Case StudyFirst Responder Portable AED
About This Project
Early-stage client developing an AED designed to be carried in a pouch for first responders and other professions that regularly interact with the public, like ushers or stadium employees. Full Spectrum was engaged to help improve requirements, create test plans/test cases, execute system and software verification, and improve the verification approach for the proprietary ECG analysis algorithm for this Class III medical device.
- Challenges
- Approach & Solution
- Outcomes
• Development company had very little experience with verification of a Class III medical device.
• Existing software requirements and verification-related documentation were recognized at the development company as insufficient.
• The AED contains an ECG Analysis Algorithm that was custom-developed for the device. The algorithm is ~80% classical signal processing and ~20% machine learning.
• Schedule was very tight because the proof-of-concept stage was elongated due to technical and supply chain issues, which shortened the verification phase.
• Review existing software and system requirements
• Identify areas of improvement prior to creating test plans and cases
• Work with development team to execute the improvements and yield more testable requirements
• Create test cases and test plans, work with development team to review test cases
• Execute dry-runs with prototype hardware in the loop
• Analyze the ECG analysis algorithm and describe and document its operation and execution.
• Much improved system and software requirements by identifying and breaking down compound requirements.
• Built confidence with the development team that the test cases would cover all functionality.
• Exposed system flaws that required attention at the software level.
• Ongoing project that is currently paused for software fixes before resuming dry-runs with hardware in the loop.
• The description of the ECG analysis algorithm was used to communicate the design and operation of the algorithm to the FDA in support of the 510(k) submittal.