ASSURE Wearable Defibrillator Failure Investigation Lab: Process Improvements

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Kestra Medical's mission is to provide innovative, intuitive medical technologies to protect and support at-risk patients. In 2021, Kestra received pre-market approval (PMA) from the FDA for an innovative new Wearable Cardioverter Defibrillator (ASSURE WCD) and is now on market and rapidly growing with distribution across the US. The ASSURE WCD is a prescription medical device that protects patients at high risk of Sudden Cardiovascular Death (SCD), often following cardiac events such as Myocardial Infarction. It is designed to be reliable, discreet and comfortable and components are re-used between patients. Kestra is responsible for assessing the WCD's performance in the field, investigating any failures and identifying opportunities for improvement. As systems reach end of life or experience faults or failures, they are returned to the Kestra Failure Analysis lab for investigation. This student team worked to create a detailed process map of the ASSURE failure analysis workflow and will work to identify methods of organizing the investigation process. Additionally, this student team sought to design a storage and cataloging system to archive items being investigated. Anticipated outcomes this student team worked towards included: -A defined process workflow of the important failure analysis process. -Insight into the best ways to apply resources and technology to improve response time. - A physical organization system for hardware under investigation. -Interfacing and collaborating with a team of skilled students and exposure to new engineering skills. Potential experience for the student team included: -Hands on work with an innovative medical device company. -Team ownership of a real-world engineering challenge, with a direct impact to saving lives of at-risk medical patients. -Exposure to medical device hardware and reconditioning processes.

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