COMPANY OVERVIEW
Jul 16, 2015
COMPANY OVERVIEW
About EG GILERO
Stable, privately held parent company - EGI 1500+ dedicated employees
$750M+ annual revenue
Serving four key industry sectors
EG GILERO, trusted design and manufacturing partner
Focus in 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
Company History
• EGI is founded (1981)
• Injection Molding & Assembly
• Just in time delivery
• Lean manufacturing
• ISO qualified quality systems
• In-house Med. Dev. Design
• GILERO is founded (2002)
• ValTech is founded (2003)
• Medical Device Test Lab
• Clean Room MFGR
• In-house tool-building
• 1st customer 510(k)
• EGI forms eNNOVEA
• Microbiology Lab
• GILERO merges with eNNOVEA and Medacys: EGI acquires ValTech
• EG GILERO is formed (2015)
EG GILERO Facilities
EG Facilities
EG GILERO Facilities
Columbus, OH
Durham, NC
Rochester, NY
Asheboro, NC
Erie, PA
Atlanta, GA
Shenzhen, China
EG GILERO Facilities
Design & Development
Tooling Testing Regulatory Manufacturing Commercialization Strategy
Key Services
Medical Innovation From Start to Finish
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
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
Testing
Breadth Protocol development Engineering, Verification, and Design Validation
functional testing Human Factors Formative & Summative Studies
Physical Test Labs High speed packaging, thermoformed trays,
pouches 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
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
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
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
OUR EXPERTISE & PRODUCT EXAMPLES
Single-useMechanical
Plastic & Elastomeric
Materials
MedicalDrug Delivery
Devices
Product Examples: General Surgery
Endomechanical instruments Ports
Surgical TrocarMfgr: Rochester, NY
Product Examples: Drug Delivery
Opthalmology Inhalers Injectable drug access and delivery
devices Prefilled syringes Topical applicators
Metered Dose InhalerMfgr: Asheboro, NC
Product Examples: Respiratory/Anesthesia
Ventilator accessories Pulmonary hygiene Pain management
Humidification ColumnDesigned: Durham, NC
Product Examples: Urological
Catheters Prostatic stent Incontinence
control
Intermittent Urinary CatheterDesigned: Durham, NC
Mfgr: Erie, PA
Product Examples: Vascular Access
IV disposables Catheters
Flush SyringeDesigned & Mfgr: Rochester, NY
Your Trusted Design and Manufacturing Partner for Medical and Drug Delivery Devices