BME1801H
BME1801H Biomedical Product Development II
Streams
Clinical Engineering
Sessions
Fall
Description
This course introduces students to the interplay between medical device regulation and product design. Medical device regulations determine the types of testing required for product validation, the associated costs, and the time to market. We examine how these regulations influence product design strategies, with a focus on the US Food and Drug Administration's regulatory framework for medical devices, software, and the use of artificial intelligence (including neural networks, regression, and large language models). The course also covers the regulation of combination products involving both devices and drugs, as well as digital health. Students will learn how to formulate regulatory arguments for new designs in healthcare—whether software, AI, or physical devices—and how to reverse engineer product designs based on regulatory requirements. The course is team-based and includes a major project.
Prerequisites
MSE352 Biomaterials and Biocompatibility or equivalent. Equivalency will be assessed by the course instructor and determined on an individual basis.
Components
Lecture
The BME1801 course is a parallel course to the BME460 course taught to Engineering Science students, and the students will take several courses together. However, BME1801 students will have their own group project teams.
Restrictions
MEng students only (not suitable for PhD or MASc students)