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Author: Logan Luke





July 9, 2026

Design and Development Roads Converge at Biocompatibility

Biocompatibility is often treated as a milestone, a box to check on the path to regulatory approval. In reality, it is the cumulative outcome of hundreds of decisions made long before a device ever reaches a test lab. Every choice...

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May 28, 2025

3D Printing Considerations for Regulatory Acceptance

In this article Bryce Telford and Logan Luke discuss the unique considerations, such as sterilization and packaging, to chart a course for regulatory approval of 3D-printed devices. Read the Article in ODT Learn more about the authors.

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March 26, 2024

Whitepaper: Container Closure Requirements: Preparing for USP <382> <661.1> and <661.2>

Container closure integrity, which is verified by container closure integrity testing (CCIT), is critical to ensure the sterility of drug products. Physical, chemical, and biological assessments must be carried out to make sure components are compatible and fit for use....

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