The medical device industry is on the brink of profound transformation, driven by breakthroughs in artificial intelligence (AI), wearables, additive manufacturing (AM), and enhanced cybersecurity. Medical device manufacturers (MDMs) are starting to embrace the integration of automation, digitization, and Internet of Things (IoT) technologies. So far in 2025, testing firms report increased interest in the end-of-life use of reusable devices, human factors testing for instructions for use (IFU), and low-temperature sterilization methods for temperature-sensitive devices.

With regulations changing every year and MDMs submitting increasingly complex medical devices, testing services are in high demand. However, “regulators are still fairly conservative in what they will accept as evidence of safety and efficacy, while also under intense pressure to modernize,” said Lisa Olson, senior vice president of global laboratory services for NAMSA, a Toledo, Ohio-based provider of medical device testing services for biocompatibility, analytical chemistry, preclinical development, and microbiology. “Testing facilities are trying to balance using time-tested methodologies with emerging technical advancements.” 

On the regulatory front, cleaning protocols are a top concern. The FDA continues to heavily enforce medical device instructions for IFU for cleaning validations to ensure each method of cleaning within an IFU is supported by a comprehensive Association for the Advancement of Medical Instrumentation (AAMI) ST98 validation. “Since last year, many companies have been performing gap analysis on legacy devices that were validated with the previous AAMI TIR30 to assure compliance with AAMI ST98,” said Don Tumminelli, senior technical manager of client services for HIGHPOWER Validation Testing & Lab Services, a Rochester, N.Y.-based provider of reusable device testing and healthcare sterilizer validations. “Many device manufacturers are also assessing large product lines for worst-case challenge devices, rather than test the entire product line.” 

As regulatory shifts, industry consolidations, and innovative pricing models continue to impact the industry, it is imperative “testing service providers embrace agility and adaptability to stay ahead in 2025 and beyond,” 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.

Current Trends

Testing services for medical devices are becoming increasingly sophisticated, driven by the need to accommodate smaller, more complex, and smarter devices. In particular, many MDMs are focused on product safety, sustainability, and regulatory compliance. 

“Testing methodologies are evolving, driven by advancements in materials science, technology, and stricter industry regulations,” said Chrystel Lloyd, senior manager of lab operations and strategic development, healthcare reprocessing, for Nelson Laboratories, a Salt Lake City, Utah-based global provider of laboratory testing and advisory services. “We are also seeing end-of-line testing, not only for durability and material science but safety as well.”

Automation and AI have made device testing more efficient and precise, reducing errors and accelerating time to market. New biocompatible and lightweight materials require specialized testing protocols to ensure safety and performance. “In addition,” said Alan Evans, senior manager for medical package testing for Life Science Outsourcing, a Brea, Calif.-based provider of medical package testing services, including bubble emission testing, seal strength testing, and peel strength testing, “the focus on sustainability has grown, with labs adopting eco-friendly practices to minimize resource use while ensuring compliance. These trends highlight the ongoing evolution of testing services to meet market demands.”

For example, sustainability plays a more significant role, influencing both the materials used and the processes applied to testing. The re-use versus single-use debate is still strong. “As disposable devices create more waste, healthcare facilities are re-evaluating the sustainability of single-use versus reusable devices,” said Alpa N. Patel, director of lab operations, healthcare reprocessing, for Nelson Laboratories. “Reusable devices, when properly tested and validated, are often seen as a more sustainable option over the long term.”

Biocompatibility assessment of medical devices continues to evolve relative to both regulatory guidance and laboratory test methods. The complexity of medical devices, including device/drug delivery combination products, “raises the question about whether the current regulatory guidelines, as well as testing platforms/assays, are sufficient to assess not only efficacy but also safety of the devices,” said Daniel Radiloff, Ph.D., director of business development for Pacific BioLabs, a Hercules, Calif.-based contract research organization that specializes in preclinical testing services, including in vivo, in-vitro, analytical chemistry, and microbiology testing services.

In addition, MDMs are beginning to evaluate and adopt alternatives to animal-based testing modalities for many of the biocompatibility tests described under ISO 10993, such as cell-based or in-vitro models. “Although regulatory agencies have not issued official guidance related to alternative testing, many companies, particularly in Europe, are making this transition,” added Dr. Radiloff.

Olson pointed out there is still significant hesitation about using alternative tests “because the ability to compare results to past data is limited,” she said. “Part of the growing interest in these models is the ability to understand the mechanism of the potential risk factors to help elucidate the eventual biological relevance of the data. For example, the device industry is maturing its thoughts on chemical evaluations of devices and materials. Better study design and improved understanding of materials and the appropriate toxicological evaluation, have started to become more prevalent.”

What OEMs Want

MDMs are focused on the combination of efficiency, adaptability, and sustainability in their evolving testing demands. This balance ensures consistent quality and operational efficiency across diverse product portfolios. Compatibility and validation for sensitive devices, such as those with embedded electronics or IoT functionality, are also critical priorities.

“OEMs are asking for advanced sterilization methods and more low temperature-sterilization methods, particularly vaporized hydrogen peroxide,” said Patel. “Regulatory stakeholders have also shown an increased interest in this area as more devices are thermally sensitive.”

“There is also growing interest in surface integrity testing to ensure that devices do not degrade after multiple reprocessing cycles,” said Lloyd. “This includes testing for material wear, functionality, and the potential for bacterial growth in hard-to-reach areas.”

Time to market (at a reasonable cost) is a huge consideration for MDMs when selecting a testing partner. 

“OEMs want faster test turnaround times with real-time data reporting, comprehensive security assessments for connected devices, and cost-effective solutions for rapid prototyping and small batch testing,” said Thor Rollins, vice president of medical devices for Nelson Laboratories.

“Speed and quick turnaround times are universal requests from all device manufacturers,” agreed John Hodges, senior business development director for Eurofins Medical Device Services, a provider of cleanroom validation and certification services, ethylene oxidation (EO) sterilization, and validation and regulatory support. “For example, our small-scale sterilizers allow for routine and commercial sterilization requests to be processed in days, not weeks. This also allows us to turn validations around in weeks, not months.”

MDMs can streamline time to market by using pre-validated packaging, enabling them to meet compliance requirements and still accelerate product launches. “Pre-validated packaging has become a popular approach for achieving these goals,” said Evans. “By leveraging packaging solutions that have already undergone rigorous testing and validation, OEMs can bypass much of the traditional validation process, saving both time and resources.”

Perhaps the most pressing need for MDMs is partnering with a testing firm that can help them navigate intricate regulations and test standards in a dynamic device marketplace that demands both agility and a thorough grasp of compliance requirements. 

For example, “many manufacturers are still getting lots of questions about the setup of their chemical characterization studies, which could be driving overtesting and an overcautious approach to testing,” said Tyler Hollingshaus, global sales and marketing manager for TÜV SÜD Medical Health Services, a global third-party provider of medical device testing, including biocompatibility, chemical characterization, microbiological testing, and packaging. “EU-notified bodies are more receptive to in-vitro testing, while the U.S. market is slower in adopting such methods.”

The FDA has been involved in many industry conversations that address how to meet these testing challenges. Even with this constructive dialogue, MDMs are still struggling to keep up with the current interpretations of guidance by regulators. “While there are improvements in consistency within offices, overall interpretations of the data needed still tend to change over time,” said Olson. “As regulators see more data and more devices, their opinions evolve. But it can be difficult for MDMs to keep track of these nuances, so many depend on their partners for advice.”

Technology at the Forefront

High-precision measurements are an absolute must in the testing world. Testers increasingly rely on AI to analyze data and predict performance. The integration of AI into testing processes will transform the industry by enhancing efficiency, accuracy, and adaptability. AI-driven systems can analyze vast datasets, identify patterns, and predict potential failures, streamlining the validation process and significantly reducing time to market. This makes testing faster and also improves precision, as these systems can detect subtle anomalies that might otherwise go unnoticed. 

In January 2025, the FDA issued a comprehensive draft guidance that includes recommendations to support the development and marketing of AI-enabled devices throughout the device’s total lifecycle,¹ “ensuring these technologies are implemented safely and effectively,” said Evans.

AI is advancing testing services by enabling predictive analysis and optimizing test setups. It can also identify significant patterns and anomalies that might otherwise be overlooked, improving both speed and accuracy. For security needs, “AI can be used to support the development of individual scripts for penetration testing of devices,” said Malte Knowles Schmidt, global portfolio manager for software for TÜV SÜD Medical Health Services. “Similar to how AI might be used when code is developed on the manufacturer side, we use AI to develop respective scripts—for example, in Python—for penetration testing.”

Digital twin technology is another AI-related breakthrough—by simulating real-world conditions in a virtual environment and testing different variables, manufacturers can predict device performance with stunning accuracy before any physical testing begins. “This not only saves time and resources but also allows for more informed decision-making early in the product development process,” said Evans. “It is a transformative shift in how testing is approached.” 

Computerized tomography (CT) scanning continues to evolve with new capabilities enabled by advanced software. CT scanning of parts in the medical device space has accelerated over the last few years—not just to support test requirements for regulatory purposes but also first article inspections. “Since so many parts used in the life sciences are made of plastic, this technology has proven to be very effective,” said Liss. “Using scanning to create 3D images of products allows manufacturers to have dimensional analysis/first article inspection completed on internal features and other key parts of components.”

CT scanning also allows manufacturing defects, such as porosity and shrinkage, to be evaluated in a faster, more reliable manner since a part no longer has to be sectioned to observe internal features. These images can be compared to drawing specifications or even directly to computer-aided design models of parts. “Using this allows manufacturers to make changes to non-conforming parts faster than ever before,” said Liss.

Wireless mobile applications are expanding in the medical device world of interconnected devices. For example, the integration of radiofrequency wireless technologies—such as Wi-Fi, Bluetooth, and cellular networks—into medical devices has revolutionized patient care by enabling remote monitoring, device control, and seamless data transfer. 

However, technological advancement also brings forth significant cybersecurity challenges that must be addressed to safeguard patient safety and data integrity. 

“Ensuring the security of these devices involves comprehensive risk assessments to identify potential threats, rigorous penetration testing to uncover vulnerabilities, and strict adherence to established security standards,” said Joseph Silvia, CEO of Medware Cyber, a Boston, Mass.-based provider of security testing services for medical devices, including compliance testing, incident response, penetration testing, and vulnerability assessment. “MDMs must also be sure to implement robust encryption protocols and maintain vigilant lifecycle management to effectively mitigate risks, ensuring that the benefits of wireless medical devices are realized without compromising security.”

“Ideally, cybersecurity is considered from the beginning of the product development to ensure the device is as cyber-secure as possible,” said Hollingshaus.

As a first step, MDMs should conduct comprehensive risk assessments to identify potential threats and vulnerabilities, adhering to standards such as ISO 14971. This involves hazard identification, risk estimation, and evaluation to prioritize risks and implement appropriate mitigation strategies. “Also, implement rigorous penetration testing (ethical hacking), which is essential to uncover vulnerabilities in software, hardware, and communication protocols, allowing for remediation before exploitation,” said Silvia. 

Compliance with other recognized security standards, such as FIPS 140-2, provides guidelines for implementing cryptographic modules and other measures to protect data transmitted over wireless networks. Securing data in transit and at rest through robust encryption protocols prevents unauthorized access, ensuring sensitive patient information remains confidential.

“Maintaining vigilant lifecycle management, including regular software updates, continuous monitoring, and incident response strategies, also ensures that emerging threats are promptly addressed, keeping the device’s security robust throughout its operational life,” added Silvia.

Regulatory Issues

As medical device technology continues to advance, regulatory bodies are pushing for more traceability and data integrity. Ensuring 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 the testing outputs are recorded correctly is critical to ensure confidence of data and results.

Testing services must now demonstrate compliance with a broader range of standards while still remaining agile in adapting to evolving regulatory guidelines. This necessitates a proactive approach to audits and the identification of regulatory challenges early in the development process, both of which are critical for ensuring smooth approvals and timely market entry.

“To meet these challenges, testing firms must leverage solutions such as effective eQMS [electronic quality management systems] to streamline compliance tracking, document control, and audit readiness,” said Evans.

One of the biggest regulatory challenges today is the EPA’s request to significantly lower the amount of EO gas released into the atmosphere. “Eurofins Medical Device Services has worked within the new EPA regulations to ensure that more than 99% of EO gas used during sterilization is removed from any air passing into and out of the lab,” said Hodges. “We continue to monitor this, as EO sterilization is the only means of sterilization for greater than 50% of all medical devices, due to the penetration of the gas into the device. Like other testing firms in the industry, we are researching alternatives to reduce our dependence on EO gas for sterilization, without sacrificing safety.”

The FDA continues to refine and streamline the 510(k) process for MDMs. This allows for more lifesaving devices to reach patients faster. In turn, this puts more pressure on 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 approach ensures a device has been fully reviewed and proven prior to submissions. The results are 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.”

With the changes in the EU MDR (Medical Device Regulation) and other regulatory agencies, the need for data integrity and validation of methods and systems has never been more important. Part of the FDA’s risk-based approach ensures the test methods are validated and the results are repeatable and reproducible; the other part ensures the systems are validated. This reflects the push by the FDA for improved data integrity and traceability—a response to the challenges that exist for consistently ensuring systems and software are properly validated before they are used. 

Parting Thoughts

Testing labs often receive requests for testing on tight timelines, with a turnaround that is often unrealistic. As with any testing project, the sooner the testing gets started, the better. 

Sometimes, MDMs also do not know if the testing they have requested is destructive or not and, if so, how this will impact their sampling plans. Non-destructive testing (NDT) methods allow for thorough evaluation of a device’s integrity and performance without causing damage, ensuring products meet quality standards. The FDA’s recognition of standards such as ASTM F2338-09, which supports vacuum decay testing for package integrity, has helped advance the adoption of NDT technologies. By eliminating the need for destructive sampling, NDT makes testing more efficient and cost-efficient.

OEMs often consider doing testing in-house to save money and shorten timelines. Before doing this, they should seriously consider the initial cost of the equipment, the cost to maintain and calibrate the equipment, and the cost to retain people with the technical expertise to run the equipment and perform the testing. “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. Also, having a third-party lab perform testing provides a more independent and less-biased view of the data.”

Some MDMs assume it is impossible to test novel materials or delicate devices under real-world conditions without causing damage to the device; however, advancements in testing technology have proven otherwise. “For instance, environmental chambers now allow for precise replication of extreme conditions, such as high humidity, sub-zero temperatures, or intense UV exposure, enabling performance validation without compromising device integrity,” said Evans. “These advancements open up new possibilities for innovation, allowing OEMs to explore ideas that might previously have seemed too risky or impractical.”

Demonstration of safety and effectiveness of a device can take many forms; no one-size-fits-all program exists. Regulators across the globe have been revising guidance for years to help MDMs critically think about the safety factors related to their specific device and intended use, and how to develop a program of testing that is reflective of the risks. 

“This does not mean that MDMs are required to do every biological test available or perform analytical assessments that have no relation to toxicologic risk,” said Olson. “The point is to create a body of evidence that is meaningful in the context of patient use and risk. Regulators are keen to work with MDMs to get to the right evidence development strategy.”

Evans noted testing is no longer just a regulatory requirement; it is also a critical component of product development. “By working with experienced partners and leveraging advanced technologies, MDMs can navigate challenges with confidence and bring innovative, high-performing devices to market more efficiently,” he said.

Source:MPO