The medical device and implant testing market continues to expand, driven by greater product complexity, evolving materials and manufacturing technologies, and heightened regulatory scrutiny. While innovation in areas such as digital health, automation, and advanced devices continues, “manufacturers are equally focused on risk reduction, compliance, and speed to market, creating increased reliance on CROs [contract research organizations] with deep technical, regulatory, and integrated testing capabilities,” said Mike Bond, senior vice president, medical device services for Eurofins Medical Device Services North America, a provider of cleanroom validation and certification services, ethylene oxidation (EO) sterilization, and regulatory support.

In the reusable medical device space, there is a growing emphasis on rigorous cleaning and disinfection validation, even for non-critical devices. These include products that contact only intact skin, such as blood pressure cuffs, as well as equipment used to support surgical procedures, including monitors, consoles, and other ancillary tools. 

“Regulatory bodies are applying stricter expectations in these categories, reflecting a broader push to ensure consistent and verifiable reprocessing outcomes across all device types,” said Alpa Patel, director of lab operations, healthcare reprocessing for Nelson Laboratories, a Salt Lake City, Utah-based global provider of laboratory testing and advisory services.

Another major area of increased scrutiny is risk management assessment throughout the entire device lifecycle. Regulators now expect manufacturers to generate testing data that supports these assessments, particularly around material durability and long-term safety. “For example, biocompatibility evaluations are increasingly being reviewed not just at the start of a device’s life, but across multiple reuse cycles to confirm that repeated cleaning, disinfection, and sterilization do not compromise patient safety,” added Patel. “This shift underscores a more holistic approach to evaluating reusable devices, where performance and safety must be demonstrated over time.”

Overall, medical device manufacturers (MDMs) are leaning toward more advanced methodologies, such as greater use of artificial intelligence (AI) tools, automation, and high-precision in-vitro models to strengthen predictions of safety and performance, beyond traditional animal testing. “Sustainability and lifecycle testing, such as reusable device validation, have risen on testing agendas, reflecting industry and healthcare system priorities around environmental impact and cost over device lifetimes,” said Thor Rollins, vice president, medical devices, for Nelson Laboratories.

From a business perspective, the medical device testing industry has seen a surge of consolidation via merger and acquisition activity by private equity firms. This creates fewer options for MDMs and higher pricing control by the large laboratory firms. “Additionally,” said Aaron Liss, director of sales and marketing for DDL, a Minneapolis, Minn.-based third-party testing laboratory that provides package, product, and materials testing for the medical device industry, “the medical device industry is on the brink of profound transformation, driven by breakthroughs in AI, wearable technology, 3D printing, and enhanced cybersecurity. With regulatory shifts, industry consolidations, and innovative pricing models reshaping the landscape, testing service providers must embrace agility and adaptability to stay ahead in 2026 and beyond.”

Latest Trends 

The medical device industry is undergoing steady technological innovation. Advancements in AI, wearable devices, and cloud computing are enabling more connected solutions and advancing precision medicine. Testing equipment manufacturers continue to innovate and upgrade systems for software/comma-separated values to support data integrity under 21 CFR Part 11 and 211. These cutting-edge technologies enhance patient outcomes and reshape the landscape of data management, regulatory requirements, and safety standards for medical device companies that require a more risk-based approach with testing.

“Regulatory bodies continue to focus on risk-based approaches in all aspects of safety and efficacy testing,” said Liss. “Certain sectors of testing, such as ISO 10993, continue to be heavily outsourced to support biological evaluations.”

For example, lifecycle testing for reusable medical devices is becoming increasingly prominent, due in part to the latest revision of ISO 10993, which now requires manufacturers to evaluate device safety at the end of its usable life. This shift means that biocompatibility and material degradation assessments must account for the cumulative effects of repeated cleaning, disinfection, and sterilization cycles—not just the device’s initial state.

In the last few years, MDMs have expressed greater interest in microbial ranking. Companies are receiving pushback from the FDA if they neglect to perform microbial ranking on their aged samples. “We’re also seeing more requests for real-time aging at controlled conditions,” said Sean Thompson, senior sales engineer for Packaging Compliance Labs (PCL), a Grand Rapids, Mich.-based provider of package testing, packaging engineering, and contract packaging services for the medical device industry. “In addition, many clients are inquiring about the latest ASTM F1886 updates for whole package visual and not just seal integrity.” 

Another emerging area of focus is human factors testing related to reprocessing instructions. “Historically,” said Patel, “human factors evaluations have centered on engineering and device operation, but there is growing recognition that instructions for use [IFUs] play a critical role in ensuring safe and effective reprocessing. This gap in the industry is now receiving overdue attention, as regulators and manufacturers acknowledge that unclear or impractical IFUs can directly impact cleaning outcomes and patient safety.”

One of the most significant trends in testing services is the accelerated industry-wide effort to identify and validate viable alternatives to EO sterilization. Heightened regulatory and environmental scrutiny of EO—driven by concerns related to occupational exposure, environmental impact, and residual toxicity—has created uncertainty around its long-term use. 

“Although regulatory actions by agencies such as the EPA and FDA have primarily targeted commercial sterilization operations of single-use devices, their impact is increasingly being felt within healthcare facilities,” commented Tonia Giglio, technical manager, client services for HIGHPOWER Validation Testing and Lab Services, a Rochester, N.Y.-based provider of reusable device testing and healthcare sterilizer validations.

In response, MDMs, healthcare systems, and testing laboratories are investing in evaluating alternative low-temperature sterilization technologies. “Although EO remains a critical modality today, its long-term availability in the U.S. market is uncertain,” continued Giglio. “We expect to see a continued decline in EO use over the next several years, and hopefully, alternative sterilization solutions will be discovered.” 

What MDMs Want 

Current testing trends are driven by innovative devices that are smaller and more complex, often with multiple functions. For example, “with more combination products coming to market, we are seeing more temperature-controlled packaging, whether it’s refrigerated, frozen, or cryo,” said Greg Schwinghammer, principal engineer for WESTPAK, a California-based independent third-party testing laboratory that specializes in product and package validation for the medical device industry. “Each of these has its own challenges with thermal mapping and transportation testing.”

Popular tests so far in 2026 include biocompatibility and safety-focused testing, mechanical and physical performance evaluation, microbiology, sterility, and package validation, and advanced analytics and chem/bio characterization. 

Published in November 2025, the revised ISO 10993-1 presents a risk-based strategy to see if characterization studies are truly fit-for-purpose and designed to address the biological endpoints relevant to the device’s intended use. To ensure MDM needs are met, testing firms collaborate closely with manufacturers to gain a thorough understanding of the device, develop an appropriate biological evaluation plan aligned with the submission strategy, and execute the testing. 

“By identifying potential concerns early—whether related to new submissions or changes such as materials, suppliers, or processes—we proactively address risks to ensure a seamless and efficient path to regulatory approval,” said Kimberly Ehman, head of regulatory toxicology for Eurofins Medical Device Services North America. “For example, in recent years, chemical characterization followed by toxicological risk assessment has emerged as a preferred approach for addressing many biological endpoints, helping to reduce animal testing while shortening overall testing timelines.”

A notable development in the reusable medical device industry is the growing adoption of UV-based disinfection technologies. “UV systems are increasingly explored as a supplemental or alternative method for disinfecting reusable medical devices, both in healthcare settings and in homecare environments,” said Patel. “This shift reflects a broader interest in faster, chemical-free disinfection options that can support effective reprocessing, while reducing the burden on traditional cleaning workflows. It is essential to ensure that validation of these technologies will support their use in these environments.” 

Sometimes, noted Liss, MDMs still need education when it comes to test standards—especially combination product companies and meeting good manufacturing processes (GMP) requirements. “Navigating intricate regulations with innovation in a rapidly evolving device marketplace demands both agility and a thorough grasp of compliance requirements,” he said. 

This dynamic environment highlights the need for robust testing that not only adheres to current standards but also an  ticipates and adapts to future regulatory changes. “The need to support EU Medical Device Regulation [MDR] remediation has declined dramatically,” added Liss, “which has allowed MDMs to focus more on innovation and new product development.” 

New Technologies, More Testing

Wearables and home-care devices are beginning to cross over into the realm of formal cleaning and disinfection validation—a relatively new development for the reusable device industry. This shift introduces significant complexity, as many of these products were not originally designed to withstand the rigors of medical-grade reprocessing. “Their intricate geometries, sensitive electronics, and diverse material compositions make them highly susceptible to damage or degradation when exposed to common disinfectants or cleaning chemicals,” said Patel. “As a result, validating safe and effective reprocessing methods for these devices has become a growing challenge for manufacturers and testing laboratories alike.”

3D-printed medical devices present unique challenges for cleaning and disinfection that differ significantly from those seen in traditionally manufactured products. Materials, surface characteristics, complex geometries, and the additive manufacturing (AM) process itself all contribute to these difficulties. Many 3D-printed components have porous, micro-rough, layered surfaces filled with tiny crevices and channels. These features can trap bodily fluids, debris, and microorganisms, making effective reprocessing far more difficult and increasing the risk of residual contamination.

Unlike traditional manufacturing, AM properties are process-dependent, not just material-dependent. Testing programs typically include:

• Powder or feedstock characterization (chemistry, particle size, contamination)
• Build-to-build and lot-to-lot variability studies
• Heat treatment and post-processing validation

“For AM,” said Rollins, “it is also essential to prove the process is stable and repeatable.”

New designs—especially for miniaturized connected devices—increasingly rely on Internet of Things (IoT) and AI. These technologies are now influencing what gets tested, how it is tested, and what equipment and services MDMs want for their medical device testing. For connected devices, testing routinely includes:

• Connectivity and wireless performance (Bluetooth, Wi-Fi, Bluetooth low energy, latency, dropouts)
• Interoperability with hospital systems, apps, and cloud platforms
• Data integrity and reliability (loss, corruption, synchronization issues)
• Power management and battery life under real-world use

“Cybersecurity testing is no longer optional,” advised Rollins. “Testing services increasingly include vulnerability scanning and penetration testing, secure data transmission and encryption validation, and failure-mode testing under cyberattack scenarios. This has pushed testing labs to add cybersecurity expertise and tooling, often in partnership with software and IT security specialists.”

AI is also used to iterate designs and develop packages faster. “In the past, engineers built samples for each idea and tested each iteration to determine which was best,” said Schwinghammer. “Today, they can use AI models to select multiple options and conduct preliminary testing on those options, shortening the development cycle and time to market.” 

Industrial computed tomography (CT) scanning has become a popular way to evaluate medical devices in great detail. Since many of the parts are made from plastics and other lower-density materials, this technology allows parts to be scanned and a point cloud created for that part. “With this data, we are able to look at different dimensioning needs of the device by comparing these measurements to either a drawing or a CAD model,” said Liss. 

With all the new technology being developed, regulatory bodies want more documentation regarding traceability and data integrity. Ensuring these electronic records remain unbiased and correct is a critical part of a third-party testing lab’s quality management system.

“Validation of these systems to ensure outputs of testing are recorded correctly is very important to ensure confidence of data and results,” said Liss. “AI and the internet complicate the demand for traceability and integrity while continuing to ensure devices remain secure. Complex firewalls and systems increase the need for software validations during all of the different stages of device development now to ensure a device comes to market with no bugs or software issues.” 

Regulatory and EU Challenges

“At present, biocompatibility testing is a commonly reverberated pain point across the medical device industry,” stated Hal Stowe, senior manager, regulatory intelligence for Eurofins Medical Device Services North America. “In our conversations with clients, FDA, and industry alike, there is a consensus that FDA frequently requests data beyond that outlined by ISO 10993 and associated guidance. These requests from the agency are more typical in pre-market submissions for innovative devices, such as new materials, extended contact or implantation timeframes, or devices presenting other safety risks.”

The FDA’s guidance to industry stakeholders is straightforward—when developing a biocompatibility testing strategy, MDMs should engage with the review branch to receive guidance and address data gaps before submitting their 510(k), De Novo, or pre-market approval (PMA). 

“Recommendations to our clients echo FDA’s expert guidance,” continued Stowe. “Before committing intensive resources to your medical device, engage with FDA via Q-Submission to discuss your strategy. Although this additional planning may appear time-intensive, the potential for avoiding additional expenditures on further biocompatibility testing can create a competitive advantage for your device.” 

The FDA continues to refine and streamline the 510(k) process, allowing for more lifesaving devices to reach patients faster. In turn, this puts more pressure on the third-party testing houses to deliver results faster. “In the last year, the FDA has really started to enforce a risk-based approach on conducting testing and validation of devices,” said Liss. “This ensures a device has been fully reviewed and proven prior to submissions—creating a road map for what is needed in a submission of a device to the FDA/regulatory bodies when a manufacturer is submitting a device for review.”

Challenges Ahead

Led by miniaturization and AI, innovation keeps advancing, pushing testing technologies to their limits.

For example, miniaturization has a profound effect on chemistry testing because smaller devices force every part of the analytical process to operate at much smaller scales. Miniaturized devices also generate weaker chemical or physical signals, pushing testing systems to achieve far higher sensitivities and lower detection limits. In some cases, the levels needing to be measured push the limits of conventional testing instrumentation and methods, causing new methodologies to be considered and perfected. Calibration also becomes more difficult at smaller scales, since standard reference methods are designed for bulk chemistry rather than microfluidic or chip-based systems. Altogether, these challenges mean chemistry testing must evolve toward ultrasensitive detection, rigorous material characterization, and tighter environmental control.

One of the most significant barriers to innovation in testing services and equipment is the growing difficulty of meeting regulatory expectations as medical devices become more intricate and technologically advanced. Standards often lag behind these design trends, offering limited guidance on how to properly test, measure, or validate next-generation devices. “This creates uncertainty for manufacturers and testing laboratories striving to demonstrate compliance in areas where clear methodologies simply don’t yet exist,” said Patel.

At the same time, increasing device complexity makes effective cleaning and disinfection far more challenging. Intricate geometries, delicate materials, and miniaturized components push the limits of what day-to-day sterile processing departments in hospitals can reliably manage. “As a result, the burden on healthcare facilities continues to grow, highlighting the need for more robust, intuitive, and innovation-friendly testing solutions,” Patel added.

Yet another challenge with smaller and smarter devices is the variety of different software and custom fixturing required to fully test these products. Technology advances, combined with the increasingly complex requirements MDMs want, make testing more complex and customized. This means it takes longer to be certain that testing is set up properly; more validations are also needed to ensure results can be trusted. Even with the added challenges of custom applications, MDMs still push their testing labs to keep lead times down, when, in reality, it takes longer to program and set up these tests.

Despite these significant hurdles, some MDMs still consider doing testing in-house to save time and money. Before committing resources to in-house testing, they should keep in mind the initial cost of the equipment, the cost to maintain and calibrate the equipment, and the effort and cost to train and retain staff with the technical expertise to run the equipment and perform the testing. It is also essential to have an in-depth understanding of complex regulatory requirements. 

“Time is also a critical aspect to consider if a test needs to be completed quickly in order to meet a deadline,” said Liss. “For most MDMs, it is still more cost-efficient in the long run to outsource their testing. Having a third-party lab perform testing also provides a more independent and less biased view of the data.”

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.