Don’t underestimate the “small stuff”

Christina C. Mendat, PhD, Managing Director, Eurofins Human Factors MD

When most companies think of human factors testing, they think of the heavy hitter…the Human Factors Validation Test. This article focuses, instead, on presumed innocent “tweaks” that can be made to a product post-commercialization and oftentimes catches companies flat-footed. In the last six months alone, we have conducted several human factors efforts focused on addressing changes to a product’s design and/or labeling.

Case Study 1: Approximately 10 years ago, one of our clients conducted a human factors engineering program for a combination product to be used by healthcare professionals. Following many HF activities, the product went on to receive regulatory approval and has since been in successful circulation. The company, with supporting clinical data in hand, updated the indication to include an additional administration route that resulted in text updates and additional imagery for the product’s labeling, resulting in an FDA inquiry regarding the status of human factors activities. To address the agency’s question, our team updated the use-related risk analysis and conducted a human factors labeling comprehension test to evaluate the changes.

Case Study 2: To reduce the cost of goods (COGS) associated with manufacturing, a company updated several internal parts, and in doing so, some of the external characteristics were modified ever so slightly. When sharing the updated design with the FDA for review, they were asked if the human factors documentation had been updated to reflect the modifications and if testing data could be produced. Recognizing the device design had been modified, our team conducted a threshold analysis to assess whether any of the changes may have a potential effect on any critical use-related tasks. Taking a conservative approach, a small human factors test was conducted to evaluate if these changes had any effect on the safe and effective use of the product.

Case Study Outcomes: In both case studies, the human factors tests demonstrated that the design and/or labeling changes did not affect the safe and effective use of the products, were in fact minor, and did not introduce any other use-related risks.

Key Takeaways: A small update to the device itself and/or the labeling may seem minor, but a lack of data to support this can be a roadblock to your updated submission. Rely on the experts that have been navigating this space for years – let us help you answer the questions before they are even asked. Be a step ahead.