Summary

Many pharmaceutical companies see equivalence claims as the fastest and most cost effective route to market for new respiratory drug devices. In reality though, the process is often not as simple as first thought. By their very nature, equivalence claims mean adopting existing, often old, technologies and user interfaces. Furthermore, the task of demonstrating equivalence can be protracted and expensive. Thus, in many cases, manufacturers are left accepting sub-optimal devices, with known usability issues. Moreover, opportunities may be missed to explore different products, technologies and services that would improve usability, compliance, patient satisfaction and market share. This paper uses tools from the discipline of human factors to explore what a fresh approach to requirements capture and design might mean for devices designed from first principles.

A structured approach is described for designing medical devices based on patient and stakeholder information requirements. The approach is based on the premise that better designs are informed by an explicit understanding of what information is required, where and when, along with an understanding of who needs it and how it should be presented. To develop more usable and engaging products these information requirements are explored at the earliest stages of the design process and revisited throughout the design.