Successful commercialization of medical technologies requires manufacturers to obtain regulatory approval and payment for those technologies. This course will first give an overview of the regulatory and payer environment in the U.S. and abroad, and introduce methods for health technology assessment that are commonly used. Second, a framework will be presented to identify factors that are relevant to the adoption of new medical devices, and to the management of those factors early in the design and development phases. Lectures and case studies. Guest speakers from government (FDA) and industry.

This course is listed in and offered by the Management Science & Engineering Department, and is part of the broader curriculum of Stanford Biodesign courses. It is one of the core courses of the Biodesign Certificate Program offered through the Stanford Center for Professional Development.

This course is open to students of all levels and majors that are interested in medical technology and its commercialization. No prerequisites are required. Limited enrollment.

Attendance of all classes is required if the course is taken for credit. Because the teaching of the content benefits from discussion, active class participation is desired. The course can be taken for 1 unit (attendance only, CR/NC), 2 units (class and paper, CR/NC or Letter Grade), or 3 units (class and project, CR/NC or Letter Grade). Please register for this course directly in Axess, or through the Stanford Center for Professional Development.

The class meets on Fridays from 1:15 - 3:05 pm in Thornton 102. This is one of the two class rooms in the Thornton Center, next to the Terman Engineering Building. The first class will be on April 4, 2008.