workers have to fight for PPE so they can fight the virus.” “Nurses in a New York city hospital

wearing garbage bags.” "We are all shopping China to try to get these materials and we're

all competing against each other." “The state of New Hampshire secured and just received

millions of pieces of personal protective equipment from China

but thanks to in large part to the man who invented the

Segway.” This mad dash for PPE has thrown a tiny item into the spotlight: the nasopharyngeal

swab. These aren't your average q-tips. They need to be long enough to reach the back

of your throat, with synthetic fibers to effectively sweep for a sample. Doctors need millions

of these swabs to test and contain the spread of covid-19. But that demand has been met

with a major bottleneck in the global supply chain. Right now, there's really only two

manufacturers, that's partly why we have this severe shortage. And the entire world is going

after the same supply. One is in Maine in New England in the US and the other is in

Northern Italy. So that region was one of the first to be affected.

So a network of 3D printing companies and

clinical researchers sprung into action to design, prototype, and mass print swabs and

other forms of PPE at breakneck speed. We're able to really be nimble and responsive to

the needs and flip the switch quite literally overnight. Because the file can be shared

digitally anyone qualified can take that production into their own hands. This has opened all

of our eyes about the impact and the value that 3D printing can bring to the medical

space. Working with digital files that you can modify and print within your own facility,

can really change the game.

March is really where the scale of this pandemic became evident.

We started just getting an influx of emails, people asking for everything from N95 masks

and face shields, to ventilator components, to swabs for patient sampling. And we sort

of said, "What should we prioritize?" Carbon is a Bay Area based digital manufacturing company.

We immediately pivoted from producing some consumer products

to producing face shields to support those

people on the front lines. We came up with several designs, we drove those

back and forth between physicians at Stanford and Kaiser. Within a

matter of days, we had posted a digital design file on our website so that all of our production

partners could use their printers and our technology to make these face shields and

support their local communities. Those are sort of some of the inherent advantages of

additive that we've known about for a while, and this pandemic has just brought them to

the forefront. Formlabs is a 3D printing company. We have well-over 60,000 3D printers deployed

around the world. We've built up a base of well over 100 hospitals in the US and abroad

that have brought our 3D printers on site to print different patient's specific surgical

tools and surgical devices and medical models. I received an email from a doctor at USF Health

in South Florida, who was working with a clinician at the largest health system in New York state. Both

of them had been working on a dozen designs at this point to 3D print the swabs that were

out of stock. They asked us for some input from an engineering perspective in terms of

how do we print 3,000 of these a day or 10,000 a week? And that's where we can use our resources

to say you can fit 325 swabs on one built platform for a printer and turn that around

in less than 24 hours. In the last month we've received a request for well over 10 million swabs.

This is a major moment

for the additive manufacturing industry. A distributed technology that can rapidly customize

and print spare parts is, in a sense, an ideal first responder tool. If you're thinking

about traditional medical device development, you're talking about one to three years

between prototyping, documentation, trials. I was looking at the timeline from when we

first started hearing these requests for swabs given the shortages to the time when we launched

that product And it was 20 days, which is pretty incredible. But printing rapidly is

only part of the equation. This is a brand new medical device. It's made in a novel way,

and it's pretty clear that we're all trying to understand what is good enough to deploy

to the masses. It's important for all of these concepts to be evaluated by clinicians and

by regulatory professionals.

For many medical devices, they recommend that the resins are biocompatible. They typically

have to do with how resins or parts interact with the human body and also measuring how

long that contact can take place in a safe way. For the face shields that we're making

at our Carbon facilities, we're using a resin that we've tested for cytotoxicity, irritation,

sensitization. The clinical evaluation for swabs has really been focused on a few things. One

is human factors or comfort. I don't think anybody has ever said that nasopharyngeal

swab is comfortable, but you try to make it as comfortable as possible. The second is

specimen collection. The third was for PCR compatibility. This

is basically the test equipment and assays to make sure that using this new material

or new design doesn't interfere with that test result in some way. And when comparing

the Formlabs swab to the traditional ones. There are well over 100 clinical cases showing

that Formlabs swabs are just as effective as the traditional swabs. And for Carbon the

printed swab gave the same result as the traditional swab. To show superiority

you would just need a much, much larger study. I think that's something

we look at on the horizon. It makes us feel really good to be part of this industry, to

see all of our customers and partners rise to the challenge. It really breaks

down traditional barriers that exist between competitors. We are, in some cases sharing

printable files with each other and making connections just really trying to get as many

impactful parts out there as possible regardless of the vendor of the 3D printing machine.

We were receiving a few dozen emails a day from customers and from 3D printing enthusiasts

around the world. We're now at a few

weeks in, and we have over 3,000 volunteers

who are willing to not only print for their local hospitals and communities

but also to provide pro bono design and engineering services. And it's really been a heartwarming

initiative, honestly seeing all the goodwill. Our mission is to make what the world needs.

And this is a perfect embodiment of that. Even though there's no playbook for this we were

prepared and had some of those critical pieces in place. If we can go from design to product

launch in 20 days, you sort of say, "Well, why aren't we doing that for other

sorts of devices.

Right now, hundreds of billions

of dollars of inventory of physical goods are stored around the world, not just healthcare

supplies, but industrial equipment. There's a lot of reasons why you'd want to have that

inventory in the cloud. And basically just have a digital design file that can be downloaded

and printed as it's needed. It's important in this time but even when you're not in crisis mode.

Working alongside the additive manufacturing industry are a network of makers who turned

to 3D printers to help their local communities. Check out the second part to see what they built.