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HFCSI provides a wide range of verification and validation services including (but not limited to):

  • Gap Analysis
  • Expert Heuristic Analysis
  • Formative Testing
  • Summative and Actual Use Testing
  • Prototype Testing and Down-Selection
  • Ethnographic Research
  • Marketing Research and HF Testing Integrated!
  • Post-Market Evaluation
  • IFU Development and Testing
  • Other needs? Contact us!

Gap Analysis

Evaluation of your product’s current design and documentation, and identification of any missing components needed to meet FDA and International standards. HFCSI can then specify a complete road map for providing all HF requirements needed for a successful submission.

Expert Heuristic Analysis

This is a fast, inexpensive way to determine major design issues before performing costly studies. HFCSI uses a mix of standard and proprietary techniques to produce this precision snapshot summarizing issues likely to result in critical use errors or significant usability problems.

Formative Testing

Exploratory and targeted studies to guide development and prepare you for validation. HFCSI’s capabilities include any testing needed, from early market explorations to pre-Summative “dress rehearsals”. We specialize in providing you with design-relevant data presentations.

Summative and Actual Use Testing

Comprehensive validation testing provides evidence for submission to the FDA and EU. HFCSI can handle all aspects of test design, recruitment, data collection, statistical testing and root cause analyses.

Prototype Testing and Down-Selection

Customized testing to evaluate the relative performance and/or preference of alternative designs your team is considering. Provides invaluable insights to guide early development.

Ethnographic Research

We can test completed products or advanced product prototypes in the field where users would use, or are currently using, your product. Both end users and/or HCPs can be studied.

Marketing Research and HF Testing Integrated!

HFCSI can perform early market studies or post-launch evaluations. We also offer unique combinations of marketing-oriented research with usability studies or human factors heuristic or performance studies. A blend of our techniques can provide important cross-functional insights.

Post-Market Evaluation

Gathering intelligence on how your product is performing in the field provides insights to guide future development. Methodologies are customized for each client depending on your specific objectives (e.g., to address known pain points, conduct general assessments of user
groups, gather subjective insights, compare international to domestic markets, etc.)

IFU Development and Testing

IFUs (Instructions for Use) are crucial for successful products & FDA submissions. Are your IFUs designed at the end of development?  Is your IFU production not user-centric (most are not!)? Are you experiencing a delayed approval due to an ineffective IFU?  If any of these questions sound familiar, contact us to discuss our Task-Driven IFU® devlopment and testing service.

Have "Other" HF/UX Needs?

HFCSI can provide other related analyses and customized services. Feel free to contact us to discuss your needs.