Software is being incorporated into innovative medical devices ranging from wearables, telehealth and clinical decision support to robotics and software as a medical device (SaMD). In 2023 alone, the FDA added 171 Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices to the approval list. How can researchers be sure to protect both the copyrightable and patentable subject matter to create an attractive industry partnership or licensing opportunity? Join the session to learn about the types of medical devices that incorporate software, rules of thumb for which categories fall under the jurisdiction of the FDA, how to find patent counsel that can best assist with protecting multiple types of IP, and ways to structure licenses to commercialize MedTech technologies.