Background: Consumer Medicine Information (CMI) forms an important basis for the dissemination of medicines information worldwide. Methods: This article presents an overview of the design and development of Australian CMI, and discusses 'user-testing' as an iterative, formative process for CMI design. Findings: In Australia, legislation and templates guide the creation of CMI by pharmaceutical manufacturers using principles of written health information design, giving consideration to both content and structure. Following these principles to the letter, however, does not always assure the creation of a useable document. A suggested method to gauge the usability of CMI is 'user-testing'. The process, based on observing individuals using the CMI to answer specific questions, aims to identify areas of weakness in the document allowing targeted improvement. Each question identifies whether (a) the individual can find the relevant information and (b) they can understand it. It is an iterative process designed to be performed repeatedly until it results in a highly-useable CMI. Crucially, the revisions of this information between rounds of testing need to be based on principles of good writing and information design. Other methods of analysing CMI do not actively engage the target audience while simultaneously testing the usability of both content and structure. Although developed in Australia, user testing is not routinely performed on Australian CMI. This is despite the fact that user testing is a legal requirement for leaflets for all new medicines across the European Union (EU). Conclusions: Given CMI's role in empowering patients with information, it follows that every attempt should be made to ensure that they are consumer friendly and usable. There is a strong argument that user testing should be employed in writing medicine information.