Formlabs Becomes First 3D Printing Manufacturer to Receive Emergency Use Authorization from FDA

By Niraj M Wanikar, Chief Editor, CNCTimes.com, 2020-05-25 22:51:00

Formlabs Becomes First 3D Printing Manufacturer to Receive Emergency Use Authorization from FDA for 3D Printed Adapters Designed to Convert BiPAP Machines into Ventilators.

Formlabs has the capacity to produce up to 3,000 3D printed adapters a day as countermeasures to the current public health emergency and is now shipping the adapters to hospitals for critically ill COVID-19 patients.

 Formlabs, a leading 3D printing company, announced today that it has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) to print bi-level positive airway pressure (BiPAP) adapters designed by Northwell Health, New York's largest healthcare provider. Formlabs is the first 3D printing manufacturer to receive an EUA and is now shipping these adapters to hospital systems throughout the U.S. to combat the shortage of ventilators and provide life-saving treatment to COVID-19 patients. The 3D printed adapters convert BiPAP machines, typically used for patients suffering from sleep apnea, into functional invasive mechanical ventilators. 

The key component to converting the BiPAP machine is a small, plastic T-shape adapter, which is easily produced on 3D printing machines in hospitals across the country. Formlabs will also produce these adapters at its FDA-registered headquarters in Somerville, MA to distribute to hospitals and government systems throughout the United States. Formlabs will allocate 150 3D printers at its headquarters towards printing these adapters, enabling the company to print up to 3,000 parts per day once production is fully ramped up.  

“Prior to the COVID-19 pandemic, the FDA had only authorized a handful of  EUAs over a 30 year period,” said Max Lobovsky, CEO and co-founder of Formlabs. “Formlabs’ EUA for BiPAP adapters signifies the need for these components and 3D printings' unique ability to fill that need. 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. 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.”

Northwell Health has been a key partner of Formlabs throughout the COVID-19 pandemic. The hospital system began working with Formlabs in 2018 and that partnership has led to the creation of 3D printed test swabs, in collaboration with the University of South Florida Health, and now 3D printed BiPAP adapters. Northwell designed these adapters to provide life-saving care to hospitalized COVID-19 patients during the peak of the virus in New York City. After using these adapters on a number of patients in their New York City ICUs during the peak of the virus in the city, Formlabs will now print these adapters at scale to aid hospitals in other hard-hit cities.

The industry’s response to COVID-19 is a seminal moment for 3D printing, and Formlabs is uniquely positioned to assist the medical community in providing critical supplies and equipment to combat COVID-19. Supporting hospitals and many others in the COVID-19 response was a natural extension of Formlabs’ work given the trust, credibility, and relationships the company has built with medical professionals and institutions over the years. From test swabs and test kits to respiratory masks and now BiPAP adapters, Formlabs has collaborated with its medical partners every step of the way.

For more information on Formlabs response to COVID-19 visit, formlabs.com/covid-19-response. Those looking to volunteer their time and 3D printers to help combat COVID-19 can find more information here. 

About Formlabs

Formlabs is expanding access to digital fabrication, so anyone can make anything. Headquartered in Somerville, Massachusetts with offices in Germany, Japan, China, Singapore, Hungary, and North Carolina, Formlabs is the professional 3D printer of choice for engineers, designers, manufacturers, and decision makers around the globe. Formlabs products include the Form 3, Form 3B and Form 3L, powered by an advanced form of stereolithography (SLA) called Low Force Stereolithography (LFS)™ 3D printing, Form 2 SLA 3D printer, Form Wash and Form Cure post-processing solutions, Fuse 1 SLS 3D printer, and Form Cell manufacturing solution. Formlabs also develops its own suite of high-performance materials that continue to push the boundaries for 3D printing, as well as best-in-class 3D printing software.

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