Spanning the Atlantic

    15th August 2017

    Medical Device Usability have four studies (one formative and three validation) to design, plan, prep, attend and report all in the States and all fielding within the next eight weeks.  We are excited about the scope of the studies, ranging from autoinjectors to complex surgical devices.  With seven team combinations travelling to destinations that include Chicago, Fort Lee […]

    EMA relocation will not affect CE marking

    4th August 2017

    The BBC story on Monday 31 July 2017, Race to host EU agencies relocated from London (, was an interesting read. Of particular interest for Medical Device Usability is to see where the European Medicines Agency (EMA), currently based in Canary Wharf (London), will end up being based with reports of a possible 21 states […]

    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 […]

    MDU research study accepted by AHFE

    22nd June 2017

    Delighted to have just got confirmation that our paper on usability outcomes will be published in the July American Human Factors and Ergonomics conference proceedings. The study is a culmination of almost 2 years of work, funded by ourselves. It involves a meta analysis of over 200 usability evaluation sessions, and looked at the relationship […]

    Recruitment – how hard can it be?

    19th June 2017

    FACT: There are more than 320 million people in the US. MDU gets a call …..…… “can you find the following, three groups of 18 participants for a study?” Well that sounds quite easy, 54 out of 320 million. So we wait for the brief ……….. THE BRIEF ARRIVES: We get told we need three […]

    Sharps prevention devices – simulated use testing

    2nd June 2017

    All new prefilled syringes are being developed with integrated sharps prevention features, typically a retracting needle that engages once the user has fully depressed the plunger. FDA guidance on sharps prevention features from 2005 asks manufacturers to conduct simulated use testing to show that the intended users can use the feature. The guidance recommends testing […]

    Busy month of May

    1st June 2017

    The month of May seems to have flown past. The office has been busy with preparations for future studies and final report writing for completed studies. A formative study report for diabetic research carried out in the first week of May was sent to our client a fortnight ago and another report for a surgical […]

    Pre-validation checklist

    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, […]