eg gilero company presentation 7-9-15
TRANSCRIPT
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COMPANY OVERVIEW
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About EG-GILERO
Trusted design and manufacturing partner Focus on medical and drug delivery devices Responsive size, $75M+ annual revenue Established in-house expertise in
Design & Development Tooling Testing Regulatory Manufacturing Commercialization Strategy
Globally competitive, sites in North America and Asia Proven capacity to innovate, scale, and commercialize Stable, privately held parent company – EG-Industries
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About EG-INDUSTRIES
Stable, privately held company 1500+ dedicated employees $750M+ annual revenue Serving five vertical, customer-focused divisions
Assembly & Systems
Automotive
Medical & Drug Delivery
Retail Solutions
Industrial/Consumer
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Company History
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EG-GILERO Facilities
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EG-GILERO Facilities
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Design & Development
Tooling Testing Regulatory Manufacturing
Commercialization Strategy
In-House Service Offering
Medical Innovation From Start to Finish
We are your single-source, trusted partner for design, development and manufacturing within the medical devices, drug delivery, and primary pharmaceutical packaging markets.
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Design & Development
Voice Of Customer Clinical interviews/observations Creation of exhaustive “customer
needs” and product requirements
Concept Development Standout ideas to differentiate your
product from the competition Source of new IP generation for our
customers
Rapid Prototyping In-house machining, SLA, FDM,
silicone molding, film forming
Product/Package Design Designed with clinical and
manufacturing needs in mind Design for Human Factors Fully detailed drawings and
specifications
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In-House Moldmaking Highly skilled designers and
toolmakers Rochester, NY & Shenzhen, China Moldflow integration, shrink & warp 24-hour operation Complete maintenance & repair
program for all tooling
Tooling Options For Every Need Corporate tooling standard Trusted tooling partners Aggressive lead times Rapid prototype, pre-production, single
cavity production, bridge tools, multi-cavity, stack molds
Full tool capabilities: unscrewing, family tools, hot or cold runner, multi-shot, gas assist, unit tools, insert molding
Tooling
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Testing
Breadth Protocol development Engineering, Verification, and Design
Validation functional testing Human Factors Formative & Summative
Studies
Physical Test Labs Vision measurement Precision force testing Environmental chambers, including
accelerated aging Package testing Electrical continuity Material Moisture
Microbiology Lab Full-time microbiologist staffing Bioburden Cleanroom air quality Custom analytical methods
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Scope Develop regulatory strategy Ownership of all required
elements Provide a path to approval
Deliverables Prepare and Maintain DHFs Risk Analysis, including Design
& Process FMEAs Develop packaging & labeling
layouts
Routine Submissions 510k CE Technical Files Documentation to support
NDAs
Regulatory
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Manufacturing
Injection Molding Scientific molding process
development Real-time process monitoring Two-shot, gas assist, insert molding
Assembly Components to finished device
assembly Automation and robotics expertise Manual & low cost labor options CNC machining Ultrasonic, spin, and vibration
welding Pad printing, laser engraving, hot
stamping Painting/Decorating Cold and hot staking inserts (e.g.
CNC) Lubrication dispensing (e.g. silicone
spray)
Packaging & Sterilization High speed packaging, thermoformed
trays, pouches Sterilization validation &
management
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Process Technology, market, & IP
assessment Business planning Strategic introductions Negotiations for license, sale,
& distribution Investment
Proven track record University & hospital
technologies Entrepreneurs & start-ups Large OEM distribution
agreements
Commercialization Strategy
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OUR EXPERTISE & PRODUCT EXAMPLES
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Single-useMechanical
Plastic & Elastomeric
Materials
MedicalDrug
DeliveryDevices
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Product Examples: General Surgery
Endomechanical instruments
Ports
Surgical TrocarMfgr: Rochester, NY
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Product Examples: Drug Delivery
Opthalmology Inhalers Injectable drug access and
delivery devices Prefilled syringes Topical applicators
Metered Dose InhalerMfgr: Asheboro, NC
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Product Examples: Respiratory/Anesthesia
Ventilator accessories
Pulmonary hygiene
Pain management
Humidification ColumnDesigned: Durham, NC
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Product Examples: Urological
Catheters Prostatic stent Incontinence
control
Intermittent Urinary Catheter
Designed: Durham, NCMfgr: Erie, PA
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Product Examples: Vascular Access
IV disposables Catheters
Flush SyringeDesigned & Mfgr:
Rochester, NY
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SHENZHEN FACILITY
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High-quality, In-house Moldmaking
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Cleanroom 1 Molding
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Cleanroom 2 Molding – Plenty of Capacity
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Cleanroom 3 Assembly
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Quality-Focused
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Responsive Team
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ROCHESTER FACILITY
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In-house Moldmaking & Repair
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High-Volume, Fully Automated Molding & Assembly
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Manual Assembly Cells
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Real-time monitoring; Automated Inspections
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ASHEBORO FACILITY
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Cleanroom Molding
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Automated & Manual Assembly
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High-Speed Packaging
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Your Trusted Design and Manufacturing Partner for Medical and Drug Delivery Devices
Surgical Coagulation Instrument
Designed: Durham, NC