In medical device development and surgical training, having a suitable test environment is essential for screening device concepts and reliably training surgeons. Traditionally, this process relied on excised animal or human cadaveric tissue—but the use of such tissue is problematic from both ethical and practical perspectives, including issues with stability and variability.
Hydrogel systems now offer a promising alternative: they are ethical, reliable, and mass-producible tissue models, thanks to their wide range of potential material properties. Yet, matching hydrogel properties to natural tissue is no trivial feat. Consider the simple act of cutting tissue with a scalpel: what mechanical properties are needed to achieve the correct cutting “feel”?
The Hidden Complexity of Tissue Cutting
Cutting tissue with a scalpel is a surprisingly complex process, involving a delicate balance of mechanical and rheological behaviors, as well as the natural inhomogeneity of tissue. Because many tissues and organs are non-uniform, accurate mechanical testing is challenging. The most common property reported in the literature is modulus—typically in compression—but this alone cannot capture the complexity of real tissue.
Cutting is fundamental to surgical procedures, whether using a scalpel or more advanced techniques like radiofrequency ablation, laser cutting, or electrocautery. To ensure effective surgical training and device prototyping, it is crucial to replicate the appropriate “feel,” or psychorheology, of cutting natural tissue.
Beyond Modulus: The Role of Fracture Resistance and Lubricity
When a scalpel cuts into tissue, modulus is important, but it is not the only factor influencing the cutting experience. The process begins with the compression of tissue under the blade, followed by the slicing motion and ultimately the separation of tissue. The initial contact is characterized by the compression modulus: soft tissues like lung or brain may be difficult to cut due to excessive compression, while firmer tissues like cartilage or skin provide a more stable feel.
However, compression modulus alone is insufficient to predict or mimic the cutting experience. Another critical factor is the tissue’s resistance to stretching and tearing. Imagine cutting through chicken or steak: as the blade moves, the tissue is stretched (in tension and shear) until it fractures. The cutting feel depends on whether the cut is made with or against the grain.
Muscle tissue, for example, contains a fibrous network. Along the fiber direction, it is harder to stretch; perpendicular to the fibers, stretching is easier. Compression, tensile, and shear moduli all contribute to the overall cutting feel.
Cutting with the grain is generally easier, as the blade can slip between fibers to slice through softer tissue, which has lower fracture or tear resistance. Most natural tissues have a fibrous network that prevents catastrophic tear propagation—this is crucial, as it means small nicks do not become life-threatening tears.
Most natural tissues are moist and/or contain oils. The lubricity—how easily the blade moves—is affected by the presence of fluids like blood or fatty oils. If tissue sticks to the blade, the cutting action can feel dull or draggy. Lubricity is therefore another key component of the cutting experience and can be quantified through tribological measurements of the coefficient of friction in the presence of relevant lubricants.
Overview of “psychorheological” components of simple cutting of tissue.
The Challenge of Mimicking Natural Tissue
As this overview shows, even the simple act of cutting with a scalpel depends on many interrelated factors. The blade’s shape, surface energy, and roughness also play roles, but here we focus on the tissue itself. The complex structure of natural tissues is difficult to replicate with hydrogels, despite recent advances in achieving a wide range of stiffness values.
To truly mimic the feel of cutting natural tissue with a synthetic hydrogel material, it is essential to recognize the interplay between modulus, fracture resistance, and lubricity. Enhancing one property may diminish another, making this a significant challenge for material scientists and engineers.
Conclusion
The “psychorheological” experience of cutting tissue is shaped by a combination of mechanical, rheological, and structural factors. As the field advances, understanding and measuring these properties—modulus, fracture resistance, and lubricity—will be crucial for developing realistic, reliable, and ethical alternatives for surgical training and device development.
At Cambridge Polymer Group, we are committed to advancing the science of tissue simulation, helping to bridge the gap between synthetic models and the real-world demands of medical practice. If you’d like to learn more about how we can support your projects, please reach out!
Hydrogels are rapidly transforming the medical device landscape, offering material properties that more closely emulate natural tissues than traditional rigid alternatives. In the upcoming webinar, “Squeezing the Most Out of Hydrogel Medical Devices,” Dr. Gavin Braithwaite will provide an in-depth perspective on how these unique polymers are advancing the field, what considerations must be made when designing with them, and how both testing and regulatory pathways are struggling to keep pace.
What Makes Hydrogels Special in Medicine?
Hydrogels, found naturally in places like the vitreous of the eye and cartilage of the knee, are networks of polymers that retain large amounts of water, combining the flexibility of liquids with the structural integrity of solids. This duality makes them especially suited for medical device applications where a material needs to interact harmoniously with human tissue—for example, soft contact lenses, wound dressings, and implantable devices. The morphology of hydrogels and their dynamic response to environmental conditions encourages their use in combination products where both therapeutic drug release and mechanical properties are needed.
Selecting and Designing with Hydrogels
Dr. Braithwaite will detail the complex process of choosing the right hydrogel for specific device needs. Unlike metals or plastics, hydrogels offer a vast chemical palette, allowing engineers to tune stiffness, porosity, and water content to suit a particular biological function. This customization means designers must weigh numerous factors:
Hydrogel chemistry: The base polymers selected greatly impact biocompatibility and durability. Intentional degradation behavior can be designed into the chemistry.
Structure and architecture: Network density and cross-linking affect performance and response in the body.
End-use environment: Considerations like exposure to fluids, enzymes, or physical stress guide design choices.
Testing Challenges: Not Just Any Protocol Will Do
One of the standout points in the webinar will be the unique testing and characterization challenges posed by hydrogels. Standard tests designed for hard plastics or metals often fall short when used on soft, dynamic materials like hydrogels. Dr. Braithwaite will highlight several critical areas:
Fatigue testing: Hydrogels experience wear in very different ways than rigid materials.
Thermal aging: Their water-rich nature means temperature changes can alter properties considerably.
Biocompatibility: Absorption of aqueous solvents and expulsion of water from the hydrogel in non-polar solvents can make assessment of biological safety challenging.
Testing protocols must be adapted or reinvented to accurately assess the safety and longevity of hydrogel devices.
The Regulatory Maze for Hydrogel Devices
The regulatory landscape is another domain where hydrogels face unique obstacles. Many established standards were originally developed for rigid materials and can present mismatched requirements for hydrogels. Dr. Braithwaite will explain:
Legacy tests may not be “fit for purpose” for soft materials.
Evolving standards: Developers sometimes need to work with regulators to establish new or modified test methods for hydrogels.
Impact on innovation: These regulatory complexities can slow development and approval of innovative hydrogel-based devices.
Moving Forward: Balancing Opportunity and Challenge
Dr. Braithwaite’s session will emphasize both the potential of hydrogels, from mimicking real tissue to enabling next-generation therapies, and the hurdles that still slow their adoption. From the chemistry bench to regulatory filings, every step demands careful consideration and sometimes, entirely new approaches.
Key Takeaways:
Hydrogels are reshaping how we replicate and repair human tissue in medicine.
Material selection requires a careful balance of chemistry, structure, and intended use.
Standard testing and regulations often need significant adaptation for these polymers.
Close collaboration with regulatory bodies is crucial for successful device approval.
Mark your calendar for Wednesday, August 13 at 2 p.m. For anyone interested in the intersection of materials science and medical innovation, this webinar is your opportunity to learn how hydrogels are shaping the future of medical devices and what it takes to bring new hydrogel-based solutions to market. Reserve your spot today!
While we’ve previously celebrated the kitschy charm of plastic flamingos, today we turn our attention to the remarkable living birds and the science behind their mesmerizing feeding behaviors. With their beaks and most of their heads submerged near their feet, the birds stomp their feet in a rhythmic manner while chattering their beaks. But what exactly are they doing beneath the surface?
Unlocking the Flamingo’s Secret Techniques
Driven by curiosity, Víctor Ortega-Jiménez from the University of Maine, alongside collaborators from Georgia Tech and Kennesaw State University, decided to find out. Using detailed, 3D-printed models of flamingo heads, the team recreated and analyzed the birds’ signature feeding actions. Their findings, published in the Proceedings of the National Academy of Sciences (PNAS) in May 2025, finally unveiled the sophisticated strategies flamingos use to feed—movements that have captivated both bird enthusiasts and scientists for years.
The Dance That Drives Dinner
Flamingos perform a sort of underwater ballet: spinning and stomping their webbed feet in circles, stirring up the muck below. Far from random, this “wading dance” is a carefully choreographed routine designed to conjure swirling currents—vortices—that lift shrimp and other tiny morsels from the lakebed. The circular motion funnels these snacks into the water column, right where the flamingo’s beak can reach them.
Beak Work: Precision and Power
With their heads submerged, flamingos rapidly chatter their beaks up to a dozen times per second while their tongues pulse in sync. This rapid-fire action generates suction and whirlpools, channeling food particles toward the beak’s tip. As flamingos sweep their beaks backwards, these miniature vortices gather prey, making each mouthful more efficient.
The Grand Finale: The Head Lift
Every so often, flamingos abruptly lift their heads, creating a final swirl of water that draws even more food upward. This dynamic combination of footwork, beak action, and sudden head movements transforms the flamingo into an active predator, not just a passive filter feeder. Every part of their anatomy—from flexible feet to uniquely shaped beaks—works in concert to manipulate water and maximize their feeding success. These birds have studied and mastered complex chaotic fluid mechanic predictions, something that engineers sweat in their final years of undergraduate degrees.
Inspiration for Technology
The lessons learned from flamingo feeding could spark innovations in water filtration, microplastic collection, and aquatic robotics. By mimicking how flamingos harness fluid dynamics, engineers might develop new ways to capture tiny particles from water, offering nature-inspired solutions to modern challenges.
See Flamingos in Action
For those eager to witness these pink mathematicians at work, check out the videos and supplementary materials in the PNAS journal article.
Tentative Identifications in Medical Device Chemical Characterization
Analytical chemical characterization and toxicological risk assessment are essential for evaluating the risk posed by chemicals that may be present in medical devices. As detailed by ISO10993-17 and ISO 10993-18, this process can support the biological safety of a device through assessment of the toxicological risk of extractables and leachables.
The Role of Mass Spectral Expertise in Identification
In practice, the burden of identification of these chemicals relies heavily on mass spectrometry and the expertise of analytical chemists, without guidance from toxicologists. Confidence levels are assigned to each analyte based on the quality of the spectral data and the availability of reference standards. These confidence levels range from confirmed identifications to unknown, along with tentative or partial assignments, reflecting the real-world complexity of chemical analysis.
The Reality of Tentative Identifications
As highlighted in the recent article, “Unknown Confidence in Chemical Characterization Identification Levels: When Tentative Identifications Are Adequate for Toxicological Risk Assessment of Medical Devices,” are common: a review of approximately 600 chemical characterization reports from a range of laboratories, including manufacturer-operated analytical facilities and contract research organizations, found that about 43% of reported organic compounds were only tentatively identified. Although there has been a recent push for confirmed or confident identifications for toxicological risk assessment, ISO 10993-17 does not specify how to handle varying confidence levels. As such, through collaboration between toxicologists and chemists, a pragmatic approach that balances analytical rigor with practical constraints is possible.
Rather than evaluating every compound independently, the article highlights grouping chemicals with similar structures for toxicological risk assessment. This approach allows for efficient evaluation of potential hazards, even when full identification is not possible. To support this method, the authors developed a decision tree that encourages early communication between chemists and toxicologists and helps analysts determine when additional analytical information is needed to improve compound identification. This structured process ensures that the toxicological risk posed by all chemicals can be assessed appropriately, including those of higher risk that may require a more detailed investigation.
The article’s insights are informed by the expertise of co-author Rebecca (Becky) Bader, PhD, Director of Regulatory Services at Cambridge Polymer Group. With over 20 years of experience in polymeric materials, drug delivery, and analytical chemistry, Becky brings deep expertise from both industry and academia. Her leadership at CPG is instrumental in advancing analytical techniques and ensuring that chemical characterization studies meet the highest standards of scientific rigor and regulatory compliance.
Join Our Upcoming Webinar The Tightrope of Tentative IDs: Balancing Analytical Uncertainty with Toxicological Risk Assessment
July 9, 2025 | 2:00 PM EDT
Don’t miss this opportunity to dive deeper into balancing analytical uncertainty and toxicological risk! Study authors Becky Bader and Steph Street, a Senior Principal Toxicologist and Biocompatibility SME for Medtronic, will host a webinar discussing:
Regulatory expectations regarding compound identification and toxicological risk assessment
The grouping of chemical compounds, including those with tentative identifications, for toxicological risk assessment
Strategies for streaming lining the chemical characterization and toxicological risk assessment process
Case studies on collaborative chemist-toxicologist workflows
Cambridge Polymer Group specializes in comprehensive material and chemical characterization services, including extractables and leachables testing for medical devices. Our team, led by experts like Becky, leverages analytical instrumentation and deep knowledge of polymer science to:
Design and execute tailored extractables and leachables studies
Identification of unknowns for toxicological risk assessment
Provide clear, defensible reports for regulatory submission
Guide clients through the decision-making process, from data collection to risk assessment and regulatory strategy
Every medical device is unique, and our approach ensures that analytical methods and risk assessments are customized to your product’s specific materials, manufacturing processes, and intended use. Whether you need targeted testing or a comprehensive chemical risk assessment, CPG’s experience and expertise can help you navigate the evolving regulatory landscape and bring safe, effective devices to market.
The Food Additives Amendment to the Federal Food, Drug, and Cosmetic Act (FD&C Act) was established by Congress in 1958. In the Code of Federal Regulations, the rules that the FDA applies to food additives are spelled out in sections 21 CFR 170.3 and 170.30. A food additive is considered to be any substance that is intentionally added to food or may reasonably be expected to become a component of food, such as leachable components from packaging. These additives are required to be reviewed and approved by the FDA before the additives can be used in food products as part of a premarket approval process.
However, there are exceptions to this review requirement. If the substance is Generally Recognized by qualified experts As having been adequately shown to be Safe (GRAS) under the conditions of its intended use, the substance does not require FDA approval and is not considered a food additive. GRAS assessment can be performed through scientific analysis, or from safe historical consumption of the substance if it has been used in food prior to 1958.
The Self-Affirmation Pathway and Its Controversy
Since 2016, the FDA has operated a voluntary GRAS notification program. Under this system, any qualified individual can notify the FDA that a substance is not subject to the premarket approval process as it is considered GRAS. The FDA may not question the basis for the GRAS conclusion, or it may conclude that there is insufficient information to make a GRAS conclusion.
Although the FDA had a GRAS affirmation process in place around 1972, it was discontinued by 1997 due to lack of resources and was replaced with the notification process. The FDA maintains a GRAS database of notifications. The GRAS list, which is not comprehensive, is located in 21 CFR 182, 184, and 186.[1] Notably, the GRAS notification process is voluntary, and does not require either notification or affirmation from the FDA.
This self-affirmation pathway has been criticized as a “loophole,” enabling manufacturers to introduce new food ingredients without sufficient safety data or transparency. While the process allows for efficiency and rapid market entry, it also means that the FDA and consumers may be unaware of new substances in the food supply.
Proposed Changes in 2025
In March 2025, the Health and Human Services secretary directed the FDA to consider removing the self-affirmation process of the GRAS program.[2] Companies would need to publicly notify the FDA of their intended use of substances in food products, along with safety data, before they could go to market with the substances. This substantial change in legislation would require many companies to re-evaluate their safety data and may require retroactive approval from the FDA.
Current vs. Proposed GRAS Process
Aspect
Current GRAS Program
Proposed Changes (2025)
FDA Notification
Voluntary
Mandatory
Public Disclosure
Not required
Required
FDA Premarket Review
Not required
Required
Industry Burden
Lower
Higher
Transparency
Limited
Enhanced
Time to Market
Shorter
Longer
Implementing these changes will not be immediate. The FDA must conduct formal rulemaking, and because the GRAS exemption is written into federal law, Congressional action may be required. These steps could take years and may face industry resistance and legal challenges.
Establishing Safety Profiles for Food Additives
Deliberately Added Ingredients: Toxicological evaluation of the ingredients based on the chemistry and amount can assist in establishing the safety profile.
Inadvertent Additives (e.g., from Packaging): Inadvertent food additives may be introduced from materials contacting food products, including food processing equipment, containers, or food preparation surfaces. In these cases, substances may diffuse into the food from the contact materials, which are often plastic and may contain antioxidants, colorants, plasticizers, and other stabilizers. For these substances, migration testing needs to be performed using food simulants to assess the amount of substance that is anticipated to be incorporated into the food product. This testing is comparable to leachables/extraction testing performed for medical devices.
On May 6, 2025, the ASTM Workshop on the Characterization of Hydrogel Medical Devices brought together researchers and engineers to discuss current test methods for hydrogels in medical devices. Led by Stephen Spiegelberg of Cambridge Polymer Group, the workshop focused on current test methods, industry challenges, and the need for new standards.
Why Are ASTM Standards and Workshops Important?
ASTM standards play a crucial role in the medical device industry by:
Establishing best practices for testing methods for researchers, especially those new to the field.
Improving repeatability and accuracy across different laboratories.
Assisting regulatory agencies in verifying the quality and reliability of submitted data.
Providing companies with confidence that their test methods will withstand regulatory scrutiny.
ASTM workshops are designed to:
Share the latest understanding and best practices on the topic area within the industry.
Gather feedback from regulators on test methods to facilitate regulatory clearance.
Identify gaps in current testing methods and associated standards.
Establish task groups to develop new and improved standards.
Identifying Hydrogel Gaps and Needs in Hydrogel Characterization
A notable finding of the May 6th workshop was that only two relevant standards for hydrogel testing currently exist across ASTM, ISO, and USP. This lack of established guidance highlights a significant unmet need, especially as hydrogels are being used more often as structural components rather than just as coatings.
Development of animal models for safety and effectiveness testing
Evaluation of high-water-content hydrogels
Characterization of degradable and specialized hydrogels
Standardization Priorities
During a closing discussion led by co-chair Jon Moseley, participants identified several top priorities for new standards, with the development of a common terminology for hydrogels emerging as a particularly urgent need. Inconsistent language can create confusion among manufacturers, regulators, and end users, so establishing clear definitions is essential.
Other priorities for standardization include:
Friction measurements
Mechanical testing methods
Dynamic property assessment (rheology and DMA)
Accelerated aging protocols
Environmental conditioning
Chemical risk assessment, particularly regarding solvent selection
Mechanical testing and accelerated aging generated the most discussion, as they appear to be the most challenging currently. Chemical risk assessment was also a discussion, particularly with regards to solvent selection for chemical characterization. Task groups are being formed to address these topics, and participation from those with relevant experience is encouraged.
Looking Forward: Opportunities and Advice
For those new to hydrogels, it’s important to recognize that standard test methods for other polymers, such as thermoplastics, elastomers, and thermosets, may not be suitable due to hydrogels’ unique properties and greater batch-to-batch variability. As one participant aptly summarized,
“Hydrogels always find a way to mess with you.”
Manufacturing hydrogel devices presents ongoing challenges related to their compliance, temporal variability, and unique chemistries. As hydrogels are used in more advanced applications, such as degradable implants or piezoelectric devices, the need for robust, widely accepted testing standards will only grow. Regulatory requirements are currently quite stringent for hydrogels, particularly degradable ones, due in large part to lack of industry-wide experience with these materials.
Collaboration between experienced developers and regulatory agencies will be vital as new standards are developed. If you are interested in contributing to these efforts, please contact Cambridge Polymer Group at info@campoly.com. Stay tuned for further updates as the ASTM task groups work to advance hydrogel testing standards and support innovation in medical device development.
ASTM International will host the Workshop on the Characterization of Hydrogel Medical Products on May 6, 2025, in Toronto, Canada, during the spring meeting of the ASTM Committee F04 on Medical and Surgical Materials and Devices. This event brings together leading experts to discuss best practices, emerging analytical techniques, and the urgent need for standardized testing methods for hydrogels used in medical devices.
Workshop Focus and Objectives
Hydrogels are increasingly vital in medical applications, from regenerative medicine to implantable devices, due to their unique properties as water-swollen, three-dimensional polymer networks. However, the lack of standardized characterization protocols presents challenges for manufacturers, regulators, and researchers. The workshop aims to:
Review current analytical techniques for hydrogel characterization, including assessments of chemistry, morphology, mechanical properties, and in-use performance.
Identify critical gaps in existing ASTM standards and discuss the need for new or improved test methods, particularly those relevant to both implantable and non-implantable hydrogel medical products.
Foster collaboration among engineers, chemists, scientists, regulators, and industry stakeholders to advance the field and improve product safety and efficacy.
Who Should Attend
This workshop is designed for professionals involved in the development, testing, and regulation of hydrogel-based medical products, including:
Attendees are encouraged to participate in an open discussion at the conclusion of the workshop to help shape the future of hydrogel test standardization. This collaborative session will be instrumental in determining priorities for new ASTM standards and identifying opportunities for further research and interlaboratory studies
Workshop Co-Chairs
Stephen Spiegelberg, Cambridge Polymer Group
Jon Moseley (Retired)
Featured Speakers and Presentations
Speaker & Affiliation
Title
Becky Bader, Cambridge Polymer Group
Chemical Risk Analysis of Hydrogels
Barbara Boyen, Virginia Commonwealth University
Development of a Rat Model for Assessing Safety and Effectiveness of Hydrogels as Dural Sealants
Scott Epstein, Boston Scott Corporation
In Vitro Testing of a Very High Aqueous Content Structural Hydrogel Medical Device
Gavin Braithwaite & Becky Bader, Cambridge Polymer Group
Characterization of a Degradable Ocular Hydrogel Implant
William Koshut, R J Lee Group
Tensile Fatigue Testing of PVA Hydrogels
Liisa Kuhn, University of Connecticut Health Center
Update on ASTM F2900 - Hydrogels Used in Regenerative Medicine
Ikra Shuvo, Massachusetts Institute of Technology
Anti-Dehydration Hydrogels for Piezoelectric Ultrasound Devices
Ethan Schrodt, Andrew Short, J.M. Canty
Hydrogels and Microspheres - Online Size and Shape Control
Lawrence Anderson, Exponential Business and Technologies
Hydrogel Contact Lens Characterization Using Nanoindentation, Contact Angle, and Friction Measurements
Microplastics have become a pressing topic in environmental and health discussions, with increasing attention from the media and scientific community. These tiny plastic particles, typically defined as ranging in size from 1 micrometer to 5 millimeters, can be composed of various types of polymers and are now being detected in an array of consumer products. A recent study by Huang et al. (2025)[1] examined the presence of microplastics in intravenous (IV) infusion bags, a common component of medical treatment.
What Are IV Infusion Bags?
IV infusion bags are flexible containers designed to deliver aqueous solutions, such as drugs, electrolytes, or saline, directly into a patient’s bloodstream. Given their direct interaction with the body, the potential presence of microplastics in these containers may be of concern.
Key Findings from Huang et al.’s Study
Huang’s study focuses of two brands of saline IV bags made from polypropylene. The contents of these bags were filtered, and the researchers employed Raman spectroscopy, scanning electron microscopy (SEM), and optical microscopy to identify and quantify the particles in the filtrate. The Raman spectroscopy confirmed that the particles were polypropylene. Particle counts revealed concentrations between 7020-7900 particles per liter of saline, with the majority (68%) measuring between 1-10 micrometers, and an overall size range of 1-62 micrometers.
The study did not speculate on how these microplastics entered the IV bags.
Health Implications
The authors note that microplastics have previously been discovered in human blood and adjacent organs, including the lungs, liver, kidneys, and spleen. Scientists at Cambridge Polymer Group are actively engaged in identifying and quantifying microplastics in products and tissues and in a recent study, we have detected microplastics in multiple lung tissue samples. The health implications of these microplastics remain uncertain at this time.
Regulatory Standards for Particulates
According to USP Particulate Matter in Injections, the limits for particles exceeding 10 micrometers should not surpass 12,000/L and 2,000/L for particles greater than 25 micrometers in containers holding more than 100 ml of solution. For containers with less than 100 ml, the limits are set at 3,000 particles (>10 micrometers) and 300 particles (>25 micrometers) per container. While the concentrations of microplastics found in Huang’s study fall within these regulatory limits for larger particles (>10 micrometers), the sheer number of smaller particles raises questions about whether current standards adequately address this emerging issue.
What’s Next?
The detection of microplastics in IV infusion bags highlights a critical gap in our understanding of their potential health impacts. Further research is needed to explore:
How microplastics enter medical products during manufacturing or storage.
The long-term effects of introducing microplastics into the human body through medical treatments.
Whether existing regulatory standards should be updated to account for smaller particles.
As scientists continue to investigate this issue, healthcare providers and manufacturers must remain vigilant about minimizing contamination risks. In parallel, regulatory bodies may need to revisit particulate limits to ensure patient safety in light of emerging evidence on microplastics.
By shedding light on studies like Huang et al.’s, we can better understand and address this growing concern—ensuring that medical products meet the highest standards of safety and efficacy.
[1] Huang, T., et al. (2025). “MPs Entering Human Circulation through Infusions: A Significant Pathway and Health Concern.” Environment & Health. https://doi.org/10.1021/envhealth.4c00210
Companies regularly rely on third-party laboratory testing data to support regulatory medical device and pharmaceutical submissions, particularly when lacking in-house expertise or facilities. The credibility of these third party laboratories is crucial to regulatory success, but recent actions by the FDA highlight the risks associated with unvetted or noncompliant third party data.
Escalating FDA Scrutiny on Data Integrity
The FDA recently published warning letters to laboratories in China and India with concerns about fraudulent or unreliable testing data from these laboratories. One warning letter to a Chinese laboratory[1] concerned data from cytotoxicity and sensitization studies conducted on different dates with nearly identical results, raising suspicion that the data was not genuine. A series of letters released to an Indian laboratory in 2024 and 2025 notified pharmaceutical companies that any in vitro studies conducted by this laboratory for new drug applications and abbreviated new drug applications must be repeated at different study sites that do not have data integrity concerns.[2]
These warning letters reinforce a memo released from the FDA in February, 2024, warning medical device manufacturers to carefully examine data from third party laboratories to ensure the data is reliable.[3]
“The FDA has noted an increase in unreliable testing data generated by third-party testing facilities on behalf of device manufacturers and sponsors. This has resulted in the FDA being unable to reach a substantial equivalence determination or otherwise authorize marketing for medical devices whose submissions rely on such data.” — FDA Notification, March 2025[4]
Consequences for Manufacturers and Patients
This surge in data integrity issues has led the FDA to reject entire submissions, preventing the agency from reaching substantial equivalence determinations or authorizing marketing for affected medical devices. When the FDA cannot rely on submitted data, not only are sponsors forced to repeat costly studies, but patient access to new devices is also delayed, and supply chains may be disrupted.
Cambridge Polymer Group’s Commitment to Data Integrity
At Cambridge Polymer Group, we recognize the regulatory and reputational risks associated with unreliable data. Our protocols follow published standards, with calibrated, verified equipment, rigorous data checks, and comprehensive review processes. All raw and processed data, as well as equipment information, are available for client and regulatory inspection, ensuring transparency and readiness for regulatory review.
Conclusion
The FDA’s ongoing focus on data integrity makes it clear: the cost of unreliable third-party testing is high, with potential for regulatory setbacks, financial loss, and reputational harm. Selecting a transparent, compliant, and reliable laboratory partner is essential for successful regulatory submissions and for maintaining patient and market trust.
Traditional headlamps (worn above) are cumbersome and don’t accommodate face shields.
A groundbreaking surgical task light has been introduced by MezLight in collaboration with Syensqo[1], demonstrating a thoughtful approach to product design by considering key factors such as:
Customer needs
Sustainability concerns
Environmental durability
Material suitability
Addressing Customer Needs: Enhanced Usability and Safety
Traditional surgical task lights are typically worn as headlamps by surgeons (see image above), which can become uncomfortable and cumbersome during extended procedures. The new MezLight task features an adjustable arm allowing for precise positioning and eliminating the burden of a headlamp. This design also accommodates the use of face shields, thereby prioritizing both usability and safety for surgeons.
Sustainability: Built for Repeated Use
In terms of sustainability, the task light has been engineered to withstand repeated cleaning and sterilization through steam sterilization using an autoclave, successfully enduring over 100 autoclave cycles. This capability ensures a long lifetime of repeated cleaning cycles for the product. As a result, the light has been designed to be robust enough for mechanical positioning and adjustment during surgical procedures over many repeated uses.
Material Selection: Meeting Rigorous Medical Standards
To meet the stringent requirements for mechanical performance and sterilization, the design team chose Radel®, a polyphenylsulfone (PPSU) supplied by Syensqo. This material was selected based on its exceptional properties:
High heat deflection temperature of 207°C, ensuring stability under autoclave conditions and preventing deformation from the LED heat source.
Good hydrolytic stability, enabling it to withstand repeated exposure to high-temperature steam without degradation
Impact strength comparable to other durable plastics such as polycarbonate, ensuring mechanical integrity during use.
Radel® has also been historically used in surgical instrument handles and trays, proving its ability to endure multiple sterilization cycles.
A Model of Comprehensive Design
This surgical task light exemplifies the comprehensive considerations involved in material selection for medical products, while ensuring the fulfillment of customer needs. By addressing the unique challenges faced in surgical environments, this product not only meets the practical demands of healthcare professionals but also aligns with sustainability goals in medical device manufacturing.
