FDA & IP Commercialization

2.0 credits

This interactive course focuses on Intellectual Property (IP) and FDA regulatory pathways for medical innovations. Emphasis will be placed on how knowledge of IP protection and evaluation, and regulatory barriers can optimize design, testing and commercialization strategies. Building on BME431 material, students will learn about the processes and barriers to bringing medical products through clinical trials. Instruction will include lectures, case studies, guest speakers and integrated assignments that will ask students to explore examples of IP and regulatory challenges, successes and failures. Lectures on regulatory and IP topics will alternate so students can appreciate the difficulty presented by balancing these two challenges in the innovation process. Some assignments may be tailored to individual student's research, design or work concentration areas. A project conducted in partnership with the FDA will provide students an opportunity to submit a mock pre-submission to the FDA for review and feedback.