Joint FDA/VHA medical device pilot aims to create digital stockpiles, bolster distributed manufacturing technologies

The US Food and Drug Administration (FDA) and the Veterans Health Administration (VHA) have formed a partnership aimed at curbing medical device shortages. A 22 May memorandum of understanding (MOU) between the two agencies was born out of troubles that cropped up at the height of the COVID-19 pandemic when many essential products were in short supply.

“As part of this partnership, FDA and VHA will jointly develop emergency preparedness and response tools and protocols intended to help increase medical device manufacturing capacity and flexibility, and improve resilience of domestic supply chains during emergencies, shortages, and pandemics,” said James Coburn, the advanced manufacturing team lead in the FDA Office of Counterterrorism and Emerging Threats (OCET).

Coburn told Focus that OCET is working hand-in-glove with the FDA Center for Devices and Radiological Health (CDRH) to put the project in motion.

The pilot is focused on “medical devices and accessories that may be made using advanced and distributed manufacturing methods,” he said. So-called advanced manufacturing happens when companies use novel, developing or already established technologies in a way that uniquely advances how they make their products. Examples of technologies used in advanced manufacturing include 3D printing, artificial intelligence (AI), machine learning (ML), and virtual modeling and simulation, just to name a few.

Coburn explained that the pilot “includes identifying gaps and developing requirements for trusted networks needed to enable the use of distributed manufacturing and digital stockpiles, which could ultimately enable veterans and civilians to more rapidly access innovative medical products to support their care.”

He explained that digital stockpiles do not store physical goods and products; rather, they store electronic plans, instructions, and methods to make and test medical products. Meanwhile, distributed manufacturing technologies would allow devices such as personal protective equipment and nasal swabs to be made near the point of care to stave off shortages caused by disruptions in the supply chain.

The FDA/VHA partnership “will help to identify the types of systematic controls, scientific data, and certifications that may be necessary to institute trusted manufacturing networks during emergencies,” Coburn said.

Beth Ann Ripley, acting director of the VHA Office of Healthcare Innovation and Learning, said the lessons from the pandemic inform much of the FDA/VHA pilot’s work.

During the pandemic, “people realized they were out of face masks, so they began making and 3D printing them. And that’s exciting. But as it turns out, if you make something that looks like a face mask, it may or may not actually act like a face mask,” Ripley said in an interview. “You still must come back to, is it safe and effective? Is it doing what it’s supposed to be doing? Because if you make a mask and you think you’re protected, but you’re not, that’s not good.”

And that’s what makes the concept of digital stockpiles enticing for both agencies. Ripley likens the stockpile to HelloFresh or Blue Apron meal kits, which provide novice cooks with detailed instructions on how to make specific dishes.

“If people want to print things, then let’s give them blueprints that actually work. Let’s make a few designs that we’ve tested, and we know they’re good. And then let’s share those designs,” she said. “We need to think about how we can make devices in advance so we’re not scrambling at the end during an emergency.”

Ripley explained that the joint FDA/VHA pilot is focusing first on compiling a list of devices that are likely to be in short supply in the event of a pandemic, severe weather event, or another major incident.

“Let’s get a list of, say, the top 30 devices, and then let’s find out which ones we can actually make, because some of these products aren’t going to be able to be made at home, per se,” she said. “So we’ll rank which ones we think are feasible, and we’ll probably start with four or five that we’ll try. And to be honest, a few of them might not go so well. But that’s all part of the learning for these digital stockpiles.”

Ripley pointed out that the partnership between the FDA and the VHA comes naturally because the VHA is the largest provider of healthcare in the US, taking care of roughly 9 million people.

The VHA has “more than a thousand clinics and hospitals, and we’re the largest medical teaching organization – about 70% of all med students rotate through the agency,” she said. “So, although we are taking care of veterans, we’re also taking care of a large number of Americans. And a lot of the disease that we see is the same disease that you’re going to see in the civilian population.”

Both VHA and FDA have been pushing industry to adopt advanced manufacturing concepts for years. And more recently, the Medical Device Innovation Consortium (MDIC) announced the opening of an online clearing house where device makers using advanced manufacturing techniques can share the story of their journey with other companies and the FDA – and get cash for their efforts.

Like the joint FDA/VHA pilot, a goal of the MDIC Advanced Manufacturing Clearing House is to find ways to avoid product shortages. Companies that plan to use advanced manufacturing tools can apply for project funding through the MDIC, but firms that take the money must be willing to share their experiences via the clearing house portal. Successful applicants will receive funding of up to 30% of overall project costs, not to exceed $300,000 (RELATED: MDIC aims to encourage, fund advanced manufacturing with online clearing house, Regulatory Focus, 23 May 2023).

Ripley said her interview with Focus was the first time she heard of the new clearing house. The MDIC “is a group that would definitely be great to reach out to,” she said. “But for right now, our pilot is brand new; we’re just launching; we just put out this MOU. But I will be reaching out to them.”

Joint FDA/VHA medical device pilot aims to create digital stockpiles, bolster distributed manufacturing technologies

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