1. Southeast Region Technology Transfer Directors Meeting July 13, 2012
The Global Center for Medical Innovation “Accelerating Medical Device Innovation in the Southeast”
Southeast Region
Technology Transfer Directors Meeting
July 13, 2012

2. GCMI: Key Highlights
Non-Profit Founded Leading Academic & Healthcare Organizations:
Georgia Tech
Saint Joseph’s Translational Research Institute/Emory
Piedmont Healthcare
Georgia Research Alliance
Only Comprehensive Medical Innovation Center in the Southeast Region
Awarded i6 Challenge Grant by U.S. Dept. of Commerce
$1.0 MM grant to drive commercialization & entrepreneurship
Exclusive Southeast recipient
Awarded Facilities & Equipment Grants
$1.3 MM from US Department of Commerce (EDA)
$1.3 MM from Georgia Research Alliance
Officially opened April 18, 2012

3. GCMI: Our Mission
The mission of GCMI is to accelerate the development and commercialization of next-generation medical devices and medical technology that can save lives and improve quality of life.

4. Critical Market Need for GCMI
Medical Device commercialization and job creation is lagging in the Southeast.
Medical Device ideas, talent, IP and high value employment either fail to take root or are lost to other regions.
Root Causes:
Major infrastructure gaps
Lack of investment capital
Limited commercialization expertise available to inventors, startups and small companies

5. GCMI: Our Approach Focus on Region’s Core Strength – Medical Devices
Develop a Regional Network of Partnerships between Universities, Clinicians, Entrepreneurs, Investors and Industry
Facilitate Collaborative Projects, Grants, Resource and Expertise Sharing
Provide Independent Development Resource Capability
A Fully Equipped & Functional Prototyping Center
“One Stop Shop” for Commercialization
Enable STTR/SBIR Grants for Small Companies

6. GCMI is Providing the Infrastructure for Medical Device Commercialization
DEVICE/DRUG
COMPANIES
INVESTORS
ADVANTAGES:
Access to Critical Resources
Provider of Key Services
Opportunities for Collaboration and Networking
Rapid Review and Funding of High-Potential IP
Cost & Time Savings in the Development Process
Access to Industry
EARLY-STAGE COMPANIES
UNIVERSITIES
RESEARCH CENTERS
CLINICIANS

7. GCMI Partner Network Promising IP
“Complimenting the Collective & Collaborative Expertise, Experience and Capabilities of GCMI’s Member Organizations”
Program Development & Support
Expert Reviews
IP & Patent Support
Development Plans
Business Plan
Consultant Network
Project Management
Industry Partners
• Capital Investors
• Strategic Partnering
• License to Major Companies
• Establish Independent Companies
• Contract Management
Design,
Prototyping & Development
Center
IP Collaboration Opportunities
Pre-Clinical/GLP Testing
Promising IP
Grant & Investor Network
Advanced Imaging
Clinical Assessment
Quality Systems Support
Regulatory Affairs Support
IDE, 510k, PMA Application Support
CRO Network

8. Medical Device Development is a Complex Process
Concept
Plan
Design
Evaluate
Clinical
& Regulatory
Too Long
Critical Need = Go Faster

9. Prototyping & Development Capabilities
Design Engineering
Material & Mechanical Engineering
Rapid & Functional Prototyping
Basic Functional Testing
Certified Clean Rooms (Class 10K & 100K)
cGMP Clinical Production & Packaging

10. Prototyping & Development Lab
A sample of GCMI’s functional & rapid prototyping equipment available – capability to develop broad range of medical devices.

11. GCMI Membership

12. Other benefits include preferred pricing and access to:
GCMI Member Benefits
GCMI Members are positioned as leaders in supporting the latest medical technology innovations and have first-hand opportunities to identify specific areas of involvement. GCMI prominently promotes members and services to a global audience.
Other benefits include preferred pricing and access to:
Prototyping, cGMP Manufacturing, GLP Preclinical Studies
Intellectual Property & Start-up Services
STTR/SBIR Grant Opportunities
Education Series
Marketplace for Intellectual Property
Industry Advisory Network
Corporate Partners Program

13. Prototyping & Development Resources
GCMI Members receive design & prototyping services at discounted rates.
Members are given scheduling priority on prototyping and cGMP manufacturing services.
Member organizations have access to the latest in prototyping technologies and access to validated cleanrooms without a major capital investment.
Leverage established network of prototyping & manufacturing resources that complement GCMIs services.

14. IP, Regulatory & Commercialization Guidance
GCMI facilitates intellectual property and start-up services to innovators and entrepreneurs.
GCMI supports and strengthens Member institution technology transfer resources around medical devices.
Partnership with e-Zassi provides access to InnoVision™ decision support tool, generating valuable regulatory, market and other product development insight.
Access to a network of industry collaborators and resources, connecting Member innovators to help their project move forward along the development path.
Attracts new technologies to the Center that potentially benefit Member organizations with individual projects.

15. STTR Grant Assistance
GCMI is classified as a “Non-Profit Research Institution,” which allows GCMI to collaborate with small businesses on STTR awards.
GCMI provides a unique service to fund up-front support to help select medtech companies secure STTR grants and provide ongoing project support.
STTR grant thresholds are $150K for Phase I and $1MM for Phase II – R&D dollars.
Focus on collaboration & commercialization supports proposal and may increase likelihood of success.
The GCMI grant program will provide high quality grant writing/submission expertise without the need to hire new employees or redirect valuable human capital.

16. GCMI Education Series
GCMI has created a quarterly Education Series to help Member organizations explore and understand medical innovation and entrepreneurship.
Members have priority registration.
GCMI will coordinate personalized education sessions for Members on a case-by-case basis:
Include regional experts
Broaden network across Southeast
Expand partnerships between academic and healthcare institutions

17. Industry Advisors
GCMI is building a network of experiences life sciences and device executives with specific areas of expertise who will be able to assist with specific commercialization initiatives.
Through GCMI’s Partner & Advisory Network, Member organizations will have access to:
Product development expertise
Specialized engineering expertise
Market analysis
Preclinical facilities
Seed funding
Clinical trials
Venture capital advisors

18. Building A Regional Network
Communication
Establish formal communication, site visits and regularly scheduled working sessions – identification of project managers.
Commercialization Grants
Identify and pursue innovation & commercialization grants through highlighting regional strengths.
Resource Sharing
Build complementary resources across Membership.
Attract industry, investment, talent.
Expansion of Regional Network
Bring together medical device development experts across the region.

19. Tiffany Wilson Karp tkarp@devices.net 678.764.2383