C. Bernstein
BB Medical Surgical,
United States
Keywords: Surfactant, respiratory distress syndrome, liquid suspension, oral balloon
Summary:
The COVID19 pandemic started the fiscal quarter after we were awarded the initial Phase 1 STTR. Because research institutes, laboratories, vendors and suppliers for our Aims all shut down and later struggled with their supply chains and business models, as did we, we pivoted. We achieved the Aims using a different path than originally planned. We have stayed in contact with the NIH, FDA, and our vendors and co-Investigators during this time, and have adapted together. Despite this unprecedented challenge, we learned how to get the prototypes produced, verified and validated in some challenging circumstances. We contracted with the USC Center for Advanced Manufacturing (USC CAM, Los Angeles, CA) lab to 3d print flexible SAAVI parts to rapidly and cheaply build test bench (non-functional) devices for the oropharyngeal anatomy of our neonate simulators. In tandem with the engineering specification developments, we engaged the USC Regulatory Science Department consulting group (Los Angeles, CA) to help us develop quality system (21 CFR 820, aka current Good Manufacturing Practice) standard operating procedures for document controls, design transfer, design controls, and supplier qualification as necessary for safety, efficacy, and successful commercialization of the SAAVI device. Much of this work was done by the team dispersed amongst different geographies and time zones, as the USC campus was closed. After we purchased our first simulator, the 24 week model, our co-Investigator, a neonatologist, suggested investigating the use of the simulators, as he thought using a preemie airway trainer model could be a good platform to test the functionality of device prototypes. This was a timely suggestion because during the initial pandemic lockdown period, The Lundquist Institute did not process any IRB study applications as the research campus was closed and Harbor-UCLA hospital was under severe stress. Airway trainer models for adults, children, and full term babies are readily available, but not so for preemie babies. We spent at least 100 hours adapting our simulators to be airway trainers. The 24 week simulator does not come with actual simulated lungs, and in the end we figured out a way to use pieces of clear exam gloves, the y-connector and tubing from an 8 french nasogastric tube, and craft putty and adhesives. A special thank you to Mr. Scott Yanofsky, a real estate developer and licensed contractor who fabricated the first set of these simulated lungs in his garage, during pandemic lockdowns. Mr. Yanofsky also gave us suggestions on different types of glue guns, silicone adhesives and building supply stores in the Torrance/South Bay section of Los Angeles County. Our 28-30 week simulator did come with actual removable lungs, and when it came time to create the 1-1.5kg SAAVI device prototypes, our CMO made several extra sets for our bench top testing. Our research associate tested