Some medicines cannot be delivered orally (in a pill). When a medicine cannot be delivered using a pill an alternative delivery mechanism is required, such as an injector pen to deliver the medicine through your skin.

The team at DCoE work with an array of external partners to design the best possible devices for patients, managing the development from concept through to transfer and finally, to manufacture. Specific skill areas include device design, human factors engineering, risk analysis, industrialisation, validation and regulatory design control.
 

The medicines delivery devices developed by DCoE are initially used in clinical trials, to assess the combined effect of the medicine and the delivery device in patients. Following successful trials, the medicine delivery device and medicine will be developed through to commercial supply to the patient.
 

Human Factors Testing

Human factors testing is required to ensure that any medicine delivery device can be used safely and effectively in the hands of the patient. It is also known as usability testing.

To create a device that can be used safely and effectively it is important to know about the patient group - are there special conditions that might apply? The initial work of human factors is about understanding the patient group and the environment in which a medicine may be delivered. For example, how firmly can a patient hold their device?

Once the patient group is understood and a device has been designed, a series of hands-on tests will be run with volunteer patients. These tests enable valuable insights to be gained that can help refine and improve the design of a patient-friendly device.

Following all the human factors testing, a human factors report is created, which is a required element of a medicine and delivery device regulatory submission.

This patient-centric approach has enabled DCoE not only to improve the device designs, but has also led to the development of peripheral tools to help with the use of devices, such as intelligent packaging, mobile applications, infographic instructions and device accessories.
 

Device Design

Device design is an ongoing cycle of improvement in order to develop the ideal device. Initial designs are improved using human factors and by testing for reliability in a series of laboratory and computer-based scenarios. This process leads to the best design in terms of usability and reliability.

DCoE have many tools to aid in the device design, including computer-aided design (CAD), Computer Numerical Control (CNC) tooling workshop for developing prototype components, a prototype assembly lab and X-Ray analysis to view the working components of medicines delivery devices in action.