This collaborative effort between 219 Design, Stanford, CZBioHub and others is a success story about overcoming challenges encountered in new product development. COVID created a host of significant and varied challenges around designing for EUA approval, supply limitations, a distributed and virtual team, and an accelerated timeline. This team successfully tackled them all, resulting in an FDA Emergency Use Authorized ventilator. “I have the utmost respect for the 219 Design team who are incredibly dedicated, creative, and hard working. They are not typical consultants who are just doing work for hire, they joined us in our mission and worked tirelessly to help our end customer, patients sick from COVID-19. There is no way we could have taken O2u ventilator from concept to FDA approval in less than 1 year without them.” David Camarillo, Co-Founder O2u