StealthStation AxiEM Post-Exposure Verification Method
Problem statement
The StealthStation S8 Surgical Navigation System has been vital for over 3.5 million procedures, including spine surgeries and brain biopsies [1]. The system uses objective tracking of surgical instruments to perform higher precision procedures. To ensure patient safety, it is essential to validate medical devices by executing test protocols that verify the system’s robustness before and after exposure to environmental conditions. Currently, there is no repeatable and reproducible method to test the system before and after exposure to shock, vibration, and heat cycling conditions, making it difficult for the client to identify whether accuracy differences are caused by exposure or manual operation. While some may argue that existing manual tests provide sufficient validation, these methods are prone to human error and lack the consistency necessary to ensure repeatability across multiple trials.
Team members
Lauren Jafuta – facilitator
Kate Nelson – communicator
Megan Mulrooney – accountant
Meta Simon – admin
Client
Sarah Esser
Medtronic