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Helping to Bring Lifesaving Technology to Market Faster

A MAJOR GLOBAL HEALTHCARE COMPANY // Portable Defibrillator

A 16-year old football player collapses after a blow to the chest during practice. He’s not breathing. His heart has stopped. Luckily, his school has a defibrillator. That defibrillator and a fast-acting coach saves his life.

A defibrillator saves lives when seconds count. Because of this, the demand for transportable defibrillators in schools and businesses is on the rise. In response, healthcare companies continue to research and develop (R&D) defibrillators that are easier-to-use, lighter weight for ease of transport, provide faster battery recharge time, and can be used on adults, children and infants.

CHALLENGE

A major global healthcare company committed to designing a new defibrillator with all of the features previously listed, and for that system to be used by both basic life support (BLS) and advanced life support (ALS) personnel.

As a Class III medical device used in life-critical applications, this new system would be subject to the most stringent design methodology. Every step of the development process would be carefully controlled, reviewed and documented. Even with a team of 100 or more employees, and ideal circumstances, this new system would require up to four years to complete. And, unanticipated problems could add months or years to that timeframe. This healthcare company wanted to accelerate the development process to deliver its new system to market in less than four years.

SOLUTION

To meet this aggressive timeframe, the company needed more expertise and resources in the areas of electrical and software engineering. The development team had already selected one of Logic PD’s System on Modules (SOM) to speed up the development process and decided to also employ Logic PD’s product lifecycle management services to solve resource and technical expertise constraints.

Logic PD’s OMAP3530 SOM-LV was chosen because, while many technical products have short life expectancies, a medical device like this one can have a 10- to 15-year lifespan. The Logic PD SOM used in the device was engineered with customer-selected options that included:

  • ARM reduced instruction set architecture
  • Ethernet
  • USB power management
  • I2C bus for connection of the audio codec, analog digital converter, real-time clock and secure ID chip
  • Controllers for the LCD display and touchscreen

Preparing for FDA submission, the customer also chose the OMAP3530 SOM because the company knew Logic PD would manage continuation-engineering throughout the product lifecycle using ISO 13485-compliant processes. If a component on the SOM becomes obsolete, Logic PD identifies, designs-in and tests a replacement component.

Another advantage of selecting Logic PD’s SOM was the head start it enabled with software testing. Developing software can be the most time-consuming part of the Development Phase and debugging requires that the software be run on the same hardware that will be used in the finished product. If that hardware is developed from scratch, software developers often have to wait until the hardware is completed before they can begin testing the software. Using Logic PD’s SOM, however, the company was able to gain access to SOMs early in the development process, insert them onto evaluation boards and start testing the software while the hardware development was still in production.

Getting the SOM up and running on a medical-specific operating system from Green Hills Software was the first task turned over to Logic PD’s software engineering staff. Based on successful completion of that work, the healthcare company employed Logic PD for additional work on the application software.

Over the lifecycle of the product, Logic PD engineers played several critical roles, including:

  • Designing and helping to build the baseboards for the SOM.
  • Designing verification for both hardware and software components.
  • Developing a Field Programmable Gate Array (FPGA) chip that directs internal data flow to a variety of software components, including drivers and enhancements for the Green Hills Integrity RTOS (Real Time Operating System), a custom bootloader, the printer subsystem controller and driver software, and the system software upgrade manager for tracking system software revisions and coordinating software upgrades.
  • Participating in Failure Mode and Effects Analysis (FMEA) and risk mitigation efforts.
  • Helping to implement Agile software development methodologies to accelerate the project timeline.
  • Participating in development of the system’s therapy software, and in development and test of the system’s incident recorder.
  • Providing ongoing software engineering services as needed, including optimization and performance tuning of the system software, ongoing support of system enhancements and quality assurance testing.

RESULT

Logic PD began work on the project in May 2008, and the system was delivered to market in September 2011 – months ahead of the original timeframe.

According to the development team’s system architect, “Across high tech industries, a lot of development efforts—maybe even the majority—seem to go over budget and past deadline. We had challenges along the way, but we made our goals, on time and within budget. Getting a whole team working together the way we did is a huge accomplishment.”

“There were some pretty aggressive milestones along the way, and when it took extra effort to achieve them, our people and Logic PD’s stepped right up. What differentiates an effective partner isn’t whether you have problems; it’s how they deal with them, and the people we dealt with at Logic PD were always open, always had solutions, and were never adversarial. We would certainly consider Logic PD again for work on other products we have in the pipeline.”

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