Usability Testing

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Usability Testing of Medical Devices

Usability or human factors testing reveals how easy, satisfying and safe a medical device is to use. The findings not only guide design teams during design and development, but they also are required in documentation submitted to regulatory authorities.

In accordance with the requirements of ISO/IEC 62366:2007 and the FDA's draft guidance document, we have designed and conducted successful formative and summative (validation) usability tests for manufacturers across Europe and United States.

We are able to assist with the following activities:

  • Develop Usability Test Protocols: Well-defined test protocols lead to successful usability tests. Our in-house template ensures that nothing gets missed out. We can help develop acceptance criteria for validation tests, determine sample sizes and set screening criteria for recruitment.
  • Recruit Participants: Using our in-house database, we can directly recruit various types of participants including lay users, biomedical engineers and healthcare professionals (nurses, doctors and surgeons). Our database spans different global regions, however we also work in partnership with market research agencies if further assistance is required.
  • Organise Venue & Equipment Hire: We have an extensive network of usability test centres around the globe. Depending on your requirements, we can advise on a suitable venue ranging from hospital to patient home settings.
  • Conduct Usability tests: We can assist with/conduct successful usability tests according to regulatory requirements. We are skilled in the collection of both performance and subjective data and can manage participant scheduling to ensure you meet your minimum numbers.
  • Prepare Usability Test Report: We use a common industry format for preparing usability test reports, which is recognised by regulatory authorities. We can clearly present key findings according to the test objectives or acceptance criteria.

Summative (Validation) Usability Testing

Required by regulatory authorities in the United States and Europe, summative (validation) testing is carried out on a pre-market ready device. The purpose of the test is to demonstrate that a device is safe to use for its intended users, uses and environments.

Within the test, a representative sample of prospective end-users are asked to perform frequent and safety-critical tasks (primary operating functions) in a setting(s) of appropriate realism. The performance of participants is assessed against acceptance criteria, which is specified in a usability validation plan.

The test must clearly show that the risk of any use-related hazards is being adequately managed. Typically a minimum of 15 participants per homogenous user group is required for summative usability tests, however special control devices like infusion pumps and radiation emitting devices require a minimum of 25.


Formative Usability Testing

There are different types of formative usability testing. Deciding on which type to use is determined by the stage of development. For instance, 'exploratory testing' is performed early in design, often with paper/foam-based models; 'comparison testing' compares two or more prototypes; and 'assessment testing' is carried out on a higher-fidelity, working prototype.

Similar to summative testing, participants are asked to perform tasks with the device, however mostly subjective data is collected to explore needs, likes and dislikes, difficulties and risk control strategies.

Key findings inform design decisions and allow user-interface requirements and usability goals to be refined. While it is generally recommended that manufacturers perform multiple tests at key stages of development, the good news is that formative usability tests can be done with as little as 5-8 participants.