Research / Human Factors
Design begins and ends with the users
Application of Human Factors. Our focused innovation process relies heavily on user research and human factors evaluations to verify that user needs are satisfied, and safe, intuitive products are developed. Our expertise and understanding of the intended users, uses and use environments allows our staff to ensure design concepts take these elements into consideration.
The HSD Research and Human Factors team operates under the FDA’s HF Guidance, IEC 62366 Application of Usability Engineering to Medical Devices and AAMI/ANSI HE75 Human Factors Principles for Medical Device Design and examines a product’s potential use-related risks through heuristic evaluations, use-related risk analysis (URRA), formative and summative (HF Validation) studies, and other comprehensive methods.
We conduct Formative Studies throughout the development process to identify potential issues with the design and to support decision making throughout the project. We run Summative (HF Validation) Testing on devices ready for market with the intended users and use environments.
Clinical Connections. Our experience and network of affiliated healthcare professionals obtains valuable research data through case simulations, pre-clinical testing, and clinical studies.
Our capabilities in User Research and Human Factors include:
- Contextual Inquiry
- Design Strategy and Value Proposition Analysis
- Task Analysis, Use Related Risk Analysis (URRA)
- Usability testing/ Formative and Validation Studies
- Consent and Assent Forms
- Heuristic Evaluations
- User Needs Documents
- Study Planning/ Protocol and Recruiting
- Competitive and Analogous Analysis
- Human Factors Evaluation and Ergonomics
- Strategic Design in Medical Device and Instrumentation
OUR RESEARCH PROCESS
Pre-Study
Phase 0
- Project Scope
- Secondary Research
- Study Planning
- Generation of Analysis Tools
Data Collection
Phase 1
- Site Visits and Observations
- Human Factors Evaluations
- Usability Studies
Data Analysis
Phase 2
- User Behaviors
- Use Errors and Risks
- Data Management
Insight Translation
Phase 3
- Key Insights
- Product Requirements
- Visualize Findings
- Value Proposition
Contact Us
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HS Design, Inc. Headquarters
906 Mt. Kemble Ave
Morristown, NJ 07960
5900 Keyes St, Ste 102
Frederick CO 80504