The EU’s MDR implementation has created significant unrest among medical device manufacturers. As such, many are reevaluating their product portfolio for the region. For those who wish to remain, new rules surrounding testing will require most to resubmit their devices to obtain the proper documentation to support their device for the MDR CE mark. 

Meanwhile, the U.S. Food and Drug Administration (FDA) is going through its own shifts for certain aspects of its guidelines. A primary example of this is the agency’s requirements involving biocompatibility. These changes necessitate orthopedic OEMs and their partners to adjust the testing protocols and, in some cases, designs for their devices. 

To help get a better handle on what’s happening within the testing segment of orthopedic device development, ODT spoke with almost a dozen experts. 

• Tom Archer, product marketing specialist—Healthcare at Lucideon
• Breanna Barber, consulting study director, healthcare reprocessing at Nelson Labs
• Richard Brown, vice president and principal engineer at Engineering & Quality Solutions Inc.
• Thomas Eigentler, Senior Product Specialist, TÜV SÜD
• Vicki Hughes, Senior VP, QA/RA, at Millstone Medical Outsourcing
• Jason Langhorn, technical manager, Medical Devices, at Element Materials Technology
• Jeni Lauer, Ph.D., expert consultant (biocompatibility) at Nelson Labs
• Chris Parker, principal consultant biocompatibility at Nelson Labs
• Thor Rollins, V.P. medical device segment at Nelson Labs
• Victoria Trafka, president and principal engineer at Engineering & Quality Solutions Inc.
• Don Tumminelli Sr. technical manager, Client Services, at HIGHPOWER Validation Testing & Lab Services

Sean Fenske: What are the trends driving the orthopedic device testing industry? 

Richard Brown: Implants that are now embedding sensors and essentially producing “smart” implants. These implants may provide feedback to an AI system that evaluates that feedback. So, technology is creating the need for new test standards to be created. The industry that used to be all mechanical testing now needs to understand how the software and sensors work to best understand the needs for specific testing. With the sensors attached to the implants, the current required testing and standard may need to be modified, or a new one created as a result of the physical sensor or the way it interacts with the software.

Thomas Eigentler: The orthopedic device sector is rapidly evolving, shaped by several major trends.

First, additive manufacturing enables patient-specific implants and complex geometries, pushing testing programs to include powder characterization, process validation, lot release controls, and mechanical and biocompatibility assessments.

Second, smart and robotic systems are entering the orthopedic field, requiring functional, electrical, wireless, cybersecurity, and software validation under harmonized standards (e.g., IEC 80601-2-77, IEC 81001-5-1). Notably, electrical and cybersecurity requirements are relatively new for traditional orthopedic devices, adding a digital and systems-level testing dimension unfamiliar to many manufacturers.

Third, MRI safety is gaining increasing attention in orthopedic device testing. This is driven by multiple factors: the expanding use of MRI in diagnostics, with nearly 10% of the population undergoing MRI annually; an aging population in need of orthopedic treatments and diagnostics; and finally, the improved medical technology and services worldwide. Together, these factors have led to a high prevalence of orthopedic devices in MRI environments. As a result, legacy MR-untested or contraindicated implants are being progressively replaced by MR-conditional or MR-safe devices. This shift is further accelerated by growing awareness among clinicians and patients, which in turn, drives market pressure and replacement cycles.

Finally, integrated, multi-modal testing is becoming essential. Manufacturers are now expected to manage combined mechanical, chemical, microbiological, electrical, and digital performance evaluations across all stages: research and development, production, and post-market surveillance.

Vicki Hughes: The orthopedic device testing industry is largely shaped by the innovations in material science and additive manufacturing. These innovations are enabling the development of highly complex, often patient-specific implants. Consequently, the testing landscape must evolve to account for novel geometries and the intricate mechanical behaviors inherent in these next-generation devices. Parallel to this, digitalization is transforming our capabilities, allowing for the integration of simulation and computational modeling to supplement traditional physical testing. This not only enhances efficiency but also significantly improves predictive accuracy. Furthermore, there’s a growing emphasis on accelerated and real-time durability testing. As minimally invasive and active devices become more prevalent, accurately simulating actual patient use environments—including physiological loading, wear, and biological interactions—is critical.

Jason Langhorn: As with almost all industries, AI and machine learning are being increasingly integrated into medical technology for diagnostics and surgical planning, with predictive algorithms helping identify musculoskeletal disorders, predicting medical device efficacy, and reducing surgeon-to-surgeon variability in the operating room. So, as technologies evolve and we see increasing volumes of newer, complex smart technologies and devices, new test approaches are being developed to validate them.

Research into bioresorbable materials has been strong in recent years, and bioresorbable glasses and polymers (e.g., PLGA, PLLA) are becoming increasingly mainstream. These bioresorbable implants dissolve over time, eliminating the need for secondary surgeries to remove them. From a testing standpoint, these materials have different requirements than more traditional materials (such as metal, alloy, polymer, ceramic, etc.) used in implants.

Additive manufacturing (AM) is growing in the market, which is driving increased focus on improving the patient experience with patient-specific solutions to implants and instrumentation. AM can be implemented far more efficiently than more traditional subtractive techniques of manufacturing (i.e., machining) for such devices. Custom devices need process validation and more individual validation approaches to regulatory approval rather than some of the more standard testing methodologies.

As knee and hip arthroplasty is becoming commoditized, we see a change of focus in implant innovation hardware and, subsequently, in the testing world, for novel devices to improve patient quality of life in the areas of extremity implants, biologics, restorative and regenerative therapies, novel materials, and robotics. With the increasing use of ASCs for outpatient surgery, there is also a need to reduce instrumentation and shrink some larger equipment typically used in the O.R. These things have led to a marked increase in more specialized testing needs and custom protocol development.

Dr. Jeni Lauer: Challenges to the medical device industry are currently driven by the pending updates to ISO 10993-1. These changes are dramatic, and their sheer magnitude is currently overwhelming all other challenges. The challenges for orthopedic devices (and medical devices more generally) arise from predicting how these changes will be implemented by regulatory reviewers. Based on the “no” vote from the U.S., we expect the FDA to selectively recognize portions of the updated ISO 10993-1. It will be important to read the FDA guidance document outlining their interpretation of this standard. We are already seeing differences in how the ISO 10993 standards are interpreted by reviewers around the world, and there is a likelihood that the differences will be more dramatic under the updated ISO 10993-1 standard.

Chris Parker: New chemistry formulations and biologics in the regenerative orthopedic space continue to advance the efficacy of different implant materials. Also, 3D printed implants allow for custom implants to be created for each patient to match their specific physiology as a part of the personalized medicine push in healthcare.

Thor Rollins: When speaking with my orthopedic customers, I hear them mention several trends. For starters, personalized implants seem to be spurred by 3D printing and are pushing demand for custom testing protocols. Also, devices supporting minimally invasive surgery are getting smaller and more complex, making testing requirements more difficult. Smart implants and connected devices bring challenges because now we have batteries and electronic components that are not just challenging to test but can also cause positives in results.

In addition, I always joked we were testing the same materials repeatedly, but the growth in bioresorbable and composite materials demands specialized biocompatibility and mechanical tests. Finally, we were on a good trajectory for more standardization across the globe, but recent controversial standards (like the new ISO 10993-1 FDIS) might increase complexity in different regulatory markets. 

Victoria Trafka: There is a push within the orthopedic ASTM committees to verify and update test standards with interlaboratory data. Most test standards hadn’t been verified for repeatability across various testers and labs upon original release. After large variations in test results were reported, committees decided to assess standards to determine repeatability and reproducibility. In some cases, the study results have led to changes in test standards and methods, such as improving instructions, adding diagrams, adding measurements, etc., to reduce the variation in results. Across the board, standards are being updated to include the study results. This has led to some test labs reviewing and updating their internal procedures to be more consistent with the standard and accepted practices.

Fenske: What are the most prominent challenges involved in orthopedic device testing today?

Tom Archer: At Lucideon, one of the biggest device testing challenges we see our clients face is in the development of tailored testing programs for non-standard or novel devices, for which there are often no ISO or ASTM methods. The challenge lies in striking a delicate balance between ensuring testing is comprehensive enough to demonstrate device safety and performance, while avoiding conducting unnecessary additional studies that increase cost and timelines. In many cases, device testing must proceed without direct feedback from regulatory bodies on whether it is the correct path until submission, meaning early decisions on the testing strategy are critical.

Breanna Barber: As technology advances, reusable devices have become more complex in design. These complex design features pose a challenge to effective cleaning. Effective cleaning is essential before sterilization for the safety of the patients and the functionality of devices. 

Cleaning validation testing is required for reusable devices. Cleaning validations of critical orthopedic surgical instruments require visual examination alongside evaluation of quantitative endpoints to ensure residual levels of protein, hemoglobin, carbohydrates, or total organic carbon are below certain limits. We have seen an increase in visual examination of soil on devices with difficult design features during the cleaning validation, which requires updates to the cleaning method or manufacturer’s Instructions for Use (IFU). 

It is crucial for reprocessing to be thought of during the design phase to avoid these challenges during testing. 

Brown: For some of our clients, keeping up with changes to the standards utilized for testing is becoming more time-consuming to product development timelines, as the testing is becoming more involved and therefore will take longer to complete. Changes to the testing requirements, especially after the initial 510(k), can cause timeline issues if they aren’t discovered early in the R&D process. Products that were cleared to the old version of a test standard or FDA guidance may need to be retested to the new standard or guidance. We have seen testing such as reprocessing of reusable medical devices and, specifically, the cleaning validation requiring increased testing because of changes in the standard. Additionally, some devices that were previously cleared without cadaveric testing now require cadaveric testing to be cleared for a new 510(k). The test standards are continually being created, improved, and updated. To stay abreast of the testing standards, Engineering & Quality Solutions maintains membership in ASTM as a voting member on the committees that are creating and maintaining the medical device standards, as well as keeping our relationships with the testing vendors current.

Eigentler: Today’s orthopedic device testing landscape faces several pressing challenges beyond the purely mechanical. As devices become more complex, incorporating new materials, digital components, and software, the scope of required testing has expanded dramatically.

One of the most significant challenges is the need for multi-disciplinary testing. Orthopedic implants, once tested mainly for mechanical strength, fatigue, and wear, now undergo a broad spectrum of evaluations. These include chemical analysis for leachables and extractables, microbiological assessments for sterility and endotoxins, electrical and electromagnetic compatibility (EMC) tests for powered components, MRI safety checks, and even cybersecurity assessments for connected or smart systems. Coordinating these highly specialized tests often involves multiple expert teams and accredited laboratories, which can create logistical and technical hurdles for manufacturers, particularly smaller companies unfamiliar with managing such integrated test programs.

Hughes: Perhaps the most prominent challenge lies in ensuring testing methodologies keep pace with the relentless advancements in orthopedic device manufacturing, particularly concerning patient-specific implants and novel biomaterials. The complexity of these devices demands sophisticated testing protocols. Another significant hurdle is accurately replicating the in vivo environment. Orthopedic devices must withstand the multifaceted challenges of physiological loading, wear mechanisms, and complex biological interactions within the human body. Fully mimicking these intricate dynamics in a laboratory setting remains a considerable technical and scientific challenge.

Langhorn: With a drive to improve the patient experience, reduce variability in the surgical process, and address more complex conditions, orthopedic devices have become much more complex. The FDA has identified three gaps in medical device development and is driving to improve: 

• Lack of established test methods for innovative/novel solutions
• Limitations in existing methods that don’t incorporate both real-world and worst-case data
• The low adoption of validated computational techniques as a surrogate for physically derived data.

When new device types don’t fit existing standards, it creates challenges for everyone.

Materials characterization requirements have expanded significantly; for example, regulatory bodies such as the FDA require comprehensive screening of polymeric implants and packaging materials for impurities like residual monomers, solvents, light stabilizers, and antioxidants. Increased testing to standards such as ISO 10993-18 is increasing in demand as scrutiny increases.

Parker: Coatings and new biologically based materials, unfortunately, aren’t always compatible with some of the biocompatibility test systems. Adaptations, in particular to sample preparation according to ISO 10993-12, may be required, potentially posing a challenge to justify the effect of any method adjustments necessary.

Rollins: I mentioned regulatory complexity earlier, but navigating evolving and differing global regulatory requirements (e.g., FDA vs. EU MDR) is a major burden. Another challenge involves creating clinically relevant in vitro models that accurately mimic in vivo performance (realistic simulation). Also, as devices become more complex, testing becomes more expensive and time-consuming, impacting time-to-market or even innovation. Finally, the ethical and technical shift from animal testing is yet another worth mentioning; getting regulatory acceptance of validated alternatives to in vivo studies is challenging.

Tumminelli: Validating the integrity, durability, and sterility of the devices. 

Fenske: How have the new MDR regulations affected orthopedic device testing?

Archer: The new regulations are driving a significant increase in device testing, with many manufacturers now needing to address gaps in historic submission data. Lucideon is seeing device manufacturers postpone device testing programs until late in the development process due to the cost burdens of these additional tests. This approach results in much tighter deadlines for device testing projects.

Barber: We have seen an increase in requests for repeated processing (soiling, cleaning, and sterilization) cycles before biocompatibility testing. This comes from a biological safety standpoint. Is the device safe to use on the patient over its lifespan? These kinds of repeated processing cycles impact the device manufacturer in both time and cost.

Eigentler: The introduction of the EU MDR has significantly reshaped orthopedic device testing requirements, raising both the complexity and the stakes for market access. Manufacturers are required to provide stricter technical documentation, demonstrating alignment with general safety and performance requirements and offering robust justifications for any exemptions.

One critical area that has emerged under MDR—and increasingly under FDA and other global regulatory frameworks—is MRI safety. While some regulations address MRI considerations explicitly, many refer to them indirectly through requirements for state-of-the-art adherence, thorough risk assessment, and mitigation strategies. Given the high prevalence of orthopedic implants in the global patient population and the widespread use of MRI (with nearly 10% of people undergoing MRI exams annually), the interaction between orthopedic devices and MRI environments is now an integral part of regulatory scrutiny. Legacy MR-untested or contraindicated devices are being replaced by MR-conditional or MR-safe models, driven by rising expectations from clinicians, patients, and regulators. Failing to address MRI safety can lead to risk management gaps, approval delays, and market access barriers.

Hughes: The introduction of the new MDR has impacted orthopedic device testing by significantly increasing its scope and intensity. The MDR places a greater emphasis on comprehensive clinical studies, rigorous biocompatibility assessments, and robust post-market surveillance. This mandates that manufacturers adopt more robust and transparent testing strategies throughout the entire product lifecycle, from initial concept to end-of-life. Consequently, testing often involves a broader range of endpoints, increased sample sizes, and the application of advanced analytical techniques to meet the heightened regulatory requirements.

Langhorn: MDR regulations have created significant uncertainty due to shifts in requirements for European submissions and have had knock-on effects on countries such as the U.K. and Switzerland that have been closely tied to the EU for many years. Premarket requirements have become stricter, risk assessments more detailed, and many orthopedic implants have been moved to higher risk categories. Many devices that were previously Class IIa moved to Class IIb or Class III, leading to more extensive clinical evidence, stricter conformity assessment procedures, and ongoing post-market clinical follow-up requirements. Associated documentation requirements are also now much more extensive.

Rollins: The EU (MDR) significantly raised the bar for orthopedic device testing in numerous ways. More rigorous clinical evidence is now required, often including clinical performance studies. Also, stricter post-market surveillance has led to increased requirements for long-term performance data. Expanded risk management and biological evaluation requirements, including justification of all testing gaps, have increased test burdens and documentation. This has led to the removal of devices on the EU markets and even delayed the submission of state-of-the-art devices to the EU. Devices previously grandfathered under MDD now often need re-validation under MDR standards.

Tumminelli: When it comes to reusable devices such as surgical instruments, the notified bodies are asking for full end-of-life testing, which will demonstrate that after multiple uses, including reprocessing, a device still meets its intended use.

Fenske: Has the FDA’s greater emphasis on biocompatibility affected orthopedic device testing?

Archer: Absolutely. Lucideon is seeing greatly increased demand for our biocompatibility testing across a range of medical devices. To support this, we’re expanding our global capability with a new state-of-the-art chemistry laboratory in the U.S., set to launch officially in 2026. This will significantly increase capacity for ISO 10993 part 18 extractables and leachables studies. However, increased emphasis from FDA on biocompatibility testing data has had the opposite effect for some devices as some manufacturers have discontinued low-volume product lines where testing costs outweigh revenue. This situation is currently negatively impacting patient access to niche devices. Lucideon’s role is to help manufacturers achieve compliance efficiently, using effective testing strategies to both control costs and meet FDA expectations.

Brown: Yes, but it’s not just the FDA; the EU has expanded its requirements as well. The FDA specifically has been looking more closely at coatings that contact the patient, and the FDA guidance requires the coatings, as well as the underlying implant material, to be looked at in detail for biocompatibility. The guidance further indicates any changes related to coatings may require a new 510(k). Something that seems simple, like changing the coating vendor or the processing of how the same coating material is applied, may require a new 510(k). There may be a need to bring in outside biocompatibility consulting resources to navigate the documentation requirements and specific testing needed. This then affects the project timelines and cost estimates.

Eigentler: It’s still too early to know how the recent revisions to ISO 10993 are being implemented, but we have seen across the board that biocompatibility is often where most deficiencies are filed, especially as it relates to ISO 10993 -17 and -18. There are several reasons for this, but it’s primarily driven by the fact that while extractable and leachable testing is fairly common in the pharma space, it is still relatively new to medical devices. This is compacted further by the fact that different laboratories use different techniques with no shared compound database and occasional variations in compound identification across labs leading to questions about how reliable the data is.

Hughes: The FDA’s increased emphasis on biocompatibility has impacted orthopedic device testing. Manufacturers are now required to furnish more extensive data detailing how device materials interact with living tissues, with a particular focus on long-term implantation and sustained exposure to biological environments. This translates to not only conducting a wider array of standardized tests but also tailoring biocompatibility assessments to reflect the specific anatomical and physiological contexts in which devices are intended for use. 

Langhorn: With the FDA focusing on long-term toxicity, genotoxicity, and carcinogenicity data through analytical chemistry and toxicological review, a comprehensive chemical characterization of device materials and extractables is needed. This is followed by toxicological risk assessments by qualified toxicologists who evaluate whether identified chemicals pose possible risks to patients at the expected exposure levels. Updated guidance initially created some confusion about requirements and subsequently caused some regulatory issues and product delays. Companies that previously had engineers or materials scientists managing biocompatibility studies quickly discovered that this was no longer sufficient.

Parker: Recent FDA guidance documents have emphasized a better understanding of the duration of exposure of devices to the body. Materials that are repeat use or are known to absorb/degrade likely stay in the body longer than they are present at the local exposure site, potentially increasing the number of endpoints needing evaluation. 

In addition, there has been an increase in the use of chemical characterization (extractables & leachables) to better understand device constituents and the ability to use the data to support risk assessment out of certain biological endpoints.

Rollins: Yes, the FDA has increasingly emphasized several aspects of biocompatibility. Full biological risk assessment is aligned with ISO 10993, pushing sponsors to justify biological safety more thoroughly. Another involves the use of extractables/leachables studies, particularly for polymeric components. In addition, more data on long-term implant effects, corrosion, wear particles, and their systemic impact are needed. Fewer assumptions or predicate-based justifications are permitted, leading to more direct testing.

Trafka: For a very long time, biocompatibility testing was not much of a concern for orthopedic devices. The materials and their biocompatibility profile were well known, so the subject was very easy to address. Now, with increased FDA scrutiny on biocompatibility, a lot of companies are scrambling to understand the requirement, get a test plan outlined, and conduct required testing. This has had a definite impact on R&D timelines and cost.

Tumminelli: There has been a push for the full matrix of ISO 10993 to be followed based on attributes and the intended use of the device. Also, FDA has been asking for multiple rounds of simulated use to be conducted before BioComp.