PharmaSens: Simplifying diabetes management
IFU Design | Formative Research | Human Factors | Validation Testing
Diabetes is a chronic disease affecting 1 in 10 people in the world and the number of people living with the diabetes is predicted to continue to rise rapidly.
PharmaSens are simplifying the challenges of managing diabetes with their range of niia insulin patch pumps. Tackling important issues from the expense of pumps to the inconvenience of daily injections, with their digital and sustainable pump patch systems.
We are Human worked with PharmaSens, amongst other development partners, contributing towards the product and Instructions for Use development through user research and human factors.
Different solutions for different needs
PharmaSens have worked together with users to understand that different solutions are needed in diabetes care. The niia insulin patch pumps are developed to suit a range of user requirements, making daily life easier for patients with diabetes.
The range consists of 3 pumps; the Essential, Advanced and Signature, all feature a semi reusable design which lasts up to 2 years. The innovative 3mL reservoir of the pump allows the device to have a longer wear time. A unique needle insertion mechanism ensures that the 90° steel needle is protected prior to use and provides automatic insertion.
Medical device design consultancy, Shore, were responsible for the mechanical engineering and industrial design of the system and development of the IFU.
Understanding and simplifying the User Experience
The niia insulin patch pumps contain a complex system accompanied with a comprehensive IFU. Ensuring the pump can be used safely with effective drug delivery was a crucial part of the development process. Users are trained how to use the device by Health Care Professionals. In the process of use and application they are expected to set up the pump system, fill the reservoir, assemble the pump, prime the canula, apply the pump, respond to safety messages and remove the pump.
Our Human Factors pre-summative evaluation assessed the niia Essential as a complete system. During our study, a first-manufactured version of the pump was used to simulate the pump functions, which contained a needle. Participants demonstrated using the pump on themselves by sticking it onto a skin pad worn at the application site.
The participants for the study were Health Care Professionals and Patients with Diabetes. The participants had been trained by a Nurse Trainer, who had been trained by PharmaSens Team Member. Our team of experts evaluated the participants performance based on critical and essential tasks relating pump interactions. As part of the study, we collected feedback on the training from the Health care professionals, to understand if any improvements could be made.
Following the study, key findings from each participants interview were presented in a detailed report. Each stage of the set up process and use of the device was
Providing information to PharmaSens around critical use problems with each step of the process and root cause analysis