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Developing and implementing a verifiable additive manufacturing process is crucial to maintaining device quality and meeting regulatory standards. A panel discussion during the AM Medical Virtual Summit hosted by The American Society of Mechanical Engineers (ASME) reviewed key considerations for developing a quality system, validating and verifying processes and working with FDA. The panel included representatives from FDA, Stryker, Mayo Clinic and Advanced Regenerative Manufacturing Institute (ARMI), all of whom have successfully developed robust quality systems.
Panelists emphasized the importance of utilizing FDA’s additive manufacturing guidance and working alongside the agency to establish standards and learn together. Here is a recap of the main takeaways from the discussion.
Development and Implementation of Your Quality System
A quality system takes time, money and knowledge to establish. Smaller manufacturers that possess fewer resources may find it more difficult to develop a robust quality system. ARMI, which has more than 100 members, saw that establishing a quality system was a challenging process for some companies. The organization put together a baseline quality system through its BioFabUSA program to give members a jumpstart.
Mary Clare McCorry, Director for Technology Process Development, emphasized that the product development phase is the best time to think about implementing quality processes. Starting early allows companies to develop manufacturing processes in a scalable way that enables understanding of the process and product, and provides companies with important information should they need to make changes later in the commercialization cycle.
Having a solid quality system is also needed for your regulatory filings. Stryker representatives noted reliance on quality systems for installation qualification and performance qualification, test planning and FDA submissions.
Amy Alexander, a Senior Biomedical Engineer at Mayo Clinic, echoed that it’s vital to have a strong quality system in place and stressed the importance of verification and validation. Organizations should go through installation, performance and operational qualification tests to validate the printing process, as well as the equipment and end part.
Alexander gave the following example pertaining to verification and validation. “While there’s always some soft tissue on the bone that prevents a perfect contour verification, it is possible to prove that what you sent to the printer is what the printer has given you, so that’s what we do with our verification.”
Point-of-care and medical device manufacturing differ in some respects, but the two aren’t so dissimilar on the surface, Alexander said. While FDA has issued guidance for device manufacturers using 3D printing to create medical devices, it has also set forth a framework to identify five scenarios for printing in hospitals. Alexander said that the Mayo Clinic continues to build its quality management system so that it can “flip the switch” and follow FDA 21 CFR Part 820 Quality System Regulation should they get the go-ahead to print devices onsite.
Working with FDA
Additive manufacturing is rapidly changing, which means that companies need to stay updated on advancements with the technology and its regulations and standards. Panelists noted that it’s important that all players and FDA work and learn together.
While FDA published guidance for additively manufactured medical devices in 2017, Matthew DiPrima, an FDA Material Scientist, said the organization is working with standards organizations to stay on the edge of technology and ensure that FDA is asking the right questions regarding safety and effectiveness. FDA is also working with the Drug Enforcement Administration and Department of Defense to look at quality systems for hospital production.
Valerie Giambanco, Principal, Regulatory Affairs at Stryker, said her company has found success collaborating with FDA. There’s been an “evolution of understanding” among FDA, Stryker and external reviewers, she said, noting that Stryker’s first additively manufactured product was cleared before FDA published official guidance.
Giambanco said one highlight of the relationship has been taking part in FDA’s Experiential Learning Program, a collaborative approach to closing the knowledge gap between emerging and innovative technology and the pre-market review of resulting medical devices. Mayo Clinic is looking to participate in this program too.
Industry has lauded FDA in recent years for treating additive manufacturing similarly to traditional, subtractive manufacturing when it comes to the design, manufacturing and testing processes.
“FDA does a really good job of explaining what the considerations need to be,” DiPrima said. “It’s important to remember that, at the end of the day, on a high level, all of the quality systems requirements are the same. Manufacturing is manufacturing. From our perspective, we want to make sure our investigators have the training and knowledge to visit these additive manufacturing locations.”
Kathie Zipp is an ORTHOWORLD Contributor.
