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Course Descriptions

Currently accepting applications Apply now >> Next program starts: Autumn 2008 Program location: Bellevue Next information meeting: Thursday, July 24 (see details >>) Sign up to receive e-mail updates >> Contact a program representative >>   Program at a glance >>

General Course Information

• Students earn UW academic credit.
• Although some flexibility is possible, courses in certificate programs are designed to be taken in sequence.
• Instructors and courses are subject to change. Those listed are the most recent. All instructors are approved by the UW Bioengineering Department.
• Each academic year of coursework is available as an individual certificate program. Courses in certificate programs taken before admission to the MME degree program can be applied retroactively, after admission, to satisfy the requirements of the degree. Students should apply for GNM status after successfully completing the first certificate (see Applying for GNM Status).

Interested in taking a single class? Some courses (designated by a below) may be open on a space-available basis to professionals who are not seeking the certificate. See Single-Course Enrollment for details.

Medical Device Design

Schedule: Schedule: (10 sessions) Wednesday evenings, Sept. 24-Nov. 26, 2008; 4 credits; $1,644.
Instructor: Dan Baker.

This course emphasizes human factors on the design of medical devices and intellectual property in the medical device industry. We will also examine the useful and safe design of medical devices for patients, caregivers, physicians, technicians, and manufacturers. The class addresses the physical, mental, and environmental constraints which affect fitting a device to the human user in workplaces ranging from clinical medical systems to emergency field use. Design for changing populations during the device's life cycle is also considered.

Students will learn how to design systems that are effective for a wide range of people. The course will also include an overview of intellectual property and regulatory affairs in the context of the design and production of medical devices. The intellectual property section of the course covers patents, copyrights, and other intellectual property from business considerations related to intellectual property are included.

How to sign up for individual enrollment in this course

Regulatory Affairs for the Medical Device Industry

Schedule: (10 sessions) Wednesday evenings, Jan. 7-March 11, 2009; 4 credits; $1,644.
Instructor: Martha Feldman.

This course reviews the government oversight of medical device development and those laws and regulations that apply to development, testing and production. In addition, the responsibilities of a regulatory affairs specialists in companies are reviewed. Topics include:

• U.S. and international regulations for medical devices
• Regulatory and clinical strategies
• Clinical trials
• Design and scale-up manufacturing
• Quality assurance and inspections
• Complaints and reporting

How to sign up for individual enrollment in this course

Medical Device Commercialization

Schedule: (10 sessions) Wednesday evenings, April 1-June 3, 2009; 4 credits; $1,644.
Instructor: Ram Bedi

This is a practical course designed to introduce the practical skills and tools in commercializing medical device technologies. Topics include:

• Entrepreneurship
• Funding models and sources (such as angels, VCs, or internal funding at established companies)
• Licensing options and product portfolio growth models
• Introduction to developing and delivering the business plan
• Building teams or integrating teams
• Market assessment
• Converting R&D to sales and distribution
• Manufacturing start up strategies
• Program and project management