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Course

Title:

  Technology Assessment and Regulation of Medical Devices
Course Number: MS&E 256
Date:   Spring Quarter 2010

Time:   Fridays 1:15 - 3:05pm

Location:   Thornton 102
Course details:  

Successful commercialization of medical technologies requires manufacturers to obtain regulatory approval and payment for those technologies. This course gives an overview of the regulatory and payer environment in the U.S. and abroad, and introduces methods for health technology assessment (HTA) and comparative effectiveness research (CER) that are commonly used. A framework is 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. Students investigate real-world diagnostic and therapeutic technologies in course projects.

Instructor: Jan B. Pietzsch, Ph.D.

Additional information and/or registration:  

1 unit (class attendance only, CR/NC)
3 units (project)

SCPD course; Core course of the SCPD Biodesign Certificate Program, the Cardiovascular Bioengineering Certificate Program, the Product Creation and Innovative Manufacturing Certificate Program, and the MS&E Certificate Program.

Additional information on the class website 

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