Covid Care Innovations
Re-Enabling Positive Pressure Ventilation
Auriel August and Mariel Bolhouse engaged in COVID-related needs finding as part of the Stanford Biodesign Innovation Fellowship. They found that COVID patients were often intubated without first attempting non-invasive respiratory support measures, such as positive pressure ventilation (PPV). This was due to the hazardous respiratory aerosols that accompany CPAP and BiPAP device use. Within six weeks, August and Bolhouse were on their fourth prototype of a novel adjunctive device designed to contain aerosols and safely re-enable PPV use.
Funding from the PDC supported initial manufacturing of the device, which the team committed to developing for all ages. The device went through multiple rounds of usability and efficacy testing, aiming to fit into the current infrastructure for PPV use and achieve safety measures equivalent to the use of an N-95 mask. While the team is working to develop a robust evidence base beyond what is required by the FDA Emergency Use Authorization (EUA) pathway, they recognize the external pressure to manufacture their product in a timely fashion.
The team is finalizing their design, has submitted testing plans to the FDA, and is evaluating contract manufacturing partners. After testing is complete, they hope to see uptake of the product across the US and Europe, where PPV typically is an important step in respiratory support for patients that fail nasal cannula. In the long-term, the team hopes the product can join PPV portfolios in companies that have the capability to efficiently distribute the adjunctive device.
Low Cost, Single-Use Ventilator for All Ages
As the early threat of a national ventilator shortage became apparent, David Camarillo felt that his Stanford lab’s work with electromechanical devices made his group well suited to contribute to a solution. In March 2020, Camarillo and Sam Raymond launched a project to develop and test new ventilation designs with the help of the engineering firm 219 Design. The team, now co-led by Camarillo and Ryan Van Wert has since developed a low-cost precision ventilator that can be used for neonates through adults.
A Stanford PDC grant was the first investment to catalyze building the new ventilator. The team has since raised nearly $1M and submitted an FDA application. They have been supported by lead clinical advisors David Cornfield and Brett Ley as well as the Chan Zuckerberg Biohub. The technology uses hospital wall gas O2 and a precision valve to deliver the small volumes of air appropriate for neonates. Most of the rapid low-cost COVID-19 ventilators built by other universities include an AMBU bag squeezing mechanism, which is not sufficiently precise for neonates.
Six months after starting the project, the team submitted an Emergency Use Authorization to the FDA for the ventilator. Although the current indication is for COVID-19 in the US, this low-cost technology may prove even more useful for neonates and young children in developing countries where they cannot afford a high-cost precision ventilator. The team is therefore exploring international partnerships to allow for local manufacturing and distribution of the product in countries hit hardest by ventilator shortages, including Brazil, India, and Mexico.