Tag Archives: usability

Which option would you choose?

You’re running late, you’re hungry and won’t have another chance to pick up something to eat before your journey.

There’s a busy food retailer nearby, and you go in to find something to tide you over, scanning the sandwiches, wraps and salads. A couple of the products on offer look safe to eat, but there’s no labelling on the shelf or the wrapper about allergens.

You are faced with three options;

  • Buy the product that looks like it would be safe to eat,
  • Leave the shop and search for something else, or
  • Join the queue for the counter and when you finally get there, ask for the allergens information folder, to search through for the information you need.

Which option would you pick?

For those with food allergies, It is hard enough finding safe foods to eat when you’re out and about. How challenging it must be, especially if you’re not confident in public, to have to ask at the counter for information on allergens. You’re then probably confronted with a folder full of hard to find, hard to read information.

When you’ve plenty of time to sift through the information, it’s a large emotional burden. When you’re pressed for time, how much harder must it be to take those steps.

For many in the UK, the unfolding story from the family of Natasha Ednan-Laperouse this week was heartbreaking. The paucity of legal requirements for food labelling was hammered home by the experience of Natasha’s Grandmother, who went into her local branch of the national chain in question, and asked for allergen information for the same sandwich her Granddaughter had eaten. She recounted the stress and difficulties experienced in asking for and then struggling to understand allergen information from within a folder.

As of this Wednesday, the company at the centre of the storm have agreed to steps that ought, one might be forgiven for thinking, have been in place for years – placing food allergen information on freshly made products. The company were complying with the law on food labelling. However, that law includes a loophole permitting establishments that prepare food freshly on the premises to simply have a folder available on request with allergen information. It is even permissible to impart the information verbally to the customer.

It shouldn’t take the death of a person for change to happen, but so often it does. In light of the Coroner’s findings in this family’s case, a review of current Food Labelling legislation has been promised by the UK Government.

You only have to look at the history of medicines regulation to see that many pieces of legislation were put in place as a result of human tragedy. Thankfully, there are now regulatory requirements for labelling and Instructions for Use on all medical devices and drug / device combination products

Even so, when developing a new product we must be mindful of what else the user or patient may have to contend with whilst using our device. Ask yourself, is it reasonable and practical to use the materials we provide with the product. If the answer is “no”, how else might the product be designed to reduce uncertainty over its use, how could information be better provided, to be more readily accessible to the user?

Considerations for Usability studies for medical devices with complex user groups

Medical devices, and combination products, are typically targeted at therapeutic areas with large patient populations, so recruitment is fairly straightforward. Usability studies recruit participants from groups of representative users, commonly from;

  • Healthy, able bodied adults,
  • People with Type II Diabetes,
  • People with Rheumatoid Arthritis,
  • Non-specialist Healthcare Professionals.

Key aspects of the study design must be tailored to the representative users and adequate to deliver a sound piece of development;

  • Participant informed consent,
  • Study design ethics,
  • Participant data protection and anonymisation,
  • IRB or Ethics committee review, where required.

And of course, design the study to provide the maximum feasible insight into the device design, Use Errors, and risk mitigations, gathering data that can be directly related to design inputs and envisaged design outputs, all whilst ensuring the cognitive burden upon participants is appropriate.

Developing a medical device for a challenging user group

There are additional challenges when you’re developing a medical device for an unusual or complex group of users.  The picture is further complicated when you’re developing a medical device that is intended for use by several, disparate, user groups.

Specific additional requirements arise for study design, when the user groups include;

  • Minors (i.e. people under the legal age of majority), either as a discrete and separate user group or as a sub-group,
  • Vulnerable adults,
  • Disease groups with extremely low incidence, or
  • Specific specialisms of healthcare.

When you’re considering designing a Usability study for a device for these user groups, consider how you’ll address;

  • Recruitment of the participant and their parent/guardian,
  • Identifying a study centre (or centres) located where there is a sufficiently large pool to recruit from. Achieving adequate participant numbers often results in conducting your study across multiple centres,
  • Working with a recruitment partner that can adapt to the unique challenges these groups present,
  • Consent and involvement of someone with parental responsibility in the study,
  • Design of study documentation to ensure both the carer and participant are able to give informed consent based upon information that is understandable to them,
  • Identifying study facilities that are suitable for the particular needs of your participants (e.g. venue and study room access).

For low incidence disease groups, evaluate the number of participants you’d want for a study against the numbers of people, in the chosen country, who are likely to fit the anticipated inclusion criteria.  This will guide your thinking about how many people are needed/can participate in your Usability study, forming part of your rationale for the study design.  You may even decide to hold the study in another country than originally envisaged, to get sufficient participants involved.

Evaluating external support

Often, development teams look for external support to Usability study design, execution or reporting.  If your project is in that situation, it would be sensible to include some or all of the considerations we’ve mentioned, in your discussions with potential suppliers, particularly for complex study requirements.

Answers to these questions will help you select the optimum support package to ensure you get the most out of the study.

Benefit from our experience

We have undertaken a number of studies that involved challenging user groups like those described above, both in the UK and North America.

As a result, we have developed strong relationships with expert recruiters and study facilities across the UK, East Coast USA, Midwest USA, Canada. These organisations understand the specific requirements and constraints, to support successful formative and validation studies for our clients.

Perhaps your development project involves an unusual or challenging user group demographic? Get in touch today for support in delivering a Usability programme and studies that meet your requirements from the start.

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.