Latest FDA Expectations for Conducting Human Factors Validation Tests of Combination Products

FDA outlines its fundamental expectations for applying human factors engineering (HFE) to combination products in its published guidance documents. These documents clearly communicate that applying HFE during development is essential to supporting claims that combination products are safe and effective. While some of these documents apply to medical device and combination products alike, FDA describes its expectations specific to combination products via multiple formal guidance documents, including Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development [draft], issued in February 2016.

While helpful, the guidance leaves room for interpretation, and it can be challenging to verify that your planned approach to various activities, including the key HF validation test, reflects FDA’s evolving expectations for implementing this guidance. During recent conference presentations and letters to Sponsors, FDA has expressed several new and often nuanced expectations related to the preparation, conduct, and reporting of data from HF validation tests of combination products.

The experts from Emergo by UL’s Human Factors Research & Design (HFR&D) team will share insights learned from helping numerous pharmaceutical companies interpret and respond to FDA’s feedback and latest expectations.

During the webinar, the presenters will cover the latest FDA expectations regarding activities such as:

• Identifying critical tasks from a comprehensive use-related risk analysis
• Determining the right user groups to include in HF validation testing
• Implementing representative training for test participants
• Presenting hands-on use scenarios in a suitably realistic and non-biasing manner
• Designing knowledge tasks to supplement hands-on use scenarios
• Reporting HF validation test findings
• Understanding modifications to FDA’s expectations due to the ongoing COVID-19 pandemic

Webinar attendees will come away with the latest insights about how to perform HF validation tests for combination products, and greater confidence that they are proceeding in a manner most likely to be acceptable to FDA.

PRESENTERS:
Andrea Dwyer is an Associate Research Director with the HFR&D team. A board-certified human factors professional, Andrea leads and oversees research activities required to meet regulators’ expectations for applying human factors engineering (HFE) during medical device development and particularly to combination products. She composes HFE project plans and helps medical device and pharmaceutical manufacturers develop key HFE documents for their design history files, including authoritative HFE reports and comprehensive use-related risk analyses. She frequently conducts workshops, speaks at industry events, and advises clients on how to implement HFE in the medical device development process. Andrea is co-author of Medical Device Use Error – Root Cause Analysis. She holds a B.S. in Human Factors and an M.S. in Engineering Management, both from Tufts University.

Allison Strochlic is the HFR&D team’s Research Director based in Concord, MA. Allison routinely advises clients on how to meet FDA’s and other regulators’ expectations, and frequently supports or leads clients’ meetings with FDA to discuss various human factors topics and concerns. Additionally, she contributes to and manages a wide range of research projects such as usability testing, contextual inquiry, and interviews. Moreover, she helps clients develop key HFE documents for their design history files. Allison is a board-certified human factors professional, and has undergraduate and graduate degrees in human factors engineering from Tufts University and Bentley University, respectively. She is a co-author of a book titled Usability Testing of Medical Devices and several technical articles, and she frequently speaks at industry events and in graduate-level university courses on human factors.

This webinar was recorded on June 25, 2020.