Human Factors and Usability Testing

Get FDA Support Without Breaking the Budget

In both early stage design and late-stage usability validation, nuances of human behavior will affect the medical device design process. Contextual, hands-on observational research is critical for optimizing your product and gaining FDA approval.

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The 4 Stages of Medical Device Usability Research

Stage I

Heuristic Study

Stage II

Formative

Stage III

Summative

Stage IV

FDA Submission

Develop Your Market Access Strategy

Steps for Heuristic Evaluation

  • Conduct heuristic evaluation and report
  • Develop test plan for formative evaluation
  • Submit to FDA for preliminary review

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Steps for Formative Evaluation

  • Revise test plan based on FDA feedback
  • Conduct formative evaluation
  • Write formative evaluation report
  • Submit to FDA for secondary evaluation

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Steps for Summative Planning and Evaluation

  • Develop test plan for summative evaluation
  • Submit to FDA for review
  • Revise test plan based on FDA feedback

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Steps for FDA Submission

  • Conduct summative evaluation
  • Write human factors validation report for inclusion in 510(k) submission
  • Submit to FDA for Final review
  • Revise test plan based on FDA feedback

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We help medical device companies develop strategies that fuel cost-effective innovation and improve patient outcomes.

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Let’s work together

Interested in discussing a potential project? Head to our contact page and submit an inquiry providing some additional information about your engagement. Feel free to describe project goals, deadlines, and budget. We will reply within 24 hours to discuss in more detail.

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