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trial · open

Usability study for a point-of-care diagnostic

Nurses, a device, and the moment it becomes obvious the lid is on the wrong side. Formative usability before anyone mentions a pivotal trial.

Budget

£12–20k

Duration

8 weeks

Closes

22 Sept 2026

Background

We have a working point-of-care device and a design that is not yet frozen. This is precisely the moment at which usability work is worth doing, and we are aware that most companies do it eighteen months later, after tooling, when every finding becomes a change request with a cost attached.

We want eight to twelve clinical users, structured tasks, and observers who will record what people actually do rather than what they say afterwards. We expect to be told things we will not enjoy.

This is formative work. We are not seeking to demonstrate that the device is usable; we are seeking to find out where it is not, while that information is still cheap.

Scope

  • Recruit 8–12 clinical users under an approved protocol.
  • Run task-based sessions and capture the unkind observations.
  • Recommend the three changes that would prevent a theatre.
  • Record use errors and near-misses distinctly, with severity assessed.
  • Advise on what a subsequent summative study would need to demonstrate.

Constraints

The awkward facts, stated now rather than in week six.

  • The device is a working prototype and will occasionally misbehave for reasons unrelated to usability
  • Participants must be genuine clinical users, not proxies
  • Eight weeks includes recruitment, which is usually the binding constraint
  • We hold no ethics approval yet, and the package may need to include obtaining one

Deliverables

  • Protocol and ethics pack (if not already held)
  • Session notes and clips (consented)
  • Prioritised design-change note
  • Use-error log with severity assessment against the risk file
  • Recommendations for the scope of a later summative study

Milestones

  1. Week 1Protocol drafted; ethics position confirmed
  2. Week 3Approvals in place and recruitment under way
  3. Week 6Sessions complete, preliminary findings presented verbally
  4. Week 8Final report, use-error log and prioritised design changes

Who should apply

  • Clinical research group or specialist usability house
  • Experience with MHRA-shaped evidence
  • Demonstrated ability to recruit clinical users within eight weeks
  • Human factors expertise, not solely market research capability

How applications will be judged

In roughly this order.

  • Prior formative studies delivered for device sponsors, with references
  • Realism of the recruitment plan, which we will scrutinise
  • Approach to distinguishing use error from prototype malfunction
  • Whether the proposal understands the difference between usability and preference

Terms

  • All study data and recordings belong to the sponsor; participant consent governs any reuse
  • The provider may describe the methodology, but not the device, in professional contexts
  • Findings feed directly into our risk file and design history file
  • Payment in two stages: on approvals in place, and on report acceptance

Apply

Tell the publisher who you are and what you would do. We pass it on. The rest is between grown-ups.

If your proposal promises that the study will demonstrate the device is usable, we will read no further. We are buying findings, not reassurance.