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

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

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.

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

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

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

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

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

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

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

GCMI Membership

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

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.

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.

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.

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

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

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.

Tiffany Wilson Karp tkarp@devices.net 678.764.2383