Meeting FDA Expectations for Human Factors Engineering Activities

FDA has provided industry with guidance on how to apply human factors engineering (HFE) to the development of medical technology in two primary documents: (1) Applying Human Factors and Usability Engineering to Medical Devices [final], and (2) Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development [draft], both issued in February 2016. The documents clearly communicate that HFE is an integral part of the product development process, and its application is crucial to mitigating use-related risks and producing medical devices and combination products that are safe and effective.

However, the guidance leaves some room for interpretation and, as one would expect, circumstances arise that call upon FDA to issue case-specific guidance to a manufacturer. Sometimes, FDA presents requests and clarifying guidance within additional information request letters following a submission. Other times – and, preferably, FDA provides such information in response to pre-submission materials.

Through their work supporting many medical device manufacturers and pharmaceutical companies, the presenters from Emergo by UL’s Human Factors Research & Design (HFR&D) team have gained numerous insights regarding how to address FDA’s formally and informally communicated expectations on various HFE topics. During the webinar, the presenters will cover such topics as:

• Developing comprehensive, convincing use-related risk analyses
• Casting a wider net to identify device user groups
• Implementing representative training during HF validation usability tests
• Taking special steps to evaluate generic or biologic products
• Preparing FDA pre-submission and submission documents to facilitate FDA review

Webinar attendees will walk away with new insights about how to perform human factors engineering activities, and greater confidence that they are proceeding in a manner most likely to be acceptable to FDA.

About the presenters:

Erin Davis is an Associate Research Director in Emergo by UL's Human Factors Research & Design (HFR&D) team. She earned her MS in human factors engineering from Tufts University and her BS in biomedical engineering from Marquette University. During her undergraduate studies, Erin served as a systems engineering and human factors co-op at Baxter Healthcare and interned with the FDA. At Emergo by UL, Erin develops and implements HFE programs and leads projects requiring expertise in user research, design, and usability testing of medical devices. She is a co-author of Medical Device Use Error - Root Cause Analysis.

Allison Strochlic is a Research Director in Emergo by UL’s HFR&D team. A board-certified human factors professional, Allison contributes to and manages research projects such as usability testing, contextual inquiry, and interviews. Furthermore, she helps clients develop key HFE documents for their design history files and advises clients on how apply HFE to meet regulators' expectations. Internally, she provides oversight to the team’s quality management system and associated procedures. Allison is co-author of Usability Testing of Medical Devices and several technical papers focused on applying HFE to medical device development.