Concept to Commercialization: NP Swabs in America
Concept to Commercialization: NP Swabs in America
Author: Ryan Hayford
Publish Date: August 20, 2020
Nasal Swab Case Study
Eight weeks. That’s how long it took GKN Additive (Forecast 3D) to create an agile manufacturing plan for the nasopharyngeal swabs and immediately go-to-market for mass production. As of today, GKN Additive (Forecast 3D) has produced over 1 million FDA approved NP swabs, and now has the capacity to produce 100,000 swabs per day. Utilizing the largest service fleet of HP Multi Jet Fusion printers in North America, GKN Additive (Forecast 3D) is able to manufacture nasopharyngeal swabs on-demand to meet the immediate concern around the detection of respiratory diseases. This response to meet emerging demands for PPE and medical devices demonstrates that 3D printing is a viable manufacturing solution.
The question for everyone is, what’s next?
AM Adaptability
In April 2020 Ford, Boeing, and Airbus facilities across North America halted production and repurposed their additive machines to produce medical equipment. Boeing began printing face shields and Ford designated its impressive 3DP facility to create personal protective gear for healthcare workers. In addition, companies like General Electric and GE Healthcare are identifying ways to simplify the supply chain and immediately produce ventilators that are much more cost effective. Instead of spending time and money on design verification with external suppliers or tool development, these companies were able to quickly adapt with the use of 3D printing. What would have taken months was reduced to weeks.
Dig Deeper: COVID 19 Impacts on Additive Manufacturing presented by HP
Additive Manufacturing (AM) has historically been lauded as a prototyping tool that engineers and designers rely on for concept design and product verification. However, the advancements in materials, printing and sintering processes have uniquely positioned AM as a viable alternative for on-demand manufacturing. No longer must a company rely on overseas-sourced tooling or be burdened with expensive transportation costs. 3D printing removes the historical barriers of mass production and embraces a concept everyone ambitiously hopes for—local manufacturing.
GKN Additive (Forecast 3D) has already demonstrated its ability to provide relief and stability during this pandemic through production of face shields, mask fitters, ventilator components and many other healthcare-related devices. GKN Additive (Forecast 3D) is a trusted 3D printing manufacturing partner for some of the largest healthcare companies in the world. Not only is GKN Additive (Forecast 3D) commercially and technically capable, GKN Additive (Forecast 3D) is prepared to scale to meet the demands required to address the SNS and expand domestic manufacturing.
Agile Manufacturing NP Swabs from GKN Additive (Forecast 3D)
The Harvard BIDMC addressed the value of 3D printed NP swabs with the following statement: “Advantages include simplicity over the multistep process of applying flock, the widespread availability of 3D printing capacity, and the ability to iterate prototypes rapidly.”
“We needed to perfect the process before going to mass production,” said former 3M Corporate Research and Manufacturing Technology Engineer, Justin Swartz, who now heads up the strategic business segment at GKN Additive (Forecast 3D). With over a decade of experience in precision product development that includes medical devices, Swartz understands the necessary components to a successful product launch. “Of course we can print a swab, anyone can. This is about real manufacturing of traceable, repeatable and sterilizable swabs that pass our own strict procedures and guidelines.” he said, going into further details about the steps GKN Additive (Forecast 3D) takes in order to digitally create batch production swabs on the HP MJF printers.
Thanks to the work previously done by several partner organizations such as Harvard Medical (BIDMC) and LLNL, GKN Additive (Forecast 3D) is able to 3D print FDA approved swabs that are ready for distribution immediately.
Step 1: Product Development & Manufacturability → On March 28th, GKN Additive (Forecast 3D) and several supply chain partners began collaboration to meet the immediate demand for nasopharyngeal swabs in America. As the coronavirus spread across the country, it became obvious that our institutions needed an approved solution for testing. As COVID-19 spread across the world, demand for testing equipment grew. GKN Additive (Forecast 3D) was able to identify the right suppliers to meet the strict medical device requirements and finalize a manufacturing plan that was efficient and economical. After the single swab design was approved, GKN Additive (Forecast 3D) needed to put their Design for Additive Manufacturing (DfAM) skills to the test for repeatable and traceable results.
Step 2: Traceability → By creating digital labels, the manufacturing process is analyzed for improvement and can quickly pinpoint any flaws or defects. The healthcare industry requires this level of traceability, and GKN Additive (Forecast 3D) met the challenge head-on by integrating specific digital tools with the help of HP to track printer performance and fine-tune the results. “Nothing leaves our facility without meeting our QC guidelines,” said Carlos Aquino, VP of Quality and Engineering at GKN Additive (Forecast 3D), indicating that this process must be meticulous.
Step 3: Quality Assurance → The NP swabs are specifically designed and printed to optimize space, functionality and strength. After several redesigns, GKN Additive (Forecast 3D) dialed in the parameters of the HP MJF printer and implemented a mechanical testing fixture with every production batch. This fixture verifies if parts are built to specification, and the coupons printed inside the cage provide additional assurance. For more information about how to optimize your next batch production run, contact our expert DfAM team.
Step 4: Mechanical Testing → An important part of QC is a comprehensive testing process with multiple checkpoints. Specifically, NP swabs are tested for durability and breakaway features. The stem cannot break too easily nor can it be indestructible. After only four weeks of product development, the GKN Additive (Forecast 3D) engineering team successfully implemented a complete QA protocol that ensures the product meets all the necessary requirements. On April 25th, GKN Additive (Forecast 3D) officially announced its commercial offering of F3D Nasopharyngeal Swabs available immediately. 
Step 5: Ramp Up & Production → On April 30th, GKN Additive (Forecast 3D) began printing Nylon PA11 swabs on its MJF 3D printer line in Carlsbad, California. Nylon PA11 is the ideal material due to its optimal mechanical properties and excellent chemical resistance properties. Furthermore, PA11 meets the requirements of USP Class I-VI and FDA guidance for skin surface devices (learn more about Nylon PA 11). With the largest fleet of HP 3D printers in North America (over 31 machines), F3D strategically positions itself as an immediate resource for on-demand manufacturing of NP swabs. GKN Additive (Forecast 3D) is currently equipped to produce 100,000 swabs per day and has the capacity to meet 5-10x that number when called upon. With the unknown situation, it’s imperative to be prepared.
Step 6: Packaging & Distribution → Once the swabs leave the printing chamber, they are meticulously tested and processed for packaging and distribution. As is the case with most 3D printing technologies, support structures and material must be removed from the part. F3D has a proprietary sanitization and powder removal system that prepares these swabs for packaging and distribution. F3D clients are offered one of two options, (1) Bulk swabs that are ready for sterilization or (2) Individually wrapped and sterilized swabs.
“I’m really proud of this team and how much has been achieved in such a short period of time,” Swartz said, reflecting on the value of shared experience and why additive manufacturing is an ideal solution for on-demand manufacturing. “Recent events have highlighted many weaknesses in the supply chain and we believe that additive manufacturing is an ideal alternative to outdated production methods.” In just eight weeks, GKN Additive (Forecast 3D) was able to immediately adapt and go-to-market with an approved healthcare product that will impact thousands, if not millions of people.
How quickly can your company go from concept to commercialization? Speak to a GKN Additive (Forecast 3D) subject matter expert to learn more.