We’ve all been there, using our teeth or a pair of scissors to open packaging from any number of domestic products. It seems crazy that in this day and age when manufacturers are surrounded by so much information from their consumers and given such an insight via their own development research but also from Youtube, blogs, and forums that we are still left struggling. This was really brought home when a recent piece of quantitative research carried out on behalf of packaging specialist Payne identified that 85% of consumers said they had experienced some level of frustration with packaging. It’s a pretty extensive problem. So, if opening a packet of soup can be such a challenge, what chance have patients got with their medical devices? An oversight in this area won’t just result in a spillage but could be detrimental to successful treatment delivery and at worst could be harmful to the patient. If we then add in the changing market place with aging and more obese populations, higher patient technology expectations, patients having more of a voice and the updated FDA usability regulatory requirements, it’s vital that we understand the appropriate context of device usage to ensure devices are designed in the best possible way. The most important point to bear in mind is that usability studies are not traditional market research studies; we have to move away from solely understanding liking and preference and shift the focus to interaction, risk reduction and improving adherence. Our 3D Research approach takes into consideration 4 key elements across the device development pathway to ensure that we access the reality of the device usage experience: 1. Understanding the research objectives. This may seem straightforward, but it can change a project hugely depending on whether the research is designed to support a regulatory approval or if it’s about risk assessment, or device selection at later stages of development. 2. Taking a holistic approach. The research should understand the engineering and design (the whole job map of the device process) as well as biomechanics and kinaesthesiology all the way through to the social, emotional and psychological elements of importance. You can design the device perfectly but if patients are going to inject through their trousers for reasons of discretion, this has to be part of the research understanding process. 3. Duty of care and good clinical practice (GCP). Understanding the specific patient target and their practical challenges as well as the therapy area and disease context are key, but this needs to be aligned with the ability to conduct research to the right clinical standards. We believe working to these ethical standards are so important for the best research outcomes. 4. Bringing the research to life. We have found that to really understand what users are doing, people need to see it. Using a visual approach incorporating film into presentation and mapping out the job path and risks visually to fully communicate patient experience is so important for the wider brand and design team. Ultimately, in order to give patients the best chance with their devices, we need to be challenging ourselves as to how ‘real world’ our research actually is, and making sure we are truly addressing the usability and not just something more superficial. For more information on HRW’s 3D Research approach please contact us on +44 (0)1491 822515 or email@example.com. Apply Now!