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Capabilities

Human Factors, Usability and Inclusive Design

Product comparisons

We often support clients with product usability benchmarking and Threshold Analysis. There are many reasons why you may want to compare two products, we can deploy a selection of our Human Factors assessment tools to assess and quantify relevant usability metrics for comparable products.

Threshold Analyses are specific to medical devices. A Threshold Analysis makes a detailed comparison between the user interfaces of two products to identify and assess the potential impact of any differences. When developing a new medical device for a generic drug, a Threshold Analysis is used to demonstrate that the proposed new device is suitable for substitution – meaning that the generic product can be prescribed in place of a legacy, approved, product without additional training or other HCP intervention.

This involves demonstrating that either:

  1. There are no differences between the two products
  2. The differences between the two designs do not impact critical tasks
  3. The differences that may impact critical tasks, do not influence the safe and effective use

User studies

The key factor that unites all user studies is a desire to learn from stakeholders. These might include those using the products (e.g. patients, consumers), they might also include people using the products for someone else (e.g. healthcare workers).

In the medical environment, we conduct two types of user studies, for Formative evaluations and for Summative evaluations. Formative user studies are used throughout the design process to explore how users interact with products in conditions that are as close to the intended use as possible. These formative user studies can also be used to answer specific questions - such as, ‘how are people likely to hold this?‘, and ‘what is the maximum force that they can apply while gripping the device?‘ Summative user studies form part of Design Validation, to help demonstrate that the product is safe and effective to use - that the use errors predicted are mitigated and that there are no unforeseen use errors.

Irrespective of the sector, user studies give stakeholders a clear voice in the design process. User studies ensure that the real-world needs of end-users are captured and explored and that the products stay on track throughout the design process.

The key factor that unites all user studies is a desire to learn from stakeholders

Helping our clients achieve success through great product design