With the revision of the EU medical devices directive that entered into force last year stricter requirements on usability engineering have entered into force. The very first essential requirement under that directive was changed to that effect and provides that this includes:
— reducing, as far as possible, the risk of use error due to the ergonomic features of the device and the environment in which the device is intended to be used (design for patient safety), and
— consideration of the technical knowledge, experience, education and training and where applicable the medical and physical conditions of intended users (design for lay, professional, disabled or other users).
A manufacturer must reflect in his technical file that these points have been addressed and must continuously update his technical file on this point through PMS and gather information for this purpose. For manufacturers that want to involve users more actively in all stages of a device’s life cycle but would like a structured model for this, the model developed by researchers of Brunel University that I came across may be very interesting. It looks like this:
The charm of the model is that it is well thought out in the way it fits on the boxes that must be ticked under the essential requirements (e.g. covers all user types mentioned in different stage of the life cycle of the device) and adds some options for user involvement methods. On the other hand it leaves all the flexibility a manufacturer needs to adapt his technical file to the particular device. All in all a model well worth considering for a manufacturer that is looking for a model to capture user input in all stages of the device’s life cycle.