Course 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.
Estimated Course Enrollment: 50
Estimated TA Support: 70 hrs
Class Schedule: Tuesdays 9:00-11:00 Lecture, 11:00-13:00 Tutorial
Sessional Dates of Appointment September 1, 2026- December 31, 2026.
Salary:
Sessional Lecturer I: $ 9,997.48
Sessional Lecturer I Long Term: $ 10,699.22
Sessional Lecturer II $ 10,699.22
Sessional Lecturer II Long Term: $ 10,953.96
Sessional Lecturer III: $ 10,953.96
Sessional Lecturer III Long Term: $ 11,228.90
Please note that should rates stipulated in the collective agreement vary from rates stated in this posting, the rates stated in the collective agreement shall prevail.
Minimum Qualification:
10+ years’ industry experience in medical device commercialization
Demonstrated knowledge and expertise in applying FDA regulations for medical devices
Strong organizational, interpersonal, and communication skills required.
Teaching experience at the university level or equivalent industry level required.
Preferred Qualifications:
Medical Device Consultancy Experience
Demonstrated evidence of excellence in business, product development, and regulatory/clinical affairs.
of Duties:
Normal duties associated with the design and teaching of university degree courses or sections of courses. These may include the preparation and delivery of course content, including lectures, labs and/or seminars; creation of course ware; the development and administration of assignments, tests and examinations; the marking and grading of student work and the submission of grades to appropriate University officials in accordance with policy; the maintenance of reasonable hours of student contact outside of scheduled contact hours; and the supervision of the day-to-day work of any Sessional Instructional Assistants or Teaching Assistants assigned to the course. There is no expectation of or requirement for research or administrative service.
Application Instructions:
All individuals interested in this position must submit their application to Paul Ceruti (hr.bme@utoronto.ca). This includes submitting an updated Curriculum Vitae and the CUPE 3902 Unit3 application form available at https://uoft.me/CUPE-3902-Unit-3-Application-Form.
