Case Study

Reducing the potential for use-related errors in an at-home diagnostic device

The Challenge

To provide regulatory compliance and demonstrate safe and effective use for an at-home, non-invasive diagnostic device to be used by the general public. This usability work was conducted in parallel to – and fully integrated with – the product development stream of work undertaken at eg technology.

The challenge was to ensure that we tested early-stage proof of principle prototypes on several device variants. This needed to be carried out with a representative selection of potential users of varying capabilities, in order to demonstrate ease of use and the ability for users to achieve repeatable and reliable results on the at-home lateral flow device. This was undertaken during Covid-19 lockdown restrictions, so we had to overcome the logistical challenges associated with usability testing in these conditions.

Incorporated data and an explicit understanding of the user, tasks and environment into design | Focused on creating a product that meets requirements and is safe and effective to use | Met the regulatory and commercial needs of our clients, in accordance with IEC 62366

Our Approach

This project required a multi-faceted approach. This included defining the use specification and UI specifications, undertaking detailed use-risk analysis tasks, completing a heuristic design review and carrying out multiple rounds of formative usability testing.

We ensured that a representative group of both typical and ‘worst-case’ users were selected. These included those with dexterity and cognitive challenges, so we were able to assess the steps for use and device usability within a representative home setting, with a draft IFU (instructions for use). We additionally wanted to gain insight from potential users into the non-invasive sampling method. Due to Covid restrictions, we conducted the user testing remotely, which was successfully achieved using video conferencing.

Our Results

The testing provided useful design directions on both the device and input for the IFU. This was fed back into – and directly influenced – the product design at several key stages of the development, mitigating the use risks by design and optimising ease of use early in the programme. This testing also further informed our use specification, UI specification & risk analysis documentation.

Testing the prototypes in users’ homes proved to be a huge benefit. By gaining accurate insights on the use environment, we learnt how and where potential users may conduct the lateral flow testing and subsequently identified potential issues they would face in the process.

One general consensus across these studies was a noticeable pushback on the use of single-use plastics from an increasing number of users – this is consistent with a growing trend seen in recent years.

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