FDA Offers Funding for Adoption of Advanced Manufacturing Technologies

By MedTech Intelligence Staff
May 29, 2023


• Categories: 03-Manufacturing Execution, 04-Product Design & Development, 05-Quality/Regulatory, RC - PLM for Medical Devices

Medical device manufacturers that are in the process of—or interested in—exploring advanced manufacturing technologies can receive funding from the FDA through the Advanced Manufacturing Clearing House (AMCH). The program, which is being run by the Medical Device Consortium (MDIC) in partnership with the FDA, provides funding for 30% (not to exceed $300,000) of total project costs.

The goal of AMCH is to speed adoption of advanced manufacturing technologies in the MedTech market. “Other industries, including semiconductor, aviation and automotive, have already incorporated many of these advanced technologies to help with supply chain resiliency and product agility,” says Steve Zera, Sr. Manager, AMCH, MDIC. “The FDA realized that we’ve got to get these advanced technologies into the medical device world, because we’re seeing so many positive gains in other industries.”

The program is funded through 2024 with a rolling application process. Companies can apply through the application portal on the MDIC website. “If they meet certain criteria that we’ve set in place they can get funding with essentially no strings attached, other than to complete the project and share your learnings and your experiences with us, minus any intellectual property or confidential information,” says Zera. The FDA and AMCH are interested in the use of advanced technologies in all stages and areas of the medical device ecosystem—from design to manufacturing to service all the way down to the doctors. This may include the use of artificial intelligence, machine learning, digital twins, or virtual reality, for example. “Our goal is to figure out where within the total product life product cycle we can implement some of these advanced technologies,” says Zera.

There are no restrictions on company size or years in business. However, the products developed do need to be intended for the U.S. market, and the AMCH encourages companies to get leadership buy-in for the project before applying for funds. “We want to make sure you have a good structure in place and that this is going to happen,” says Zera.

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Once a company applies, the AMCH reviews the application and scores it. “If we feel it should be funded, we will notify the company and they then submit a formal project plan with timelines,” says Zera. “We don’t tell them what to do with their projects, but we do ask for monthly updates to make sure the project is progressing.”

Companies receive partial payments as certain milestones are hit with full payment made once the project is complete. The AMCH then works with the companies to share their learnings with industry through white papers and/or educational webinars.

You can apply at any stage in your program—companies that have recently completed adoption of advanced manufacturing technologies are eligible as are those that have a project in mind, but need funding to begin implementation.

“This is free money. The FDA is committed to the adoption of advanced technologies in MedTech,” says Zera. “All we’re asking is to finish the project on time and work with us on getting your learnings out to the larger industry: Did you get the improvement you expected?  Was there a benefit?”