BioVoice News eMag September 2025 | Page 41

In today’ s rapidly evolving medical device landscape, ethical compliance is no longer a final checkpoint— it’ s becoming a foundational design principle. At the heart of this transformation is data-led material behavior analysis, a predictive approach that uses AI and large-scale datasets to anticipate how materials will interact with human biology.
Rather than relying solely on postproduction testing, developers now use data to guide decisions from the earliest stages. This shift not only enhances safety and performance but also aligns with ethical imperatives by reducing animal testing and promoting transparency.
Key elements of the approach include Material Property Databases which
capture critical attributes like surface energy, porosity, and chemical stability, Biological Interaction Profiles which link material characteristics to biological responses such as cytotoxicity and inflammation, Post- Market Surveillance Data that provides real-world insights into long-term material performance across diverse populations and Omics-Driven Insights that Integrate genomics and proteomics to predict molecular-level interactions.
The benefits of predictive, ethical design include early identification of high-risk materials, reduced need for animal testing, faster regulatory approvals and more inclusive and equitable device performance
While AI plays a central role in

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