MHRA Human Factors Guidance for Medical Devices including drug-device combination products

    20th September 2017

    The UK’s Regulatory Agency MHRA has just published its Human Factors and Usability Engineering – Guidance for Medical Devices including Drug-device Combination Products. The guidance states that it is intended for “manufacturers of all device classes and developers of medical devices and drug-device combination products, and notified bodies responsible for assuring the quality of those […]

    Usability testing of auto-injectors and safety syringes

    18th September 2017

    One team left at the weekend for nine days formative testing in New Jersey, starting today. The study will be testing the usability of safety syringes and auto-injectors to deliver a new medication. Five different users group have been recruited to take part including patients, caregivers and Healthcare Professionals.

    MDU sponsors Essential Human Factors Gala Dinner 2017

    14th September 2017

    Medical Device Usability (MDU) is pleased to be sponsoring this year’s Essential Human Factors Gala Dinner at the Hilton Hotel, Cambridge on 8 November 2017. The Gala Dinner takes place on the second evening of the course, which runs from 7-9 November 2017. The course will be taught this year by Dr Bob North and […]

    How costly is postponing a Human Factors and usability study?

    1st September 2017

    Whilst everyone is keen to get the latest medical devices out on the market as soon as they have been approved by the regulators, this enthusiasm can be costly if the device isn’t ready for usability testing and the study has to be delayed too close to the original date, thus incurring costs from venues […]

    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 (http://bbc.in/2tQePsU), 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 […]