All hands effort to make ventilator parts

U.S. automakers are assessing whether they can convert their plants to manufacture critical medical equipment, like ventilators, that will be in short supply as the COVID-19 pandemic spreads throughout America.

The Food and Drug Administration has temporarily waived its enforcement and inspection requirement to allow companies outside the healthcare industry – such as automakers and other manufacturers – to begin manufacturing much-needed parts for ventilators and other respiratory hardware.

General Motors, Tesla and Ford have begun ramping up their efforts to shift the all but halted production of their vehicles by partnering with medical equipment companies in an effort to combat the present scarcity of these life-saving machines.

The development of these assembly lines will meet with several challenges as any new manufacturing facility needs to be validated by the FDA – a process that can take up to 180 days.

The equipment also needs to be made in sterilized rooms with a much higher level of sanitation than your typical automotive paint booth.

There are other difficulties as well, as the ventilators use highly specialized single-use breathing tubes and masks made from medical grade materials, with most of these components currently manufactured overseas in Costa Rica, Japan, South Korea and China.

Recently, GM has partnered with Ventec Life Systems, to enable Ventec to increase production of its respiratory care products to support the growing fight against the COVID-19 pandemic.

Ventec will leverage GM's logistics, purchasing and manufacturing expertise to build more of their critically important ventilators.

SpaceX and Tesla CEO Elon Musk tweeted Saturday that he been in discussions with Medtronic, another medical device manufacturer, about its ventilators. Medtronic later confirmed those talks with their own tweet.

Finally, Ford Motors has aligned with GE Healthcare and 3M to help them dramatically increase their production of much-needed medical supplies to fight the scarcity.

Ford and the other automakers specialize in their output of vehicles in high volume, using global supply chains. Thereby, that mass production expertise has become a critical solution as medical technology companies try to meet surging demand during the crisis.

With the logistics still being worked out, a silver lining has begun to appear, as small companies, groups and individuals have been pushing towards alleviating some of the pressures of the shortage by using 3D printers to render certain parts of the breathing machines.

While these grassroot allies are unable to fabricate an entire ventilator, those who are sick do have need of a particular part that can be 3D printed.

In its simplest form, modern ventilators consist of a compressible air reservoir or turbine, air and oxygen reserves, a set of valves and tubes and a disposable or reusable "patient circuit."

The patient circuit usually consists of a set of three durable, yet lightweight plastic tubes, separated by function. Determined by the type of ventilation needed, the patient-end of the circuit may be either noninvasive or invasive.

Noninvasive methods, such as continuous positive airway pressure (CPAP) and non-invasive ventilation, which are adequate for patients who require a ventilator only while sleeping and resting, mainly employ a nasal mask.

Invasive methods require intubation, which for long-term ventilator dependence will normally be a tracheotomy or direct insertion into the throat.

Current cases of the coronavirus have shown the need of both methods of respiratory care.

The American Hospital Association has said that COVID-19 could require the hospitalization of 4.8 million patients, 960,000 of whom would need ventilators. As the demand for the equipment surges, making timely repairs and replacement parts will be critical to saving lives.

3D printing, while still a relatively new and niche technology has remained mostly on the fringes of the manufacturing and health care sectors.

But the coronavirus has suddenly made it a crucial resource. A call for people with 3D printers to help make protective masks for hospital staff has shown the worth of this still emerging technology.

Engineers, designers and technologists have begun to collaborate with medical experts and technical ventilation specialists to build a device that allows a single existing hospital ventilator to treat multiple patients at the same time or a new type of low-cost ventilator that could be manufactured and distributed quickly.

A newly formed coalition at Massachusetts General Hospital are planning a virtual open "moonshot" competition, aptly named CoVent-19, to develop a rapidly deployable mechanical ventilator within 90 days.

The team has assembled an international panel of experts to shape the development of the ventilator and will officially launch the competition, inviting anyone to participate.

With the infection rate on the rise, the need for ventilators has become imperative to treating patients sick with this virus and the all hands measures by the combined efforts of the auto company giants and the grassroots developers shows a remarkable level of solidarity in the face of this crisis.

Whether the automakers can begin output with their large-scale production expertise or the coalition of grassroot 3D printers begin developing a new, less costly respirator, this concerted effort shows that regardless of the situation, man will push through to find a way.