Technology Assessment and Regulation of Medical Devices

Technology Assessment and Regulation of Medical Devices


The healthcare industry is an increasingly challenging environment for medical technology innovation. Health systems struggling to find the right formula for balancing and aligning risks and rewards for medical providers and suppliers. The gap is widening between health care that can be provided and health care that can be afforded. Growing cost-pressures lead to the increasing importance of economic factors for medical treatment decisions. To meet these challenges, engineers must adopt a new motto: It is not simply invention; it is inventiveness put to use.

This course gives engineers an introduction to technology assessment methods and the regulation of medical devices. The first half of the course focuses on regulation, the second half on health-economics and reimbursement. Students build a solid understanding of regulatory and reimbursement requirements, and of how to establish, demonstrate, and strategically influence the value of new technologies.

Guest lectures will be given by senior personnel from the FDA's Office of Device Evaluation and from a global medical device company. Several other guest speakers will present their companies' technologies and related regulatory and reimbursement challenges during the quarter. These will be 20-minute presentations and discussions at the end of each class. There is a project component to this course.


  • 1 year of college level calculus (through calculus of several variables, such as MATH51 or CME100)
  • Background in statistics, experience with spreadsheets recommended.
  • An undergraduate degree with a GPA of 3.0 or equivalent

Topics include

  • Regulatory and payer environment in the U.S. and abroad
  • Common methods of health technology assessment
  • Framework to identify factors relevant to adoption of new medical devices and the management of those factors in the design and development phases

Course Availability

The course schedule is displayed for planning purposes – courses can be modified, changed, or cancelled. Course availability will be considered finalized on the first day of open enrollment. For quarterly enrollment dates, please refer to our graduate education section.

Course Archived

Stanford School of Engineering