Testing and Regulatory Landscape for Additively Manufactured Devices—An Orthopedic Innovators Q&A

By Sean Fenske, Editor-in-Chief
 
Orthopedic device makers are constantly seeking ways to cut costs, increase quality, eliminate waste, and provide an innovative solution to healthcare customers. Some are exploring emerging manufacturing technologies to determine if they are the right fit for their project. As a newer option for these firms, additive manufacturing could be the answer they seek.
 
While it seems additive manufacturing has been around for a good amount of time already, it’s still quite new in terms of being used for final production of orthopedic devices and implants. As such, the regulatory and testing of products made with this fabrication method is still in flux. Updates continue to be brought forth and final rules have not been established.
 
This uncertainty can create confusion for manufacturers seeking to work with additively manufactured devices. Fortunately, Meredith May, director of consulting at Empirical Technologies, took time to provide some clarity on these topics.
 
Sean Fenske: How much growth are you seeing in additively manufactured (AM) products within the orthopedic space?
 
Meredith May: From a regulatory perspective, we have gone from zero to two submissions [510(k) or QSub] to five to seven per year in the last five years.
 
Fenske: Is the FDA up to speed on handling the questions and challenges that are arising from this manufacturing technique for finished devices? How far have they come?
 
May: FDA is on the conservative side of the pendulum swing right now. The agency went from considering AM devices in the same way they considered subtractively manufactured devices to now requesting large amounts of process validation data for each submission.
 
Fenske: Is the testing of additively manufactured orthopedic devices a set series of protocols or does the needle continue to move on them? Does it depend on the end product?
 
May: It depends more on the product design—specifically porous or non-porous structures—and whether or not porous structures are also load-bearing.
 
Fenske: What is your recommendation for a company trying to stay abreast of the latest regulatory and testing requirements for additively manufactured orthopedic devices?
 
May: The FDA guidance from 2019 is still quite applicable, but it is not 100% up to date. Attending conferences, asking other industry professionals who have recent clearances, and monitoring FDA notices are the best ways to stay current.
 
Fenske: What factors still need further clarification with regard to regulatory and testing of additively manufactured orthopedic devices?
 
May: Consistency with process validations and requests, along with an understanding of how master files might help would improve our clearance times.
 
Fenske: What are the most important aspects for developers of additively manufactured orthopedic devices to keep in mind with regard to regulatory and testing?
 
May: Work with your regulatory representative in advance of starting testing. There are important aspects of worst-case development and design-specific testing that need to be considered before testing begins. Stay in contact with your regulatory representative throughout the process, as the regulatory landscape is changing quickly.
 
Fenske: Do you have any additional comments you’d like to share based on any of the topics we discussed or something you’d like to tell orthopedic device manufacturers?
 
May: This is not the time for a company to dabble in AM. Either you are all in or you outsource. There is a company, for example, that has spent two years and over one million dollars to perfect and validate powder analysis, management, characterization, and control, including thousands of tests to understand the impact on mechanical performance.
 
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