Tag Archives: usability

Getting your medical device into the NHS

Getting a device accepted by the NHS is often described as something of a “dark art”, a mysterious journey into the unknown.  Having a map for this journey would be an attractive proposition.

To flesh out our map for the journey, we joined around 30 other industry experts for Medilink East Midland’s July 2018 conference “How to get your medical device NHS ready”, held in conjunction with Nottingham University Hospitals NHS Trust.

The day covered a range of subjects, all geared towards giving you the knowledge to best prepare your medical device for a favourable review outcome for the NHS.  Amongst the topics we discussed were;

  • The impact of Human Factors in medical device development,
  • Patient Public Involvement – why it’s so important and how to access it,
  • Regulatory support for medical device development,
  • How to undertake a clinical investigation in the NHS,
  • Using a budget impact assessment to support uptake and adoption,
  • NICE engagement and support for developers.

A number of case studies were also shared, demonstrating the value achieved by considering specific topics of the agenda.

We left the event with a clear picture of how our core disciplines supported, and could be woven throughout, the preparations for NHS “readiness”, over and above regulatory authority approval.  We’re now applying that knowledge to help our clients’ development activities.

Involving patients and the public in medical device development

There’s an often overlooked aspect of getting a medical device into the healthcare system (e.g. the NHS in the UK).

An aspect that was revealed to those attending a recent Medilink East Midlands conference in Nottingham. An aspect known as “Patient Public Involvement” (PPI). There’s lots of activity within the NHS to increase PPI throughout all aspects of health and social care in the UK.

Recognition of the importance of involving patients and public in healthcare has implications for the development of medical devices and combination products. Should you be looking for sources of grant funding for planned research, the UK National Institute for Health Research (NIHR) asks applicants to “… describe how they have involved the public in the design and planning of their study as well as their plans for further involvement throughout the research and if not, to explain why.”

NICE is crystal clear about the importance of PPI, expecting the steps taken by a manufacturer to be included in the information they provide for the decision making process, with the “patient voice” increasingly expected to be heard by review panels.

So, what is Patient Public Involvement in medical device development?

Perhaps unsurprisingly, there are many layers to PPI within the NHS. Lots of the layers revolve around Governance and service provision, with layers relating to delivery of treatment buried deep.

There exists a massive opportunity for the developer of a medical device from interaction with patients and service users. By listening to people, we can understand diverse health needs better, “to improve patient safety, patient experience and health outcomes; supporting people to live healthier lives” (NHS PPI Policy). It is revealing that patients are referred to, within the PPI Policy, as “experts by experience”.

Why should that matter to you as a manufacturer/developer?

Simply put, three reasons:

Firstly, it helps you get access to research funding from NIHR and other bodies; as you can clearly demonstrate involvement of the public at an early stage in development.

Secondly, it supports the case for your medical device to be adopted by NICE and subsequently, Commissioning Groups, as the “patient voice” is clearly listened to.

Thirdly, and by no means least, proper patient involvement massively informs the development of your product.

“No matter how complicated the research, or how brilliant the researcher, patients and the public always offer unique, invaluable insights. Their advice when designing, implementing and evaluating research invariably makes studies more effective, more credible and often more cost efficient as well.”

InvolvProfessor Dame Sally Davies, Chief Medical Officer (Foreword in Staley, 2009)

There are other, ancillary benefits too, such as:

  • Patient stories, testimonials are a useful resource to show the value of a medical device for their quality of life,
  • As a marketing tool, articulating your participation with patients and public, throughout development of products that they and the NHS want and need.

How can I involve patients in development activities?

You may already have sensed some similarities or cross-over between patient involvement and the discipline of Human Factors Engineering / Usability.

There’s a good reason for that.

Usability is a great way of ensuring patient involvement in development of medical devices destined for the NHS; in a planned, documented and well thought out manner. There is a clear link between the drive to demonstrate patient involvement and Usability studies, particularly in the earlier stages of development. Formative Usability studies, involving patients and users, inform the requirements for a medical device, test out concepts and gain valuable feedback that hugely influences the final design. Evidence of all this is looked for by grant funders and regulatory decision makers.

And let’s not forget, that early discovery of what users and patients really need a medical device to do for them, can provide you with a competitive advantage for product development. When you really understand what drives the users / patients, what they are “putting up with”, the work-arounds they (subconsciously) use to improve their quality of life with a device, your product will “just work”.

What next

When you’re writing applications for research funding, or drafting your NICE submission (or ideally much earlier in development), consider how you could weave in some Usability activities and data to make the case for patient and user involvement. If you’ve already undertaken (or plan to) as programme of Usability studies, examine how the results can support your application.

If you’re unsure how to get started, call our team now. We will be happy to explore how we can help you get there sooner.

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 hello(Replace this parenthesis with the @ sign)threecircles.eu?subject=Follow%20up%20-15%20things%20you%20need%20to%20know%20about%20MHRA%20Human%20Factors%20expectations to our team right now.