BME 4901 - Biomedical Engineering Senior Design I

• Work effectively on a team, employing project management strategies, to plan a long-term project
• Engage in a needs assessment that considers diverse needs of stakeholders and addresses global, cultural, social, environmental, and economic factors
• Follow FDA QSR guidelines to define design inputs for a medical device design
• Produce a written report and presentation that effectively and efficiently communicates a project proposal
• Determine the FDA device classification of a proposed device
• Research and identify relevant standards for a proposed medical device
• Produce a prioritized list of design input requirements that reflect the stakeholder needs and relevant regulatory requirements and engineering standards
• Conduct intellectual property research and market analysis to describe the prior art of a proposed design
• Devise and evaluate multiple design approaches at the system level, applying informed judgments that consider global, economic, environmental, and social impacts
• Create a plan to divide a system design into subsystems that can be divided among team members
• Identify proper interface specifications among subsystems in a design
• Engage in a design review to discuss and defend system level design decisions

• FDA regulation of medical devices
• Medical device standards
• Intellectual property of medical devices

• Project management and teamwork techniques
• Needs assessment in medical device design
• Documentation of medical device design projects
• Developing design requirements
• System-level block diagrams
• Developing interface specifications

• Mentor-guided biomedical engineering design