Cambridge Human Factors course

    9th November 2017

    Great to see such a large, informed and interested group at the 3-day Human Factors course in Cambridge. At the invitation of Ron Kaye, I gave an update to the group on the latest developments at MHRA on human factors, and in particular their expectations from manufacturers. I also outlined the very latest news about […]

    Inhaler errors and asthma control – largest ever survey

    30th October 2017

    Over the past few years I have had the privilege of working on a very large European observational study which set out to investigate the scale of use errors when asthma patients use their inhalers. The CRITIKAL study set out to establish the scale of use error, and also (for the first time) to try […]

    13485:2016 ACCREDITATION

    17th October 2017

    Medical Device Usability have today been audited to the new 13485:2016 standard and have passed with no warnings. Having to complete the transition of our 13485:2012 Accreditation to the new standard 13485:2016, into an already busy schedule, where it is always business as usual and so as to not cause any disruption to our client’s […]

    Surgical medical device validation testing

    17th October 2017

    Last week saw five of the Medical Device Usability team at a pilot for a validation study at the SaIL (Simulation and Interactive Learning) Centre at St Thomas’ Hospital in London. The usability testing will be carried out on a surgical medical device, which we completed the formative testing for in May 2017 in Leeds. […]

    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 […]