Medical device design and user interaction testing.
Medical device design challenges include technological complexity, interactivity with associated devices and services, and compliance with FDA and EU medical device industry regulations. Manufacturers and developers must integrate safety, anthropometrics, and different user environments into their product lifecycles to mitigate use-related hazards and risks.
Exponent's medical device support is a unique offering, combining scientific disciplines of human factors with mechanical and biomedical engineering to provide bespoke product support — from registration, to regulatory compliance, to post-market activities.
At our 6,000 square foot, multiuse Centers for Scientific User Research (CSUR) lab, we conduct simulated use tests, user group evaluations on intended populations, and use-related hazards analysis in risk management for a wide range of medical devices and components. We also offer documentation and labeling, and post-market surveillance support.
Download our medical device human factors brochure to learn more.
For 50+ years, we’ve thrived on solving unstructured problems that require bespoke solutions. Some of our services include:
• Preparation of robust FDA and EU regulatory submissions
• Design and testing of device labeling and effectiveness of instructions
• Risk assessment support based on post-market surveillance data analytics
• Risk evaluation with human factors failure mode and effects analysis/usability hazards, and fault tree analysis
• Multimodal approaches for collecting behavioral, psychological, and physiological measures to support the design phase
• Conducting robust and relevant preclinical validation testing that considers human interaction factors
• Risk management planning and documentation of HF/UE testing
• Product liability and risk mitigation analysis (design, labeling/IFU)
Our Capabilities Are Unparalleled
With expertise in over 90 disciplines and hundreds of capabilities, tools, and methodologies — we get to the root of even the most complex challenges and give you the objective answers you need.
Accident Investigation & Reconstruction: Human Factors
Multidisciplinary accident reconstruction to identify root causes, reduce risk, and improve safety.
Improve User Research & Testing
Human factors investigations for data-driven product and process design decisions.
Occupational & Process Safety
Expert consulting support for mitigating human behavior-related work and process safety risks.
Product Design & Safety
Human factors and risk analyses to help clients improve designs for a range of products.
Centers for Scientific User Research (CSUR)
Pioneering scientific user experience research across the full lifecycle of consumer, industrial, automotive, and medical device products.