that govern global healthcare markets, including IEC 62366 and guidance from regulatory agencies such as the FDA, MHRA, European Union (MDD/MDR), and PMDA. By maintaining an active dialogue with key regulatory bodies, industry leaders, and international organizations like the AAMI, our team stays up to date on current and forthcoming standards and regulations worldwide.

While we’re experts at identifying and mitigating risk, we also know that the benefits of human factors extend further. Our integration of formative usability studies into the design and development of our partners’ medical devices allows us to use these processes to iteratively identify and incorporate improvements into their products. 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 of therapeutic areas and geographies.


  • Usability plan
  • User and environmental assessment
  • Use specifications
  • Risk analysis and FMEA
  • Formative human factors testing
  • Summative (validation) human factors testing
  • Final HFE/UE report for regulatory submission
  • Instructions for use (IFU) design
  • Quick reference guide (QRG)
  • Concept generation
  • Front-end innovation
  • In-depth interviews
  • Contextual inquiry/clinical observations
  • Market analysis
  • Value proposition research
  • Design strategy
  • Product renderings
  • Appearance models
  • Participatory design
  • Concept feedback sessions
  • Packaging design
  • Rapid prototyping
  • Storyboarding
  • Application of anthropometric data
  • CAD surface modeling
  • Gap analysis for human factors standards compliance
  • Human factors remediation

Experience the Veranex Difference