In COVID-19 Crisis, Lilly Device Creators Collaborated on Ventilator Solution to Help Patients

With the U.S. Food and Drug Administration’s (FDA) authorization, Lilly’s design for a Ventilator Circuit Adaptor System (VCAS) got a green light today. [PR LINK] This system enables hospitals to support two patients using one ventilator in an emergency situation where the hospital has more patients needing ventilation than the supply of ventilators. Its design is different than other mechanical ventilator split solutions.

Lilly developed the VCAS for humanitarian reasons and will share design details and instructions free of charge to health care facilities upon request. In the interim, we’ve partnered with local suppliers to assemble a limited number of kits for distribution to hospitals as needed. The Lilly kits have not been FDA cleared or approved but are authorized for use in health care facilities during the COVID-19 pandemic under the FDA’s ventilator Emergency Use Authorization (EUA).¹

“Too many doctors and hospital administrators are having to make difficult choices about which COVID-19 patients can be ventilated because ventilators are in short supply,” said Dean Mariano, a practicing anesthesiologist and medical fellow in Lilly’s Neuroscience Design Hub. “We asked ourselves, ‘what could we do to help them?’”

In just 15 days, the team – consisting of Lilly scientists, physicians and engineers from both Indianapolis and Cambridge sites – went from project initiation to FDA submission of a VCAS.

Here’s how it happened: The team evaluated previous designs of purely mechanical split circuit ventilation, including an original article published in 2006 and the recently released New York-Presbyterian/Columbia University physician-led ventilator sharing protocol that was developed to increase the capacity of mechanical ventilation during the COVID-19 crisis. Also, the Lilly team studied the American Society of Anesthesiologists’ (ASA) recommendation against the use of purely mechanical splits for ventilation of critical patients. According to the ASA and other critical care governance bodies, a major shortcoming of pure mechanical split ventilation is that controlling independent ventilation for two patients is not possible.

With this in mind, the Lilly team focused the design on separately monitoring and adjusting ventilation settings for each patient. They added sensors and restrictor valves to regulate air flow and pressure to optimize ventilation and enable a more tailored treatment plan for each individual patient.

The team also knew that the solution had to be delivered rapidly to hospitals and decided to take an approach that used only components and supplies already available to hospitals instead of custom-designed parts.

“We had team members collaborating across the country, preparing detailed designs and fabricating early prototypes in their garages to test concepts,” said Andy Ratz, Lilly’s vice president of drug delivery and devices. “Within 48 hours, the best designs were combined, and a laboratory test system was constructed, proving the product was viable. The team’s energy and dedication to this project were incredible.”

Once the team had the initial VCAS kit design, they needed to test it under realistic COVID-19 conditions. They collaborated with the Indiana University School of Medicine (IUSM) at their Fairbanks Simulation Center in Indianapolis, which has the capability to mimic a range of respiratory distress conditions. The team spent multiple days in the center evaluating and verifying the system design and optimized componentry. In collaboration with IUSM, they ran more than 200 scenario tests on the lung simulators and produced data enabling high confidence in the design and performance of the VCAS.

On day 15 of the project, the team submitted their request of authorization to the FDA under the EUA process.

This is the latest of several solutions that Lilly has developed to help our communities and people during this challenging time of the COVID-19 pandemic. You can learn more here about our multifaceted response involving drive-through testing, research and development, social impact, and more.

Reference: 1. This ventilator tubing connector, or ventilator accessory, as applicable, has not been FDA cleared or approved.

• This ventilator tubing connector, or ventilator accessory, as applicable, has been authorized by FDA under an EUA;

• This ventilator tubing connector, or ventilator accessory, as applicable, is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of ventilators, ventilator tubing connectors, and

• Ventilator accessories under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.