Design Changes after HF Validation: How to Assess a Change's Impact and Need for Supplemental Testing

It is common for HF validation testing to uncover usability issues, especially with critical tasks, leading to some common questions:

• Can we modify the design post-validation?
• Will those changes require further HF testing?
• What testing will need to be conducted?

Join experts from Emergo by UL’s Human Factors Research & Design team as they walk through how to assess the impact of changes implemented after HF validation testing and determine whether supplemental testing is necessary.

In this webinar, we will:

• Describe the use of residual risk analysis in determining the need for changes following HF validation testing.
• Explain the nuances of determining whether post-validation changes might require additional HF validation testing.
• Provide insight into how to scope a supplemental HF validation test based on the type and extent of changes.
• Clarify what changes are more likely to require additional HF validation testing, and how to assess these changes.

About the presenters

Laura Birmingham, Associate Research Director

Laura Birmingham is an associate research director with Emergo by UL’s Human Factors Research & Design team. She has been with the team since 2011 and has extensive experience applying human factors to a wide variety of medical devices, with a particular focus on complex medical systems and those used in clinical settings. She and Stephanie are both co-authors of the book "Writing Human Factors Plans & Reports for Medical Technology Development".

Stephanie Larsen, Managing Human Factors Specialist

Stephanie Larsen is a managing human factors specialist with Emergo by UL’s Human Factors Research & Design team. She has been with the team since 2012. She has experience delivering a variety of human factors services to the medical device, pharmaceutical, and therapeutic device industries, including extensive involvement in leading HF validation testing efforts.