Transform Informal Human Factors Work into Submission-Worthy Content

By Emilee Stanczyk and Suruchi Batra 

Any product development process is inherently a lot of work, and there are many Human Factors (HF) activities that the U.S. Food and Drug Administration (FDA) suggests you complete, such as user research, known problems analysis, use-related risk analysis, formative evaluations and HF validation tests. Additionally, such HF work must be formally documented and organized into a comprehensive human factors engineering (HFE)/usability engineering (UE) report. In some cases, manufacturers perform relatively informal tasks that serve as inputs to formalized HF documentation without realizing they are completing HF-related activities. In this article, we will describe how to identify informal HFE work and then leverage it into formal HFE-report worthy content. 

One stigma around HF work is that it needs to be formally and intentionally planned, when in fact, many of these activities can be informal and might happen naturally through an instinctual product development process. 

Commonly overlooked “informal” human factors activities 

For example, a manufacturer that conducts an internal design review might not realize that the review can be considered an “expert review” falling under a formative evaluation. Or, a manufacturer that adds a few line items to their use-related risk analysis because they read an article about issues with a competitor product in the news might not realize that they’re inadvertently conducting part of a known problems analysis. Another example is a small research effort, such as conducting user research and interviews with a few participants to gain key inputs that impact design requirements and intended use. All these tasks can and should be considered formal HF work, even if not intended to be. 

How to document human factors activities 

HF work does not need to be formally documented, but the more detail collected through various seemingly unrelated activities, the more benefit manufacturers will gain. The essential information to collect and record includes: 

1. Parties involved 

Three human factors specialists participated in an expert review… 

2. Key results 

It was determined that the Instructions for Use (IFU) were unclear because… 

3. Resulting design and/or documentation updates 

The IFU and use-related risk analysis (URRA) were changed to include… 

Where to document human factors activities 

Any HF work should be captured within your HFE/UE report, even if an “informal” activity. For example, an expert review with internal HF specialists should be documented in Section 6: Summary of preliminary analyses and evaluations, or an informal web search on common problems with competitor devices should be documented in Section 4: Summary of known use problems. 

Documenting human factors activities = telling the [design process] story 

Documenting HF activities in an HFE/UE report is a manufacturer’s way of “telling their design story.” Think of this as explaining how a group of pieces are molded and shaped into puzzle pieces and then ultimately fit together to create a masterpiece. Regulatory reviewers are looking for an explanation of how manufacturers arrived at their destination and want to understand why they ultimately took that path. Informal activities influence decisions that eventually lead to final outcomes, and it’s important to explain that process. 

The goal here should be to write a compelling narrative that describes how an idea was taken and incorporated into the final submission, including details about the final product design and associated documentation (e.g., use-related risk analysis, HF validation protocol). Below, we walk through some examples of initial, informal work that can be used to demonstrate a thorough HF process and tell the design process story. 

• Example 1: Conducting web-based user research can help determine demographic information that informs your user groups. This information can then be used to identify performance-shaping factors, which will help you craft recruiting criteria for future usability testing. 

• Example 2: Internal design sprints can help identify design strengths and opportunities for improvement, which can be used to select key design features for implementation. This information will help determine use-related risks, which will serve as inputs for future design mitigations. 

• Example 3: Use environment observations can help detect any environmental constraints that might impact a product’s workflow and task breakdown. This will help craft the correlating task analysis, which leads to identifying potential use errors. 

We recognize that conducting and documenting HF activities is no small effort. The goal of any HFE report should be to demonstrate your thorough and comprehensive HF approach by telling your design process story. We hope this article helped show how to “take credit” for the activities already being performed and make the most of a significant HF investment. No activity is too small to include. 

Please contact our team to learn more about how to transform informal work into submission-worthy content. Or, sign up for a complimentary account with our human factors software, OPUS, Emergo by UL’s software platform that provides human factors engineering (HFE) training, tools, and templates.   

Emilee Stanczyk is a Managing Human Factors Specialist at Emergo by UL and Suruchi Batra is a Senior Human Factors Specialist at Emergo by UL.