As the medical device industry heads into 2026, it finds itself at a pivotal moment shaped by rapid technological change, regulatory scrutiny, and ongoing economic uncertainty. Innovation remains the industry’s defining trait, but the path from concept to commercialization is becoming more complex and, in many cases, more fragile. Artificial intelligence is now embedded in everything from diagnostics and imaging to remote monitoring and surgical tools. While AI promises transformative capabilities, it also introduces new layers of risk and ambiguity during development. Questions around data quality, algorithm transparency, bias, and ongoing performance monitoring are increasingly difficult to separate from core product design, raising the stakes for manufacturers long before a device ever reaches the market. Medical device manufacturing and reshoring efforts | Medical Economics