The nation’s largest industrial 3-D printer is getting a crash course in federal bureaucracy as it races to produce millions of critically needed N95 respirators for essential workers.
Edward Dominion, founder of D6 Inc., is optimistic he’ll win quick approval by the Food and Drug Administration for a new N95 respirator the Portland, Ore.-based company designed to meet or exceed federal safety standards. If approved, he said D6 facilities could manufacture up to 7.2 million masks per day.
“I built the entire company around being the fastest design-to-market company in the world,” Dominion told Bloomberg Law. “Anything that is plastic that isn’t nuclear we can make in 24 to 48 hours.”
But there are a lot of regulatory hurdles in the way.
Step by Step
N95 respirators are regulated by the FDA and the National Institute for Occupational Safety and Health. Under a memorandum between the two agencies, NIOSH first evaluates whether a device exceeds the threshold criteria, then FDA considers that evaluation in deciding whether to approve the device.
“Given the shortage of supplies, our hope is that FDA will grant an emergency use authorization specific for D6’s product,” said Daniel Liebowitz, an associate in the environmental and regulatory practice at Paul Hastings LLP, which is representing the manufacturer pro bono. The FDA has granted emergency use approval to a number of respirators made in China.
The catch is that emergency use authorization is temporary. If D6 wanted to continue selling the respirator after the public health emergency was declared over, it would have to go through the standard NIOSH application process, which generally takes about three months, Liebowitz said.
An N95 respirator is a close-fitting protective device designed to achieve highly efficient filtration of airborne particles, with the edges of the respirator forming a seal around the nose and mouth. Respirators with the N95 designation block at least 95% of very small (0.3 micron) test particles.
Most N95 respirators are manufactured for use in construction and other industrial jobs that expose workers to dust and small particles. Surgical N95 respirators must meet a higher standard and are tested for fluid resistance, filtration efficiency, flammability, and biocompatibility. The model D6 has developed is a regular N95 respirator.
‘Challenging’ Regulatory Specifications
D6’s goal from the start was to protect the medical community and to make N95 respirators that could meet all federal safety standards, said Claire Clelland, M.D., clinical fellow in neurology at the University of California San Francisco’s Weill Institute for Neurosciences, who has been consulting on the mask’s design.
“The regulatory specifications particularly have been really challenging,” Clelland said.
D6 filed utility patents at the start of April, Dominion said, but the prototype is still in testing at independent laboratories and not yet ready to be submitted to federal regulators. The first step was a fit test, done at Oregon Health & Science University, to determine if air could escape, and the prototype passed easily, he said. The second test is a more difficult efficiency test of the filtering material.
Clelland said she was able to get ICS Laboratories to conduct the second stage of testing. ICS calls itself the only third-party laboratory in North America fully accredited to test respirators according to NIOSH standard test procedures.
FDA is allowing for maximum regulatory flexibility for devices that are critical to the response to Covid-19, the disease caused by the novel coronavirus, an FDA spokesperson said.
“Our staff are reviewing applications rapidly. As long as data supports the application, we are authorizing these products quickly. In many cases, authorizations are issued within days of receipt,” the FDA spokesperson said.
Producing at Cost
D6 is a rapid-prototyping company, 3-D printer, and thermoforming manufacturer that normally produces an array of products, including clam-shell food packaging, semiconductor chips, and car bumpers, but also some medical components. The company owns five facilities and subcontracts work to 39 facilities globally, for a total of about 800 employees.
The base of D6’s new respirator design is plastic, made mostly out of recycled water bottles, with an exchangeable filter. It is BPA-free and “literally food-grade plastic” meant to touch human skin, Dominion said. It still uses some hard-to-find N95 fabric—a non-woven, fused polypropylene material—but much less than in traditional N95 respirators.
The company has sunk more than $600,000 into the project already with no promise of a single sale, Dominion said. If approved, D6 facilities could produce 250,000 respirators per day to start, ramping up to 6.2 million to 7.2 million per day, he said. The company has committed to pricing respirators at cost, about $3 to $4 each, and to supplying medical and essential workers first, he said.
By comparison, a retail pricing chart released by 3M sets its base model, disposable surgical respirator at 68 cents apiece, and its highest price standard disposable respirator at $3.40 apiece. The D6 prototype is designed to be reusable.
Standards Still Count
Those commitments are what led Paul Hastings LLP, a global law firm with a robust pro bono program, to offer its support to the company. “Ed’s doing the right thing,” said Bill Belitsky, of counsel in the corporate practice at the firm’s New York office. “He’s trying to do this at cost and he’s already invested a significant sum into laying the groundwork for being able to make this happen on a short time frame.”
Demand for scarce medical supplies could increase after President Donald Trump on Thursday released a plan to reopen the country that suggests states be able to quickly and independently supply sufficient personal protective equipment to handle surges in need.
Quality standards won’t be dismissed, but the FDA is cognizant that this is a public health crisis and is trying to act expeditiously, said Sonali Gunawardhana, of counsel at Shook, Hardy & Bacon LLP and a former FDA attorney.
“If they can get to something that they feel has a pretty good safety profile that they’re comfortable with, they’re going to grant the authorization,” Gunawardhana said. “If they feel that the safety profile is too slippery and it could do more damage, they’re not going to give it.”
—With assistance from Ayanna Alexander