A new approach to drug delivery device development has been unveiled by Cambridge Design Partnership (CDP), which aims to transform the experience of patients who need to regularly inject themselves for the treatment of chronic diseases.
Drug delivery
By applying its user insight service diialog to an auto-injector, CDP will assess two measures that reveal how easy or difficult a patient finds the injection process. These measures are ‘dwell time’ — how long a patient hesitates before injecting themselves once they’ve prepared the device — and ‘cap removal force’ — which in worst-case scenarios can lead to the patient accidently stabbing themselves with the needle during preparation.
“Our aim is to put the patient at the centre of drug delivery device development,” said Tom Lawrie-Fussey, healthcare digital strategist at CDP. “However, to do that you need detailed, reliable information about how a patient uses their auto-injector in the privacy of their own home. A patient might tell their doctor they never miss a dose of their medication — but in reality they might skip some of their injections because they are too awkward to administer.
“Drug delivery device developers are required to meet regulatory human factors requirements. But accurate information about usability and the whole patient experience is also crucial if a great idea is to go beyond those requirements and translate into a successful product that is patient friendly and delivers improved health outcomes. Yet trial users of a new device often tell you what they think you want to hear. With the help of diialog, you can discover what really happens — whether the device is used correctly and the drug is stored at the correct temperature, for example, or whether an elderly patient struggles to remove the cap.”
Diialog
The miniature sensing technology used by diialog is small enough to fit inside an existing clinical trial injector and can monitor a range of key factors such as orientation, preparation sequence and injection technique. Through sophisticated algorithms the system analyses data and translates it into an accurate picture of how a device is being used in the real world. The technology is even programmed to ignore ‘false positives’, such as movements due to patients carrying their device around in their bag.
“With diialog we can translate a stream of data into valuable information for our clients to enable them to make more informed investment decisions,” added Lawrie-Fussey. “It complements their existing research techniques and can help minimise the risks, especially for pharma companies facing the challenge of migrating to device development.”