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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…

For teams developing dental and implant materials, biofilm performance is a defining factor in clinical success, regulatory acceptance, and product differentiation. The challenge is not in understanding biofilms, but generating reliable, clinically relevant data that reflects how microbial communities interact with material surfaces under real-world conditions. Traditional antimicrobial testing approaches often fall short in this context. To…

Why Trace Impurities Matter Early in Development Trace impurities are still too often treated as a late-stage requirement tied to regulatory submission. In medical device development, they are more accurately an early signal of how materials and processes will perform under real conditions. These impurities are small, unintended chemical substances that remain in a material…

A monoclonal antibody may demonstrate strong target engagement, compelling preclinical efficacy, and favorable early safety signals; and yet experience altered functional durability once it reaches diseased human tissue diseased human tissue. In atopic dermatitis (AD), that risk is not theoretical. As the therapeutic landscape grows more competitive, durability and consistency are emerging as strategic differentiators.…