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A new biomaterial company, Â FibreTuff,Â has announced plans to begin manufacturing cellulose-based biomaterials that are biocompatible, absorbable, and nondegradable for Class I and II medical devices. The companyâ€™s PAPC ingredients can be compounded into pellets to make 3D printing filament that can be used to print a variety of medical devices and implants.
â€œFibreTuff compounds biomaterials that contain celluloseÂ and blends them with thermoplastics branded as PAPC (polyamide, polyolefin, and cellulose) compositions for use in Class I [and]Â IIÂ and eventually Class III permanent implants for the medical industry,â€� explainedÂ FibreTuff founder and president Robert Joyce. â€œWeâ€™ve now brought on partners, purchased manufacturing equipment, and now leased space in a facility located in West Unity, Ohio.â€�
FibreTuffâ€™s PAPC filament can be used in 3D printers without the odors traditionally associated with the printing process. The biomaterial will also cost about 30% less for device makers in need of things like cervical spacers and other implantable devices. The material also has the huge advantage of being â€œradiopaque,â€� meaning it can be seen onÂ an x-ray without requiring additives like other products on the market.
â€œYou can see in an x-ray where the tissues and bone grow into the implant made with PAPC,â€� Joyce said. â€œOur FibreTuff PAPC is a hydrophilic compound that is coating friendly to support a printed circuits design and construction through an ink process by nScrypt located in Orlando, Florida. Even the specific gravity of the compound is 20% lighter than [that of] other materials currently on the market, which can translate into lower material costs to produce 3D printed parts.â€�
Among the other characteristics of the FibreTuff filament are that it will not dissolve inside the bodyÂ and has already passed USP Class VI testing performed by NAMSA for implantation, the company reported in a news release. The filament also has a weight and composition very similar to actual human bone, which could suit it for 3D printing bones for academic use in medical school.
â€œThe human bones that are 3D printed with FibreTuff PAPC offer similar features to an actual human experience, having good screw retentionÂ and sawing and cutting ability,â€� Joyce said. â€œOther 3D printed resins have challenges with these types of features, but we have the flexibility to print different sizes of human bone that actually resemble real human bones. A local university has been using pig and cow bones for their medical students to practice on, but we are aiming to have the students 3D print bones with FibreTuff PAPC that they can actually practice on.â€�
While the company officially launched operations within the last week, the company has spent the last four years not only developing the technology, but also recruiting partners and taking orders. Now that it is moving toward a new phase in sales and marketing, Joyce saidÂ that the company hopes to begin producing PAPC implants within the next 16 months.
â€œApproximately 16 months from now we hope to have PAPC in permanent implants for spine, trauma, and sports medicine that can show much improved osseointegration versus PEEK and metal implants,â€� he said. â€œWe also hope to begin reducing the cost to produce these types of implants by 30%. We want to work with hospitals, colleges and universities, and medical device manufacturers to develop a new way to deliver education and functional tools and models to the medical market.â€�
A bioengineered spinal cord is fabricated via extrusionâ€�based multimaterial 3D bioprinting, in which clusters of induced pluripotent stem cell (iPSC)â€�derived spinal neuronal progenitor cells (sNPCs) and oligodendrocyte progenitor cells (OPCs) are placed in precise positions within 3D printed biocompatible scaffolds during assembly. The location of a cluster of cells, of a single type or multiple types, is controlled using a pointâ€�dispensing printing method with a 200 Âµm centerâ€�toâ€�center spacing within 150 Âµm wide channels. The bioprinted sNPCs differentiate and extend axons throughout microscale scaffold channels, and the activity of these neuronal networks is confirmed by physiological spontaneous calcium flux studies. Successful bioprinting of OPCs in combination with sNPCs demonstrates a multicellular neural tissue engineering approach, where the ability to direct the patterning and combination of transplanted neuronal and glial cells can be beneficial in rebuilding functional axonal connections across areas of central nervous system (CNS) tissue damage. This platform can be used to prepare novel biomimetic, hydrogelâ€�based scaffolds modeling complex CNS tissue architecture in vitro and harnessed to develop new clinical approaches to treat neurological diseases, including spinal cord injury.
The debate over 3D-printed guns has hit its melting point.
The battle about how to handle blueprints for plastic guns has raged for years, but it flared up in a big way in July after the US State Department settled a legal case and let an organization called Defense Distributed go ahead and release plans online.
Eleven more states on Thursday joined the plaintiffs — making it a 19-state lawsuit against the State Department and Defense Distributed.
The back-and-forth underscores the broader fight pitting First and Second Amendment rights protecting free speech and gun ownership against public safety and the need to protect against easy access to weapons. It also comes amid a broader discussion of gun control in light of an increasing number of public shooting incidents.Â
This isn’t a simple case, so CNET’s here to break it down for you.
So what are 3D-printed guns?
As the name implies, they’re parts for guns made using a 3D printer and plans created on a computer or downloaded online.
They may be made of plastic, but the guns are capable of firing standard handgun rounds. But they’re not complete. One plan for a plastic gun still requires a metal nail that serves as a firing pin and a six-ounce piece of steel that’s included solely to enable metal detectors to spot the guns (which keeps the weapons from running afoul of the US Undetectable Firearms Act).
The controversy over 3D-printed guns stretches as far back as 2012, when Cody Wilson announced plans to make such a weapon. It took him and members of his open source organization, Defense Distributed, just eight months.
By May 2013, Wilson debuted the world’s first 3D-printed handgun, the Liberator.
What exactly can you print?
The Liberator is the closest thing to a completely plastic gun, but it still needs a steel nail to serve as the firing pin. The rest of Defense Distributed’s blueprints relate to the frame of a gun, also known as a receiver. Those receivers serve to house the complete gun, which enthusiasts still need to assemble themselves, according to Popular Mechanics.Â
It’s important to note that these receivers don’t have critical parts like bolts, barrels, stocks or other parts. So it’s not like you can 3D print a gun and start firing it right away.
3D printersÂ can also produce metal gun parts as well, though it’sÂ much more expensive and dangerousÂ to use this type of industrial 3D printer, because of the high melting points of metals. They’re also not easily accessible.Â
Why are people worried?
Wilson published his designs online. That means anyone can download the blueprints and print out the gun parts as long as they have access to a computer and a 3D printer.
These guns are also theoretically untraceable.
The Undetectable Firearms Act makes it a federal offense to “manufacture, import, sell, ship, deliver, possess, transfer or receive” a firearm capable of defeating airport metal detection.
While the completed Liberator is a detectable firearm, as long as you stash the firing pin and the small piece of steel elsewhere, you can carry the gun and walk right through airport security checkpoints.
Also, because these guns are homemade, they don’t carry an industrial serial number (so they’re what’s called “ghost guns”). Besides that, people don’t have to go through a background check to get one, like they’d have to do to buy a commercial firearm.
On top of that, criminals can more easily get rid of the weapons, denying law enforcement the opportunity to gather material evidence. Plastic is easier to destroy than metal. The melting point for 3D-printing plastic is roughly 464 Fahrenheit (240 Celsius), while that of steel is 2,500 Fahrenheit (1,371 Celsius).
“3D-printed guns represent one dimension of a larger problem of do-it-yourself homemade firearms which is an increasing threat to public safety,” said Kristen Rand, legislative director of the gun control advocacy organization Violence Policy Center, in an email statement. “It is important that policymakers act now to address this burgeoning threat before it is too late.”
There’re already easier ways to get a firearm or a homemade one, such as stealing a gun from a legal firearm owner, purchasing one from the black market and make one yourself with a 80-percent-finished receiver — it’s not considered a firearm if the receiver isn’t finished. Thus, 3D-printed guns can’t become a norm yet.
However, if 3D printers become cheaper, better and more accessible in the future, we can’t dismiss the possibility that 3D-printed guns will change the landscape of illicit arms trade.
Who is Cody Wilson?
Wilson learned about 3D printers during his second year at the University of Texas Law School in 2012, according to The Washington Post. He was reportedly inspired by Julian Assange and WikiLeaks to create an open-source platform.
“We wanted to be the Wiki for guns,” Wilson told the Post.
Then he reportedly launched Defcad.com, an unregulated file-sharing website that eventually became the first community around 3D printed guns.
Wilson is no stranger to the media. He’s also known for starting a crowdfunding site called Hatreon, in 2017. After neo-Nazi groups got kicked off crowdfunding sites like Patreon and GoFundMe, as well as payment services like PayPal and Apple Pay, they turned to Hatreon to finance their cause.
“I think the state should be as weak as possible relative to the individual,” Wilson told the publication. “The proper posture of the state is one that at least is in fear of its citizen, not one that lords over it.”
CNET asked Wilson earlier in July if he worries about people with bad intentions getting their hands on his gun designs. He said, “no concerns regarding public access.” At the time, he also told Ars Technica that he’d been cashing in from selling the Ghost Gunner, a home tool that lets people make a key gun part out of metal and use that part to build an untraceable firearm.
Wilson also reportedly drew an analogy to World World II, when the Allies tried to deliver weapons behind enemy lines.
His critics, however, have called his method “open-source terrorism,” the Times reported.
Wilson didn’t immediately respond to a request for comment.
Wilson reappeared in the news last month after he won a settlement with the State Department on the distribution of his blueprints online and said he’d resume publication on Wednesday, Aug. 1. He said he’d make the plans available for anyone to download for free.
How does the State Department figure into this?
The State Department, currently overseen by Secretary of State Mike Pompeo, regulates the exports of defense products in accordance with the ITAR — International Traffic in Arms Regulations — which was why the department had the run-in with Defense Distributed in the first place, according to a State Department spokesperson.
Several months after the Liberator debuted in 2013, the State Department said Defense Distributed violated ITAR by publishing its designs for the gun online, since the internet doesn’t have borders, and issued a restraining order. The company then removed the files, according to Ars Technica.
Defense Distributed didn’t give up, right?
Yep. Two years later, the company teamed up with the Second Amendment Foundation and sued the State Department, arguing the government can’t prevent publication before it occurs and making it an issue related to the First Amendment’s freedom of speech protection.
In July, the State Department agreed to waive its prior restraint order against Wilson and Defense Distributed, allowing his organization to freely publish designs and other technical files about 3D printed guns, according to SAF’s release.
“The Department of Justice suggested that the State Department and the US government settle this case, and so that is what was done,” said Heather Nauert, a spokesperson for the State Department, during the Department press briefing on Tuesday. “We were informed that we would have lost this case in court, or would have likely lost this case in court based on First Amendment grounds.”
The State Department also voluntarily settled with Defense Distributed and SAF because it will soon transfer the responsibility of regulating exports and manufacturing of commercially available firearms to the Commerce Department. As a result, the issue raised in the lawsuit won’t fall under the jurisdiction of the State Department in the near future, according to a State Department official.
“We took the device — the advice of the Department of Justice, and here we are right now,” said Nauert.
The Justice Department declined to comment.
How do the states play into this?
Eight US state attorneys general, Massachusetts, Connecticut, New Jersey, Pennsylvania, Oregon, Maryland, New York and the District of Columbia, on Monday filed a lawsuit to block the distribution of 3D-printed gun designs online due to a State Department settlement with the gun Wilson and his company Defense Distributed.
“The federal government is trying to allow access to online plans that will allow anyone to anonymously build their own downloadable, untraceable, and undetectable gun,” said Massachusetts Attorney General Maura Healey, in a release. “This is an imminent threat to public safety and violates the law. We have a responsibility to ensure that these files are not made easily available to the public.”
Their complaint asked the court to declare that the public release of Wilson’s 3D-printed gun blueprints is an unlawful, unconstitutional violation of the Tenth Amendment and prohibit anyone from releasing the designs once the injunction is established.
The attorneys said the Trump administration has infringed on their states’ exercise of police power and enforcement of public safety laws by letting people prohibited from owning a firearm, including children, felons and the mentally ill, have access to these plans.
Simultaneously, 20 state attorneys general sent a letter to the State Department and the Department of Justice asking for the same thing.
The hearing to determine whether this order should become a preliminary injunction — a court order that prohibits the parties to do something until a final ruling is made — is set on Friday, Aug. 10.
What was Wilson’s response?
Wilson has started a campaign and fundraiser on his website to unblock his Defcad.com. Defense Distributed’s LEGIO, the company’s “political and technical fraternity,” is collecting membership fees from $5 to $1,000.
The Justice Department is representing the State Department in this lawsuit, and the Justice Department declined to comment.
A State Department official told CNET in an email that the department has no role in domestic gun control policies and the broader question of this technology’s potential. He said the agency has already completed the actions required under the settlement agreement.
“I think it would be wise for news organizations and people having conversations about this to be aware that at least since the year 2013, these have been available, these Computer Assisted Designs for making these 3D guns — have been available online for several years,” said Nauert.
This isn’t a new debate, right?
Nope. Wilson’s plastic gun designs has been online for years. Download counts at Defcad.com suggest the gun plans had already been downloaded over 20,000 times.
And it wasn’t the first controversy on 3D printed firearms.
MakerBot later removed the designs for a printable AR15 and other weapon components from its 3D-printing file library.
Where’s Congress in the midst of all this?
The Congress renewed the Undetectable Firearms Act in 2013, which required all firearms to contain at least 3.7 ounce of steel so they could be detected.
But it didn’t say which part has to be metal.
In the heat of the 3D-printed gun controversy, US Democratic Senator Bill Nelson of Florida on Tuesday filed legislations — the Untraceable Firearms Act and the 3D Printed Gun Safety Act — to make it illegal for anyone to intentionally publish a digital file online that programs a 3D printer to automatically manufacture a firearm, according to a release emailed by Nelson’s representative. The bills were also backed by Senators Richard Blumenthal, Ed Markey, Chuck Schumer, Jack Reed, Dianne Feinstein, Bob Menendez and others.
“Just think about all the work we’re doing to hardening our schools in the wake of the Parkland shooting,” Nelson said in the release. “None of that will do any good if you can simply print one of these undetectable plastic guns at home.”
The legislations also require every firearm to have a serial number and to have at least one main component, such as the frame or the barrel, made of metal — an effort to prevent people from detaching a small metal part from a plastic gun to go through security and then reattach it afterwards.
Nelson asked the Senate for “unanimous consent” — the bill can be approved right away unless any one senator objects. After he made the request, Republican Senator Mike Lee of Utah objected based on free speech concerns.
“Any legislation that comes forth from this body that begins with the following words will attract my attention and should attract the attention of anyone who’s concerned about our first amendment and other constitutional rights,” said Sen.Â Lee on the Senate floor. “It begins with the words it shall be unlawful for my person to intentionally publish. That ought to be concerning to us, to each and every one of us, Democrats and Republicans alike.”
As a result, Nelson’s legislations will have to undergo the normal process of passing a bill, which can take from two weeks to several months, or sometimes, years.
What is President Trump’s reaction?
President Trump weighed in on Tuesday in a tweet, “I am looking into 3D Plastic Guns being sold to the public. Already spoke to NRA, doesn’t seem to make much sense!”
Trump is incorrect in his point about 3D plastic guns being sold to the public. The designs of these guns were given out for free. The tweet didn’t specify which part didn’t make sense.
NRA and the White House didn’t immediately respond to requests for comment.
With no near-term action from the White House or Congress, the issue will next see some direction from the State of Washington et al. v. United States Department of State et al. hearing on Friday, Aug. 10.
First published on August 3, 5:00 a.m. PT.
Updates, 6:24 a.m. PT: Adds 11 more states have joined the eight plaintiff states in the lawsuit against the State Department et al.Â