MedTechID Presentation Part 1

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University of North Carolina at Chapel Hill and

North Carolina State University

Joint Department of Biomedical Engineering

Introduction to Medtech-ID

Andrew J. DiMeo, Sr., Ph.D.

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Thursday, March 1, 2012

Carolina Innovations Seminar

Five Year Outcomes

• 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 skills that are critical to succeed in a large company.”

– F. Javier de Ana

Overview: Medtech-ID

• 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…

Course Features

• 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

• Challenges

– Two-campus commute

– Graduate student time constraints

Class Topics

• Strategic Focus

• Observation and Problem Identification

• Need Statement Development

• Disease State Fundamentals

• Treatment Options

Deliverables

• Project

Proposal

• IP Disclosure

• Stakeholder Analysis

• Market Analysis

• Needs Filtering

• Ideation and Brainstorming

• Concept Screening

• Intellectual Property Basics

• Regulatory and Reimbursement Basics

• Business Models

• Prototyping

• Final Concept Selection

• 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

• Market Analysis

• Product

Requirements

• Design

Concepts

• Business Plan

• Prototype

Manufacturing

Specifications

• Prototype

• Qualification

Protocol/Report

• Risk

Assessment

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 Devices offered 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 Student

Perspective

• Augment Medical

Perspective

• Save the date:

May 1 st 3:00-8:00

BME Symposium at the NC Biotech Center

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