Category Archives: human factors

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.

Medilink Innovation Day 2018, and a Prize Draw

Our team had to pleasure of, once again, attending Medilink East Midlands’ Innovation Day earlier this month.

Unusually for industry conferences, there’s a broad mix of people attending Innovation Day, from academia, industry and the NHS, along with a variety of exhibitors – all of which make for an interesting day’s conversations.

A steady stream of visitors to our stand (we were there will colleagues from the Medical Device Alliance) led to discussions on a wide range of medical device development topics.  Passers by gravitated to our route map for medical technology development, with many printed copies leaving in people’s bags.

Many people chose to enter a draw to win a printed copy of our book introducing Human Factors for medical devices “How Humans Factor (in medical device design)”.

Congratulations to the two winners in our prize draw, who will each receive their book in the post over the next few days.

And yes, the team’s preparations are already underway for next year’s Innovation Day.

Are medicines information leaflets scaring patients?

If you have ever been prescribed a medicine, you probably won’t be surprised to hear that Patient Information Leaflets (PILs) are too complex for patients AMS report 2017-06 croppedto readily understand.

A report from the Academy of Medical Sciences (as reported by the BBC) found that, by focusing on side-effects in PILs , patients become unduly anxious about taking medicines.  It is thought that this could be the reason why fewer than 50% continue taking drugs they have been prescribed by their doctor.

“They aren’t written from a consumer’s perspective” said Prof Sir John Tooke (chair of the report preparation group).  Unsurprisingly, users find PILs to be impenetrable and even unreadable.  Both users and Healthcare Professionals are concerned about the challenges in making sense of the plethora of information available.  The report recommends the involvement of users / patients in the development of information leaflets from an early stage.

At first glance, this may seem like something that would be ideally placed to form part of  a Human Factors formative study or two, during development, with a confirmation of the PIL effectiveness during the HFE Validation Study.

That would be a correct assumption.

Where Medical Device development leads, pharmaceutical product development will follow – as the Instructions for Use (IFU) for Medical Devices and Combination Products should already be developed and their effectiveness assessed throughout product development.

Ensuring that instructional materials and training are fit for purpose and understandable by the user, is an integral aspect of Human Factors Engineering for Medical Devices.  Our team has designed HFE and instructional materials studies, conducted them, reported the results and influenced the development of a wide range of Medical Devices.

You may want to speak with us about how you can benefit from our wealth of experience, to ensure your PIL, training materials or IFU is truly fit for purpose and supports user/patient compliance in their healthcare.  Get in touch now to get the ball rolling.