Medical Device Accessibility & Human Factors
Design safer, more usable medical devices — accessibility and human factors, built in from day one
We partner with product, design, engineering, and regulatory teams to strengthen usability and accessibility practices in alignment with FDA human factors guidance and industry standards.
What we do
Human Factors Strategy & Study Design
Support the definition of usability and accessibility approaches within your development lifecycle.
- Use-related risk identification aligned to FDA guidance (e.g., IEC 62366-1)
- Identification of critical tasks and potential use errors
- Input into formative and summative study design
- Inclusive recruitment considerations across disability characteristics
Accessibility Integration in Product Design
Embed accessibility into interaction models, workflows, and system behavior—not just UI layers.
- Complex interaction modeling (multi-step tasks, device + app ecosystems)
- Assistive technology considerations (screen readers, alternative inputs, low vision use)
- Design system and component-level accessibility guidance
- Cross-functional collaboration with UX, engineering, and regulatory teams
Formative & Summative Study Support
Enhance the quality and inclusivity of usability evaluations.
- Protocol review and recommendations
- Accessibility-informed test scenarios and moderation considerations
- Identification of gaps in participant representation
- Synthesis of findings with usability and accessibility insights
Documentation & Traceability Support
Help teams translate design and research decisions into clear, structured artifacts.
- Support for Human Factors Engineering (HFE) documentation
- Linking usability findings to design considerations
- Accessibility considerations framed within safety and use context
- Input into materials that may support regulatory submissions
Best for
- Early concept and interaction design
- Design system and platform development
- Pre-validation and validation preparation
- Post-market improvements and remediation
Why it matters
Medical devices are only safe and effective if they can be used as intended by the people who rely on them. Accessibility contributes to reducing use-related risk, supporting adherence, and improving outcomes across a broader range of users.
How can we help?
We'd love to learn what you're working on and recommend the best path forward.
Ready to build something people can actually use?