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As implant design, materials and manufacturing evolve, so do the tests required to ensure safety and effectiveness. This has meant increased scrutiny on testing of devices used in high-growth markets, like additive manufacturing and extremities, and areas of focus from regulatory bodies, like biocompatibility.
We asked representatives from three testing companies about the questions they get most often, and the latest updates to regulations and standards. Here we recap their advice to orthopedic device companies.
Think about your device’s indication, said Meaghan Coates, Engineering Services Manager, Orthopaedic Innovation Centre.
“Companies ask us about our experience with tests that they’ve never done before, and they want to know specific details about how they will implement those tests and results for new and updated implants,” Coates said. For example, there’s a transition in the industry from knees and hips to things like wrists and ankles. Companies are looking for the best ways to conduct ankle wear testing and patella durability in conjunction with other devices in a patient’s body.
Another challenge Coates noted is that FDA wants testing to be done in both a pristine environment as well as in potentially adverse conditions. The agency requires information on what happens when loose particles from a part, like dust or powder, get into patients’ joints. This has become more common with the increased adoption of additive manufacturing and closer focus on biocompatibility and antimicrobials.
Instead of thinking just about a standard test, consider designing your study around the clinical indication you are trying to address, Coates said. Sure, the standard tests are important, but make sure the questions you’re asking and the tests you’re conducting meet the indication you’ve identified.
Ask FDA about testing requirements, said Kevin Knight, Chief Operating Officer, JTL America.
“Whether you’re working with new manufacturing processes or new types of devices, it’s important that you frequently communicate with regulatory bodies to stay informed about new and updated testing methods,” said Knight. Not only will this help you stay informed about new regulations, but it also provides access to information about the latest tests that FDA is privy to that may not be public knowledge yet. FDA will not share what other companies are doing, but they can share information about the most up-to-date tests and how they may be applicable to your needs. This can help your own tests run more smoothly.
For example, when it comes to testing additive manufactured devices, the challenge is finding cracks or failures in the parts that you can’t see, Knight said. There are so many layers to additive depending on the way that it’s printed, how it’s layered, the position on the build table, etc. Working with regulatory bodies can help companies establish parameters and repeatable processes for more successful testing.
Stay abreast of regulatory updates throughout the design and submission phases, says Andrew Smith, Business Development Manager, Element Materials Technology.
“There are always new and evolving regulations and standards. It’s a long process to understand what’s critical to study about evolving technology like coatings, 3D printing and more,” Smith said. Regulations can’t be standardized until processes are both understood and able to be repeated in a uniform fashion. FDA, ISO and ASTM are working to provide companies the information they need to encourage innovation. Over the last few years, FDA has become more collaborative with manufacturers and testing facilities, steering them in the right direction when there is no existing guidance or universal methodology. You should reach out to FDA for guidance during the design process through to the testing and submission processes.
Coatings and molecular modifications of components are growing in popularity and evolving much faster than the regulations can, Smith said. Because we will continue to see new developments in this sector over the next several years, it will be even more important for you to stay in contact with regulatory organizations to keep up with new testing requirements.
Image courtesy of Element Materials Technology
Kim Snell is an ORTHOWORLD Contributing Author.
