Changes to regulations and standards as well as innovation in materials and design make it a challenge to keep up to speed with testing requirements. Manufacturers should view testing and inspection companies as strong allies, involving these partners early and often in the product development process. We queried testing laboratories on the latest challenges and trends to help OEMs uncover opportunities and capitalize on efficiencies, safety and speed to market.
What challenges do your OEM customers report with materials and device testing? How do you help?
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Maciej Jakucki, Associate Director of Engineering Operations, Accutek Testing Laboratory: On-time completion of testing programs. Many orthopaedic implant tests are based on ASTM or ISO standards. For example, ASTM F2077 testing of Intervertebral Body Fusion Devices suggests up to 18 dynamic tests that run for an average of six days each. Imagine you only have one test machine—your dynamic testing would take more than three months! Add a second test machine to the mix? Your testing time is slashed in half. Accutek is fortunate to have the skill set and knowledge necessary to design and fabricate most of the test frames we use at a fraction of the cost of off-the-shelf equipment. As a result, our investment in test machines is fractional compared to our competitors, meaning we can offer plenty of capacity and consistent availability for fatigue testing.
Daniel Prince, Ph.D., President, Gibraltar Laboratories: Our customers face continuously changing regulatory requirements. As part of our testing proposals, we include all tests required to meet those requirements and consult with our customers to tailor their testing program.
Donald Shuman, Vice President, Sales & Marketing, IMR Test Labs: Material and device complexity are increasing at a greater rate as new innovations are made to increase device durability and reliability. These new materials and devices have more stringent and difficult testing requirements for proper assessment. IMR works with our clients to add to its service offerings in order to meet the needs on these more complex systems.
Kevin Knight, President, Knight Mechanical Testing: One of the challenges we hear frequently from OEMs is the uncertainty about testing requirements from regulatory agencies. This is especially true for implants and instruments for which there are no well-defined standard test methods. Because of the breadth of devices we test, we know what regulatory bodies expect to see in a submission. Balancing cost, speed to market and device safety, we work in concert with our customers to develop a test plan that is streamlined, yet addresses all of the identified risks and regulatory requirements.
What testing trends do you see in materials and devices used in the orthopaedic industry?
Jakucki: In terms of materials, the use of Vitamin E Crosslinked Polyethylene is one of the most exciting evolutions in the industry. While crosslinking significantly reduces wear, it also reduces the mechanical strength of polyethylene. Enriching the material with Vitamin E prevents material oxidation, thus increasing the strength of the device. The mechanical strength of the device, whether it is a component of a knee or a hip implant, is reinforced and offers a longer-lasting solution for the patient.
Wear testing of Vitamin E Poly is of the utmost importance to prove superiority (or equivalence, in the case of a 510(k)), so it’s critical to find an experienced wear testing partner.
Prince: Gibraltar is being asked to perform testing on multiple markers as part of reprocessing requirements in AAMI TIR30. Those markers include protein, hemoglobin, carbohydrates, endotoxin, TOC, cytotoxicity, bioburden and viruses.
Shuman: Because of the increased life expectancy of modern devices, reliability testing programs must be more robust to properly assess potential long-term failure modes. In addition, the more advanced materials being used in these devices require more complex and thorough chemical investigations to identify contaminants and durability.
Knight: Implants produced from additive manufacturing processes hold the promise of increased complexity and customization; however, the endurance properties of these devices are subject to increased scrutiny. Porous coating is another area of rapid advancement, requiring endurance and wear evaluation on both metallic and polymer substrates. Advancements in manufacturing traditional materials are driving testing as well, as OEMs evaluate new heat treatments, surface treatments and machining techniques aimed at improving performance while reducing cost.
What one question do you wish your orthopaedic device manufacturer customers would ask you in order to better serve their needs?
Andrew Smith, Senior Project Engineer of Biomechanical Wear Testing, Accutek Testing Laboratory: “Should we test both our device and a predicate device during a wear testing evaluation?” Comparing your medical device to a predicate device in side-by-side testing is key in the success of your wear testing and other testing programs. This testing is routinely performed to ensure proper comparison within the same set of testing parameters.
Prince: “What preliminary testing can we do to avoid validation failures?” Many times our customers come to us with very complicated or large instruments and trays and go straight into validation testing only to have it fail. With a small amount of preliminary testing, these situations can be avoided.
Shuman: Often, customers will request tests based on their existing knowledge of analytical and testing techniques. However, there may be other more effective methods available that would give them more information, or allow a better assessment more quickly. Rather than come up with a test plan and look for a vendor to perform it, it is better to select a laboratory with broad capabilities to act as a partner to design an effective test plan from the beginning.
Knight: The one question I wish device manufacturers would ask us is: “What do you think of this design?” Don’t forget to involve the testing folks in the design reviews. Our knowledge and expertise will save you weeks if not months in time to market, and thousands of dollars in sample parts.
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