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NP Swabs Prove 3D Printing’s Scalability and Speed-to-Market Advantages

A year ago, if you would have asked anyone in our industry what they thought might be a future killer application, it’s highly doubtful that anyone would have replied with, “nasopharyngeal swabs.” Until recently, it was a niche product and the entire market was serviced by a few dominant industry players.

While there are now other protocols, the main test for COVID-19 testing involves gathering virus from deep in a person’s nasal cavity. The SARS-CoV-2 virus is collected using a nasopharyngeal (NP) swab. Traditionally, these swabs are made in two parts, including a polyester handle and a tip with tiny rayon fibers called flock.

A 3D-printed NP swab developed by Carbon. Image courtesy of Carbon.

The two primary companies that make them, Purtian Medical Products Co. and Copan Diagnostics, bulk manufacture them in multiple steps, which include production, assembly, sterilization and packaging, among others. Their process requires customized machinery and a sizable group of relatively skilled people.

When the global pandemic struck, the demand for COVID-19 test kits skyrocketed, far outpacing the combined capacity of these two companies. For several reasons, they had difficulties scaling their businesses. They both produce many other products for the medical industry and adding new equipment is a timely endeavor. To make matters worse, Copan which is located in Italy (a hotspot for the virus) was challenged with maintaining the health of its own workforce.

3D Printing to the Rescue

As it became apparent that the normal suppliers couldn’t fully meet the need, the additive manufacturing industry began working on the problem. Markforged, a manufacturer of filament-based 3D printers, partnered with Neurophotometrics to produce 3D-printed NP swabs made from their Fiberflex Rayon.

Separately, Northwell Health teamed up with the University of South Florida, Tampa General Hospital and Massachusetts-based Formlabs and worked with physicians to design their own NP swab, which Formlabs recently started printing in its FDA-registered, ISO 13485-certified factory in Ohio.

Results from a clinical trial of 3D-printed NP swabs. Image courtesy of Beth Israel Deaconess Medical Center.

Soon after, a consortium of 3D printing companies was codified. Their goal was to deliver clinically tested, FDA-registered, 3D-printed COVID-19 NP test swab designs with superior or equivalent efficacy to flocked swabs, at scale.

Origin Partners with Henkel

Origin, manufacturer of stereolithography (SLA) 3D printers was one of the founding members of the consortium. It began working with several partners to develop what it is now calling the world’s first FDA-compliant, sterile, 3D-printed NP test swab. 

3D printed NP swabs with detailed lattice structure. (Image courtesy Origin.)

In a new announcement, the startup is providing more detail about the process. Origin collaborated with materials company, Henkel and Beth Israel Deaconess Medical Center (BIDMC) on the swab’s development. Working with generative design software, Origin was able to design a one-piece swab that performed as well as the traditional version. Henkel leveraged its own Albert software platform to specify a material that would meet the requirements for an in-body medical device. Together they tested the design’s clinical capabilities, in addition to validating each step in the sterilizations process, and conducting rigorous mechanical testing and packaging certification.

Scalability and Speed-to-Market

Within weeks they were able to bring a product to market that is classified as a sterile device and is considered a finished medical product, which is regulated by the FDA.

It’s a perfect example of two of 3D printing’s biggest benefits: scalability and speed-to-market. As Chris Prucha, Founder and CEO at Origin noted in the press release, “by working collaboratively and utilizing each other’s technologies, we identified, optimized and scaled the manufacturing process to bring an application to market extremely fast.”

Origin’s sterile NP swabs are currently shipping to leading healthcare facilities, government institutions, and independent testing centers in the U.S. and several other countries. They’re also available for purchase on Amazon.

But beyond the opportunity with NP swabs, this collaboration also further substantiates the industry’s growth into functional part production.  

In the press release, Ken Kisner, Head of Innovation for 3D Printing at Henkel said, “From inception, the vision behind Henkel’s Open Materials Platform was to enable collaboration all along additive manufacturing’s value chain. Working together with Origin, we were able to develop a product which is just as effective as its mass-produced counterpart. With the constraints commercial medical suppliers are facing, this presents a significant opportunity for the 3D printing industry to demonstrate its capabilities, beyond prototyping.”

Innovate Globally, Produce Locally

The problem wasn’t just related to the manufacturing of NP swabs. There were constraints all across the medical supply chain. Some of it had to do with the traditional model of centralized manufacturing and logistics. The healthcare industry relies on a relatively small number of producers and distributors. When they’re impeded, all bets are off. Further, the vast number of products, the niche nature of some of them, and shelf life issues make some medical products difficult to stockpile.

Perhaps more than anything else, this application demonstrates the value of a nimble, distributed manufacturing network, where identical parts can be made as close as possible to the point of need. In some cases, it can be financially beneficial, but in others like this decentralizing production provides an insurance policy in the event the unimaginable happens. We know it can, because it has.

About the Author

John Hauer is the Founder and CEO of Get3DSmart, a consulting practice which helps large companies understand and capitalize on opportunities with 3D printing. Prior to that, John co-Founded and served as the CEO of 3DLT. The company worked with retailers and their suppliers, helping them sell 3D printable products, online and in-store.

As a technology journalist, John focuses primarily on the topics of 3D printing, artificial intelligence, virtual reality and automation. His original content has been featured on Forbes, TechCrunch, Futurism, QZ.com, Techfaster.com, 3DPrint.com and Fabbaloo, among others.

Follow John on Twitter @Get3DJohn

The post NP Swabs Prove 3D Printing’s Scalability and Speed-to-Market Advantages appeared first on 3DPrint.com | The Voice of 3D Printing / Additive Manufacturing.

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Marco Valenzuela of Additive Design Studio Makes an Innovative 3D Printed Pipette

Marco Valenzuela is a designer who specializes in crafting innovative and new 3D printed products. Originally coming from the gaming world, his Additive Design Studio now is focused on using Additive Manufacturing and 3D printing exclusively in product design. The team works with Design for Additive Manufacturing methods and also works with services to deliver parts to customers in FDM, SLA, Polyjet, MFJ, and metals. Valenzuela made a pipette for a customer and this new design for a tried and true lab stalwart really interested us. We really believe that a wave of innovation will come to medical devices, medical supplies and even things like disposables through 3D Printing the right solution in medicine, and spoke with Valenzuela about his creation.
Why did you print it? 
The dual pipette was designed and 3D printed to fulfill specific needs in the fluid piping process. These needs were previously met. However the process was time consuming. The combining of the two pipettes into one provides for a speedy and more efficient workflow when processing large amounts of medicine.
The need was for two different functions:
1.The ability to suction a single fluid mixture into separate reservoirs for individual ejection into separate containers.
2.The ability to suction two different fluid mixtures separately and eject them into a single container together.
How does it work?
The dual pipette utilizes the same principles of pulsion and suction as a common syringe. The plungers are pulled up to create a vacuum and draw fluid up the spout and pressed down to eject fluid from the spout. The 3D printed plungers are fitted with normal rubber plunger tips to ensure an air-tight seal.
What is different about it?
The pipette is a 3d printable, simplistic design. The primary difference is the ability to 3D print this pipette quickly.  This means that we’re producing copies without the need for large-scale manufacturing. Reducing production time and availability to technicians by weeks.
What materials and processes were used to print it?
A variety of materials have been experimented with. The most suitable 3D printed material for the device will be EnvisionTEC’s E-Shell 200. A liquid photopolymer designed for DLP 3D printers that produces strong, tough, water-resistant ABS like parts with high detail that are Class IIa biocompatible according to ISO 10993/Medical Product Law and are CE certified for use as hearing aid products, otoplastics, and medical devices.
What software did you use?
I utilized a variety of 3d CAD design software in the development process. The final design was created in Lightwave 3D. I find a mix of traditional CAD and Polygon based modeling software helps me produce better more ascetic product designs.
Why is it a good design?
I enjoyed the creation of the dual pipette and consider it a good design because it has succeeded in fulfilling a specific need without otherwise costly measures. The dual pipette design aids in the development of medicines related to many medical treatments including Cerebral palsy.
We think that there is a bright future for 3D printed medical devices and medical supplies. Yes, this is a high touch regulatory environment so operating in it will never be simple. Medical supplies and devices have a lot of niche products however and a lot of comparatively low volume high priced goods. On the whole it will be exciting to see real low-cost innovation come to the medical world via 3D Printing.