A Biomodeling Investigation of Bracing on Clubfoot

Report
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
Deliverables
Identification
•
•
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•
•
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
•
•
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•
•
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
• 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
6
Student Perspective…
• To learn more: www.bme.unc.edu/MedtechID/
• Or email: [email protected]
• Medtech-ID Student
Perspective
• Augment Medical
Perspective
• Save the date:
May 1st 3:00-8:00
BME Symposium
at the NC Biotech Center
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