Design for Usability
Through my experience with Atomo Diagnostics I was able to develop a thorough understanding of the usability process for regulated medical products. This involved understanding the Human Factors standards for Europe and the US (FDA) and how they related to the overall design process and quality documentation required for medical compliance. The vast majority of my experience lay in planning, executing and reporting on Formative Studies in order to help us make the best design decisions as we iterate on and refine the product.
Formative studies are conducted throughout the development process and are a way of assessing user-product interaction, identifying strengths and weaknesses in the design, and discovering any potential use errors that could result in harm to the patient or user. The purpose of these evaluations is to iterate the design until all the user requirements are met and any significant risks are designed out.
The formative studies I have been involved in include cognitive walkthroughs, simulated use testing, and actual use testing in order to:
1. Inform the design of the product,
2. Assess the effectiveness of measures implemented to reduce or eliminate use errors or hazards,
3. Inform the design of any labelling and training materials that might be required.