Accelerating Medical Device Innovation in the Southeast

Report
The Global Center for Medical Innovation
“Accelerating Medical Device Innovation
in the Southeast”
Southeast Region
Technology Transfer Directors Meeting
July 13, 2012
1
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
2
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.
3
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
4
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
5
GCMI is Providing the Infrastructure for
Medical Device Commercialization
INVESTORS
DEVICE/DRUG
COMPANIES
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
6
UNIVERSITIES
RESEARCH CENTERS
CLINICIANS
GCMI Partner Network
Program Development & Support
IP & Patent Support
Development Plans
Business Plan
Consultant Network
IP Collaboration
Opportunities
Grant & Investor
Network
Design,
Prototyping &
Development
Center
Project
Management
Pre-Clinical/GLP
Testing
Advanced Imaging
Clinical Assessment
Quality Systems
Support
IDE, 510k, PMA
Application Support
Regulatory Affairs
Support
CRO Network
7
Industry Partners
Promising IP
Expert Reviews
“Complimenting the Collective &
Collaborative Expertise,
Experience and Capabilities of
GCMI’s Member Organizations”
• Capital Investors
• Strategic Partnering
• License to Major
Companies
• Establish Independent
Companies
• Contract
Management
Medical Device Development is a
Complex Process
Concept
Plan
Design
Evaluate
Too Long
Critical Need = Go Faster
8
Clinical
&
Regulatory
Prototyping & Development
Capabilities
•
•
•
•
•
•
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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.
10
GCMI Membership
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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
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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.
13
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.
14
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.
15
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
16
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:
–
–
–
–
–
–
–
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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.
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Tiffany Wilson Karp
[email protected]
678.764.2383
19

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