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In an ongoing effort to make health care more personalized, the Veterans Health Administration (VHA) is turning its attention to 3D printing.
Earlier this month, the VHA announced a new partnership with 3D Systems. The company, which engineers, manufactures, and sells 3D printers, will help the VHA build out its in-house 3D printing capacity. According to the press release, the company will offer up machines and software, help install a quality management system, and train VHA staff in becoming compliant medical device manufacturers.1
“Point-of-care 3D printing is about investing in patient outcomes—building the means to create patient-matched solutions that don’t exist in the open market,” Beth Ripley, national director of the VHA Printing Network, tells Verywell in an email. “By investing in point of care 3D printing, VHA will ensure that Veterans are first in line to receive cutting edge 3D printing solutions.”
Since its inception in 2017, Ripley and her team at the 3D Printing Network have been conceptualizing ways 3D printing can improve care. This includes everything from designing personalized prosthetics to creating models of organs to help surgeons prepare for an operation. Now, there are more than 30 hospitals that have 3D printing capabilities and the program is working towards expanding this to all VHA medical centers.
At the onset of the COVID-19 pandemic, the focus broadened to include the creation of face masks, shields, and other personal protective equipment (PPE). To support 3D manufactures across the country, the VHA, the U.S. Food and Drug Administration (FDA), and the National Institutes of Health (NIH) agreed to collaborate. Along with America Makes—a private 3D printing firm—the agencies work together to increase stores of protective equipment and other necessary devices, test them for safety and efficacy, and send them through the FDA review process.
In March, when the COVID-19 pandemic began spreading, there was a rush to create and distribute effective PPE and life-saving medical devices. At this time, John Wilczynski, executive director at America Makes, tells Verywell the 3D print manufacturing community at large expressed a desire to help these efforts. People everywhere—from those operating small, collaborative workspaces with only a couple of machines to large-scale manufacturers—required guidance on how to create effective products.
“There was some misinformation early on about what was needed, what should be made, what designs were good and bad,” Wilczynski says. “All of our agencies coming together helped to start to establish some trust within the community.”
With thousands of designs available online, it could be challenging to parse out which would allow manufacturers to create products that were effective and approved for use, especially in medical settings.
People can submit 3D printer-compatible product designs through the NIH 3D Print Exchange—a digital repository of blueprints. Per the agreement of the agencies, the VHA then tests the designs for their efficacy and recommends them for manufacturing.
So far, more than 600 designs have been submitted to the 3D Print Exchange, with 57 of those designs already designated for clinical or community use after testing and validation. “There have been over 740,000 unique site visitors to the website since the partnership was announced,” Ripley says.
Having access to these designs allows manufacturers to be sure their products can feasibly be used in medical settings, rather than creating products that will be turned away upon delivery.
“A huge step forward, I think for everyone, was getting the relationship established between the VA who was evaluating designs, reviewing them, and classifying them as ‘okay’ for use in community settings, okay for use in clinical settings,’” Wilczynski says. “That allowed all of these sites who didn’t necessarily have a direct connection back to these agencies to get the information they needed to make the right decision.”
Throughout the COVID-19 pandemic, the response strategies in the U.S. have varied from region to region. Because there are 3D printing manufacturers of all sizes across the country, they may be able to better address the needs of each community and respond to certain crises more effectively than other manufacturing models. Especially in times of crisis, the 3D printing community can be flexible enough to fill certain needs until more conventional manufacturers can catch up.
“The biggest reason for where 3D printing is well suited for crisis response is its ability to distribute manufacturing broadly,” Wilczynski says. “It is a technology that can be pretty rapidly distributed. So as long as you can get digital data to the machine, you can start producing parts. That’s a simplification but in principle that is true.”
In many large-scale manufacturing operations, it can take weeks or months to create the correct tools to produce and assemble products. With 3D printing, the design can be amended much faster and prototypes can be made in a matter of hours or days.
“While we believe that 3D printing is not the best method for large-scale production once a design is tested and approved, it is the right tool for rapidly testing and iterating on a design,” Ripley says. “I think you will see a lot more focus on device design and development using 3D printing in VHA, moving forward.”
While the capacity of each 3D printer is relatively low, Ripley says the number of printers in the U.S. is impressively large. When an emergency situation arises, it could be extremely beneficial to harness these printers for a quick and flexible response.
“We’re very interested in understanding what this means for future crises,” Wilczynski says. “All we know is we’re going to have more—whether it’s a wildfire or a hurricane or pandemic or a national security or infrastructure breakdown, it’s going to happen again. How do we have the manufacturing community well-positioned to respond?”
One possible solution is to support 3D print manufacturers around the country in finding reliable information when their help is needed. To do this, the consortium is working to build what America Makes calls a “digital stockpile” of 3D design blueprints. These blueprints can be sent to any maker with the proper quality management system to create devices that emergency response teams actually need.
Courtesy of verywellhealth.com