Risk Adverse: Avoiding deficiencies in submissions

Renée Bailey, senior manager, human factors engineering, BlackHӓgen Design explains how to avoid deficiencies in submissions with use-related risk analysis.

For companies seeking approval of their medical device in the U.S., the Food & Drug Administration (FDA)’s expectations often come as a surprise. While it is commonly known that the FDA applies serious rigor and scrutiny to their review of premarket submissions, many companies face challenges meeting these expectations and face delays or budget overages for several reasons. One deficiency area frequently identified is the Human Factors Engineering/Usability Engineering (HFE/UE) submission.

In a 2020 presentation by Medical Human Factors Network UK, the FDA reported that pre-market HFE submissions to FDA were deficient at an alarming rate. For example, of 228 submissions for 510(k) clearance, only 11 were ready for review upon first submission to FDA. Overall, FDA’s analysis showed that of 542 total HFE submissions, only 23, or 4%, were what FDA considered ready for the first time for review.

Expectations for including HFE during medical device development have been communicated since 2011 by FDA and since 2007 by international regulatory authorities. It may be tempting to think best practices integrating and executing the HFE process are a routine part of most medical device development programs; however, the statistics tell a different story. And an even bigger story is the costs manufacturers face due to these deficiencies.

When HFE submission deficiencies occur, the cost of course correction can be staggering. Costs may include go-to-market delays translating to a loss of projected sales revenue and repeating a full or partial HFE validation to collect data requested and expected by FDA. If the deficiency cannot be corrected within the time designated by the FDA (typically 180 days), additional user fees associated with the pre-market application may be required. Repeating an HFE validation or partial validation can introduce other complexities, such as exhausting a limited pool of hard-to-find end-users, like patients with rare conditions or healthcare providers within specific specialties.

Use-related risk analysis supports HF outcomes

Several decisions or strategies implemented in an HFE program increase the likelihood of experiencing HFE submission deficiencies. If the HF strategy is not integrated into the Regulatory Affairs (RA) submission strategy, or an HF validation is conducted as the only HFE activity without prior formative evaluations. Another contributor to deficiencies is making major modifications to the user interface or other integral HFE elements, such as intended users or use environments without formative testing prior to an HFE validation. However, the most common issues revolve around the Use-Related Risk Analysis (URRA).

To avoid the most common (and costly) HFE submission deficiencies, integrating risk management and development of a URRA with the HFE process early in product design and development stands out as the most important HF strategy. This is because the URRA is fundamental to the HFE process and ultimately helps demonstrate how the device user interface has been optimised for safety and effectiveness. The integration of HFE and Risk Management as a part of device design and development is a main tenet of the FDA’s expectations.

Include a URRA and start early

Per the FDA’s analysis, URRA issues contributed to 80% of the HFE submission deficiencies generated. Issues cited included not providing a URRA as part of the submission, using an unknown URRA process, and inappropriate selection of tasks evaluated based on the severity of associated harms, to name a few.

The FDA is clear in their HFE Guidance that use-related risks are a focus and priority related to HFE submissions. The FDA Guidance states that for “devices where an analysis of risk indicates that users performing tasks incorrectly or failing to perform tasks could result in serious harm, manufacturers should submit human factors data in premarket submissions.”

Use-related risks are identified and assessed through an integrated HFE and risk management approach. HFE analyses support risk management activities by identifying and documenting tasks and potential use errors that could lead to harm and the severity of the potential harm. HFE formative and validation evaluations are critical methods used to understand if the design of the user interface effectively reduces or eliminates use-related risks. This approach may also uncover new or unforeseen use errors or use-related hazards.

When Risk Management is implemented early as an integral part of the HFE process, opportunities exist to iteratively improve the design of the user interface and implement risk control measures. Risk control measures implemented to reduce use-related risks are tested through additional HFE evaluations ensuring risks during use are reduced or eliminated to the extent possible. Because risk-based HFE activities are integrated early in product development, the cost and effort to implement design changes are incremental compared to late-stage design changes.

The integrated, iterative approach to HFE and risk management is the most effective way to reduce the potential of deficiencies in a pre-market submission to the FDA. Thus, avoiding the previously mentioned costs of late-stage design changes, or worse, the added costs to resolve HFE deficiencies identified by the FDA after submission.