Apr 22, 2020

Is 3D printing ready to fill the gaps in COVID-19 medical equipment needs?

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Second question: Once it's made, would the FDA quickly approve and certify 3D-printed PPE?

There’s a lot of hope that 3D printing can play a crucial role in creating medical supplies during the COVID-19 crisis. Companies like Ford and HP are using their 3D printers to create masks, nasal swabs for tests and ventilator parts. University research labs are doing the same as they try to ramp up creation of test kits. Also, makers at home are using their own 3D printers to create masks for themselves and others. 3D printing is definitely a growing industry, but because of a lack of regulation and supply chain issues around getting raw materials, it’s an industry that might end up being more useful in the next big emergency than in this one. 

I spoke with Avi Reichental, an early pioneer of 3D printing, and the founder and CEO of the investment and product development firm XponentialWorks. He told me his company is trying to make critical medical supplies quickly. The following is an edited transcript of our conversation.

Avi Reichental (Photo courtesy of Reichental)

Avi Reichental: We’ve been working around the clock to create just the basic personal protective gear, to work on 3D knitting of N95-equivalent masks. We’re working on creating the availability of nasal test swabs. The existing supply chains are just incapable of gearing up so quickly, yet with 3D printing, we have the ability to digitally teleport parts. Within days, we’re able to take designs that were sourced to the crowd and replicate it across the world.

Molly Wood: What are the barriers? You have to fabricate that, for example, N95 mask replacement from something, right?

Reichental: Yes, we are extending the sourcing and availability of raw materials, and we are learning that the supply chain of raw materials is also being stressed. We will have to rethink how we look at [Food and Drug Administration] regulatory compliance in the future, because it will have to migrate from device-specific to process-specific. Because with 3D printing, we have a distributed model, and how we think about regulating medical devices will have to change.

Wood: Let’s dig into some specifics here. What material are you using? Where do you get it, and how do you get it certified?

Reichental: We use a variety of materials, and some of them are thermoplastics, which are already regulated and approved. Some of them are photo polymers that are also regulated and approved. But what we don’t know in the 3D industry is who’s actually converting the material into a part. Where are they doing it? What process are they using? Are they operating in a regulated facility that is either a Class I or Class II registered and approved FDA or equivalent? Therein lies the rub. The very essence of distributed manufacturing and the fact that over 72 hours are able to spool up all this activity and harness high schoolers and makers and professional companies all over the world, is also highlighting the fact that we need a different kind of regulatory capability here which regulates the process and the manufacturing capability, not necessarily the inputs and outputs.

Wood: You’re saying that that medical equipment might not be certifiable because of how or where it was created?

Reichental: Precisely, and I think that there is an opportunity here to think about how could we better regulate these kinds of activities in the future? We ought to think that in the future, we should have 3D printers in our emergency preparedness stockpiles.

Wood: Are you saying that, although we can spool up some capability around printing personal protective equipment, the scale is not likely to make a huge dent because of these certification problems? We’re really maybe laying the groundwork for a future response?

Reichental: Precisely. What I’m saying is that now’s the time to make 3D printing part of the next national emergency response.

Related links: More insight from Molly Wood

CNET has a pretty great guide published Tuesday for those of you who are 3D printer owners or want to be. Dan Ackerman wrote it, and he actually got two printers delivered to start cranking out supplies, like little plastic hooks to make face masks fit better, face shields and visors and little tools that you can use to open doors or press buttons on ATMs or gas station number pads or elevators. It’s awesome, and it includes a list of resources and also places to donate such printed pieces. 

There’s also a Slate story about how while it can be tricky to produce hospital-approved PPE with at-home printers, there are best practices available, and more importantly, those printers can be used to make gear for grocery store workers, local nursing homes and for elderly neighbors. It’s powerful to make stuff at your house.  

Also watching

On the testing front, which as you know is the only story, in my opinion, LabCorps has created the first FDA-approved at-home testing kit called the Pixel. Presumably, Google is going to ignore any brand confusion with its hardware devices in the interest of public health. TechCrunch notes that despite all the startups, tech companies and universities working on tests, the first emergency authorization for an at-home test, which is finally happening here at the end of April, went to the 40-year-old labs and diagnostics company. I suppose it makes sense. It’s their thing.  

Yesterday we discussed whether the U.S. Congress would allow remote voting, and I said that according to House Speaker Nancy Pelosi, it wasn’t going to happen anytime soon. The news immediately proved me wrong, as it often does these days. Reports Tuesday said the House is expected to vote this week on changing the rules to let members vote from afar. There is quite a lot of controversy over this, however, with some Republicans, like Rep. Andy Harris of Maryland, saying members should continue to vote the way they have for 200 years. Also, the United Kingdom’s Parliament voted unanimously to begin meeting, governing and voting virtually. It had been doing it the old way for more like 700 years, so maybe we don’t need to be quite so precious over here.

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The team

Molly Wood Host
Michael Lipkin Senior Producer
Stephanie Hughes Producer
Jesus Alvarado Assistant Producer