PART 1: Scenario: The COVID pandemic is surging and we have a low supply of available ventilators. In order to save lives, HCPs are getting creative and attempt to ventilate two patients on a ventilator meant for one. This has the potential to increase the load on the ventilator and potentially cause overheating which could lead to product failure... But it also might save lives. We need to answer the questions: Are we at risk of product failure if the device is continued to be used in this off-label manner? Is ventilation of two patients on one device safe and effective? Let's walk through how an integrated system with simulations can help us contextualize potential risks and make decisions as a medical device manufacturer.