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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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Why we need better UI in patient-used medical devices

It’s no secret that our healthcare bill is increasing. Worldwide, healthcare spending is at a record high, and an expanding and aging population means this shows no sign of slowing down any time soon.


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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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Highlights from Pharmapack Paris 2014

Pharmapack 2014, Europe’s main exhibition for pharma and healthcare packaging and drug delivery, has been another successful event for the PDD medical team. Attended by our well-connected Head of Medical Alun Wilcox and me – Sergio Malorni, we had many meet-ups with our past and current clients where we discussed their latest developments and initiatives. Likewise with our simple and clear message, our stand attracted other pharma reps new to us wanting to know how we can potentially respond to their many product development and usability engineering challenges. Let’s see what develops for us in the coming year. As for the exhibition the appropriate size and quality of suppliers and conference talks made this event well-liked; the show was focused which make it attractive for decision-makers to attend.


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Surgical Innovation – Pioneering doctors and devices

Surgery is a fascinating branch of medicine; rooted in science, yet still very much a craft and (whether we like it or not as a patient) frequently dependent on the skills of improvisation by the surgeon and their team. Surgery has come a long way since its early days but the pace of innovation has anything but slowed down. On the contrary, new technologies are creating new possibilities to improve safety and efficacy of procedures, and cost pressures are creating an imperative to achieve more with less.


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Planes to Pains: Human factors taking off in healthcare

When I graduated with a BSc in Ergonomics (Human Factors Design) in 2011, it was clear that the subject is neither widely known nor greatly recognised, in fact I am constantly corrected that I did Economics at University. However, it was also apparent that certain industries placed great value in the area I had studied for three years; these were mainly energy, rail, aviation and defence – all big industries with a lot to lose if something were to go catastrophically wrong. It is therefore baffling to think the same attention to human factors isn’t apparent in healthcare.


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Using immersion in the hospital environment to identify innovation opportunities

A global medical device company recently approached PDD with a request to identify product innovation opportunities*. Our human-centred approach for such projects typically involves full immersion in the environment of the user and this project was no different. In this post, I will share some of my experiences of working in the hospital environment, the techniques used, and just generally what I enjoyed from my time in the field.


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The medical consumer

I recently watched a TED talk by Joseph Pine entitled ‘What Consumers Want’ (2004), where he talks about an “important change to the very fabric of a modern economy” and takes us through the evolution of ‘economic value’. The journey begins with a commodity-based economy, advances to a goods-based economy, and then progresses to a service-orientated economy. He points out that as a population we are moving past pairing economic value with services delivery, to regarding experiences as the “predominant economic offering”.


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