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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.

Every year on March 17th, we commemorate the invention of the rubber band, patented by Stephen Perry in 1845. This innovation followed Charles Goodyear's groundbreaking discovery in 1838 that adding sulfur to polyisoprene creates crosslinks, significantly enhancing its elastic properties. This breakthrough led to the development of rubber tires.

Composition of Rubber Bands

Rubber bands are traditionally made from polyisoprene, a polymeric elastomer derived from either the latex sap of rubber trees or petroleum products. They can also be made from ethylene propylene diene (EPDM) rubber and silicone. Polyisoprene rubber bands are prone to degradation, especially when exposed to sunlight, which causes them to become brittle over time. In contrast, silicone and EPDM rubber bands are more resistant to degradation.

Elastic Properties

Rubber bands are almost purely elastic, meaning they return to their original dimensions after being stretched and released without any permanent deformation. This elasticity is due to the crosslinks in the rubber that connect adjacent long polymer chains, forming a three-dimensional network. This process can be repeated multiple times without causing permanent deformation.

Thermal Dynamic Principles

In the mid-1800s, Lord Kelvin developed the theory of thermodynamics using rubber samples as examples of entropy principles. James Joule confirmed Kelvin's theory with experiments showing that rubber samples increase in temperature when stretched. Two key principles underlie the thermodynamics of rubber bands:

1. Internal Energy Independence. The internal energy $U$ of a rubber band is independent of its length L0L0, expressed as U=cL0TU=cL0T, where $T$ is the temperature and $c$ is a constant
2. Linear Tension Increases. The tension $\sigma$ of a rubber band increases linearly with its length, given by $\sigma =bT\Delta L$, where $b$ is another constant and $\Delta L$ is the change in length.

Kelvin described the thermodynamics of stretching a rubber band using the Helmholtz free energy ($A$) expression: $A=U-TS$, where $S$ is the entropy of the system. $A$ represents the total energy available to do work. The internal energy $U$ includes potential and kinetic energy, expressed as $U=Q-W$, where $Q$ is heat added to the system and $W$ is work done by the system. Heat transfer can be written as $dQ=TdS$, and work done on the rubber band as $dW=\sigma dL$. Rearranging these expressions yields $dF=\sigma dL-SdT$, where $dF$ is the change in free energy, $dL$ is the change in length, and $dT$ is the change in temperature.

The temperature change in a rubber band is given by $dT=dL(\sigma /S)-dF(1/S)$. When a rubber band is stretched ($dL$ positive), its temperature rises. Conversely, when it relaxes ($dL$ negative), its temperature falls. At points where the rubber band is held at a fixed distance, heat either dissipates into the environment or the environment warms the cooled rubber band.

Molecular Alignment and Entropy

On a polymeric level, stretching a rubber band aligns and orders its molecules, decreasing entropy. When the rubber band relaxes, the polymer chains also relax, increasing entropy again.

Experimenting with Thermodynamics

You can easily demonstrate these principles by lightly placing a rubber band against your lips, which are sensitive to temperature, and moderately stretching it. You should feel a temperature rise. When the rubber band is relaxed, a cooling sensation should be noticeable. This simple experiment illustrates the effects of microscopic molecular motion. 

Remember to wear safety glasses when conducting this test.

Over the February 15-16, 2025 weekend, the new U.S. administration laid off a substantial number of FDA reviewers from the Center for Device and Radiological Health (CDRH), the branch that reviews the safety and efficacy of new medical devices, including hip and knee implants, cardiovascular and respiratory devices, ophthalmological treatments, wound care, and thousands of other types of medical devices.

MDUFA Commitments and Funding Concerns

The Medical Device User Fee Amendments (MDUFA) program, funded by fees from medical device companies, was established to ensure timely and thorough reviews of new medical devices. Many of the laid-off employees were hired specifically to fulfill MDUFA commitments. This raises questions about:

• Resource allocation: How will the FDA maintain its review capacity with reduced staff?
• Financial implications: Given that user fees largely cover reviewer costs, the rationale behind these layoffs in terms of government spending remains unclear.

Potential Consequences of FDA Layoffs

Review Process Challenges

The reduction in the reviewer workforce is likely to have several immediate effects:

• Delayed reviews: Fewer reviewers may lead to longer wait times for device approvals.
• Compromised quality: The scientific rigor of reviews may be affected due to the increased workload on remaining staff.

Expertise Gaps

The layoffs have created critical gaps in specialized knowledge:

• AI expertise shortage: The layoffs also included reviewers with specialization in artificial intelligence. Given the trend towards incorporating AI into medical data interpretation and hardware responses, reviewers with this expertise are particularly needed at this time.
• Respiratory device oversight: The dismissal of half the subject matter experts in respiratory devices is alarming, especially given recent issues in this area.

Industry and Patient Impact

The FDA's ability to advance regulatory science and facilitate medical device innovation may be compromised, potentially affecting the United States' leadership position in the field.

The loss of experienced reviewers is likely to have far-reaching consequences:

• Medical device companies: May face longer approval timelines and increased uncertainty.
• Healthcare providers: Could experience delays in accessing new medical technologies.
• Patients: May face potential safety risks and delayed access to innovative treatments.

As the situation continues to evolve, medical device companies, healthcare providers, and patients should stay informed about potential impacts on device approvals and safety monitoring. We will continue to monitor the situation and advise our clients as we can.

Blood vessel with hemostatic agent 

In the world of material science and product design, understanding and measuring rapid rheological transitions is crucial. These transitions, which can be triggered by various stimuli such as UV light, electrical fields, or chemical interactions, play a significant role in applications ranging from hemostatic agents to 3D printing materials. While standard methods exist for common applications, less conventional scenarios often lack specialized tools for accurate measurement.

The Challenge of Rapid Rheology Transitions

Conventional methods for measuring rapid rheological changes often face limitations:

1. Large sample volume requirements
2. Inability to capture transitions faster than one second
3. Lack of quantitative accuracy for rapid changes

For instance, the stir bar stop method, while useful for qualitative ranking, falls short in providing precise measurements for transitions occurring in less than a second.

Stir bar stop method typically used as a qualitative metric to measure near rapid rheological transitions. Example shown for crosslinking. Time accuracy is only as good as the human pressing the start/stop button on a stopwatch.

A Novel Approach: Custom Vane and Baffled Cup Geometry

To address these challenges, an innovative method was developed using a custom-designed vane and baffled cup geometry. This approach offers several advantages:

• Reduced sample volume: Only 6 mL required, compared to ~20 mL for standard vane accessories
• Rapid mixing capability: High-speed rotation ensures near-instantaneous mixing
• Precise measurement: Captures transitions within seconds of stimulus application

Experimental Setup and Calibration

CAD sketch of custom vane (left) and custom baffled cup (middle). Machined vane and 3D printed baffled cup assembly (right).

The custom setup consists of:

1. A TA Instruments DHR-2 rheometer
2. A 3D-printed baffled cup
3. A CNC-machined aluminum vane fixture

Due to the smaller-than-recommended gap, the geometry required calibration using both concentric cylinder and parallel plate analogies to determine accurate stress and strain factors.

Measuring Rapid Absorption Kinetics

The method was applied to measure the absorption kinetics of a powder absorbent in a liquid "spill":

1. The vane rotates rapidly in the liquid
2. Powder absorbent is added to the cup
3. Torque is monitored until a threshold is reached
4. The test switches to oscillatory mode to measure slurry modulus

Results and Implications

Powder absorbent added to liquid “spill.” Blue curve from the initial mix step: powder added at ~3.7 seconds, mixed rapidly for ~0.5 seconds until a predetermined torque threshold was surpassed indicating the slurry was sufficiently mixed. Red (G’) and green (G”) curves: modulus growth kinetics shows crossover within ~1.8 seconds after addition of powder and full absorbency within 17.9 seconds from addition of powder.

The custom method yielded impressive results:

• Crossover time: 1.79 seconds after powder addition
• Full absorbency: Achieved within 17.85 seconds

These precise measurements provide valuable insights into the rapid rheological changes occurring in the absorbent material system.

Conclusion

This novel approach to quantifying rapid rheological changes offers a powerful tool for material scientists and product designers. By overcoming the limitations of conventional methods, it enables more accurate and detailed analysis of fast-acting materials, potentially leading to improved designs in various applications, from spill cleanup to medical treatments. The ability to capture such rapid transitions with minimal sample volumes opens new possibilities for research and development in fields where material behavior in the first few seconds is critical. As we continue to push the boundaries of material science, tools like this will play an increasingly important role in understanding and optimizing rapid rheological phenomena.

 

Read the full application note.

 

Medical device development relies heavily on standards to ensure patient safety, efficacy, and regulatory compliance. Organizations such as ASTM, AAMI/ISO, and USP establish critical test methods to ensure adequate cleaning and sterility, mechanical performance, biocompatibility, and material integrity. These standards streamline innovation while safeguarding patients, reducing redundant testing, and maintaining U.S. competitiveness in global markets.

The FDA’s Critical Role in Standards Development

For decades, FDA scientists and regulators have been active participants in shaping these medical device standards and often hold leadership roles on individual standards or committees. Their direct experience with reviewing ~20,000 medical device submissions per year renders their input invaluable on both the types of standards needed and the specific content needed within those standards. Because biomedical technology is advancing rapidly, particularly in design innovation and material selection, it is critical to patient safety that standards keep pace. Up-to-date standards not only protect patients but also benefit U.S. companies by streamlining the regulatory process. With well-defined, current standards, US manufacturers can focus on conducting only the studies necessary for patient safety, and avoid unnecessary, costly and time-consuming testing that would put them at a disadvantage in the global market.

Executive Order Freezes Communication and Participation in Standards Development

A chair of an AAMI working group announced last week that the FDA will be pulling away from communication and participation in standards development within AAMI and ISO as a result of a January 20, 2025 executive order from the White House. Other FDA scientists confirmed the freeze applies to all regulatory activities, including their ASTM participation. The freeze is not a permanent cessation of standard development activities, but no timeline has been given.

Risks of Reduced FDA Participation

Without FDA’s frontline regulatory experience, standards may lag behind medical device advancements, in areas such as AI-driven devices, nanotechnology, and biocompatible materials. Outdated standards could fail to address emerging risks, including cybersecurity vulnerabilities in connected devices or novel biomaterial interactions. U.S. manufacturers may face redundant testing to meet divergent global standards, increasing costs and time-to-market compared to international competitors.

If the freeze becomes permanent, the lack of FDA participation in standards development is likely to increase the regulatory and development burden, and therefore increase costs on American medical device manufacturers, causing delays to get products on the market and potentially put patients at risk. We sincerely hope that the new administration permits continued involvement of FDA personnel in the standards process.