Designing Devices for Self-management. The market for drug delivery devices continues to grow at a rapid rate,1 largely due to an expanding elderly population with an increasing frequency of chronic diseases. Biotherapeutics have played a significant part in this growth, with biologics frequently administered via subcutaneous injection. As a growing number of biosimilars come onto the market, it is likely the market for subcutaneous drug delivery devices will develop further.
More than ever before, chronic conditions are being treated outside of a hospital setting, with drugs administered by carers and patients themselves, without advanced medical training. As the greater agency is placed on drug delivery devices, reliable and intuitive design is essential alongside ensuring safe and effective treatments, while maximising patient comfort and convenience.
Increasing Device Functionality with Connectivity
The growing trend of adding connected functionality to these devices allows the medical profession to simplify the capture, transfer and display of injection data; automatic upload of key treatment data can be crucial in tracking and improving patient adherence to treatments. Meanwhile, introducing additional electronic features to the device itself provides an opportunity to offer real-time step-by-step feedback to the patient during the injection procedure. In addition, educational tools and instructions provided by digital content in the associated app can help to simplify the injection process.
As with any system, the temptation to increase the functionality of a medical device comes with the potential to increase the complexity of the user interface and impact ease of use. A user-centred design approach is desirable to optimise the user experience and associated benefits, and essential to ensure that the potential for use error is managed.
This article will look at the importance of applying human factors engineering (HFE) during the development of new connected drug delivery devices and how we employed these principles when creating our first connected auto-injector.
Human Factors and Usability Engineering Requirements
In the EU, manufacturers must demonstrate compliance with requirements set out in the Medical Device Regulation (MDR). These requirements align with the international standard for IEC-62366-1:2007 (note it is recommended that HFE is conducted according to the 2015 update), with IEC-62366- 2 (2016) as a guide. Meanwhile, in the US, the Food Drug Administration (FDA) provides recommended human factors engineering guidance for both medical devices and combination products and more recently has provided further draft guidance on the inclusion of human factors and usability engineering as part of the market approval process. Therefore, most developers will incorporate usability engineering as a matter of protocol.