Our company has a long history of performing human factors validation testing and authoring Human Factors Engineering Summary reports used in FDA submissions.
For over 20 years, our team members have planned and conducted human factors validation tests on dozens of different combination products and medical devices. Some of these devices include:
Identifying and recruiting the appropriate participants is fundamental to evaluating potential risks associated with using your medical device or combination product. We have experience testing a single user group of 15 participants up to twelve user groups totaling 180 participants. We have had the pleasure of working with a variety of participants, including:
Oftentimes the intended use environment is glossed over as not being overly important if you are testing the appropriate participants. We disagree! Instead, designing the appropriate simulated test environment is vital to truly understanding how your device will be used in real life. We have simulated the following test environments in validation tests:
How We Can Help
Our staff will develop an overall plan for testing your device based on our understanding of its intended use, the intended users, and the intended use environment. We will leverage the Use-Related Risk Analysis (URRA), developed by either your organization or ours, to craft appropriate test scenarios and knowledge questions that will evaluate the identified use issues. This information will serve as the basis for drafting a human factors validation test protocol for FDA review.
Once you have received Agency feedback, we will update the protocol (if necessary) before recruiting the appropriate participants and conducting the test sessions in one or more locations. Once completed, we will analyze the data and generate a concise human factors validation test report.
Finally, we can write up a Human Factors Engineering Summary report that will be included in your premarket submission. This document is your opportunity to tell a story that captures all the human factors efforts undertaken to design and develop a safe and effective product while also addressing any FDA feedback you’ve received. This is arguably one of the most important documents that, if poorly written, can jeopardize the likelihood of receiving Agency approval.
If you have a medical device or combination product that needs human factors validation testing, reach out so our highly experienced staff can help you develop a personalized solution that best fits your organization’s needs.