FDA Approved: A Human Factors and Usability Case Study

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FDA Approved: Creating and Implementing a Compliant Usability Engineering Process

Challenge

PMA supplement for usability updates not approved.

A medical device manufacturer made an update to the design of their Class III device to improve usability and promote proper care and maintenance, and they submitted a PMA supplement to the FDA for the changes. The PMA supplement included a human factors test report from a usability study intended to demonstrate the effectiveness of the changes. The company received a letter from the FDA expressing concern with the level of evidence provided by their human factors testing. The FDA noted that the recent usability study had focused on ease of handling rather than comprehensive safe and effective use, engaged company employees as study participants rather than unaffiliated representative users, and failed to demonstrate that risks related to the most critical aspects of device use had been appropriately addressed in the design and evaluated in testing. The FDA requested that the client conduct another human factors study that addressed these concerns, validating safe and effective use of the device by intended users.

Solution

Implementing a compliant usability engineering process.

The company called on R&Q to establish a usability engineering process compliant with IEC 62366 and FDA expectations for industry, and then to implement that process for this project. The R&Q team developed a usability engineering process to integrate with the client’s quality management system. R&Q created a strategy to implement this process for the design updates and developed a specification to meet all of the considerations outlined in IEC 62366. R&Q worked with the client’s engineering team to break down the device workflow into individual tasks users would be expected to complete, analyzing the risks associated with each one. Usability requirements were developed as testable criteria for evaluating the effectiveness of use-related risk mitigations. The team planned and completed another human factors validation study addressing the FDA’s concerns and demonstrated that the device could be used safely and effectively by representative users.

Results

The PMA supplement was approved.

R&Q completed the human factors validation study report and the client submitted it to the FDA. The FDA replied to inform the client that their PMA supplement had been approved! Also, a compliant process was established for the future.

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