We are a strategic human factors research partner, providing medical product usability engineering services and research solutions for our global clients.
User Characteristic Research
Gain cutting-edge insights into your user population’s needs through our information analytics and user characteristic attribute assessments.
Patient Experience Research
Support your patient-focused product development process through our comprehensive patient experience research options.
Technical / Regulatory Analysis & Documentation
Ensure your medical product documentation needs are met with our quality system led HF assessments and usability documentation offerings.
Human Factors / Usability Research
Identify use-related risks, refine design, and enhance usability through iterative formative testing in preparation for your HF validation study.
Human Factors Support Service Offerings
Promote safety, compliance, and success at every stage through our comprehensive HF support services.
How can we guide your product life cycle success?
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Integrating HF Activities throughout the Development Process
We understand the challenges you face when bringing a new medical device, drug, and/or combination product to market. For the past 27 years, our passion has been to help our clients develop and demonstrate safe and effective products that proactively address regulatory requirements, increase product safety, and improve people’s lives. Listening carefully to our clients’ needs, we have developed various tools that not only support your HF requirements but reduce project and regulatory risk.
Target Product Profile
- Exploratory Key Stake Holder Research
- Patient Therapeutic Assessment Research
- User Characteristic Research
Phase 2 Clinical Trial
- Proposed Product(s) Assessment/Formative Studies
- Clinical Study Design Assessment
- Clinical Study User Material Development
- Known Use Problems Assessment
Phase 3 Clinical Trial
- Use Related Risk Analysis (URRA)
- Pre-Phase 3 Clinical HF Validation Study
- HF Documentation Development/Support
- Clinical Study Device Staff Training
Market Submission
- Commercial Product Use Evaluation
- Commercial Product Final Packaging Summative Testing
- Summary of Usability Report
Pre-Design Control
- Patient Experience Research
- Known Use Problems Assessment
- Information Sciences/Analytics
- User Characteristics Assessment
Design
- User Specification Development
- Risk Assessment Development/Review
- URRA
- Concept/Prototype Formative Studies
Development
- Packaging & Labeling Evaluations
- IFU Comprehension Testing
- Simulated and/or Actual Use Formative Studies
Validation
- Summative Testing
- Summary of Usability