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University of North Carolina at Chapel Hill and North Carolina State University Joint Department of Biomedical Engineering Andrew J. DiMeo, Sr., Ph.D. Program Funding primarily via gifts from individuals and industry Thursday, October 13, 2011 BMES Annual Meeting.

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  1. University of North Carolinaat Chapel Hilland North Carolina State UniversityJoint Department of Biomedical EngineeringAndrew J. DiMeo, Sr., Ph.D.Program Funding primarily via gifts from individuals and industryThursday, October 13, 2011BMES Annual Meeting You may use this template or slides of your own design.  However, please limit your slides to only 5, and prepare for a 5 minute presentation, so there is plenty of time for discussion of the snapshots. If using this deck, please delete this textbox.

  2. Inspiration • Emulate a real industry experience • FDA Quality System Regulations • Meet ABET Requirements • design… to meet desired needs… • function on multidisciplinary teams • Identify… and solve… problems • professional & ethical responsibility • communicate effectively • knowledge of contemporary issues • techniques, skills, and modern engineering tools

  3. Overview: Senior Design • Undergraduate Seniors in BME at NCSU • Two-Semester Capstone (6 credits) • 40-50 Students (8-10 teams) • All projects student derived • Clinical Immersion • WakeMed Health & Hospitals • Other local healthcare providers • NCSU College of Veterinary Medicine • Five-Phase Design Control Process • Based on FDA’s Quality System

  4. Course Features • Challenge • Hospital Orientation • Includes Immunizations, Criminal Background Checks, Confidentiality, etc. • Distinction • Magnitude of the clinical immersion • All 40-50 students participate • Interviews and observation • Needs assessment ~ 8 weeks • Product Requirements & Ideation ~ 5 weeks • Clinical Feedback and User Evaluation • Proof of Concept Design ~ 5 weeks • Manufacturing ~ 6 weeks • Qualification ~ 4 weeks

  5. Five Year Outcomes • Three provisional & one full patent application • One licensing deal • One spinout company • Augment Medical • Won Inaugural NCIIA BMEstartCompetition • Industry feedback on new hires “Students taking your class show a level of preparedness for medical device development…providing them skills that are critical to succeed in a companylike Smith & Nephew.” – F. Javier de Ana, Biologics and Spine

  6. Overview: Medtech-ID • Graduate Level Multidisciplinary Program • Students from UNC and NCSU • Engineering, Business, Medicine, Law, Design, Etc. • Four 7-week modules (1.5 credits each) • Student derived projects • Clinical Immersion Primarily at UNC Health Care • Also NCSU College of Veterinary Medicine and other local healthcare providers • FDA Quality System Design Control Process

  7. Deliverables by Module

  8. Course Features • Challenges • Two-campus commute • Graduate student time constraints • Distinctions • Industry Coach • Facilitates small group setting • Conference room (not lecture hall) • Industry Mentors • Access to Research Triangle Park Expertise • Modules • Short courses allow team flexibility • Ability to recruit student talent to team • Proximity/Access to UNC Health Care

  9. Questions and Discussion

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