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.

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.

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.

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.

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

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.

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.

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.)

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.

• Worked on a diverse array of medical products for 50+ clients, across a variety of disease states and user populations
• Conducted over 250 explorative and formative studies and 50 summative validation studies
• Had no FDA rejections of our HF validation studies since our founding

• HFCSI was founded in 2006 in Los Angeles, California and operates in the U.S., Europe, Asia, and Australia
• Our team members have Master’s or Ph.D. level training in HF psychology, engineering and advanced research methods
• To date, we have conducted usability testing with a total of 3,000+ users world-wide…and counting!
• We cover HF/Usability needs in all phases of medical product development
• Our specialists can integrate seamlessly with your cross functional teams
• HFCSI adapts to tightening deadlines or changing requirements
• Our team maintains high standards of quality, service and on-time delivery
• We have a proven 12 year track record of successful performance

Though we have traveled the globe to conduct research with diverse user populations, we also have our own research facility space at our headquarters in Los Angeles.