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.