Tag: healthcare
PDD completes its transition to the 2016 version of ISO13485 for Medical Devices.
PDD has completed its planned transition to the latest version of this rigorous international quality assurance standard for medical devices, building on the success of earlier transitions and successful audits to the FDA 21CFR Part 820 in 2015.
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FDA: Outlook on legacy devices
Chris Vincent and I recently attended an AAMI training course held in Dublin on Human Factors for Medical devices. EU manufacturers and consultancies all attended with the hope of having some questions answered by the FDA.
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“Measuring usability”: The siren song of quantitative reasoning
How do you measure usability? How do you really measure the efficiency of interface characteristics and user satisfaction in a way that can feed opportunities to develop and innovate? As a usability consultant, it is not that uncommon to be asked to evaluate usability. Some would even go so far as to say it comes with the territory.
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Innovation trends in Pharma and Medtech
Earlier this week, I attended an event at Imperial College on Innovation in Medtech. The event was well attended by academics and a diverse group of industry representatives from pharma and medical device companies, start-ups, consultancies and investors.
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Why we need better UI in Professional Medical Devices
As a follow on from my previous blog, with more technology being used to treat patients, user interface (UI) design is key to making devices safe and effective. Patients aren’t the only ones who need good UIs however, Health Care Professionals (HCPs) are more reliant than ever on technology to do their job and this is only set to rise. They – more than most – need informative, error proof UIs especially considering errors kill 12,000 patients a year in the UK and no doubt cause complications for many more. Here are a few design recommendations tailored to designing devices with the needs of health care professionals in mind.
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Human error or use error…Make the switch!
FMEAs (Failure Modes and Effects Analysis) are a common tool used in industry by device manufacturers to help members of R&D think of risk mitigation strategies to embed within their process whilst they are in the product development stages. FMEAs traditionally focus on system/component failures that can affect the operation of a device whilst UFMEAs (User Failures Modes and Effects Analysis) are intended to help members of R&D to focus on use-related errors. The term ‘Use Error’ has recently been introduced to replace the commonly used terms ‘Human Error’ and ‘User Error’, after the need to change the term was prompted by a high number of manufacturers commonly attributing errors to the users as opposed to investing in fixing error-prone device design.
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Human Factors: The art of asking a good question
In Human Factors the art of asking a good question that is non-leading yet to the point, simple yet scenario driven, open yet has boundaries to stop people going off on a tangent, whilst trying to get the user to answer as honestly as possible sounds like a breeze doesn’t it? Think again!
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A Doctor’s perspective on learning Human-Centred Design
During my internship with PDD, I participated in the LUMA Institute + PDD’s Human-Centred Design (HCD) for Innovation workshop that the PDD HCD team runs several times a year in London.
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