Tag Archives: human factors

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.

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.

Improving Paediatric oral medicine delivery – workshop

Workshop on Improving the Administration of Paediatric Oral Liquid Medicines using Dosing Syringes and Enteral Accessories

11th September 2018, London, United Kingdom

The workshop is likely to be of interest to many of our readers, so here’s information provided by the organisers:

The European Paediatric Initiative (EuPFI) is inviting expressions of interest in a workshop organised to identify and discuss challenges and potential improvements in the development, control and utilization of oral dosing syringes and enteral accessories for paediatric liquid medicines.

The workshop which will be held at University College London (UCL) School of Pharmacy premises in London, is a crucial step to find the optimal path towards correct dosing to all paediatric patients using these oral administration devices. A broad range of stakeholders, including patients/caregivers, healthcare professionals and representatives from the pharmaceutical industry, drug delivery device suppliers and academia, are invited to the workshop to share current practices and issues regarding the development and handling of oral dosing syringes and enteral accessories, to facilitate awareness and identify areas for improvement. Representatives from national competent authorities, EU institutions and other stakeholders will also attend.

Completed forms for expression of interest to attend the workshop should be submitted by 20th July 2018.

Places are limited and will be allocated to ensure a fair representation of all stakeholder groups and organisations, and so please do not book travel arrangements until your attendance has been confirmed.

Further details are available at http://www.eupfi.org/devices-workshop/

We have submitted our expression of interest in attending, and hope to see you at the workshop.

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.