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3D-Printing Manufacturer Nabs EUA to Convert BiPAP Machines into Ventilators

TAGS: 3D Printing
Image Credit: Northwell Health 3D-Printing Manufacturer Nabs EUA to Convert BiPAP Machines into Ventilators
The authorization allows Formlabs to print adapters, designed by Northwell Health, to convert bi-level positive airway pressure (BiPAP) machines into functional invasive mechanical ventilators. BiPAP machines are typically used for sleep apnea.

3D printing has emerged as a hero technology during COVID-19 because the technology enables rapid prototyping and production of personal protection equipment (PPE), diagnostic testing swabs, and an array of other medical device components. While there remains limitations with technology, additive manufacturing is far better positioned to respond to urgent supply needs than traditional manufacturing methods.

Case in point, Formlabs recently became the first 3D-printing manufacturer to receive emergency use authorization (EUA) from FDA to print bi-level positive airway pressure (BiPAP) adapters designed by Northwell Health, New York's largest healthcare provider. BiPAP machines are typically used to treat sleep apnea, but these plastic T-shaped adapters are designed to convert the machines into functional invasive mechanical ventilators.

The Somerville, MA-based company said it is now shipping the adapters to hospital and government systems throughout the country in response to the COVID-19 ventilator shortage and plans to ramp up production to 3,000 parts a day.

Gaurav Manchanda, Formlabs' director of healthcare, told MD+DI that the company has been working with Northwell Health since well before the COVID-19 outbreak. Northwell was the first customer of Formlabs' automated enterprise production solution called Form Cell back in 2018, he said, and the healthcare provider is now using Form Cell for the production of COVID-19 testing swabs, BiPAP adapters, and other medical devices.

"With the swabs Northwell Health and [University of South Florida Health] approached Formlabs with the design and we helped to optimize that for throughput and print success. In this case Northwell Health had already done the design validation and actually started using the devices within its health system and there were several patients connecting to these adapters by the time we were involved," Manchanda said. "Things are changing on an hourly basis these days in the COVID response effort and there are new technologies being developed at a very rapid rate."

Because more than 100 hospitals were already using Formlabs' machines prior to the pandemic, the company had an established relationship with clinicians and healthcare systems like Norwell who are now approaching Formlabs with all of their great ideas, Manchanda said.

And at the end of the day, the 3D-printed BiPAP adapter represents the whole purpose of FDA having an EUA pathway for manufacturers. The device was designed during a time when ventilator shortage was a much bigger concern, especially in New York where the device was created, compared to the current situation.

"It is our hope that nobody needs this, right? It's our hope that there are more traditional ventilators are available within hospitals at the quantities that are needed for all the patients who require ventilation systems ... but we're happy to have this as a backup in case it is ever needed," Manchanda said.

At the same time, the EUA represents a significant milestone for the 3D-printing industry.

"3D-printing enables rapid iteration and prototyping of new, innovative medical equipment, while expediting the production process, shortening supply chains, and allowing for localized manufacturing," said Max Lobovsky, CEO and co-founder of Formlabs. "Hospitals around the country can also use Formlabs' printers to create these adapters locally under their own practice of medicine, meaning printing the adapters at scale in the hardest-hit areas is as easy as uploading a design and pressing print."

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