What was the challenge or problem to solve?
In the field of materials used in medical applications, conducting biocompatibility testing to ensure their safety and efficacy is essential before their approval and clinical use. ISO 10993-1 standards set a series of essential tests for approving these materials, which can involve lengthy and costly processes.
The standard allows for the optimization of the approval process by “eliminating” tests if there is literature to justify it. Therefore, a literature review was conducted to determine exactly which tests are essential based on the specific characteristics of each material, its manufacturing method, and sterilization.
This project was led by the Forensic Engineering team, who conducted an exhaustive search to support this optimization, thereby reducing the number of required tests without compromising the integrity and safety of the final product.
How was it addressed or what was the solution?
To tackle this challenge, INFINITIA undertook a meticulous study in two main phases. The first phase consisted of a detailed literature review of the material’s use in surgical implants. This stage allowed the team to identify and categorize the already tested properties and interactions of the material with the human body, a crucial factor in determining the necessary toxicity and biocompatibility tests.
The second phase focused on reviewing the manufacturing and sterilization processes of these implants, aspects that directly influence the sterility and safety of the finished product.
The most significant benefit of this approach was the reduction in the scope and number of required tests, resulting in decreased time and costs associated with the approval process.