University of North Carolinaat 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, 2011BMES Annual Meeting

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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

• 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

Overview: Senior Design

• 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

Course Features

• Challenge– Hospital Orientation

• Includes Immunizations, Criminal Background Checks, Confidentiality, etc.

• Three provisional & one full patent application

• One licensing deal• One spinout company

– Augment Medical• Won Inaugural NCIIA BMEstart Competition• 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

Five Year Outcomes

• 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

Overview: Medtech-ID

Medtech-ID I• Project Proposal• IP Disclosure• Expense Report

Medtech-ID II• Market Analysis• Product

Requirements• Design Concepts

Report

Medtech-ID III• Detailed

Manufacturing Specifications

• Business Plan

Medtech-ID IV• Product Risks

(FMECA)• Proof of Concept

Deliverables by Module

• 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

Course Features

• Challenges– Two-campus commute– Graduate student time constraints

Questions and Discussion