Microsulis

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Medical device software

The challenge

Microsulis is a provider of high tech medical devices to the healthcare industry based upon a microwave technology platform. Microwave based techniques offer physicians the capability of performing safe and effective treatments that are minimally invasive to their patients.

The first product, the Microwave Endometrial Ablation (MEA) System is a device that can be used by physicians to treat women experiencing heavy menstrual bleeding (menorrhagia). This product was successfully CE certified in Europe and the device has subsequently received regulatory body approvals in the United States, Canada, and Australia.

As part of the regulatory body approval process, Microsulis required software enhancements that would improve the performance of the product and secure the required product approvals in the U.S. and Canada. As a result of this need, IPL was selected because of their ability to implement and perfect software enhancements while complying with industry, international, and regulatory body standards for developing and testing software solutions.

The solution

Using IPL's extensive experience a development, validation and testing strategy was defined to meet the needs of Microsulis. IPL produced an associated automated testing infrastructure to verify software in accordance with the defined strategy. As part of this work IPL developed the necessary tools, including a hardware simulator to support fully automated unit testing and semi-automatic integration testing of the software.

IPL quickly and successfully implemented the planned product enhancements using the testing infrastructure. The whole development was completed within the customer's timescales and under budget.

The product successfully achieved regulatory body approvals in both the U.S. and Canada, and. Microsulis is now rapidly expanding the commercial distribution of the MEA System within the North America, Europe and Asia.

The highlights

IPL's experience and know how in the development of software solutions directly assisted Microsulis in the development of the MEA System. The investment in an automated testing infrastructure has provided Microsulis with the ability to rapidly respond to the changing market demands while providing and maintaining the highest quality standards.

Based upon the success achieved, IPL and Microsulis continue to work closely and IPL is currently assisting Microsulis with:

• the development of software for new medical devices; and
• the maintenance and enhancement of the software for existing Microsulis devices in commercial distribution.