Blog

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…

E&L testing, more formally known as extractables and leachables testing, has become a defining constraint in modern device development timelines. A device may be fully designed, materials selected, and verification underway; and yet encounter significant delays once extractables and leachables testing begins. For medical device developers, that shift is not theoretical. The U.S. Food and…