Medical Device Human Factors

Download our Medical Device Human Factors handout.

Exponent understands user-device interaction and can assist throughout the medical device life cycle,  from development through the regulatory submission process and post-market activity.

Exponent’s human factors and usability engineering (HF/UE) professionals provide the necessary expertise, services, and facilities to enable rapid and uninterrupted execution of important product development, testing, and marketing/registration activities.

  • Preparation of robust FDA and EU regulatory submissions
  • Design and testing of device labeling and effectiveness of instructions for use (IFU), including 
  • warnings and caution statements
  • Risk assessment support based, among other things, on postmarket surveillance data analytics,human factors failure mode and effects analysis (FMEA)/usability hazards, and fault tree analysis
  • Integration of multi-modal approaches for collecting behavioral, psychological, and physiological measures to support the design phase
  • Development support, creating robust and relevant preclinical validation testing that considers the interaction of device user groups, use environments, use scenarios, and user interface
  • Risk management planning and documentation of HF/UE testing for inclusion in design history file
  • Product liability and risk mitigation analysis (design, labeling/IFU)

We approach every client need through customized, multi-disciplinary teams.

Exponent’s approach to supporting the testing needed to meet regulatory requirements and global health authority expectations is fully customized and unique to each client. We assemble multi-disciplinary teams comprising thought leaders with both medical device industry and FDA experience. Our professionals have collectively published hundreds of peer-reviewed papers and hold positions on editorial boards and standards committees. Our teams are commonly composed of experts in the following disciplines:

  • Human Factors/Usability Engineering
  • Biomedical Engineering
  • Mechanical Engineering
  • Electrical Engineering
  • Regulatory Affairs
  • Health Sciences
  • Statistics and Data Sciences
  • Physicians and Nurses

We provide support as you need it and can lead you through all phases of design, registration, and postmarket activities. We provide the insight and experience needed to understand and mitigate use-related hazards and risks so that customers and patients can safely and effectively operate medical devices.

Human Factors and Usability Engineering Services Spanning the Total Product Life Cycle, Including Premarket, Development, Risk Management, and Postmarket Activities

User Group Evaluations

  • Assess intended user populations, whether patients or medical specialists, and their unique cognitive, behavioral, developmental, and anthropometric characteristics.

User Requirements Gathering for Design Inputs

  • Identify user requirements by utilizing early design ideation, task analysis, contextual observation and inquiry, interviews, and focus groups.

Use-Related Hazards Analysis in Risk Management

  • Perform methods such as FMEA and FTA, task analysis, adverse event reporting analysis, heuristic evaluation, and expert reviews to identify and categorize possible and known use-related hazards and product failures.

Documentation & Labeling

  • Evaluate efficacy of warnings, labeling, and instructions for use based on standards, requirements, user comprehension testing, and user product interactions.

Formative Testing

  • Conduct user research to evaluate user interfaces through various methods, such as usability testing and measuring user performance, error rates, physiological responses, user preferences, and accident potential.

Simulated-Use Validation/Summative Testing

  • Comprehensive device evaluations to assess use errors, risk for harm, and risk management controls to evaluate whether the product is safe and effective for its intended use.

Postmarket Surveillance Support

  • Utilize adverse event databases to identify potential existing and emerging safety signals and conduct root-cause analyses.

We have the testing facilities, labs, and the recruiting resources to get it done.

  • Exponent’s Phoenix User Research Center (PURC) is a 6,000-ft2 multi-suite human factors and user experience lab equipped to support a wide variety of medical device usability research.
  • Biosafety Level 2 Facilities for cadaver specimen storage and dissection, including procedure suite with fluoroscopy.
  • Accredited & compliant biomedical engineering laboratories:
    • ISO 17025 accredited (A2LA Certificates 2561.01 through 2561.04)
    • ISO 9001 accredited (Quality Management System certificate FS 65829)
    • Fully compliant with US FDA Good Laboratory Practices (CFR 21 Part 58)
    • Equipped to test a wide range of medical devices and components



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