Hardware Podcasts

#418: Biocompatibility Brief - What Medical Device Companies Need to Know

Global Medical Device Podcast · 4 Aug 2025 · 29m · Episode 418

What this episode covers

Marina Daineko, a MedTech expert and chemist specializing in biological evaluations, explains the critical importance of integrating biocompatibility into a company's Quality Management System (QMS) rather than treating it as an isolated task. She details the necessity of analyzing raw data, such as the silver ion cytotoxicity anomaly, and distinguishing between extractables and leachables to assess cumulative risks for long-term implanted devices like the Ishur contraceptive. Daineko emphasizes that the revised ISO 10993-1 standard drives a shift from reactive testing to proactive risk assessment, requiring cross-functional communication to ensure patient safety throughout the device lifecycle.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Greenlight Guru, FDA
Products
Ishur
Materials
Silver, Nickel, Polypropylene
Also
ISO 10993-1, Netflix

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