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Southeast Region Technology Transfer Directors Meeting July 13, 2012 PowerPoint PPT Presentation


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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

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Southeast Region Technology Transfer Directors Meeting July 13, 2012

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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

“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


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 [email protected]


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