Challenge

A medical device manufacturer was notified that the supplier of a critical polymeric component used in their device had changed manufacturing sites. While the supplier claimed no changes to formulation or specifications, the sponsor faced internal and regulatory pressure to verify material equivalence, as the device was recently commercialized and subject to EU MDR and FDA oversight.

Unverified differences in resin properties could pose risks to biocompatibility, mechanical performance, and regulatory acceptance. The client turned to Chemva to conduct a third-party equivalency evaluation and biological risk justification.

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Chemva’s Solution

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

1. Document Review & Gap Analysis:
   • Compared Certificates of Analysis (CoAs) and Safety Data Sheets (SDSs) for both sites.
   • Reviewed supplier technical data sheets, processing conditions, and formulation statements for discrepancies.
   • Identified a lack of detailed analytical comparison to confirm sameness at the molecular and performance level.
2. Request for Additional Analytical Data:
   • Worked with the supplier to obtain Differential Scanning Calorimetry (DSC) data to compare thermal behavior, crystallinity, and curing profiles of the materials.
   • Requested Gel Permeation Chromatography (GPC) results to analyze molecular weight distribution and detect potential changes in polymer chain length or polydispersity.
3. Material and Biological Equivalence Justification:
   • Confirmed that mechanical, thermal, and molecular properties were within acceptable variability for the intended device function.
   • Evaluated previous biocompatibility test results and mapped them to the unchanged material chemistry and processing.
   • Documented a paper-based Biological Equivalence Justification, aligned with ISO 10993-1 and ISO 10993-18, showing that the site change posed no new biological risk.

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Impact Delivered

The client proceeded using the new material source, with no delays in the market.
Chemva’s independent equivalency assessment:

• Prevented unnecessary retesting, saving 6-9 months and an estimated $200K in E&L studies to establish materials equivalency.
• Enabled the sponsor to maintain regulatory confidence and continuity of supply across regions.
• Established a repeatable risk-based process for future material changes or supplier transitions.