Human factors testing and ethics approval – protecting you and us

14th July 2017

There are occasions where it is necessary to simulate a use scenario with a very high degree of realism. For example, a manufacturer approached us recently asking us to run a study which would have involved participants taking a sample of their own blood with a sterile lance. Not a problem in principle, but for […]

Sharks with laser beams

7th July 2017

(With apologies to Dr. Evil!) One of our clients has a saying, ‘Sharks with Laser Beams’ to describe the situation when you have been so convoluted in assessing the possible impact of use error that you end up with such a string of extremely unlikely events that all have to align to produce the harm. […]

Regulation (EU) 2017/745, what does it mean for usability testing?

5th July 2017

For those of you out there who thought usability testing was a small-time, unimportant aspect of medical device development (or are dealing with upper management who believe so), this new Medical Device Regulation (MDR) is further evidence (62366 and UCM259760 already making the point) to prove otherwise. Chapter 1 of Annex 1 of the Regulation […]