Case Studies
Insulin Infusion System
Developed the software associated with an insulin infusion system with user-programmable handheld controller and disposable RF-linked delivery system and assisted in the regulatory approval process.
Description
Problem
With the idea to create a new insulin infusion technology, a customer lacked the resources to take their hardware platform to a completely realized system meeting regulatory guidelines and including user interface design. BCA provided the software development resources, the FDA regulatory expertise, and the usability expertise to bring this idea into a reality.
Solution
BCA developed the software for a
reusable remote controller with a graphical user interface,
communicating with the pump over an RF link. BCA was responsible
for:
- Refining the user interface for the remote.
- Writing the first revision of the Software Requirements
Specification
- Designing the operating system for the remote
- Designing and implementing the application for the remote
- Performing hardware hazards analysis
- Developing FDA Documentation
FDA documentation included:
- Design specifications
- Unit testing scripts and execution
- Formal documented code reviews
- Traceability between design and
requirements
To facilitate development, BCA
wrote a Windows simulator for the remote controller. This program
was used to develop a majority of the 'C' code base of the
application, which then ported directly to the embedded device. A
graphical 'skin' was used to mimic the exact appearance and
operation of the controller. It was also used to demonstrate the
device to prospective investors and board members.
Client Insulet Corporation
Year Completed 2006