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Texas A&M University William A. Hyman

Texas A&M University William A. Hyman. Workshop on BME Teaching of Innovation, Design & Entrepreneurship. Course Title (1):BMEN 441/2 – Analysis and Design Project I & II. The “traditional” senior design project Assigned teams Problem definition Written proposal emphasizing specifications

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Texas A&M University William A. Hyman

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  1. Texas A&M UniversityWilliam A. Hyman Workshop on BME Teaching of Innovation, Design & Entrepreneurship

  2. Course Title (1):BMEN 441/2 – Analysis and Design Project I & II • The “traditional” senior design project • Assigned teams • Problem definition • Written proposal emphasizing specifications • Engineeringanalysis • Cost, safety, human factors, etc. • Supporting guest lecture series • Written and oral interim presentations • Final report and presentation Texas A&M University

  3. Course Title (2): BMEN 430 – Medical Device Regulation • Overview of the FDA regulatory process because you can’t (or shouldn’t) design anything in the real world without knowledge of FDA regulations, which reach all levels of the design team Texas A&M University

  4. Course Title (3): BMEN 440 – Design of Medical Devices • Not how to design any particular thing, but the design process (in a regulated industry) • Requirements definition • Internal proposals • Project management • FDA Design Controls including design and development planning, design input, design review, design output, verification and validation, design transfer, design changes, documentation • Interface of Design Controls with the rest of the QSR • System safety methods including risk analysis methods, fault tree analysis, failure modes and effects analysis, HACCP • Human factors • Product liability Texas A&M University

  5. Innovation & Entrepreneurship • Innovation is the key to design, but much of real world design is not intellectual breakthroughs but rather incremental improvements • “Breakthroughs” should therefore not be the core message of design courses • Guest lectures by entrepreneurs Texas A&M Univeristy

  6. Measuring outcomes • Work product from the class • Former student (alumni) feedback on the value and relevance of various classes • Employer feedback on the skills and training of hires from our program Texas A&M Univeristy

  7. Example of 441/2 course project • Project definition: Provide the wheelchair user with a means to disable anti-tip bars to negotiate obstacles • Why? When? How? • SAFETY IMPLICATIONS • Technical specifications • Testing • Documentation Texas A&M University

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