A volunteer assists at a COVID-19 testing site in Virginia. (Photo: HHS)A volunteer assists at a COVID-19 testing site in Virginia. (Photo: HHS)

This is an excerpt from Medically Necessary, a health care supply chain newsletterSubscribe here.

The story: Thousands of small businesses, schools and enthusiasts came out of the woodwork last year to produce personal protective equipment with 3D printers. 

A recently released report found that those nontraditional producers filled a critical gap early in the COVID-19 pandemic. 

The report, conducted by America Makes, suggests increasing government funding to boost the production capacity of 3D printing during future crises.

However, outside experts question those recommendations. They say the technology is too slow to make a significant impact on PPE supply and the quality of 3D-printed products is questionable

Rather than investing in 3D printing to prepare for a future pandemic, they argue it would make more sense to support traditional PPE manufacturers, which can make larger volumes.

“We do have a lot of 3D printers around the nation, so it’s a great idea,” Tinglong Dai, a health researcher at Johns Hopkins’ business school, told FreightWaves. “But I don’t think it can gain traction unless we see revolutionary breakthroughs in the technology itself. It’s just too slow.”

Background: In the early days of the COVID-19 pandemic, PPE from 3D printers fell into a regulatory gray area. 

Most 3D-printed products weren’t cleared by the FDA, but PPE was scarce and some health care providers were forced to use bandanas or trash bags in lieu of high-quality masks. Products made with 3D printers offered another option. The FDA warned that 3D-printed PPE could offer a physical barrier, but it wasn’t as safe as FDA-cleared devices.

However, the agency also looked for ways to use 3D printing to mitigate shortages. In March of 2020, FDA started formally collaborating with America Makes, an organization that promotes 3D printing. The collaboration also included the National Institutes of Health and the Veterans Health Administration.

The new report, conducted by America Makes and funded by FDA, details the outcome of that effort. FDA is now reviewing the report to determine how 3D printing could fit into the public health response for future emergencies. 

The report: Data is scarce, but America Makes estimated that nontraditional PPE makers used a network of 33,000 printers to make millions of face shields and testing swabs. 

The 3D printer maker Budmen reported making more than 3 million face shields in total. The 3D printing manufacturer Photocentric received a contract to make 7.6 million face shields for the U.K.’s health care system.  

While community members were enthusiastic about making PPE, health care providers weren’t eager to use it. Less than half the health care providers surveyed by America Makes procured 3D-printed products. The study doesn’t specify whether they used that PPE, and many providers said they were concerned about quality.

Organizations making PPE initially focused on producing face masks, but health care providers rarely used them. They were much more likely to use simple face shields. 

The concerns: During the pandemic, NIH created an online repository of 3D printing designs for PPE. VHA reviewed the quality of designs to help health care providers select the safest products. Makers submitted almost 700 designs, but VHA only deemed a handful of those designs appropriate for clinical use.

Dai said those quality concerns are one of the biggest obstacles preventing 3D printers from becoming a useful tool for responding to a public health crisis like a pandemic.

Without real regulatory authority, he said there’s no guarantee that these products are safe. However, he points out that regulators struggled to monitor PPE manufacturers, so he doesn’t think they would have the capacity to regulate 3D printing.

“When the capacity is so limited and the benefit is questionable, it’s difficult to think of allocating resources, especially human resources, to regulate this,” he said.

Robert Handfield, a supply chain researcher at North Carolina State University, said that 3D printing technology isn’t appropriate for large-scale production because it’s too slow.

“I think you could make it a stopgap measure. You could easily convert equipment to PPE production on short notice if you needed to,” he told FreightWaves. “I think it would make a lot more sense if they just started supporting PPE manufacturers in the U.S. and started paying a little bit more.”  

The America Makes report largely acknowledges those limitations, noting that 3D printing is “not economical or time-effective for mass manufacturing large product volumes.” 

In addition, it can be difficult for hospitals to on-board new suppliers, according to Ravi Anupinde, a researcher who studies health care supply chains at the University of Michigan.

He believes 3D printing could be a useful tool for mitigating supply shortages in the future, but said that health care providers should identify suppliers with 3D printing capabilities ahead of time.

“Production is only one piece of it. There’s a lot of other things that need to happen for somebody to actually acquire the product,” he told FreightWaves. 

What’s next? Despite those concerns, Todd Spurgeon, a project engineer at America Makes, argued that 3D printing still has a role to play in future crises, primarily because it’s so flexible. 

The technology is relatively inexpensive and distributed across the U.S. It’s also easy for makers to quickly switch from personal projects to needed supplies.

“The pandemic has shown that additive manufacturing is more capable than what was previously understood by the regulatory community,” he wrote in an email. “Time will tell if it sees persistent use outside of a stop-gap measure.”

In addition to more government funding and greater support from regulators, the America Makes report suggests providing infrastructure allowing 3D printing communities to collaborate and share ideas.  

“This investment is expected to be less than the cost of not having solutions prepared at all,” Spurgeon argued. “When evaluating the cost for preventative measures … we need to contextualize it against the cost of doing nothing.”

However, the federal government hasn’t exactly been idle when it comes to pandemic preparedness. The Office of the Assistant Secretary for Preparedness and Response, one of the main federal agencies focused on pandemic preparedness, has requested an 18% budget increase

Last year, former Sen. Lamar Alexander, R-Tenn., published a wide-ranging report — which noted 3D printing’s role in supplying PPE — detailing recommendations for pandemic preparedness. A bipartisan group of lawmakers aims to create legislation to implement some of those ideas, according to a report from STAT.

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