Project Aura

In the 2000s, the CDC estimated a shortage of 40~70,000 ventilators in case of pandemic influenza. From this assessment resulted *Project Aura*, a public-private initiative to design a frugal, 3,000 US$ mechanical ventilator, simple to mass-produce, and able to supply the Strategic National Stockpile. Newport Medical Instruments was granted the contract, designing and prototyping (2011) the frugal ventilators to CDC officials, and expecting to later profit from the product by moving into the private market were other competing devices were sold for 10,000US$. On April 2012, US Health and Human Services officials confirmed to the US Congress that the project was on schedule to file for market approval in late 2013, afterwhat the device would go into mass-production. On May 2012, 12B$-worth medical conglomerate Covidien, a top actor of the mechanical ventilation market, acquired Newport for 100 millions US$. Covidien soon asked to cancel the *Project Aura* contract since it wasn't profitable enough. Former Newport executives, government officials and executives at rival ventilator companies suspect Covidien acquired Newport to prevent the frugal 3,000 ventilator design from disturbing its profitable ventilation operation. Covidien has merged in 2015 into Medtronic. *Project Aura* looked for and then signed a new contract with Philips Healthcare. In July 2019, the FDA signed for 10,000 units of their Trilogy Evo portable ventilator, to be delivered to the SNS by mid-2020.

On March 25, Andrew Cuomo made a detailed 1h COVID19 press conference, emphasizing an expectation of a severe shortage of ventilators, and their importance in sustaining life in severe COVID-19 cases. Cuomo said New York state would ultimately need about 30,000 ventilators to handle the influx, while having only 4,000 as of March 25; on the 27th, President Trump expressed doubt about the need, saying "I don’t believe you need 40,000 or 30,000 ventilators," and resisting calls to force businesses to produce them. Later on the 27th, the President acceded to calls to assist states in ventilator procurement, using the Defense Production Act; fears remain that procurement will not happen in time to prevent severe shortages.

## Industrial suppliers

In Europe, the company Löwenstein Medical producing 1500 ICU-level ventilators and 20,000 home-level ventilator per year for France alone, pointed out of the current high demand and production shortage. Based in Europe, all their components are European and not relying on Chinese's supply chain. As for production ramp up, it was suggested to increase the production of home-level ventilators, more basic and which can be assembled in half an hour yet able to support patients through acute respiratory distress syndrome. The current bottleneck is mainly a question of qualified human resources. In business as usual, ICU-level ventilators are to be renewed every 10 to 15 years. Due to the coronavirus pandemic, Germany and other European countries have started to take control over the company's supply.

In China, local manufacturers are racing to answer the demand.

## Hackers

See also: Open-source ventilator

3D makers have been working on various low-cost alternative ventilation devices or adaptations.

Anesthetist Dr. Alan Gauthier ifrom Ontario, Canada, turned one single-patient ventilator into a nine-patient device thanks to a 2006 YouTube video by 2 doctors from Detroit. The method uses T-shaped tubes to split airflow and multiply the number of patients provided with respiratory support.

In Ireland, volunteers started the *Open Source Ventilator Project* in collaboration with medical staff.

In Italy, local journalist and journal director Nunzia Vallini of the *Giornale di Brescia (Brescia Daily)* was informed that nearby Chiani hospital was running out of valves which mix oxygen with air and are therefore a critical part of reanimation devices. The valves supplier was itself out of stock leading to patient deaths. Vallini contacted FabLab founder Massimo Temporelli, which invited Michele Faini, an expert in 3D print manufacturing and a research and development designer at Lonati SpA to join a 3D printing effort. When the supplier didn't wish to share the design's specifics, they reverse-engineered the valves and produced a limited not-for-profit series for local hospitals. In order to satisfy biomedical requirements that can withstand periodic sanitation, Lonati SpA used their SLS 3D printers to print about 100 valves in Nylon PA12. Faini and Temporelli still acknowledge the limitations of their production: 3D printing not being able to reach the quality and sterilized context of the original valves and manufacturing process. Contrary to rumors online, the valves don't cost US$10,000 each and the original manufacturer did not threaten to sue the 3D printers team.

Hackers of the *Ventilator Project* have brainstormed to propose to re-purposing CPAP machines (sleep-apnea masks) as ventilators, hacking single ventilators to split air-flow and treat multiple patients, and using grounded airplanes as treatment facilities to leverage their one-oxygen-mask-per-seat infrastructure. Engineers familiar with devices design and production, medical professionals familiar existing respiratory devices and lawyers able to navigate FDA regulations if the needs arise are key participants among the 350 volunteers involved. The central avenue of exploration is to ditch away the most advances features of modern mechanical ventilation, which includes layers of electronics and patients monitoring systems, to focus solely on assisted respiration by pressured airflow. The group is, by example, looking for an old Harry Diamond Labs "emergency army respirator" model to study. While hopeful they will be able to submit viable and mass-producible design, several questions linger at this later levels: mass production line, FDA approval, personnel training, personnel availability, and eventually actual needs on the battlegrounds to come.

An MIT team has designed an emergency ventilator.