DOI: https://doi.org/10.15368/theses.2011.154
Available at: https://digitalcommons.calpoly.edu/theses/599
Date of Award
7-2011
Degree Name
MS in Biomedical Engineering
Department/Program
Biomedical and General Engineering
Advisor
Lily Laiho
Abstract
Software testing, specifically in the medical device field, has become increasingly complex over the last decade. Technological enhancements to simulate clinical scenarios and advancements in communicating to medical devices have created the need for better testing strategies and methodologies. Typical medical device companies have depended on manual testing processes to fulfill Food and Drug Administration (FDA) submission requirements specifically Class III devices which are life supporting, life sustaining devices. At St. Jude Medical, software testing of Class III devices such as implantable cardioverter-defibrillators (ICDs), pacemakers, and pacing analyzers are given top priority to ensure the highest quality in each product. High emphasis is made on improving software testing for ease of use and for catching more software errors in each device. A significant stride in testing has automated the process and has provided software verification teams with the tools they need to successfully test and deliver high quality products. By creating software libraries which interact with communication to the other interfaces needed to test medical devices, test engineers can focus on fully testing device requirements and will not be concerned with how each test will interact with the device or any other testing tools.
The main focus will be a specific St. Jude Medical device known as the Pacing System Analyzer (PSA). The PSA device will be used to demonstrate how verification engineers are able to benefit from software libraries and allow the testing process and test development to be fully automated.
New technologies and standards will be created to simulate clinical scenarios and to communicate to new devices. The goal is to use software engineering principles to create standard test libraries which sustain these changes while still allowing testers to focus on finding issues for each device.