Design and Human Factors

Bringing user-informed insights and human-centered design to medical, drug delivery and diagnostic devices.


Our ethos is human-centered. From industrial design to human factors to design research, we look at the world through the eyes of the people who matter most – the people whose lives we are changing, the patients who benefit from the solutions we innovate. Our in-depth understanding of the FDA guidance on human factors for medical devices and IEC-62366, carries our human-centered approach through the process with detailed documentation that meets the expectations of regulatory bodies.

Our Expertise

  • 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
  • Heuristic Evaluations
  • Concept Feedback Sessions
  • Packaging Design
  • Rapid Prototyping
  • Storyboarding
  • Instructions for Use (IFU) Design
  • Application of Anthropometric Data
  • CAD Surface Modeling
  • Gap Analysis for Human Factors Standards Compliance
  • Use-Related Risk Analysis
  • Human Factors Remediation
  • Human Factors Formative Evaluations
  • Human Factors Validation Studies
  • Human Factors Engineering/Usability Engineering Report

Case Studies