A monumental effort to quickly provide hundreds of thousands of ventilators to U.S. hospitals is underway. The feat depends heavily on the best efforts of unusual assortment of private-sector engineers, UAW workers and government bureaucrats who have been suddenly thrown together in the trenches by the COVID-19 threat.
The pairing of Ford with GE Healthcare, GM with Ventec Life Systems and Tesla with Medtronic to make ventilators on vehicle assembly lines is supplanted by unusual mashups of dozens of other smaller companies and even innovations by university researchers and vacuum cleaner maker Dyson.
In the U.S. alone, shortages could be 300,000 to 700,000 ventilators, according to an early estimate by the Centers for Disease Control for all flu-related diseases. New York Gov. Andrew Cuomo has called for 30,000 ventilators in the state to meet the virus’ peak about two weeks away.
Work prepping so many ventilators requires technical expertise and unusual cooperation that tests the mettle of industry veterans. If something goes wrong with a ventilator, a patient can die. That’s the same concern when building an SUV or pickup truck, but the demand for ventilators is suddenly more critical.
Almost as a kind of warning, California Gov. Gavin Newsom on Saturday said the federal government sent Los Angeles County 170 ventilators that weren’t working. They were quickly sent for refurbishment to Bloom Energy in Sunnyvale, California, a company that normally repairs fuel-cell power generators, according to the Los Angeles Times.
There has been “an unprecedented reaction” to the need for ventilators, said Dave Wilson, a vice president for National Instruments, speaking in an interview. “We’re starting with ‘Yes, how can we do this?’ The obstacles are daunting, but I think this challenge will be our moonwalk equivalent.”
National Instruments makes automated testing and measurement systems used by companies to measure an array of devices. In the making of ventilators, various companies will use NI’s systems to evaluate ventilators to pass U.S. Food and Drug Administration certifications.
A ventilator basically pushes air into a victim’s lungs, which requires a test of whether the volume of air is consistent and meets the levels set by a nurse. NI testing systems will allow various organizations to start a ventilator and test the electronics, including the circuit board, and other parts. Continuity of power is a big concern as is checking the module that connects to a pressure sensor that tracks how much air is pumping.
There are many models of ventilators, ranging from models like the MIT Emergency Ventilator to carefully calibrated models that run in intensive care units. A ventilator also has to be evaluated for how it will respond if a patient coughs into the ventilator tube. Some ventilators are built to operate only for short periods, but others must pump for days. “Some are very sophisticated with a lot of redundancy, alarms and failsafes for the worst-case situations,” said Jared Aho, an automotive field marketing manager at NI who was recently called into NI’s ventilator response. Some models also rely on wireless communication, which must be tested and confirmed.
In one example, Ventec integrates five medical devices into one with its VOCSN device: a ventilator, oxygen concentrator, cough assist, suction and a nebulizer—a device that turns liquid medicine into a fine mist that a person inhales through a mask or mouthpiece.
NI’s announced partners in the ventilator production ramp up include Averna Technologies, Circuit Check and Velentium, but there are others that haven’t been announced, Aho said. Those companies, in turn, are working with auto makers and medical device makers that are suddenly required to work together. The NI test systems help such companies prioritize the right hardware and software need for testing based on previously approved testing systems, but NI is also providing engineering services for quicker turnarounds.
NI and Velentium are working to reduce the testing time for each ventilator, once production automation is fully in place, Aho said. The FDA has also stepped up certifications. NI is working along CEO Eric Starkloff’s directive: “We will not let test be the obstacle in getting ventilators to market.”
CEOs cite shortages of ventilator supplies
Proper testing is not the only ingredient to get ventilators to hospitals in sufficient numbers. At Bio-Med Devices, CEO Dean Bennett told CNBC that receiving needed parts has been difficult, especially printed circuit boards, for use in ventilator production. The company has 80 employees and has produced 50 ventilators a week but may set up a second shift and ramp production to 1,000 machines a week.
Amid the rush to make ventilators, Bob Hamilton, the CEO of Hamilton Medical, told Fortune, “It is not a question of throwing enough money and people at the issue. Ventilators are highly specialized lifesaving machines that need to be build with the utmost care and precision. So, it needs trained people to do it, and it needs time.”
Hamilton wants to ramp up production by 40% above its annual rate of 15,000. The biggest threat is supply chain interruptions, which in the case of Hamilton is due to export restrictions.
On March 22, the FDA temporarily relaxed some guidelines for ventilator makers, granting more flexibility in making changes to suppliers or materials and for automakers to repurpose assembly lines.
Patrick Keane, an attorney at Buchanan Ingersoll & Rooney who works with Hamilton Medical, warned about the dangers of improperly manufactured ventilators.
In an email to FierceElectronics, he noted: “Industrial manufacturing companies unfamiliar with ventilator technology who are now veering into the ventilator space in response to the president’s invoking of the Defense Production Act, need to be aware of the technical and legal challenges, or there could very likely be product development, manufacturing and use problems that could lead to patent infringement, product liability and FDA approval issues. Such issues can be avoided or mitigated by appropriate collaboration with the US government and experienced ventilator companies.”
Keane’s warning stands in contrast to the optimism that engineers at NI and many other companies are feeling.
Patrick Moorhead, an analyst at Moor Insights & Strategy, has followed electronics production processes for years. The mashups of auto companies with ventilator makers to produce ventilators will likely be better than starting with a completely new design and bringing it to production, he noted.
“We are trying to do our part to help,” said NI’s Jared Aho.
IF YOU WANT TO HELP: FEMA has posted a list of ways that medical personnel can help with the COVID-19 response, but there are also ways engineers and product makers might get involved. The "How to Help--Private Sector" portion on its website includes ways to sell or donate goods to the effort. If you are a private company that wants to produce a product related to the COVID response, email [email protected]