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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 Wednesday, October 12, 2011 BME-IDEA Workshop.
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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 industryWednesday, October 12, 2011BME-IDEA Workshop 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.
Overview • Graduate Level Multidisciplinary Program • BME Senior Design Capstone • 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 • NCSU College of Veterinary Medicine • Other local healthcare providers • Five-Phase Design Control Process • Based onFDA’s Quality System Regulations
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
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 company like Smith & Nephew.” – F. Javier de Ana, Biologics and Spine
Intellectual Property • University Policy • NCSU does not assert ownershipof undergraduate IP • If a graduate student, faculty, staff, or clinician is a co-inventor, then assignment is case-by-case • Student Preparation • Multiple guest lectures by university tech transfer and outside patent council • Topics include IP basics, patent landscape, freedom to operate, etc.
