An Investigational Device Exemption (IDE) allows medical device sponsors to test investigational technologies in human clinical studies to evaluate safety and effectiveness before market approval. IDE studies are essential for generating clinical evidence that supports regulatory submissions and device development. bioaccess® helps Medtech innovators navigate early feasibility and first-in-human trials in Latin America, offering faster approvals and efficient recruitment. This strategy helps companies overcome early development barriers and accelerate progress toward IDE-supported regulatory pathways.