The purpose of these guidelines, which have been developed, published and updated over recent years, is to assist medical device manufacturers with following “appropriate human factors and usability engineering processes to maximise the likelihood that new medical devices will be safe and effective for the intended users, uses and use environments.”1 Usability testing is an important aspect of any medical device design process but, when looking at devices used in home-care settings, usability engineering’s importance is further highlighted.
Figure 1: The Sorrel wearable injector
One of the primary purposes of wearable drug delivery devices is to simplify the process of self-administration for patients, making home-care treatments more feasible. With a strong preference for “hospital at home” and patient demands for greater involvement in the care process, wearable drug delivery devices provide a olution for both healthcare providers and patients, increasing patient throughput in the clinical setting while also enhancing the user experience for patients, enabling them to receive their prescribed therapy in the comfort of their own home. The challenge is making wearable injectors that are easy to use and intuitive enough that a wide range of use groups and patient populations can use them, regardless of age, tech-savviness, dexterity and other factors generally influenced by the specific indication the drug product is looking to address. Although there are not many wearable injectors on the market as of yet – or even too many in clinical stages – they differ from each other significantly in terms of how the device is to be used; the number of steps they require to be activated, the method by which the drug is filled into the device, the reusable versus disposable aspects of each device and so on.
The wearable injectors that are expected to win strong market share will be those that are reliable, comfortable and easiest for the patient to use. It is therefore essential to examine the key human factors that must be considered throughout the development of self-administration devices – from basic design to final commercial product – to ensure that they provide a safe, intuitive and seamless user experience, empowering users to take control of their health, all in a home-care setting.