Challenge

A medical device company developing a new-generation implantable sensor faced challenges in defining a biocompatibility approach that aligned with ISO 10993-1 and FDA expectations.
The device was composed of two main parts:

• A delivery device portion and an implantable device portion.
• The complexity of the material composition and the  risks required a well-structured biocompatibility testing strategy to ensure patient safety.
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Chemva’s Solution

Chemva developed a comprehensive Biological Evaluation Plan (BEP) that integrated material characterization, relevant biological endpoints, and a stepwise justification for in vitro and in vivo testing. Leveraging a risk-based framework aligned with ISO 14971 and ISO 10993, we prioritized extractables and leachables (E/L) studies and toxicological risk assessments (TRA) before initiating genotoxicity testing, maximizing efficiency and minimizing redundant studies. This strategic sequencing helped the partner allocate resources effectively while maintaining compliance.

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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.