How Early Raw Material Testing Mitigates Product Development & Regulatory Risk

By Kitu Patel and Brendan Nicholson, Secant Group; and Stacey McElhaney, SanaVita Medical

Early analytical testing offers medical device manufacturers the opportunity to produce more robust data to proactively mitigate risks to be better prepared for the regulatory submission process. This approach enables time and cost savings while contributing to a higher-quality final product. Consider, too, that industry and regulatory agencies are trending toward requiring more analytical data earlier in the development cycle.

Additionally, recharacterizing medical device components and subassemblies after each process stage helps device manufacturers understand elements of a specific material that might alter it in some way (e.g., leachables caused by contact with raw materials), allowing for remediation well in advance of the submission process.
A supplier with manufacturing and testing under the same roof can track material trends to proactively address potential issues, as well as tailor its report to a customer's needs, because the supplier knows its materials better than anybody else, including how the material integrates into the manufacturer’s product.