Tag Archives: usability

Human Factors Engineering 101

We’re pleased to be presenting again at the Medical Device School in London, UK, later in November.  Matthew once again joins a panel of industry peers to provide delegates to the School with both an introduction to the world of Human Factors Engineering for Medical Devices and the opportunity for a practical application of HFE principles.

If you haven’t yet had an opportunity to find out what it’s like to work with us, here’s a taster from two previous sessions:

Regulators and developers from across the EU, the Middle East and Baltic countries gathered together at the Autumn 2015 Medical Device School, in London. In just 50 minutes, in addition to exposing the fundamental importance of Human Factors, Matthew outlined the key steps they are expected to take along the development journey. Concluding with a Q and A segment, attendees commented:

crowd“For me, one of the most important sessions of the school

“I particularly liked that human factors was covered in detail”

“Excellent presentation”

For the April 2016 session of the School, the organisers asked Matthew to include two sessions. Delegate feedback about the whole Autumn school asked for more interactive elements, so our second session would give them practical experience of several of the key steps along their usability journey. With that in mind, we would focus on something that everyone would be familiar with and allowed them to get to grips with applying concepts immediately.

As before, our first session started by explaining why Human Factors is important, before moving on to share what is involved in a good Usability programme for device development. wide eyedThought provoking images underlined steps on the journey, interwoven with stories gathered from experiences in the field. At the climax of an account of one usability study, you could feel the collective wince as Matthew described a patient’s long term practice with Type A needles (which are supposed to be single use). To finish, participants attained an insight into how all of this fits together with other paths in development.

“Great insight into the detail involved and how I can get started”

“Brilliant and easy to talk to. Really good interactive activities”

How easy is it to make a cup of tea?A quick leg stretch and freshening of coffee mugs later, we dived straight into putting this newfound approach to work. Over the course of three group activities, the room was plunged into the world of making a cup of tea. Sounds straightforward? It was. Until, that is, they became exposed to the challenges faced by someone with impaired vision and arthritis, walking a while in their shoes. How difficult it became to perform an everyday task!

“A great way to get inside the heads of our users and understand things from their point of view”

“Workshops were very energetic and welcomed”

“Excellent, very well paced, good practical demonstrations”

meeting penThis newfound sense of place enabled them to work on defining User Needs and extending that knowledge towards risk analysis, teasing out some of the less obvious use related risks. When it came to ideas for ways to mitigate these problems, creativity and appreciation for a different view of the world resulted in some unusual solutions.

The conversation continued over lunch. Delegates were talking about how they could use what they’d just learned when they got back to the work environment.

“I’d like to steal your first workshop, because it’ll explain to our teams why and how we can think like the people we’re making it for”

“I got a better understanding of how to apply this to manage my risks”

“I know now what we should be doing, and who to call for expert help”

You can achieve similar results.  Get in touch to find out how you can benefit from this or other training courses we have delivered.

 

 

15 things you need to know about MHRA Human Factors expectations

We now have official guidance for Human Factors and Usability Engineering in a member state of the EU.

19th September 2017 saw publication of official guidance from MHRA (the UK medicines and medical devices regulator) for Human Factors and Usability Engineering for medical devices and drug-device combination products. You may recall that the agency published a draft document for consultation in mid 2016. The final document extends to 47 pages and includes many changes as a result of consultation responses.

While of detailed interest to people working within human factors, everyone else probably wants to find out “what does it mean for me?

So, here are 15 things you need to know about the MHRA guidance:
Thing 1.

MHRA’s newly released final guidance emphasises its applicability to all classes of medical devices and device-drug combination products, there’s absolutely no avoiding usability engineering.

Thing 2.

Content of the guidance appears closely aligned with FDA guidance and international standards, with some useful additional information to that discussed by FDA.

Thing 3.

MHRA provide a great tool for anyone making the case for usability activities within their organisation; the guidance spells out exactly the essential requirements in the Medical Devices Regulation (MDR) and In-Vitro Diagnostic medical devices Regulation (IVDR) that mandate usability activities, along with a helpful annex mapping the MDD and IVD to the new regulations.

These breadcrumbs will also help manufacturers who are working to prepare their devices for the end of the MDR and IVDR transition periods.

Thing 4.

Clearing the once muddy waters surrounding drug-device combination products, MHRA establishes that the Essential Requirements enshrined in the MDR and IVDR are equally applicable to the device components of drug-device combination products.

Thing 5.

The document provides a helpful compendium of regulations, standards and guidances that should be referred to for development. The information can be seen as a signpost for those just venturing in to this arena, and serves as a reminder for the seasoned manufacturer.

Thing 6.

MHRA appear to have adopted a more realistic approach to the guidance on risk analysis, pulling back from the previous stance of expecting documentation of all possible use errors to a more realistic approach of capturing “reasonably foreseeable” use errors. This sits well with FDA expectations. A gift for usability professionals battling to influence sensible and design oriented risk management, MHRA have included an expectation of a rationale for the prioritisation of risk mitigations, often overlooked by development teams.

Thing 7.

Thankfully, the finalised guidance requires the development of a user interface specification and a usability plan at an early stage in development, aiding the inclusion of usability activities within project timelines, resourcing and budgeting, rather than as a last minute “add-on”.

Thing 8.

The value of formative usability studies is enhanced by closing the loop from risk analysis informing formative study design through to feeding back into the risk analysis the results of a formative test (unforeseen use errors, occurrence levels, etc.).

Thing 9.

Rightly, there’s now heavy emphasis on the ethics dimension of formative testing and manufacturers responsibility to ensure appropriate ethical consideration is given to the design and execution of formative and summative studies.

Thing 10.

Summative testing (called validation by FDA) now explicitly includes training that may be needed, and sets the realistic expectation for inclusion of users who are unfamiliar with the particular device.

Thing 11.

The HF Summary Report, whilst a very useful document to describe the usability journey, does not achieve all FDA expectations (in particular a greater focus on risk), so manufacturers will need to determine how best to fulfil both sets of guidance, if they intend to market their device(s) in both the EU and US.

Thing 12.

Helpfully, the section on Post Market Surveillance identifies some potential data sources, that will help manufacturers get more out of these activities for both existing products and future development projects.

Thing 13.

Guidance is now given about what to do for older products, of particular relevance as their manufacturers gear up to ensuring compliance with the MDR in the near future.

Thing 14.

The whole topic of simulation, which previously gave rise to concern amongst manufacturers, has now been removed from the guidance. Instead, the reader is pointed towards information covered in ISO 62366 (parts 1 and 2).

Thing 15.

With regard to drug/device combination products, the guidance points to changes in the MDR that require an assessment of device components with the Essential Requirements (including those related to human factors / usability). Helpfully, the MHRA document also references EU guidance relating to drug-delivery devices and specific products.
 
What next?

Now that you’ve read all 15 things, you may find it helpful to talk with someone about what you’ll be doing differently for your upcoming projects, and existing products.

Pick up the phone today, or write an email to our team right now.

Three ways to smooth your path for device development

Medical Device Development routemap v5.0 narrow viewSpring of 2013 still seems recent, so I was surprised to realise that the route map for medical device development will shortly be 3 years old. If it were a child in the UK, we would be able to get 15 hours free childcare a week from this September.

Children learn and grow at an alarming rate, especially when you’re looking back over what seems like a very short time and realise that the baby you remember holding in your arms “yesterday” is now a teenager.

The route map too is growing up fast. It’s being used across the world, from Australia, through Asia to Europe and on to North America. Users have fed back great experiences. Uses ranging from a desktop aide mémoire, a teaching aid, through to a planning and design review tool!

There comes a time when a child learns new skills, and naturally integrates them into their daily lives and toolkit.

We’re proud to announce the launch of the route map for medical device development 5.0 today. Numerous user suggestions have been incorporated in this new version, along with two new tracks; Intellectual Property and Market Research.

The route map continues to help you in three ways, it;

  1. Describes the journey you’ll embark upon, from a device idea through to launch.
  2. Sets out the main activities for each of 9 disciplines, through four stages of product development.
  3. Identifies the points where there are major interactions between disciplines.

And here it is…

Click to open a pdf version you can download

Click to open a pdf version you can download

You may already see how this picture will be helpful, whether you’re working in medical devices, combination products, pharmaceuticals, aerospace, defence, electronics…..

Send me your thoughts on how you can use the route map, because having a straightforward, independent view is always valuable.

What A Difference A Medical Device Can Make

This week, a guest post…

John Lennon famously said, “Life is what happens while you are busy making other plans”. And so it did. I had planned a week of developing ideas, gathering data for a project, business meetings and so. Then life struck. With a bladder that felt like the size of a football I was rushed to the local Medical Centre where a urinary catheter was inserted to my great relief! Everything was put on hold. However, as an engineer with an interest in equipment that help people manage or recover from an illness the situation was one I had explore further during my recuperation.

The purpose of a medical device is to “diagnose, prevent, or treat a disease or other conditions, and does not achieve its purposes through chemical action within or on the body.” They can range from disposable gloves through to Robotic Surgeons. The market for medical devices is projected to be a market worth $398 bn globally by 2017. The urinary catheter market is estimated to be worth $2.37 bn by 2020. Big business !

The urinary catheter has been around for 3500 years. The earliest ones consisted of bronze tubes, reeds, straws and curled-up palm leaves ( ouch ! ). The device has evolved throughout the centuries to the one that I am using with all of its parts made from soft plastic. There must be many design challenges and off the top of my head they would include: minmise infection, no leakage, minimal pain during installation and extraction, ease of use. The actual list I am sure will be significantly longer.

It is interesting how the world changes for the user of a medical device. In my case, public toilets were key points of reference when out shopping. I developed a mental map of where and when the toilets were open. Of course planning is critical to cover all eventualities when out and about especially when drinking too much !

Using the catheter requires some basic plumbing skills that most of us who connect garden hose pipes can easily master. The valves used on the bags are an example of keeping it simple with an intuitive way of switching it off and on. Also, for my own interest, I started to gather data on how much I was drinking and volumes when emptying my bag ( inputs and outputs in engineering terminology ), which produced a fascinating insight into how my body was working. Given the problem that the catheter is managing – emptying urine from my body – and the constraints of everyday use, the one I used worked well.

One final point. The District Nurses gave me great practical advice based on their experience of helping other people managing their catheters. For any medical device designer getting feedback from the people who are using it is an invaluable source of information for revisions to the design. In general, the users of medical devices can very often find better solutions to the problems of using it even if it involves Duct Tape !

Next time I am sitting in the waiting room of my medical centre, probably listening to some John Lennon classics, I will be reflecting on the many people, over the centuries, who developed the urinary catheter and how the current version saved me from torturous pain !

Big thanks to the Doctors, Nurse Practitioners, District Nurses, and the people in the Dispensary for their professionalism and kindness during my urinary problem.

You can read this and other posts on a range of topics on David’s blog;  http://dtinblack.github.io