The coronavirus crisis has led Elon Musk to take an unexpected jump into the medical device industry.
Musk’s moves come as General Motorsand Ford also team up with medical device makers to help them accelerate production, though neither of those automakers has touted their own designs. Instead GM and Ford, like SpaceX, plan to make components at auto parts plants, which companies including Medtronic, Ventec, GE Healthcare and ResMed“It’s not a final ventilating manufacturing problem. It’s a parts problem,” ventilator maker Mick Farrell said in an.
The FDA accelerated the approval process for coronavirus-related treatments on March 31 to help with the health crisis. Nevertheless, ventilators made for patients with the most severe breathing problems are extremely complex and certification will take time, according to Gail Baura, an engineering professor at Chicago’s Loyola University who specializes in medical device technology and is author of a textbook on the subject that’s widely used at medical schools.
“There are all these engineering standards that are used to design these medical devices, and the FDA looks to make sure that you have tested and proved conformity to these standards before you can get FDA clearance and legally sell these devices,” she tells. A lot of time will be required to validate ventilators coming from these new manufacturing partnerships, “even with the emergency use authorization that the FDA is providing.
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