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Medical device developers have more antimicrobial testing options than ever before, but selecting the right study remains a challenge. Throughout product development, teams must answer different questions about antimicrobial performance. One study may evaluate growth inhibition, while another assesses microbial killing or how an antimicrobial material performs on a device surface. The challenge is that no single…

Medical device manufacturers developing antimicrobial technologies often prioritize early efficacy data as a primary development milestone. While antimicrobial performance is essential for 510(k) clearance, strong results alone do not automatically translate into a claim that will withstand regulatory scrutiny. As Aaron Strickland, Vice President of Research and Development at iFyber, emphasizes, the critical distinction is not…

The Mechanistic Gap in Wound Healing Studies Clinical wound healing studies have traditionally relied on endpoints such as wound closure, healing rate, and time-to-heal to evaluate therapeutic performance. While these measures remain clinically meaningful, they provide limited insight into the biological mechanisms influencing tissue repair, treatment response, and patient variability. For sponsors developing advanced wound care therapies,…

From Data Generation to Data Confidence In today’s rapidly evolving life sciences landscape, high-resolution LC-MS proteomics is shifting from a discovery-oriented technique to a quantitative, decision-enabling platform. This transition is being driven by advances in instrumentation, acquisition strategies, and data analysis approaches that collectively address long-standing challenges in sensitivity, reproducibility, and depth of coverage. At the center…