The covid-19 pandemic has created a global shortage of personal protective equipment. “Healthcare
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.
