Additive Manufacturers Work to Bridge Gap in PPE Supply

YOUNGSTOWN, Ohio – It’s been just over a month since the Food and Drug Administration put out a memorandum of understanding with America Makes, the Veterans Administration and the National Institutes of Health to put additive manufacturing to work in addressing health needs during the coronavirus pandemic.

The results, experts from the NIH, FDA, VA and America Makes say, have been overwhelming. The NIH repository of designs for equipment that can be made with additive manufacturing has gathered 27,000 views from around the world. As of Monday, 523 designs have been uploaded to the repository, with 18 under clinic review by the VA and 14 being reviewed for community use.

Over the past month, additive manufacturing companies have “bridged the gap” in the traditional supply chain of personal protective equipment, which early on in the crisis saw a shortage of such equipment.

“There are some cases where we’re actively investigating what the long-term role of AM is in updated or new designs and components,” says John Wilczynski, executive director of America Makes. “Some of those are yet to be proven, so we need to be careful over how excited we are over them, but there’s certainly opportunity in that space.”

Nonetheless, there’s certainly been an impact.

“We’ve seen it play a significant role in face shields. It clearly demonstrates filling the gap in the conventional supply chain for face shields,” he says.

So far, America Makes members have gotten equipment requests totaling units “in the low hundreds of thousands,” he adds, noting that at this point, such requests are almost exclusively facemasks. Members have also been working on designing face shields and ventilators.

Wilczynski was joined by FDA materials scientist Matthew DiPrima, NIH 3D printing biovisualization program lead  Meghan McCarthy and VA 3D printing advisory committee member Beth Ripley for a panel discussion on how additive manufacturing has been used in the COVID-19 outbreak.

Among the efforts led by America Makes during the pandemic has been the Face to Fit Challenge, which tasked additive manufacturers with developing masks and shields that better fit wearers’ faces. During the panel, Wilczynski announced designs from Carnegie Mellon University and Alliance PCB Solutions of Mt. Pleasant, S.C, as the winners, with designs from re:3D and a team from the National Institute of Standards and Technology getting honorable mention.

“We’ll be providing some more feedback. There are a couple things that need tweaked even though they had a really good fit,” Wilczynski says. “Hopefully, those will turn into designs we make available to the community quickly through the NIH site.”

Much of the personal protective equipment designs hosted on the NIH 3D Print Exchange are not top-tier medical grade equipment like what would be used by workers in intensive care units. Rather, they’re pieces meant to be used by other medical workers in health-care settings or even every-day use by average people.

“Based off standards from the NIH, FDA and VA, we’re looking at the requirements for PPE in health-care or medical purposes,” says the FDA’s DiPrima. “But there are looser restrictions when they’re not used in health care and that’s where community use comes in. There are a number of products that have been deemed appropriate for community use.”

In most cases, additive manufacturing companies are starting their work from scratch. While 3D printing has found use in the medical field for things like prosthetics or dental work, most America Makes members that offered their services haven’t done work in the field before.

“There are people who didn’t know until a month what [good manufacturing practices] were, but they may have a quality system in place that’s comparable,” the America Makes director says, noting that some companies that once made parts for the aerospace industry are now making medical equipment.

“Our intent is to put clarity around complex questions about how to make [this equipment] and make sure they’re safe,” says the VA’s Ripley, adding the jumping off point was creating “something better than a bandana.

“There are two things you want to do. One is source control; wear a mask so you don’t spread the virus. Then there’s the mask you wear to protect yourself from getting the virus. … If we go with either, the question has to do with stopping movement of coughs, liquid, etc.,” she says. “Though we have not put bandanas through rigorous testing, we’re doing so now so we can truly tell what’s better.”

Because the designs featured in the 3D-printing repository are available to anyone, the creation of protective equipment isn’t just limited to companies.

“Given that we have a broad spectrum of people from manufacturers to makerspaces and individuals to fill this gap, there’s really an opportunity for every-day maker to fill,” says the NIH’s McCarthy. 

Adds Wilczynski: “I’d have companies with four, five, six employees asking the same questions as a Fortune 100 company, some the biggest players in AM. That put us in a unique position to take input, whether in regards to parts manufacturing or materials, to be the voice of that community.”

It’s likely too soon, DiPrima says, to know what the impact of fostering connections between health care and additive manufacturing will be. 

“This was very much a global pandemic, but look at regional disasters. If there’s one plant making all of your product and then there’s an earthquake, hurricane, massive blizzard that shuts it down, does distributed manufacturing start looking more attractive?” he says. “There are lots of changes AM will bring as a result of experiences during the COVID pandemic, but I think we’re still too close to fully understand it.”

What the pandemic has brought to light is that work still needs to be done in preparing for disasters like this, Wilczynski says. Inevitably, there will be another disaster, either on a global scale or local one, that causes disruption.

“Additive has proven that it can make an impact here in this particular issue,” he says. “What we need to think about is how do we prepare for future crises? How do we identify that strategy and make a roadmap? How do we have something like a repository?”  

Copyright 2022 The Business Journal, Youngstown, Ohio.