University of North Carolinaat Chapel Hill

and North Carolina State University

Joint Department of Biomedical Engineering

Introduction to Medtech-IDAndrew J. DiMeo, Sr., Ph.D.

Thursday, March 1, 2012Carolina Innovations Seminar

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• Three provisional & one full patent application

• One licensing deal• One spinout company*

– Augment Medical• Won Inaugural NCIIA BMEstart Competition

– 60 entries from 30 universities• Industry feedback on new hires

“Students taking your class show a level of preparedness for medical device development…providing them skillsthat are critical to succeed in a large company.”– F. Javier de Ana

Five Year Outcomes

• Graduate Level Multidisciplinary Program• Students from UNC and NCSU

– Engineering, Business, Medicine, Law, Design, Etc.

• Four 8-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• Sincere business considerations

– Regulatory, Reimbursement, IP Strategy…

Overview: Medtech-ID

• 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

Class Topics Deliverables

Identification

• Strategic Focus• Observation and Problem Identification• Need Statement Development• Disease State Fundamentals• Treatment Options

• Project Proposal

• IP Disclosure

Ideation

• Stakeholder Analysis• Market Analysis• Needs Filtering• Ideation and Brainstorming• Concept Screening

• Market Analysis• Product

Requirements• Design

Concepts

Innovation

• Intellectual Property Basics• Regulatory and Reimbursement Basics• Business Models• Prototyping• Final Concept Selection

• Business Plan• Prototype

Manufacturing Specifications

Implementation

• IP Strategy and R&D Strategy• Clinical and Regulatory Strategy• Quality, Process Management, and Reimbursement

Strategy• Marketing, Stakeholder, Sales, and Distribution Strategy• Competitive Advantage and Business Strategy

• Prototype• Qualification

Protocol/Report• Risk

Assessment

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Program Differentiation• Academic, private, vet-med hospitals + other local providers• Expert coaching from Research Triangle Area professionals• Support structure of two major universities• Industry-ready employee training• Innovation process built considering

needs of large company and startup environments

• Unique immersion experience• Opportunity for a Certificate

in Medical Devicesoffered by the Biomedical Engineering Dept.– Includes 6 additional credits in business

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Student Perspective…• To learn more: www.bme.unc.edu/MedtechID/

• Or email: ajdimeo@gmail.com

• Medtech-ID StudentPerspective

• Augment MedicalPerspective

• Save the date:May 1st 3:00-8:00BME Symposiumat the NC Biotech Center