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 Outdated standards could fail to address emerging risks, including cybersecurity vulnerabilities in connected devices or novel biomaterial interactions.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.
NAMSA, a medical device contract research organization, announced last week the acquisition of the US medical device testing operations of WuXi AppTec, a biopharmaceutical and medical device testing laboratory headquartered in China. This acquisition is part of a recent trend of acquisitions of medical device testing laboratories by larger multinational testing conglomerates over the past few years. This trend, predicted to continue, results in larger, consolidated operations with higher volumes and the ability to offer routine standardized testing on complex projects. However, it comes with a cost.
Challenges in Biological Safety Evaluation
Evaluation of the biological safety of medical devices with compliance to new standards and revisions of existing standards has become increasingly challenging. Given the shift in regulatory expectations, along with an increase in the use of unique materials and manufacturing processes, each premarket submission often requires a custom-designed strategy for assessing biological safety that takes in to account the details of the device’s indication and composition. This approach dictates constant communication between engineers and regulatory affairs specialists at the medical device manufacturer, the research lab conducting the biological endpoint and chemical characterization testing, and the toxicologists and biologicals safety specialists conducting the biological evaluation and making a final determination on safety.
CPG’s Collaborative Approach to BSE
Material scientist and biocompatibility specialists at Cambridge Polymer Group work directly with the client through the submission process to ensure a successful outcome with regards to evaluation of the biological safety of the device. Although communication often begins with a conversation between a single engineer at a medical device company and a scientist at CPG, CPG in-house experts often become part of the cross-functional team that is necessary to effectively address FDA feedback. As needed, CPG can also rapidly bring in additional external expertise to further support the submission process.
The customer-driven, interactive approach offered by CPG has resulted in a high success rate with premarket submissions. Ultimately, the support offered by in-house experts at CPG, along with external partners to CPG, can reduce the timeline and overall cost for bringing a medical device to market. Turnkey contracts for biological safety evaluation may increase the risk that the premarket submission does not meet current regulatory expectations.
The recent announcement of INEOS’s decision to permanently close its ABS (acrylonitrile butadiene styrene) production facility in Addyston, Ohio, has sent ripples through the medical device manufacturing industry. This closure, set to begin in the second quarter of 2025, will significantly impact manufacturers who rely on ABS plastics for various medical applications. The situation calls for a comprehensive strategy to address supply chain challenges and regulatory requirements.
Understanding ABS and Its Applications in Medical Devices
ABS is a versatile thermoplastic polymer widely used in the medical device industry due to its durability, chemical resistance, ease of processing, and biocompatibility. Applications include:
Diagnostic equipment housings, including imaging machines and laboratory instruments
Drug delivery devices, such as nebulizers, auto-injectors, and portable drug delivery systems
Intravenous Access Devices, including components of IV connectors and luers
Respiratory care devices, such as ventilator valves, medical masks, and tracheal tubes
Non-absorbable sutures and tendon prostheses
ABS can be sterilized using methods like ethylene oxide gas, gamma radiation, or steam. The material can be easily colored and shaped to meet specific design requirements.
Challenges for Medical Device Manufacturers: Supply Chain Disruptions
The closure of the Addyston facility may lead to potential shortages and longer lead times for ABS materials. Manufacturers will need to diversify their supplier base and potentially look for alternative sources.
Cost Implications: A change in the ABS supplier could result in ship holds during qualification of a new supplier, resulting in a loss of profit from medical device sales. Further, the supplier change could impact material costs, potentially affecting the cost of medical devices.
Quality and Regulatory Concerns: ABS from new suppliers will need to be qualified to ensure that safety and effectiveness have not been impacted.
Innovation Pressure: This situation may accelerate the exploration of alternative materials to reduce dependency on traditional ABS.
Specific Healthcare Manufacturing Aspects
Drug Delivery Systems. Impact: Potential redesign of portable drug delivery devices and auto-injectors
Diagnostic Equipment. Impact: Possible delays in production of imaging machine housings and laboratory instruments
Respiratory Care. Impact: Potential shortages of components for ventilators and other respiratory devices
Surgical Instruments. Impact: Possible delays in production of certain non-absorbable sutures and prostheses
In each of these areas, the challenge will be maintaining biocompatibility and device specifications with new materials.
Regulatory Challenges
Qualifying new ABS suppliers involves navigating complex regulatory pathways, which vary based on the device’s risk classification. For 510K cleared devices, a supplier change can be documented with a letter to file that confirms verification with the new material or, if the new material impacts safety or effectiveness, in a new 510(k) submission. For PMA cleared devices, a supplier change can be documented in the annual report or, if the new material impacts safety or device effectiveness, in a PMA supplement.
How CPG Can Help
CPG can assist medical device manufacturers in developing a tailored regulatory strategy for qualifying new ABS suppliers. This strategy will consider:
Supplier Qualification Process: Developing criteria for selecting and evaluating new ABS suppliers based on FDA expectations, as well as REACH, RoHS, Prop-65, and MDR compliance.
Testing Protocol Development: Designing and implementing necessary tests to qualify ABS to ensure safety and effectiveness of the device have not been impacted.
Regulatory Documentation Preparation: Assistance in preparing documentation that support the continued safety and effectiveness of the device, including biological risks assessments, memos, and letters to file. If necessary due to a change in safety or effectiveness, CPG can also assist in the preparation of new 510(k) submissions and PMA supplements.
By leveraging CPG’s services, medical device manufacturers can navigate this supply chain challenge efficiently, minimizing disruptions to their production and market access while maintaining regulatory compliance. Collaboration between manufacturers, regulators, and material scientists will be crucial to maintain the quality and availability of essential medical products.
Please note that our lab will be closed on the following dates to allow our team to enjoy the holidays:
December 24 – 25 (Christmas Eve & Day)
December 31 – January 1 (New Year’s Eve & Day)
We will resume normal business hours on January 2nd, ready to tackle your new materials challenges in the coming year.
If you have any questions or need assistance on existing quotes or projects, feel free to reach out by email or contacting us at 617-629-4400.
Additionally, if you have any new consulting or testing needs, we would be happy to discuss how we can assist you.
We are truly grateful for your partnership and look forward to providing you with game-changing material science consulting and testing in 2025 and beyond.
ASTM recently published a new version of F2459 “Standard Test Method for Extracting Residue from Medical Components and Quantifying via Gravimetric Analysis.” This updated standard expands its scope beyond metallic implants to include ceramic and polymeric medical devices.
Key Updates and Applications
Expanded Scope: The standard now covers residue assessment for metallic, ceramic, and polymeric medical devices.
Cleanliness Assessment: It serves as a high-level evaluation method for medical device cleanliness.
Additive Manufacturing: The standard provides a basis for preparing extracts for particulate residue assessment in additive manufacturing standards.
FDA Recognition: The FDA recognizes this standard for quality assessment of medical device manufacturing facilities.
Significance and Contributions
The standard identifies two techniques to quantify extractable residue on medical components.
It allows investigators to compare relative levels of component cleanliness.
The method’s applicability has been demonstrated through numerous literature reports.
Impact on the Medical Device Industry
The expansion of ASTM F2459 to include ceramic and polymeric medical devices is a significant development for the industry. As medical technology advances, the materials used in device manufacturing have diversified, necessitating more comprehensive testing methods. This update ensures that a wider range of medical devices can be assessed for cleanliness using a standardized approach.
Benefits for Manufacturers
Consistency: Provides a uniform method for cleanliness assessment across different material types.
Quality Assurance: Helps manufacturers maintain high standards of cleanliness in their production processes.
Regulatory Compliance: Aligns with FDA expectations, potentially streamlining the approval process.
Implications for Patient Safety
The enhanced standard contributes to patient safety by:
Ensuring more thorough cleanliness assessments for a broader range of medical devices.
Reducing the risk of contamination-related complications in patients.
Promoting confidence in the safety and quality of medical devices.
The Role of Gravimetric Analysis
Gravimetric analysis, the core technique in ASTM F2459, involves precise weighing of residues extracted from medical components. This method:
Provides quantitative data on the amount of extractable residue.
Is highly sensitive, capable of detecting minute amounts of contaminants.
Offers reproducible results, crucial for quality control and regulatory compliance.
Future Directions
As the medical device industry continues to evolve, particularly with the rise of additive manufacturing and novel biomaterials, standards like ASTM F2459 will likely undergo further changes. Areas of potential future development include:
Integration with other analytical techniques for more comprehensive residue characterization.
Adaptation to emerging manufacturing technologies and materials.
Enhanced protocols for specific types of medical devices or materials.
Scientists from Cambridge Polymer Group contributed to the revisions of this standard and regularly conduct this test. Our involvement underscores the collaborative nature of standards development, bringing together expertise from industry, academia, and regulatory bodies.
This update reflects the evolving needs of the medical device industry, particularly in light of new manufacturing technologies like additive manufacturing. As the industry continues to innovate, the importance of robust, adaptable standards like ASTM F2459 becomes increasingly critical in ensuring the safety and efficacy of medical devices.
Polymer deformulation typically involves multiple tests to identify the type of polymer, assess the presence of potential blended polymers, and evaluate the incorporation of additives such as colorants, stabilizers, and processing aids. An elegant and more rapid alternative involves a form of pyrolysis gas chromatography mass spectrometry.
During pyrolysis, polymeric materials are rapidly heated to above their thermal decomposition temperatures such that covalent bonds are broken and rearranged. The resultant smaller fragments (pyrolyzates) are then separated using gas chromatography-mass spectrometry (GC-MS). Through identification of the pyrolyzates, the original polymer can be identified.
Challenges in Polymer Identification
Often, the pyrogram of a pyrolyzed polymeric material will contain peaks that do not originate from the polymer itself but instead can be traced back to:
Volatile or semi-volatile residual solvents
Monomers
Contaminants
Additives
These additional peaks can make accurate identification of the base resin more challenging and, likewise, identification of these peaks can be complicated by interference from the pyrolyzates. Although these compounds can be removed by an extraction process prior to pyrolysis GC-MS to separately characterize the volatile/semi-volatile compounds and identify the polymer, this approach can be unnecessarily burdensome.
Multi-Step Pyrolysis GC-MS
As an alternative approach towards characterization of both additives and the base resin, polymers can be subjected to multi-step pyrolysis GC-MS. Materials are initially heated to a temperature below the thermal decomposition temperature that allows for volatile and semi-volatile compounds to be thermally desorbed prior to pyrolysis. These compounds can then be identified and evaluated separately from the pyrolyzates of the base resin. The identity of the base resin can then be determined by heating the same sample to a temperature above the decomposition temperature. In sum, multi-step pyrolysis GC-MS can be used to evaluate the additive package and base resin of a polymeric material with only a small sample and no preparation beyond transferring the material to a quartz pyrolysis tube.
As an example of the utility of multi-step pyrolysis GC-MS, polypropylene often contains antistatic agents, slip agents, sterically hindered phenol antioxidants, and UV-absorbers. These compounds could potentially be obscured by the pyrogram that is typically associated with polypropylene pyrolysis. However, by using the multi-step approach, many of the contaminants, antioxidants, and UV-absorbers can be identified prior to pyrolysis. As shown below, thermal desorption of polypropylene at 350 °C yielded a sterically hindered phenol antioxidant, as well as a hexaethylene glycol, which likely is a functional group of a higher molecular weight slip additive. Pyrolysis of the same sample at 800 °C yielded a pattern of 1-alkenes consistent with polypropylene.
On November 6, 2024, the FDA held a workshop to discuss the potential expansion of the Accreditation Scheme for Conformity Assessment (ASCA) program to include chemical characterization per ISO 10993-18. This expansion would build upon the current ASCA program, which primarily covers select biological endpoint tests according to ISO 10993. Because the FDA has already reviewed and approved the test methods by accredited laboratories, the ASCA program is intended to reduce additional information (AI) requests and FDA reviewer time.
Morning Session
Industry stakeholders spoke about extractables and leachables (E/L) testing approaches.
Discussion focused on proficiency testing and the coverage map provided by surrogate compounds.
FDA shared results from a recent round robin E/L study involving eight laboratories.
Afternoon Session
Focused on the potential scope of an expanded ASCA program.
Outlined proposed accreditation process for laboratories.
Proposed ASCA Accreditation Process
External accreditation to ISO 10993-18, such as ISO 17025
Submission of E/L testing protocols to FDA, including:
Extraction procedures
Equipment setup and verification
Sample testing
Data analysis
Provision of personnel training evidence
If the FDA accredits a laboratory, reports can be summaries of procedures and results, with less FDA scrutiny. Challenging devices (e.g., hydrogels, degradables) that may require unique testing methods would fall outside of the ASCA accreditation program.
Key Discussion Points
The FDA sought input on various aspects of ISO 10993-18 testing, including:
Test article preparation methods
Use of response factor databases
Selection of surrogate compounds for semi-quantitation
Identification confidence criteria
Attendees, including Dr. Becky Bader and Dr. Stephen Spiegelberg from Cambridge Polymer Group, participated in the Q&A session and plan to provide additional written feedback.
Next Steps
The FDA will review workshop discussions and subsequent written feedback as they consider the potential expansion of the ASCA program. The agency will post responses to the questions raised during the workshop as they continue to evaluate this expansion.
This workshop represents another step in the ongoing dialogue between the FDA and industry stakeholders regarding chemical characterization testing for medical devices. The potential expansion of the ASCA program could have significant implications for both testing laboratories and device manufacturers.
At Cambridge Polymer Group, we are constantly pushing the boundaries of polymer science to develop innovative solutions for our clients. Our recent advancement in hydrogel technology aims to enhance surgical training by offering realistic tissue phantoms that more closely mimic the behavior of human tissue during electrosurgical procedures.
The Challenge: Realistic Tissue Simulation
As the medical device industry moves away from animal and cadaveric testing, there is a growing need for synthetic tissue models that can replicate the nuanced responses of human organs. While many commercially available phantoms may look realistic, they often fall short in simulating crucial aspects of tissue behavior during surgical interventions.
One of our clients approached us with a specific challenge: developing a synthetic tissue phantom that could char and smoke realistically during electrosurgical procedures, just like natural tissue. This behavior is critical for effective surgical training, especially when using high-energy intervention devices like electrocautery or radiofrequency ablation tools.
Our Solution: The “e-tissue” Hydrogel
Drawing inspiration from the Maillard reaction, the chemical process responsible for food browning, Research Scientist Joseph White and his CPG team developed a novel “e-tissue” hydrogel formulation. This innovative material not only provides a realistic tactile feel but also responds to electrical energy in a manner consistent with natural tissue.
Key features of our e-tissue hydrogel:
Chars and produces smoke under bipolar and monopolar electrosurgical intervention
Cuts realistically during electrosurgical procedures
Offers appropriate electrical conductivity and thermal decomposition properties
Provides a tactile feel similar to natural tissue
Putting e-tissue to the Test
To demonstrate the effectiveness of our e-tissue hydrogel, we conducted comparative tests using chicken heart tissue (a common surrogate for human tissue in surgical training) and our synthetic models. The results were notable:
Both translucent and red-colored e-tissue options produced char and smoke during bipolar electrocautery, closely mimicking the behavior of the chicken heart tissue.
When cast into specific anatomical shapes (such as a papilla), the e-tissue model charred and smoked realistically under monopolar electrocautery during simulated sphincterotomy training.
Implications for Surgical Training and Medical Device Development
Our e-tissue hydrogel opens new possibilities for surgical training and medical device testing:
Enhanced realism: Trainees can experience tissue responses that closely match real-life scenarios, improving the quality of their training.
Ethical considerations: Reduced reliance on animal and cadaveric tissue for training and testing.
Consistency and repeatability: Unlike natural tissue with its short shelf life, our synthetic models offer stable and consistent properties for repeated use.
Customization potential: The hydrogel can be tailored to mimic specific tissue types or anatomical structures.
The Future of Synthetic Tissue Models
At Cambridge Polymer Group, we are committed to advancing the field of synthetic tissue modeling. Our expertise in hydrogel chemistry, materials science, and custom test design positions us uniquely to develop application-specific tissue phantoms for a wide range of medical applications.
Whether you are looking to create surgical training tools, test beds for new medical devices, or marketing demonstrators, our team is ready to help you bring your vision to life. Contact us today to learn more about how our custom tissue model services can benefit your organization.
California, known for its progressive stance on environmental and health issues, is once again at the forefront of regulatory change. On September 25, 2024, California Governor Gavin Newsom signed the Toxic-Free Medical Devices Act (AB 2300) into law. The legislation prohibits the use of certain ortho-phthalates, specifically di-(2-ethylhexyl) phthalate (DEHP), in intravenous (IV) solution containers and tubing products.
What Are Phthalates?
Phthalates are a group of chemicals used to make plastics, primarily polyvinyl chloride (PVC),more flexible and durable. These additives are commonly found in various medical products, including medical devices such as IV bags, tubing, and catheters. They have also been used more broadly in industries ranging from toys to tools, although legislation is generally already in place outside of medical devices. In some cases, these compounds can be present at greater than 30% of the mass of the material.
Toxic Free Medical Devices Act – California AB 2300
California’s ban on phthalates in medical devices stems from growing concerns about their potential health risks. Phthalates are known endocrine disruptors and have been linked to various health issues, including reproductive problems and developmental disorders.
The ban on intentionally added DEHP will take effect on January 1, 2030, for IV containers, and January 1, 2035, for IV tubing. This legislation aligns with similar restrictions in the European Union. It is important to note that unintentionally added DEHP may still be present in quantities at or below 0.1% weight per weight (w/w).
The legislation exempts certain medical devices, including:
Human blood collection and storage bags
Apheresis and cell therapy blood kits and bags, including integral tubing
DEHP’s unique properties are considered necessary for improved red blood cell quality and stability. In the case of blood storage, changing materials is not so straightforward because DEHP acts to stabilize the blood and improve the quality of the stored blood, a phenomenon that is still not well understood.
Implications for the Medical Device Industry
Regulatory Compliance
The California medical device phthalate ban will require some manufacturers to reformulate their products, potentially leading to significant changes in production processes and materials used, including:
Reviewing and updating product portfolios to identify all items containing DEHP
Developing and implementing plans to phase out DEHP-containing products
Ensuring compliance with new regulations across the supply chain
Updating documentation and labeling to reflect changes in material composition
Supply Chain Adjustments
The new legislation will necessitate changes throughout the supply chain, including:
Sourcing new raw materials and components
Qualifying new suppliers who can provide phthalate-free alternatives
Potentially relocating or modifying manufacturing facilities
Updating inventory management systems to track and phase out DEHP-containing products
Innovation and R&D
Manufacturers will need to innovate and develop alternative materials that can provide the same functionality as phthalates without the associated health risks. This involves:
Investing in research and development of new plasticizers and materials
Collaborating with material scientists and chemical engineers to find suitable alternatives
Conducting extensive testing to ensure new materials meet performance and safety standards
Potentially redesigning products to accommodate new materials
Developing and validating new analytical methods for detecting phthalates
Implementing more stringent quality control measures throughout the manufacturing process
Conducting regular audits and testing of raw materials and finished products
Training staff on new testing procedures and regulatory requirements
Global Impact and Market Dynamics
While specific to California, it is part of a growing trend to phase out phthalates in medical devices. Although currently the FDA does not prohibit the use of these compounds in medical devices, the California legislation increases pressures on US manufacturers to phase out these materials, and increasingly aligns with EU proposals. This may result in:
Pressure on manufacturers to adopt phthalate-free alternatives globally
Changes in competitive landscape as companies adapt at different rates
Potential for early adopters to gain market share in regions with stricter regulations
Increased scrutiny of phthalates in medical devices by regulatory bodies worldwide
Challenges and Opportunities
The ban presents both challenges and opportunities for the medical device industry. Initially, there may be increased costs associated with research, development, and retooling of production lines. However, this could lead to more sustainable and safer products in the long run.
By eliminating potentially harmful chemicals from medical devices, manufacturers can boost consumer confidence and potentially gain a competitive edge in the market. Medical device manufacturers should start exploring alternative materials and testing methodologies to ensure compliance with new regulations.
The California ban on phthalates in medical devices represents a significant step towards safer healthcare products. As the regulatory landscape continues to evolve, adaptability and a commitment to safety will be key for success in the medical device industry.
How Cambridge Polymer Group Can Help
As experts in polymer science and material selection, Cambridge Polymer Group is well-positioned to assist companies in navigating these changes.
Material Selection
In addition to regulatory considerations, the choice of starting material must be driven by the anticipated end-use. Our team provides holistic thinking on material selection, considering factors such as downstream sterilization techniques that often dictate upstream material choices. We begin by obtaining a detailed description of your target application, including the expected environment, intended lifespan, and any specific material properties required.
We can help you evaluate potential alternatives that satisfy both California and EU requirements. Our approach considers not only the engineering and performance aspects but also biological safety and material regulatory trends. We assemble a list of candidate materials, filter them based on your specific needs, and can perform custom tests relevant to your application.
Chemical Characterization
Our state-of-the-art instrumentation and experienced scientists can perform extractables and leachables studies, identify and quantify chemical constituents, and evaluate potential degradation products. We use techniques such as Q-TOF, GC-MS, LC-MS, FTIR, and NMR to provide detailed chemical profiles of materials. Our testing protocols are designed to meet regulatory requirements and industry standards, ensuring thorough characterization of your device materials.
Toxicological Risk Assessment
To provide comprehensive support to our clients, Cambridge Polymer Group has partnered with Gradient, a leading environmental and risk sciences consulting firm. This collaboration allows us to offer expert toxicological risk assessment services for medical devices. Gradient’s board-certified toxicologists (DABTs) bring decades of in-house experience at medical device companies. They have a strong track record in helping clients achieve regulatory approval and address inquiries from US FDA and European Union (EU) notified bodies.
Biological Evaluation Plan
Our team at Cambridge Polymer Group can conduct biological risk assessments for medical devices in accordance with ISO 10993 standards. We evaluate the biocompatibility of materials, assess potential biological hazards, and determine the overall biological safety of devices. Our approach includes analyzing chemical characterization data, reviewing toxicological information, and assessing the risk of adverse biological responses. We can help you develop a biological evaluation plan, interpret test results, and prepare comprehensive biological risk assessment reports to support regulatory submissions.
As the medical device industry adapts to these new regulations, Cambridge Polymer Group and Gradient are committed to providing the expertise and support needed to ensure compliance and maintain product quality. For more information or to discuss how we can assist your company, please contact us.
Increasingly, manufacturers and product designers across all industries are using new materials in novel applications and pushing existing materials into new uses that stretch their performance to the limit. These materials do not always behave as expected, and conventional material specification sheets and standard testing methods are no longer enough.
Today’s successful products can only be obtained through a multi-disciplinary approach, with an emphasis on safety. Developers need deep expertise in materials across industries, along with a thorough understanding of polymer science. This includes the impact of additives, manufacturability (encompassing cleaning and sterilization), biocompatibility, and the intended use of the device or product.
Enhanced Client Collaboration through SME Leadership
To address this growing need for materials expertise, Cambridge Polymer Group is implementing a new five-position management structure. This structure empowers senior Subject Matter Experts to remain at the forefront of client collaboration – a cornerstone of CPG’s successful partnerships. This strategic shift ensures dedicated resources for complex projects, delivering the hands-on materials support clients increasingly require.
Leadership Team Focused on Client Success
Vice President of Research, Dr. Gavin Braithwaite, will step into the newly created position of Chief Executive Officer.
“By staffing our newly designed senior management structure with seasoned scientists, we can ensure the continued delivery of high-quality science to our clients, while placing a stronger emphasis on product development and challenging testing projects,” said Braithwaite. “I am excited to grow the development aspect of our work and build a deeper relationship with our clients, helping them decrease risk, expand into new markets, and increase profitability.”
After 27 years as Cambridge Polymer Group’s President, Dr. Stephen Spiegelberg is moving into the new role of Chief Scientific Officer (CSO).
This transition will enable Dr. Spiegelberg to spend more time collaborating with clients and working on large-scale projects in his subject matter expertise, such as biocompatibility, root cause analysis, product development, and medical device cleaning.
“I am personally looking forward to having more scientific interactions with our clients, spending more time on ASTM and AAMI standards development, and studying industry trends to help assist in product development,” said Spiegelberg.
Jaimee Robertson will oversee research operations in the newly created role of Director of Consulting Services.
Robertson will work with CEO Gavin Braithwaite and CSO Stephen Spiegelberg to develop and implement CPG’s research strategy and assist clients in their development projects and root cause analysis work.
Norma Turner will manage lab operations and testing services as Director of Analytical Services.
Turner will ensure CPG’s full-service laboratory provides essential support for R&D and consulting projects, as well as value-add to routine analytical testing clients. Norma will be leveraging her extensive experience in ASTM and ISO standards testing to help with both routine and non-routine testing, including residue analysis and extractables and leachables testing.
Dr. Rebecca Bader, Associate Director of Chromatography, will oversee the direction of this critical department and lead CPG’s biocompatibility and risk assessment group.
Bader’s material science and analytical chemistry expertise combined with her biocompatibility experience will help clients navigate the challenging regulatory landscape.
Benefits for Our Clients
Deeper Collaboration with Material Experts: Our clients will continue to benefit from close collaboration with CPG’s SMEs.
Enhanced Support for Complex Projects: The new structure ensures dedicated resources for even the most demanding R&D initiatives.
Future-Proofed Innovation: CPG is positioned to deliver the advanced materials expertise needed to bring groundbreaking products to market.
We are confident that this new operating model will allow us to further strengthen our partnerships and empower our clients to achieve their innovation goals.
Together, let’s turn groundbreaking ideas into reality.
Contact Us
If you have any questions or are interested in learning more about how CPG’s materials science expertise can benefit your business, please email or call us at 617-629-4400 today.
