PDD gains re-certification to the latest standard for medical devices quality assurance

Following our successful transition in June to the latest 2016 revision of ISO13485, we were certified in November for a further 3 years for our client services in research, design, engineering, pre-production manufacture, verification and validation.

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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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Learning from real world use – complementing medical device experience databases through analysis of social media

An extract taken from Chris Vincent’s knowledge piece that discusses the growing use of digital platforms such as social media to understand how people really use medical products.

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Patient Centred Design – Is the Pharma industry playing catch up?

The consumer goods sector (FMCG, apparel, automotive, electronics) has always had greater freedom to explore design research in comparison to the Pharma industry, which is significantly more restricted. One of the problems with a stricter and more constrained set of rules is that it can curb innovation by creating limitations in the approach Pharma companies take during the development process and justification for when Patient Centred Design comes into debate. Often regulatory walls can slow the development of a new products and services and directly affect the time taken to introduce a new product to market.

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Alternate worlds – What can pharma learn from other industries?

In my recent blog post on patient-centricity, I highlighted that the pharma industry has over the past years embarked on a journey towards more patient-centricity and that this trend actually has broad support across key players. At the same time, even with the best of intentions, it will take time for this new ethos to be truly embedded in the business practices of all pharma companies.

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How much Human Factors Usability is needed to prove a device is safe, effective and usable?

In my career I have been lucky enough to gain varying perspectives on the role of usability during the development of medical devices. I’ve worked as part of a design team with a responsibility for concept generation, preliminary research and detailed design. I’ve also worked as part of a human factors team with a broader remit for integrating human factors process across an organisation. One thing experience has taught me is that there is no ‘one size fits all’ when it comes to usability work.

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Virtual Reality (VR) in healthcare – focusing on the user need

Last Thursday I got the opportunity to learn about the latest and greatest in VR and its applications in healthcare, courtesy of Health Tech Women. Over the course of 2 hours, the Virtual Reality Breakfast event in London showed how VR really is no longer just about video gaming and is being used to transform healthcare across a range of therapy areas.

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The Role of Human-Centred Design in Healthcare Reform and Transformation

All too often our health care is taken for granted, and we assume it will always be available to serve our community’s needs. The question is “How healthy are our healthcare facilities to handle the diversity of services and to produce healthy outcomes for an expansive and unprecedented market of six (6) living generations – all distinctively different with a diverse set of needs and priorities?”

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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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Human-Centred Design in Healthcare

As a resident physician, I know the challenges that hospitals face in providing good quality clinical care. Many of these challenges require more than just a better understanding of clinical knowledge; they require a deep analysis of the complex problems hospitals face, including a better understanding of the physical, cognitive and emotional needs of the different kinds of people who interact with each other in a highly stressful environment.

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VOKE – Nicotine inhaler licensed by the MHRA

As a designer I have always found the most rewarding products to develop are those that improve the quality of people’s lives: whether it’s medical equipment for new therapies, easier to use pharma devices, protective equipment for industry and defence or safety products for the rugged outdoors. Improving lives for me means delivering better and safer experiences and wellbeing, preferably also in a more efficient or sustainable way. There is a clear value attached to improving the quality of lives of users, so at the same time the endeavor is more likely to be a worthwhile to the producer also. At PDD we call this objective where parties win-win ‘Meaningful Innovation’.

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Can you teach an old brain new tricks?

Heart failure, Stroke, Cancer, Dementia, Malaria, Bird Flu or even Ebola – take your pick from the latest challenges in world health. Each account of these relative pandemics sweeping societies across the globe allude to being your next arch enemy, ‘the one you need to watch out for’. At the time of writing this blog, five of the major newspapers featured health related headlines including ‘Dementia patients cut loose’, ‘500,000 denied cancer drug’, ‘Statins health risk’, and ‘Superbugs will send us to the dark ages’ – it is clear that health is high on the public radar.

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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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