MDIC aims to encourage, fund advanced manufacturing with online clearing house

Medical device makers that use novel, developing or already established technologies in a way that uniquely advances the manufacturing of their products can now apply to an online clearing house where they can share the story of their journey with other companies and the US Food and Drug Administration (FDA) – and get funding of up to $300,000 for their efforts.

The goal of the Advanced Manufacturing Clearing House from the Medical Device Innovation Consortium (MDIC) is to find ways to get devices on shelves and to patients faster, as well as avoid product shortages like those seen during the COVID-19 pandemic. Examples of technologies used in advanced manufacturing include artificial intelligence (AI), machine learning (ML), virtual modeling and simulation, and digital twins—a virtual representation of a system—just to name a few.

At FDA, “we’ve been looking at [advanced manufacturing] as the idea of any process or technology, or things that are associated even with other industries, that can be brought to bear to existing processes that really change the dynamic,” Cisco Vicenty, FDA’s Case for Quality program manager, said at an 18 May MDIC Live session.

But, he said, “it’s not just the technology-related piece, it is also that extra new way, or new process activities, that can be done that really help move that production—improve the safety, improve the quality, improve the yield and improve or optimize other processes.”

Vicenty pointed out that the medical device industry is lagging other sectors—particularly aerospace, automotive, and consumer electronics—in using advanced manufacturing techniques. Those industries are “already moving and leveraging a lot of what technologies can do in order to make better quality products [and] meet their own safety requirements,” he said. “When you see [advanced manufacturing] in a lot of these other sectors, you have to ask yourself: Why wouldn’t we be using it in the [device] space where it’s a little more critical?”

Device makers that plan to use advanced manufacturing tools can apply for project funding through MDIC; companies that accept the cash must be willing to share their experiences via the clearing house online portal. Successful applicants will receive funding of up to 30% of overall project costs, not to exceed $300,000.

“Once the project is approved for funding, we are not mandating how you would spend” the money, said Prakash Patwardhan, program director for MDIC’s Advanced Manufacturing Clearing House. “Whether [the funds are] for buying a solution platform or you’re planning to buy some machines, it’s up to the device companies to manage the project. …The only thing we are expecting in return … is [for firms] to share their success stories, share their experience of executing the project, so we can share that with the rest of the medical device companies, so we all learn from these pilots and these projects.”

Vicenty, who said he has reviewed “impressive” advanced manufacturing work by companies that adopted the concept early on, stressed that the clearing house is open to device makers of all sizes.

“I’m excited by what we’ve seen so far [and] I look forward to what will be coming down the road,” he said. “And this is not something that is only exclusive to large companies. I think there is a lot of benefit and opportunity within the small- to medium-sized company space, and oftentimes they can move a little faster, so I’m very curious to see how it applies there.”

Vicenty went on: “We as an agency are really behind the notion of these technologies being utilized and trying to advance their use in the device manufacturing space. And I think [FDA’s] commitment here as part of the clearing house will hopefully bring more people to the table.”

Joe Sapiente, MDIC’s clinical sciences & technology VP, said the clearing house offers more than just success stories. “Early adopters” of the clearing house “did not just talk about the manufacturing operation—they’re also looking at improving the regulatory operation or quality operation using AI tools for postmarket surveillance,” he said. “It really is very broad … it's really across the total product lifecycle. …That’s the value of the clearing house portal.”

Meanwhile, Vicenty pointed out that advanced manufacturing concepts aren’t only being pushed by FDA.

“It’s a national initiative [and] it’s really being driven by … Congress and the White House. It’s something that’s been at the forefront for a little while now,” he explained. “Advanced manufacturing became a much higher focus point as COVID hit—the idea and the benefits that come out of manufacturing. Not just the capability, the higher quality, and the increased control, but also …. optimizing production” to stave off supply shortages.

To avoid device scarcity, manufacturers “really need to lean on these [advanced] technologies in order to really accelerate what you can do in a manufacturing space,” Vicenty said. “Advanced technologies enable a lot more connection throughout the entire supply stream. It also makes … a lot of our production here in the United States a lot more competitive, and makes it easier to … maintain that production, especially for some of the critical life science sectors here in the US.”

MDIC aims to encourage, fund advanced manufacturing with online clearing house

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