Insulin Infusion System

Challenge

Insulet’s vision was to create the first insulin delivery system that completely concealed the pump from public view. The system included a handheld PDM that communicated wirelessly with a disposable, self-adhesive insulin pump, which held a three-day supply of insulin. The challenge was to design an intuitive, robust user interface and embedded control software that could be developed rapidly—even before hardware was available, and still meet FDA regulatory requirements for a Class II medical device.

Solution

Impact ES–Rhode Island engineers worked closely with Insulet to define the look, feel, and functionality of the Omnipod interface. Using an iterative process, the team developed LCD screen layouts and refined workflows for both users and clinicians.

Impact ES–Rhode Island developed the software for the reusable remote controller, which included:

• Refinement of the remote’s user interface

• Authoring the first Software Requirements Specification

• Designing the remote’s custom operating system

• Implementing the full application in C

• Performing hardware hazards analysis

  • Developing comprehensive FDA documentation, including:

  • Design specifications

  • Unit testing scripts and execution

  • Documented code reviews

  • Requirements traceability

To facilitate development ahead of hardware availability, Impact ES–Rhode Island created a Windows-based simulator (SimGUI) of the remote controller. This simulation tool featured a graphical “skin” that mirrored the look and operation of the device. It allowed Insulet’s marketing team to test and demonstrate the user interface to investors and board members early in the development process.

Outcome

The result was a highly functional and user-friendly handheld controller that enabled Insulet to bring the first fully concealed, wireless insulin delivery system to market. The system has since become the foundation for the widely adopted Omnipod platform.