Polymer Stability with Historical Use and Material Science

Defending Polymer Stability with Historical Use and Material Science

Solutions

Biocompatibility

Material Science

Industries

Medical Devices; Combination Products; Drug Products

Challenge

During premarket review of a long-term implantable device, regulatory agencies raised concerns about the clinical stability of a polyether-block amide (PEBA) component used in the device’s outer housing.
Citing potential long-term degradation mechanisms (e.g., hydrolytic breakdown), the agencies requested justification that the material would remain stable and biocompatible over the device’s intended duration in vivo.

‍

Chemva’s Solution

Chemva led a detailed material-specific risk assessment, supportedby both scientific literature and historical clinical use. PEBA is awell-characterized thermoplastic elastomer with a long-standing record of usein various medical applications, including catheters and implantable leads,often in dynamic or moist environments. We consolidated the following data intoa cohesive scientific justification:

- Physicochemical data confirmingPEBA’s resistance to hydrolysis and oxidation under physiological conditions.
- Extractables studies showing no extractedcompounds that could be associated with degradation products over acceleratedaging.
- Clinical and post-market usehistory of similar formulations used in long-term implants without reportedmaterial failures or degradation-related complications.

Wecontextualized these findings in the Biological Evaluation Report (BER) and atargeted Degradation Assessment report, directly addressing ISO 10993-9 and ISO10993-13 requirements for chemical stability and risk assessment of degradationproducts.

‍

Impact Delivered

By implementing a well-structured, proactive testing roadmap, Chemva enabled the company to avoid regulatory delays, achieve alignment with global health authorities, and reduce projected study costs by approximately $300,000 through targeted test selection and reliance on robust chemical characterization data.

Biocompatibility FDA Chemistry Biocompatibility Approval Toxicological Assessment Science

“Chemva’s scientific depth and speed made them more than just a testing lab — they became an extension of our team. Their proactive communication and clear documentation helped us move forward with total confidence.”

— Alex R., Regulatory Lead at Medinex Solutions

More Case Studies

More Case Studies That Reflect Your Area of Interest

Explore additional case studies that address similar challenges, industries, or technical domains — and see how Chemva’s expertise translates across different projects.

E&L Study Design for a High-Risk Parenteral Container Closure System Under FDA Submission

Chemva authored an ISO 10993-18 and USP <1663>/<1664>-aligned E&L study design for a high-risk parenteral prefilled syringe, accepted by FDA without information requests.

Cumulative Elemental Impurity PDE Calculation for a Drug-Device Combination Product Under ICH Q3D and USP <232>

Chemva built a unified ICH Q3D and USP <232> cumulative PDE model for a wearable autoinjector, accepted by FDA at pre-submission without additional elemental testing.

NDSRI (Nitrosamine) Risk Assessment for a Generic Oral API Under EMA and FDA Compliance Deadline

Chemva delivered a CPCA- and read-across-based NDSRI risk assessment ahead of FDA/EMA nitrosamine compliance deadlines, avoiding reformulation on a widely prescribed oral API.

Deriving Chemical Tolerable Intake (TI) Under ISO 10993-17:2023 for a Permanent Orthopedic Implant

Chemva converted a legacy AET/PDE toxicological framework into an ISO 10993-17:2023-aligned compound-specific TI derivation for a permanent orthopedic implant, resolving an FDA information request without repeating chemistry testing.

Establishing Toxicological/Biological Equivalence After Undisclosed Additive Change in Medical-Grade Resin

Chemva recommended a dual Toxicological Risk Assessment (TRA) strategy, using results from E&L testing

In-Silico Genotoxicity Assessment for Drug Packaging-Related Impurities

Chemva performed a tiered in-silico genotoxicity assessment using (Q)SAR tools and expert toxicological interpretation to classify the packaging-derived impurities per ICH M7 guidelines.

Addressing Carcinogenicity Concerns Without E&L for EU MDR Submission

Chemva proposed and executed a paper-based Material Risk Assessment (MRA) specifically designed to address both genotoxic and non-genotoxic carcinogenicity pathways.

Assessing the Impact of Antioxidant Reduction in a Container Closure System

Chemva performed a comprehensive risk assessment focused on understanding whether the antioxidant reduction would materially impact the polymer’s performance, stability, or toxicological profile.

Resolving Unknown Extractables to Enable Pivotal Clinical Study

Chemva swiftly conducted a comprehensive Material Risk Assessment

Defending Polymer Stability with Historical Use and Material Science

Chemva led a detailed material-specific risk assessment, supported by both scientific literature and historical clinical use.

Avoiding Simulated E&L Testing Through Read-Across Toxicological Risk Assessment

Chemva conducted a comprehensive Toxicological Risk Assessment (TRA) using a read-across strategy, allowing us to bridge data gaps with scientifically valid surrogate information.

Reverse Engineering Competitor Device Materials and Surface Coatings

Chemva designed and executed a custom reverse engineering plan targeting both bulk materials and surface coatings of the competitor’s connector and delivery components.

Establishing Material Equivalence After a Raw Material Supplier Manufacturing Site Change

Chemva conducted a comprehensive material equivalency assessment to evaluate potential variations between batches sourced from the original and new manufacturing sites.

Identifying Formaldehyde Risk Through Material Risk Assessment for a Medical Device

Chemva conducted a systematic, material-specific MRA, analyzing each component and processing additive and manufacturing steps to identify chemical structures or precursors associated with CoCs.

Custom Formulating a Non-PTFE Lubricious Coating to Solve Supply Chain Constraints & Incoming Regulations

Leveraging our deep expertise in biocompatible coatings and polymer systems, Chemva led a coating reformulation and optimization program tailored to the device’s surface, application method, and clinical use.

Material Compatibility Assessment for Solvent-Bonded Luer Hub Assembly

Chemva led a material compatibility evaluation using HansenSolubility Parameters (HSP) to scientifically assess the interaction potentialbetween each candidate hub material, the bonding solvent, and the polyurethanetubing.

Identifying Critical Gaps with E&L Protocol to Ensure Seamless PMA Application

Chemva conducted a comprehensive review of the E&L protocol, evaluating analytical strategies, extraction conditions, and toxicological relevance.

Proactive Semi-Targeted E&L Strategy for a Polymer-Additive-Based Medical Device

Chemva’s semi-targeted E&L design eliminated potential FDA objections before they could be raised.

Securing Product Integrity with Reliable Raw Materials Supply

Chemva developed and implemented a risk-based supplier qualification framework

Biological Evaluation Plan (BEP) for a Next-Generation Implantable Device

Developed a risk-based BEP to meet FDA and ISO 10993-1 standards, helping the client avoid delays and save $300K through targeted testing.

Connectors Cracking: A Root Cause Analysis and Material Selection Effort

Chemva’s systematic approach not only resolved the cracking issue but also enhanced the product’s long-term reliability and manufacturability.

Defending Polymer Stability with Historical Use and Material Science

Chemva led a detailed material-specific risk assessment, supported by both scientific literature and historical clinical use.

Overcoming Adverse Sensitization Results

Chemva led a contextual data evaluation to assess whether the positive result represented a real clinical risk.

When Failed Cytotoxicity Is Not the Whole Story

Chemva’s strategic data interpretation helped the partner avoid unnecessary re-testing and product reformulation

Strategic Vendor Selection for Biocompatible Polymers in Inhaler Development

Chemva implemented a multi-step vendor qualification strategy to identify a reliable source of medical-grade polymer materials.

Consulting. Collaborating. Catalyzing.

Accelerating innovation through expert solutions, teamwork, and education.

Book a free consultation