EG-GILERO

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

EG GILERO Facilities

EG GILERO Facilities

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.

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 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

DeliveryDevices

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, NCMfgr: 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

Surgical Coagulation InstrumentDesigned: Durham, NC