Challenge

A medical device sponsor developing a long-term implantable product engaged Chemva to perform a Material Risk Assessment (MRA) before initiating chemical characterization studies per ISO 10993-18. The device incorporated several polymers and adhesives, but the sponsor lacked full visibility into potential degradation products that could emerge during sterilization, shelf life, or in vivo exposure. They needed to ensure their E&L testing plan was robust enough to detect toxicologically significant compounds, especially those linked to Cohorts of Concern (CoCs).

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Chemva’s Solution

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. Our workflow included:

1. Bill of Materials (BOM) Breakdown & Supplier Data Review:
   • Evaluated base materials, adhesives, and any known processing aids (e.g., stabilizers, residual monomers), manufacturing steps, effect of sterilization, and packaging materials.
   • Cross-referenced components against CoCs as defined by ISO/TS 21726 and known carcinogens, mutagens, and reproductive toxicants (CMRs).
2. Degradation Pathway Modeling:
   • Identified formaldehyde as a potential volatile degradation product.
3. Risk Characterization & Recommendation:
   • While the levels of formaldehyde were not expected to be high based on material chemistry and use conditions, its regulatory significance warranted specific attention.
   • Chemva recommended targeting formaldehyde explicitly in the chemical characterization.
4. Regulatory Documentation:
   • Delivered a MRA report that clearly identified potential formaldehyde formation, the reasoning behind it, and the testing recommendation.
   • Included specific language and references to support inclusion in the protocol and subsequent justification for toxicological risk assessment (TRA).

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Impact Delivered

Chemva’s proactive risk assessment:

• Allowed the sponsor to detect and quantify formaldehyde early, preventing potential regulatory deficiencies.
• Strengthened the ISO 10993-18 and -17 strategy by focusing resources on high-risk compounds, in addition to broad untargeted screening.
• Helped avoid costly re-testing or justifications for missing CoC coverage post-submission, potentially saving 6-9 months in timeline disruptions.

The sponsor incorporated Chemva’s recommendations into their chemical characterization protocol and successfully advanced the device toward submission with no E&L-related questions from regulators.