Albert Shih, Robert Bordley, & Barry Belmont: Automakers and ventilators
With ventilator supplies unable to meet the needs of U.S. hospitals facing COVID-19, automakers have announced plans to shift production and manufacture the vital breathing machines. University of Michigan experts are available to discuss this process and the challenges ahead.
“This reminds me of the Apollo project in the 1960s,” Shih said. “The auto companies have their work cut out for them over the next 100 days. They’ll need to design and build new production lines, which they’re doing right now. They’ll need to define detailed time steps for making hundreds of parts in large quantities and then figure out the logistical issues shipping these parts to those new production lines. All of these parts have to be good and at the assembly line at the right time to build the ventilators.”
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Robert Bordley is a clinical professor of integrative systems and design who is an expert on making decisions in uncertain situations. He has more than 30 years of experience in the auto industry, including managing General Motors’ R&D.
“Even as we’re scaling up this important work, we do need to think about what happens when the pandemic subsides and society doesn’t need all these ventilators,” he said. “Both Ford and GM will have created expensive production facilities that will no longer be needed. They will have to accept a sizable loss on these production facilities. Since the automotive industry is cyclical and because many people are expecting a downturn soon, that loss could reduce their competitiveness in enduring that downturn.
“Most of us vividly remember the costs of the great recession to the Detroit automakers and their employees. This is also a time when GM and Ford have also been working to make the transition to an industry with electric and driverless vehicles and with competitors from outside the traditional automotive industry.”
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Barry Belmont is a lecturer in the Department of Biomedical Engineering who teaches courses in biomedical instrumentation and design and has expertise in physiological monitoring. He can discuss ventilators in general as well as how they’re operated and the people side of the equation.
“Ventilators are medical devices requiring substantial verification and quality control. While the specific type of ventilator to be manufactured, the pNeuton designed by Airon, is classified by the FDA as a Class II device—typically requiring specific and general controls and approved via the 510(k) pathway—often devices that sustain life are deemed Class III devices and must go through extensive auditing and trialing to ensure safety and efficacy,” he said. “Given that the FDA has already approved these ventilators (though specific clinical testing was not performed on these devices), I will trust that the design is sound.
“What is important from a scaling-up perspective is that the finished products perform as expected, since end users will need to deliver specific flow rates, tidal volumes, pressures and oxygen concentrations to treat specific patients. Ensuring that the devices are verified and calibrated at the site of manufacture so that they are ready to go when they arrive at their intended destinations should be an utmost priority.
“While addressing the bottleneck imposed by the limited number of devices is important, we must also recognize that there must be personnel to operate the machines. Medical professionals trained to use these devices are finite in number, and though they are working harder than any of us to ensure that their patients are well cared for, with such dramatic changes to the daily operations of healthcare facilities, communication among all levels involved—from the state to the manufacturers, from the distributors to the health care providers—will be crucial to these efforts.
“Ford and GE have distinguished histories in mass manufacturing and fabricating quality products via high-throughput means, and they are uniquely positioned to make this happen. What’s more, with the support and leadership of Gov. Whitmer and the institutional knowledge of the manufacturing base here in the Midwest, if it needs to be made, Michigan will make it happen.”
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