Medical devices, and combination products, are typically targetted at therapeutic areas with large patient populations, so recruitment is fairly straightforward. The usual state of affairs for Usability studies is to recruit participants from relatively straightforward groups of representative users, for example;
- Healthy, able bodied adults
- Rheumatoid Arthritis
- Non-specialist Healthcare Professionals
Nonetheless, you will still need to ensure that key aspects of the study are adequate:
- Participant informed consent
- Study design ethics
- Participant data protection and anonymisation
- IRB or Ethics committee reivew, where required
And of course, design the study to provide the maximum 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
That’s all well and good, but what about additional challenges when you’re developing a medical device for an unusual or complex group of users? Or when you’re developing a medical device that has several, disparate, user groups?
One challenge arises 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 healthcare specialisms.
The case of minors and vulnerable adults participating in a Usability Study complexities include;
- Recruitment of the participant and their parent/guardian
- Identifying a study centre (or centres) where there is a sufficiently large pool to recruit from. This often results in the need for multiple centre studies, to ensure adequate participant numbers
- 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.
- Study facilites need to be suitable for participant access
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.