FDA clears Formlabs’ 3D-printed BiPAP-to-ventilator converter

Formlabs/Lee Weissman

For hospitals that may not have the ability to print their very own, Formlabs is utilizing 150 3D printers at its Massachusetts headquarters to print the adapters. As soon as manufacturing is totally ramped up, the corporate expects to print as much as 3,000 elements per day.

“Formlabs’ EUA for BiPAP adapters signifies the necessity for these elements and 3D printings’ distinctive potential to fill that want. 3D printing allows fast iteration and prototyping of recent, revolutionary medical gear, whereas expediting the manufacturing course of, shortening provide chains, and permitting for localized manufacturing,” stated Max Lobovsky, Formlabs CEO and co-founder.

Lobovsky famous that previous to the COVID-19 pandemic, the FDA had solely approved a handful of EUAs. In March, Abbott acquired the rush-approval for its toaster-sized lab-in-a-box, and just lately, NASA’s ventilator design was accredited by the fast-track authorization.

Whereas firms from Tesla to Dyson and NVIDIA have explored new methods to fabricate ventilators, pivoting manufacturing to make the gadgets is troublesome and requires loads of experience. Plus, all ventilators need to clear regulatory hurdles and require creating new provide chains. Options like Formlabs’ adapter and right-to-repair efforts to lengthen the lifetime of current gear could also be extra sensible.

Leave a Reply

Your email address will not be published. Required fields are marked *