Testing services and equipment for orthopedic devices and implants in 2024 are in high demand. Earlier this year, however, the need for testing services was not as strong, due to inventory surplus in hospitals, high interest rates, ongoing supply chain challenges, and overall market uncertainty, all of which slowed new product development.

“By mid-year, however, there was a noticeable shift as new product development resumed and validation testing increased,” stated Thor Rollins, vice president of the medical device segment for Nelson Laboratories, a Salt Lake City, Utah-based global testing lab specializing in advisory and testing solutions for medical device companies. “This upward trend in testing activity is expected to continue through the remainder of the year.”

Top sectors for testing in 2024 are extremities, trauma, lower back and spine devices, additive-manufactured (AM) devices, and cleaning/sterility testing to support increased regulatory scrutiny across a growing number of medical technologies.

As medical devices become more sophisticated, regulators are demanding more comprehensive data to ensure product safety. For example, a recent update to the ISO 18562 set of standards for breathing gas pathways for medical devices has brought about a series of changes for medical device manufacturers (MDMs) “that will lead to safer medical devices by addressing previously overlooked toxicological concerns,” said Andrew Gottfried, director of North American sales for Eurofins Medical Device Services, a Lancaster, Pa.-based testing laboratory that specializes in biocompatibility testing and regulatory-compliant medical device and combination product testing support. “Clear guidelines and more detailed standards align product development with regulatory expectations, potentially speeding up the approval process. The challenge is balancing the updates and requirements that create more complexity in testing with the potential for additional costs due to these changes.”

Another safety concern over the past few years has been the emergence of new labs to meet the rising demand for preclinical safety testing. Not all these labs, however, possess the necessary equipment or expertise for complete chemical characterization. “Recently,” said Sandi Schaible, executive director of analytical chemistry and toxicology for WuXi AppTec’s St. Paul, Minn.-based analytical chemistry laboratory, which provides regulatory consulting, pre-clinical testing, and post-commercialization product testing support, “U.S. regulators have highlighted an increase in unreliable data from third-party labs, particularly from facilities in China and India. It is crucial for sponsors to partner with credible and capable laboratory testing labs.”

This is especially true for MDMs that do not have much internal experience navigating testing and regulatory pathways and typically need third-party guidance to avoid mistakes.

“We see a steady increase in testing requests from smaller startups and contract manufacturers, which has grown our resource focus on supporting the regulatory pathway for these customers, who have not traditionally had either testing or regulatory expertise within their organizations,” said Jason Langhorn, Ph.D., technical manager for Fairfield, Ohio-based Element Materials Technology, a provider of destructive and non-destructive materials testing and compliance and qualification testing for medical devices. “To make this process easier, we recently launched www.regnav.com, an online regulatory navigation tool that supports the full end-to-end process in device R&D.”

Latest Trends

Compared to last year, there is a significant increase in digital health devices entering the market, reflecting a growing integration of technology in orthopedic care. “The latest trends in testing services and equipment for orthopedic devices are centered around technologies such as artificial intelligence [AI] and the introduction of connected implants—for example, sensors embedded in implants that relay positional data and enable at-home monitoring post-surgery,” Rollins said.

Regulatory expectations continue to evolve and bring more scrutiny to medical devices, especially those with a significant digital component. MDMs need to be fully prepared with supportive data, especially as regulatory reviewers gain their own technical knowledge of complex testing such as extractable/leachable testing. “As a result,” said Schaible, “they continue to ask more questions and seek greater understanding of the testing for a specific product.”

New or improved technologies bring positive change to the overall process of testing and analysis, helping testing labs meet the increasingly complex demands of their MDMs and FDA regulators. “For example, advancements that reduce the reliance on animal testing can also provide more accurate and human-relevant data and improve the overall efficacy and safety of new products and treatments,” said Gottfried. “The combination of advanced chemical characterization, in-vitro alternatives, and toxicological risk assessments will play crucial roles in reducing and eventually eliminating the need for animal testing.”

Evolving manufacturing processes, combined with the increase in smaller and more complex devices as well as the growing number of contract manufacturing organizations, have led regulatory authorities to ask for more worst-case-type testing. AM-made devices have especially attracted the attention of the FDA. “There are more requests for particle and ion testing of test media post-testing, and an increase in worst-case type tests such as third-body wear simulation testing, which exercises the mechanical integrity of an articulating joint device in the presence of particles,” said Langhorn.

Although there is a steady stream of AM implant validation/revalidation work in hip and knee, much of it has been focused on process changes and small changes to implant designs already on the market. The majority of implant innovation in the additive space has occurred in compassionate care/patient-specific devices, spine, and shoulder markets, with new innovative designs incorporating structures to promote bone in-growth, together with dense structural support and/or articulation surfaces.

Regulatory expectations for extractable and leachable materials testing have also increased, with greater attention to the materials that contact devices through the lifecycle process, including packaging and labeling. The EPA has also proposed stricter regulations on emissions from manufacturing facilities that utilize ethylene oxide (EtO) to sterilize devices. This has led some MDMs to look for alternative high-temperature and low-temperature sterilization techniques. “In response, we are seeing a greater number of requests for sterilization validation/re-validation studies,” said Langhorn.

What OEMs Want

Orthopedic OEMs want faster turnaround times for testing services. “With the earlier delays in product development now resolved, there is a strong emphasis on accelerating the testing process,” said Rollins. “We’ve focused heavily on reducing turnaround times through rapid methods and streamlined processes. Speed is the top priority, second only to maintaining high-quality standards.”

Companies are also requesting more biological evaluation plans (BEPs) and biological evaluation reports than in previous years. BEPs are integral to the development phase because they encompass the entire product lifecycle. “With a tailored BEP, cost-efficient plans are aligned to regulatory expectations,” said Gottfried. “Medical device developers should ideally be able to advance seamlessly through testing and achieve regulatory compliance. Further, by incorporating a future-proof mindset, a BEP can outline expected testing needs with anticipated device upgrades and changes.”

With increased regulatory scrutiny on medical technology implants and instrumentation, MDMs are looking for assurance that the testing will be done correctly the first time. They want studies that are carefully designed to ensure regulatory requirements are met and any additional questions from regulatory bodies can be easily answered.

One of the biggest challenges that Eurofins Medical Device Services sees is clients trying to meet the analytical evaluation threshold (AET). The AET can be daunting for many manufacturers, but especially those testing smaller devices, which include lower and lower AET calculations, along with larger uncertainty factors that go into these calculations. “The lower AET drives the need for high-quality materials that go into the construction of the device that will not degrade under extraction conditions or real-life applications,” said Gottfried.

Regarding types of tests, MDMs are interested in impaction and lifecycle testing of medical instruments, third-body wear simulation testing, and particulate and ion testing. Although an increased emphasis has been placed on these tests by regulatory agencies, there is still limited guidance on what is needed to validate these processes and/or devices, which slows down the submission process.

Advances and Challenges

Over the past several years, key technological advancements include rapid sterility and bacterial indicator testing. These are crucial release tests and, traditionally, the medical device must be held until the results are available. However, with new rapid testing methods, the turnaround time has been dramatically reduced, making the process more efficient and allowing products to reach the market faster. “This advancement is pushing the limits of testing speed while still ensuring safety and quality,” said Rollins. “The traditional method relied on sufficient bacterial growth to be visible with the human eye; now we use signals inside bacterial cells that can be detected much earlier than with the visibility method, utilizing a reduced incubation time in order to get reliable results.”

For materials, MDMs are keeping an eye on the phase-out of certain fluoropolymers (PFAS) used in the manufacturing of polymers such as polytetrafluoroethylene (PTFE). “Even if a suitable alternative can be found, manufacturers are busy assessing the impact of this change on their products,” said Schaible. “And if alternatives cannot be found, it could mean a flurry of products that, without a redesign, are at risk of discontinuation.”

AM has greatly advanced the production of complex and customized parts across the medical device industry, especially implants. However, AM still creates unique challenges and requirements for testing and validation. “When looking at AM-made devices, it is critical to address variability in the material properties for these composites and biocompatible polymers, including areas like tensile strength, hardness, and fatigue resistance,” said Gottfried. “Also, understanding the materials composition is critical to create biologically safe devices when addressing ISO 10993 testing and endpoints. Standards organizations like ASTM and ISO have developed standards specifically for additive manufacturing. These standards provide guidelines for testing methods, material properties, and quality assurance processes.”

Initially, regulatory agencies had concerns regarding the safety and cleanliness of AM-made devices, but now the processes have been greatly refined, allowing any associated risks to be better understood and easier to manage. “The industry has now developed standardized methods for handling and testing these devices, making it easier for them to meet testing standards,” said Rollins. “Overall, AM-manufactured products have improved in quality and reliability, aligning more closely with traditional manufacturing methods in terms of safety and efficacy.”

The Internet of Things (IoT), especially AI, is having a significant impact on testing services and equipment in the orthopedic space. MDMs want to use AI and machine learning (ML) to accelerate product development and speed to market. “The FDA has already approved several AI-driven devices, streamlining their path to market,” said Rollins. “However, validating AI for regulatory purposes presents unique challenges, as traditional validation methods are not well-suited for systems that learn and adapt over time. Our regulatory branch, Regulatory Compliance Services, stays up to date on these evolving requirements to better support our customers.”

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MORE INFO: The Future of Artificial Intelligence in Orthopedics

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Element Materials Technology relies on AI to operate www.regnav.com, which captures a medical device’s characteristics and uses AI to generate an expert-backed compliance plan. “This plan includes suggested path and class, applicable standards, and testing requirements that are needed for FDA submission,” said Langhorn. “If a customer has a plan, we can also use this tool to verify, or essentially run a gap analysis, to ensure no standards have been overlooked.”

Connected devices and embedded electronics involve additional testing challenges, especially around security. As more orthopedic devices incorporate digital technologies, AI will be essential for improving the design, security, and reliability of these systems. In more of an administrative role, AI can also be used to draft test protocols and post-test reports, giving engineers more time for higher-level tasks.

Regulatory Challenges

Regulatory and FDA challenges for testing services and equipment often revolve around the need for consistency. “The FDA is actively working to enhance consistency, whether through its Accreditation Scheme for Conformity Assessment [ASCA] program, which it aims to extend to extractable and leachable testing, or by participating more in the creation of standards and educating their staff throughout the agency,” said Rollins. “These efforts are focused on ensuring that testing procedures and requirements are applied more uniformly, making it easier for manufacturers to meet regulatory expectations.”

The regulatory environment continues to evolve as a growing number of complex medical devices enter the market. In response, U.S. regulators are scrutinizing data more rigorously than ever before. “Regulatory agencies are employing advanced technologies to analyze submission data and compare it with historical data to identify anomalies or potential fraud,” said Schaible. “Such tools enhance the accuracy and reliability of data verification processes. Eventually, these technologies are expected to be integrated into the design, development, manufacturing, and testing of life science products.”

One of these data applications is the increased use of computer simulation and modeling to support medical device approval through regulatory submissions (examples of ASTM standards that support FEA modeling for stents and orthopedic implants include ASTM F2996-20, ASTM F3161-16, and ASTM F3334-19). The use of simulation and modeling can be an excellent tool in the research and development of new devices, as well as in determining possible failure risk areas in medical device designs. “However, it is imperative that the digital tools fully emulate the physical space—for example, test set-up, friction between design features, and mechanical properties—because differences between the in-silico model and physical counterpart may give misleading information to engineering teams,” said Langhorn. “For this reason, bench testing will likely continue to be the ‘gold standard’ for the foreseeable future, especially as both digital and physical test methodologies merge to create a much more comprehensive testing framework, allowing OEMs to take advantage of the flexibility of digital techniques while retaining the accuracy of bench tests.”

One of the biggest “regulatory” issues with MDMs is their reluctance to adopt new testing technologies or methods. Many are hesitant to move away from testing approaches they have used for decades, which is understandable. “However, testing technology and risk assessment standards are evolving, and embracing these new methods can lead to significant savings in both time and cost,” said Rollins. “Companies need to recognize that adapting to these advancements can enhance efficiency without compromising quality or safety.” A good example is using a risk-based approach to a product’s biocompatibility: many products are made from the same materials and have similar processing, but are tested over and over again because of the reliance on test methods.

An Ever-Changing Landscape

What truly stands out in the field of testing services and equipment is the extent of changes occurring in the standards.

“Nearly all the ISO and ASTM standards we use daily are undergoing significant revisions,” said Rollins. “This is driven by the increasing complexity of medical devices and the adoption of new risk assessment approaches, which are reshaping how we ensure safety and efficacy.”

For example, there are new standards in the areas of AM-made devices and shoulder implants, as well as substantial edits to established standards, on the horizon. The approval and release of these new standards and revisions will greatly impact an MDM’s ability to meet its customers’ testing needs and expectations. “Innovations in shoulder, spine, and extremity devices continue to be areas of growth in medical devices, which also drive considerable efforts in standards committees such as ASTM to modify and develop standard test methodologies,” said Langhorn.

In addition to staying on top of regulatory standards, the next big challenge for testing services is dealing with the increasing complexity and digitalization of orthopedic devices and other products. “As these devices become smaller, smarter, and more functional, the difficulty of testing them grows,” said Rollins. “Ensuring that testing methods keep pace with these advancements is crucial to maintaining accuracy and reliability.”

Testing technologies must continue to advance to solve testing challenges for increasingly complex devices and to meet MDM budgets and timelines. For example, testing absorbable devices requires careful selection of solvents because even the slightest differences in chemistries can greatly impact the accuracy and reliability of the results. “The choice of solvent must consider factors such as polarity, temperature, and the extraction method used,” said Schaible. “We recommend a pre-submission meeting with regulators to ensure testing protocols meet all necessary standards and requirements.”

The European Union’s Medical Device Regulations (MDR) has had a significant impact on the testing of medical devices, requiring that all medical devices marketed in the EU must now be certified—this creates an extra burden on OEMs for both new products and recertification of previously released products. This process has introduced many new quality and safety guidelines for medical device producers, while also providing more transparency to patients regarding the overall risk-to-benefits ratio.

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MORE INFO: The Transition to MDR and Important Considerations—An Orthopedic Innovators Q&A

Also, with the second extension of the MDR deadline, many MDMs did not use the extension as an opportunity to hustle and certify their products; instead they paused their push toward MDR compliance to take some pressure off their budgets. “While this may have seemed like a wise decision in the short term, it could pose significant timeline challenges leading up to the deadline,” said Schaible. “Regulatory requirements and changes in other areas [e.g., USP , PFAS phase-out, standard revisions] could very well tax the capacity of testing laboratories and notified bodies, once again leaving manufacturers scrambling to meet critical deadlines to get/stay on the market.”

Testing and analytical services, and all the standards and rulings that regulate them, can be confusing and frustrating to MDMs. For example, they might mistakenly think that failing biocompatibility testing is a “hard stop” for their device. This, however, is where partnering with an experienced laboratory early in device development can help determine if the medical device presents an actual risk for an end user. “If a failure can be explained, and the cause of the failure is not a true hazard for the end user, Eurofins can assist the manufacturer in documenting this result and submitting it to the appropriate regulatory agency, ensuring the testing results will pass regulatory scrutiny,” said Gottfried.

Collaboration and knowledge-sharing are the best ways to advance the field of testing and analytical services on a unified front that involves all key stakeholders. For example, Element Materials Technology is engaged with standards organizations, such as ASTM and ISO. “Ultimately, ASTM/ISO standards are evolving to improve patient outcomes and device efficacy as industrial partners, regulatory bodies, and academic institutions collaborate openly to create meaningful, and clinically relevant, methods and procedures for testing,” said Langhorn. 

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Mark Crawford is a full-time freelance business and marketing/communications writer based in Corrales, N.M. His clients range from startups to global manufacturing leaders. He has written for MPO and ODT magazines for more than 15 years and is the author of five books.