To identify where the problems lie and to create innovative new devices that can help increase adherence, Cambridge Design Partnership has developed a new approach to user trials. Tom Oakley, Head of Drug Delivery at Cambridge Design Partnership, explains that usability trials are often conducted as part of the risk assessment when a design is advanced, but if they are also used to identify areas of unmet need they can drive the innovation process at an earlier stage and far greater value can be obtained from this exercise.
“We have found that traditional usability trials tend to focus on the users’ verbal feedback on what they did and did not like about a product. This is not only subjective but often misses key issues. Traditional usability trials encourage a narrow problem solving approach which does not fulfil its potential. It’s very hard for conventional trials to identify what will make a market leading device because users can only comment on the devices in front of them.
“Our approach starts from a different angle. We begin by creating a map of all the steps that the user has to perform to take their medicine irrespective of the device they are using. Then, during usability trials, we have an objective base line against which we can asses a design solution. In addition to indentifying risks, we observe each user attempting to perform the steps so we can detect opportunities to create innovative new features, which can result in better designs that users are much happier using. We believe these enhanced devices can improve adherence.”
Assessing the risks associated with usability is not only good practice but it is required as part of the European Medical Device Directive. Cambridge Design Partnership’s approach is compliant with EN 62366 and clearly identifies areas where there is greatest risk of user error while indicating how they can be averted through good design practice. The company believes that getting a drug delivery platform right can significantly increase the effectiveness of a new therapy to both doctors and patients, essential to maximise clinical benefits and return on investment. Devices will be coming to market soon that have benefitted from these techniques.
