Case Study

Implementing an integrated development programme

The Challenge

This project focused on the re-design of a lab instrument, originally used for research into a clinical pathology diagnostic setting. The ultimate aim was to gain IVDR & FDA approval. Throughout the project, eg were required to implement a fully integrated product development programme, incorporating design, development and usability.

The team needed to identify the user requirements intended for this new use case, in a clinical use environment. To achieve this and ensure we could meet the needs within this different context, we needed to have a deep understanding of this new group of users, which included biomedical scientists and lab assistants. The expectation was that their skill set, motivations, typical workflows, and work practices were likely to be very different to the existing user groups.

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

Our Approach

We implemented the usability programme to meet the requirements of the ISO 62366 standard, in terms of process and documentation, all the way from user research to the pre-summative testing stage (the summative testing will follow in due course).

To really understand the context in which the instrument was being used and to base user requirements on actual need compared to assumptions, we spoke with potential users very early in the development; this helped our engineers determine the crucial differences between the user groups. We also explored issues, likes and dislikes with existing lab instruments to gain insight to improve the user’s experience, providing our clients with an opportunity to gain an edge in the market.

To identify use-related risks associated with the instrument, we approached this from several perspectives. Using analytical methods like detailed task analysis and PCA analysis, we identified lower frequency use risks, while conducting multiple early-stage formative user studies. This helped identify any unforeseen use-risks that our cross-functional team hadn’t already identified. It also determined whether the instrument’s functionality provided value to the user, identified concept preferences and assessed it for intuitiveness, highlighting those tasks that may require more training or instruction. Patient sample traceability risks and sample throughput handling requirements had the potential for use errors and were identified as areas of difference. These were undertaken in an early stage of the development to inform the design.

Our Results

Early on in the programme, it became clear that despite the initial usability research, user requirements were going to be very different in a clinical setting. The level of system feedback and user interaction desired by the user groups were contrasting. Clinical users, who were potentially juggling numerous tasks, wished to insert the sample and then receive a notification when the sample process was complete. However, research users required much more system feedback throughout the sample processing as they were more invested in the process. Handling samples was more process-driven and routine for clinical users, who prioritised control and repeatability, compared to the research users who needed process flexibility. This led to divergent requirements around the degree of automation in the instrument.

We were able to use this knowledge to successfully drive the redesign of the instrument for use in a clinical pathology diagnostic setting.

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