Pre-validation checklist

PUBLISHED 15th May 2017

We often get asked how to tell if a medical device is ready to put into a human factors validation study. Validation is a critical step. You only want to do it once, and you don’t want there to be any nasty surprises. Especially if you have submitted your validation protocol for FDA comments.

So, how can you tell if your device is in a fit state to validate?

Here is the checklist we use with our clients. Of course, these points are based on our experience. All devices are different, and a checklist can only ever be a guide to what’s important. So the key questions to ask yourself are:

  • Critical tasks – have you evaluated all critical tasks in formative studies?
  • Unexplained use errors – have you seen use errors that you cannot explain?
  • Design review – have you conducted a final design review, and do you believe that the design is fit for purpose?
  • Serious use errors – are you confident that you have uncovered ALL serious potential use errors?
  • Known use problems – do you know the known use problems with similar devices (for example current models, competitor products)?
  • Residual risk – are you certain that you have reduced the residual use-related risk to a level that is acceptable to you as the manufacturer?

There are of course other considerations, such as your clinical program, the business pressures to launch products on time, available budget etc. But by asking yourself a few fundamental questions you can focus on what’s important to get right before you commit to the validation study.