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