Aug 13, 2019

Many medical device companies have learned over recent years that early-use testing is not simply optional, but rather an important means to save time, money and effort during product development. But other firms that are less familiar with the process and still learning to understand the importance of such work.

“Companies that are still relatively new to human factors and its application in medical device development seem to have this idea that early use testing is ‘nice to have,’” according to Merrick Kossack, HFR&D Research Director at Emergo by UL.

“As companies start to evolve and ascend the learning curve of applying human factors, they start to incorporate it more and more, and they start to realize the benefits. Therefore, as more companies and project teams experience the benefits of early use testing, they start to include it more.”

Impact of early-use research on device development

Those comments came as part of Kossack’s participation in a roundtable sponsored by the Association for the Advancement of Medical Instrumentation (AAMI). The event focused on trends on how early-use research is impacting the development process for medical device companies.

A key to implementing early usability testing is to avoid the notion that the only way to do it is by recruiting actual users to perform a series of tasks with the product. Such an effort can require a significant investment of both time and money. If usability testing isn’t feasible, medical device companies should consider doing other forms of early evaluations such as cognitive walkthroughs, expert reviews or similar exercises for early-use testing.

Regulatory interest in product testing

The US FDA is looking for companies to do more than a “checkbox exercise” to demonstrate that they completed the appropriate product testing, according to Kossack.

“They want to look at your submission and how your design has evolved over time through efforts such as early-use testing or other formative types of evaluations,” Kossack said.

Specifically, FDA is looking for evidence that companies have identified potential use-related product issues and understand the risks associated with those issues. As follow-up, companies need to identify the steps taken to mitigate use-related issues and show that those steps were tested for effectiveness.

“By not doing the early use evaluations, it can leave the FDA wondering, ‘How did this design evolve?’ And if the agency is wondering about something, they’re going to request additional information, which means delays on getting the submission approved,” Kossack said.

Andrew Micek is Marketing Manager at Emergo by UL.

Related human factors resources from Emergo by UL:

  • Human factors user research for medical devices and IVDs
  • Webinar: Meeting US FDA expectations for human factors engineering activities