Course Objectives, BME 272-273 Sequence

Generic Statement: The objective of this course sequence is the development of design skills through lectures and exercises involving the design process and through the completion of a senior level design project.

Specific Objectives:  The successful student will be able to (assistive software packages are in italics):

• Understand the basics of device reliability and calculate metrics to predict it for mechanical, software and electronic systems,
• Use computer tools to predict and document safety related design concerns (designsafe, FMEA analysis),
• Understand how current regulations and standards impact the design process, and where to find the standards,
• Understand the high priority that the FDA and other regulatory agencies place on risk analysis and human factors,
• Learn how the design process can affect personal and company liability,
• Learn new concepts in hardware and software design, including the use of computer-aided tools,
• Learn the costs of finding problems in the field versus during preliminary testing,
• Understand design for manufacturability and design for assembly,
• Learn how to successfully prepare for an FDA audit,
• Better understand idea generation techniques (including the use software for concept mapping, such as MindJet),
• Understand idea protection methods (patents, copyrights, trade secrets) and reverse engineering techniques,
• Perform web-based searches for collaborators, technology transfer groups, patents, copyrights, and similar ideas (TechOptimizer, Innovation Workbench, various search engines),
• Understand group management software and documentation requirements (Microsoft Project, Micrografx FlowCharter),
• Appreciate the need for licensing and the role of the engineer in forensics and consulting,
• Understand the need for quality assurance and quality improvement methodology in medical and design environments,
• Understand regulations for human and animal experimentation,
• Utilize software packages for development of web pages (FrontPage), medical databases (Access), progress reporting, and process documentation,
• Understand the various roles of engineering organizations in the setting of ethical and design standards,
• Be proficient in reporting design results (PowerPoint, Word, Posters)
• Understand trends in the design process (use of CAD/CAM),
• Understand process documentation (FlowCharter, Visio) and simulation (Stella),
• Understand team dynamics, team forming, and the need for communication,
• Understand the basics of biomaterials (Cambridge Engineering Selector),
• Interact with both professional and standards setting organizations,
• Understand the basic ethics of engineering practice,
• Understand the term continuous quality assurance as it applies to device and process design, including the educational process,
• Understand the processes for FDA and MDD (CE) approval of both drugs and devices,
• Understand the implications of the Freedom of Information Act,
• Understand liability and grounds for lawsuits,
• Have some familiarity with entrepreneurship,
• Understand proposal writing,  and
• Understand the need for customer input to specifications and requirements (QFD packages).

This listing a joint effort of Paul H. King and Richard C. Fries, 1999, updated and added to in 2001

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