Human Factors and Usability Testing
Optimize your medical device success. Place your devices in the hands of real users to validate safety and usability throughout development. Our comprehensive testing identifies issues early, provides continuous improvement feedback, and supports FDA compliance for devices considered most at risk for user error, helping you bring optimized, safer medical devices to market faster.
What is Human Factors and Usability Testing?
Human factors and usability testing evaluates both the user interface and the information provided to the user by the device. At Element, we conduct testing throughout product development to identify potential risks associated with use in clinical or home environments, helping reduce user error and improve device safety.
What Can Element Offer You For Human Factors and Usability Testing?
Products we test
Products we test
At Element, we test medical devices in both clinical and home environments, evaluating user interfaces, device labeling, instructions, and training materials. Our testing validates safe use and correct interpretation of device information for both clinicians and patients, considering how medical conditions could affect device use. The evaluation covers both the physical device interface and all supporting documentation to validate total system safety.
Key tests offered
Key tests offered
We provide formative testing during device development with continuous feedback for improvement. Summative testing validates your final device version, including user interface, labeling, instructions, and training. Post-market testing is available to improve device usability and support marketing claims. Each phase includes evaluation of both the device interface and information provided to users.
There are two stages of human factors, or usability, testing:
- Formative usability testing
- Summative usability testing
Methods and solutions offered
Methods and solutions offered
We recruit volunteer users based on your product's intended population, whether healthcare professionals or home users. Testing occurs at Element facilities or through home visits where we provide device training, observe usage, document interactions according to specific evaluation criteria, and deliver comprehensive feedback for your development process or regulatory submission. Our detailed observations identify abnormalities and potential use errors that could impact safety.
Formative Usability Testing:
This occurs during device development, with continuous feedback to refine performance. It's an iterative process that allows for early identification of potential issues and ongoing improvements based on participant input and design team insights, reducing costly changes later in development.
Summative Usability Testing:
This validates the final device, including user interface, labeling, instructions, and training materials. It’s conducted once the device is finalized, and can also be done post-market to improve usability or support marketing claims.
Which labs offer this service
Which labs offer this service
Element Boulder specializes in clinical validation testing for medical devices and wearables. For more than three decades, we have proudly served as the premier clinical testing and regulatory validation partner to the medical device, wearables and consumer electronic industries.
We help navigate complex regulations and discussions with regulatory bodies while meeting FDA requirements for human factors review. This is particularly important for devices the Agency considers most at risk for causing harm due to user error, where proper testing and documentation are essential for approval.
Standards we test to and products we test
- ANSI/AAMI/ISO 14971 - Medical Devices - Application of Risk Management to Medical Devices
- ANSI/AAMI/IEC 62366-1 Medical devices — Part 1: Application of usability engineering to medical devices
- AAMI/ANSI HE 75 – Human Factors Engineering – Design of Medical Devices
Applicable regulatory guidance:
- FDA Draft Guidance Document - List of Highest Priority Devices for Human Factors Review: Guidance for Industry and Food and Drug Administration Staff
- FDA Guidance Document - Applying Human Factors and Usability Engineering to Medical Devices: Guidance for Industry and Food and Drug Administration Staff
Clinical devices
- Duodenoscopes
- Clinical diagnostic tools
- Clinical therapeutic equipment
Home use devices
- Insulin delivery systems
- Home health devices
- Patient-operated medical equipment
Your Challenges, Our Solutions
Safe device use validated
FDA requirements met confidently
Development process optimized effectively
User feedback integrated systematically
Why Choose Element
Complete testing partner
FDA requirement expertise
Flexible testing environments
Population-specific testing
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