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PharmaSens: Simplifying diabetes management

Formative Study | Pre Summative Evaluation | IFU Development | Human Factors | Validation Support | UX | URRA

More than half a billion people are living with diabetes worldwide and this number is predicted to continue to rise rapidly. 

PharmaSens are simplifying the challenges of diabetes management with the niia essential Insulin Patch Pump. Their digital and sustainable system is designed to reduce the expense of pumps and the inconvenience of daily injections, giving people more freedom and better care. PharmaSens are leading the way in Diabetes Care management, niia essential Insulin Patch Pump has ISO 13485 Certification and is set for an FDA submission at the end of the year.

We are Human partnered with PharmaSens to support the development of the niia essential Pump and Instructions for Use through User Research, User Experience Testing and Human Factors.

Reduced cost, longer wear time and increased flexibility

PharmaSens understand that different solutions are required for different users in diabetes care. The niia essential Insulin Patch Pump is developed to suit a range of needs, making daily life easier. 

“Despite known medical benefits compared to manual injections of insulin, insulin pumps are only used by a few. Pump therapy is considered too complicated and too costly. We at PharmaSens are devoted to changing this.”

Among the most compact pumps on the market, the niia essential features a semi-reusable design which lasts up to two years. The 3mL reservoir allows the device to be worn for a longer duration, and the unique insertion mechanism has a sensor and needle in a single step, with no inserter required. The pump allows for both basal and bolus insulin for greater flexibility for the user.

Understanding the complex system

With such a complex system, the usability and confidence in safe drug delivery are critical to its success. Our team of experts have collaborated with PharmaSens throughout the device development lifecycle through Human Factors, User Experience Testing and User Research. 

We are Human conducted user research, UX testing and formative evaluations to identify opportunities for iteration, including a diary study and task-focused formatives to identify opportunities for iteration. Speaking to a diverse range of people with diabetes and healthcare professionals allowed for design insights to be uncovered and implemented.

We are Human ran a pre-summative study with the full system including training, using a first-manufactured version of the pump, to assess the safety and effectiveness of the niia essential and to de-risk the summative evaluation. We are Human assessed critical and essential tasks in depth, as well as providing detailed feedback on training implementation and approach. 

Fine-tuning the usability and ease of use

Following the user research, key findings from each participant were summarised and collated to provide PharmaSens with clear and actionable feedback. Providing insights and analysis on critical use problems at each step of the process, along with recommendations, allowed PharmaSens to ensure that users are always at the heart of their design process. Through the partnership between We are Human and PharmaSens, these insights and feedback supported the design of the connected tablet, the niia essential pump interface, the training and training materials and the Instructions for Use. 

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