gilero company overview 2013

Innovation

Commercialized

• Established in 2002

– Headquarters in Research Triangle Park, NC

• Highly skilled team of best-in-class talent

– Extensive clinical, design, engineering, and

manufacturing experience

• Solid, long-term industry relationships

– Material suppliers, prototype developers, tool builders,

and contract manufacturers

• National accolades

– 2009 & 2010 Inc. List of fastest growing private

companies

– Gilero Inc. 500 Profile

– Medical Design Excellence Award

A leading provider

of medical device

design & product

development

services from

concept to

commercialization

About Gilero

Gilero Team

Management Team

Product Development Team

• 16+ years device development experience

• BSME, MBA focused on tech commercialization

• 39 U.S., and multiple foreign patents issued/pending

• 19+ years medical device industry experience

• BBA Marketing, MBA Entrepreneurial Management

• Senior sales, marketing and operations expertise

• 13+ years manufacturing and quality engineering experience

• BS Chemical Engineering

• Manufacturing and product development expertise

• 16+ years medical device product development experience

• BS Mechanical Engineering

• Manufacturing development and processes expertise

Ted Mosler, P.E. President & CTO

Tim Hopper, MBAChief Operating Officer

Kristin BenokraitisDirector of Programs

& Quality Management

Andrew CorsonDirector of Engineering

• 13+ engineers

• Expertise in mechanical, biomedical, chemical, industrial and

manufacturing engineering, and industrial design

• Support staff in lab testing, office management, and accounting

• 9+ years medical/biotech product development experience

• MS Product Design Stanford University

• Product design & entrepreneurial expertise

Ed BrowkaDirector of Design

Quality

System

ISO 13485 (BSI)

certified QMS

Internationally

recognized standard

for design and

development of

medical devices

Flexible system

allows to work under

your quality system

or ours

Product Focus

Resources

and Tools

SolidWorks

Pro/Engineer

Ansys

Corel Draw, Adobe Illustrator, SolidWorks (drawings & renderings)

Vegas Pro, SolidWorks (video editing, animations)

Web Conferencing for updates and input

Rapid Prototyping

SLA, SLS

Liquid silicone rubber (LSR) rapid prototyping

Welding, bonding, film forming, packaging, and labeling

Assembly equipment

Inspection and Testing Laboratory

Vision measurement

Precision force testing

Environmental chamber (accelerated aging)

Custom fixture design and test method development

Software

Rapid Prototyping

Inspection and

Testing Laboratory

Gilero Design Center and Laboratory

Product Development LabProcess Development Lab

Design and Engineering

Conveniently

located in the

Research Triangle

Park, Gilero has a

9500 square feet

facility that houses

a full-service

product

development lab

and process

development lab,

as well as a

collaborative

workspace with two

large conference

rooms.

Product Development Services

Voice of Customer Concept Development

Process DevelopmentProduct/Package DesignPrototyping

Regulatory Services Finished DevicesProduct Testing

From initial concept to

manufacturing transfer,

Gilero is a leading provider

of pharmaceutical and medical

device design and product

development services.

Voice of Customer

Understanding true latent clinical needs and product requirements

• Assessment of new technologies and markets

• Real life experience in the clinical environment

• Creation of exhaustive “customer needs” document and review product

requirements with every stakeholder in the lifecycle of the product


Concept Development

Generation of feasible product concepts

• Utilization of voice of customer research and output

• Knowledge of manufacturability and functional requirements

• Standout ideas that will differentiate your product from the competition


Prototyping

Generation of representative conceptual products

• Allows early clinical feedback and performance evaluation

• Stereo lithography prototypes to injection molded production quality

devices

• Packaging evaluation and in use simulation


Product/Package Design

Products designed right the first time

• Up-front consultation with internal/external manufacturing partners and

users

• Solid understanding of materials and extensive experience with

manufacturing methods

• Verification of form, fit and function


Process Development

Delivering confidence for the transition to full production

• Equipment builds with complete package of protocols, reports, and

supporting data

• Design history file documentation

• Easy integration of documentation into existing quality systems


Product Testing

Evaluation of product performance

• Competitor product testing

• Product verification and validation testing

• Failure analysis


Regulatory Services

Development of unique regulatory strategy for your device

• Prepare and maintain design history files

• Prepare 510k applications and technical files for CE Marking

• Prepare documentation to support new drug application

• Conduct risk analysis including design and process FMEAs


Finished Devices

Ensuring your innovation is commercialized

• Build and prove out processes to ensure a smooth transfer to

manufacture

• Utilization of our extensive medical manufacturing supply chain

• Private labeled devices delivered to you or your customer

• Distribution networks, strategic partners & market channels


Portfolio

Examples• dedicated pump sets, needle-free & pre-pierced valves,

pressure activated valve, IV safety catheters, passive safety needle, anesthesia delivery, stopcocks, patient controlled drug delivery device with dose counter, infection control valve, extension sets

• insulin delivery adapter, vial access devices, topical applicators, vial and bag access and reconstitution systems, pre-filled safety syringe devices, closed medication system, blow fill seal containers, Rx safety container

• pulmonary hygiene devices, dry powder inhalers, filters/HME, humidification column, pressure indication & check valves, ventilation circuit componentry, airway intubation device

• surgical lavage devices, prosthetic knee joint, orthotic brace component, finger/hands splints, meniscal repair device , cold therapy valve, arthroscopic fluid control valve

• dry eye device, eyelid speculum, eye dropper, surgical assist device, contact lenses care kit

• intravascular ultrasound catheter, surgical handle, ligation handle, ultrasound needle guidance system

IV Therapy

Pharmaceutical

Respiratory

Cardiovascular

Orthopedics

Ophthalmic

Portfolio

Examples

• ear curette, infant feeding system, stem cell collection, fibroid removal, cryogenic cord blood storage

• tissue forceps, bariatric bedpan, negative pressure wound therapy, skin stretching apparatus

• blood sampling, coagulation analyzer, monitor mounting system, cable enclosure

• radiation therapy immobilization, chemotherapy safe handling system, optical guided biopsy

• urinary catheter, male urinal, prostatic stent, incontinence devices, ostomy components

• surgical suction device

• pipettes, cell affinity column, blood separation system

• drug spike, animal vaccinator

• drowning prevention device

General Hospital

and Personal Use

Wound Care

Dental

Labware

Veterinary

Safety

Diagnostics

Oncology

Urology

DEVICE GALLERY

Safety IV Catheter(s)

Safety Drug Injection

Chemo Safe Handling

Infant Feeding

Drug Vial Access

Drug Reconstitution

Antiseptic Applicators

Urological Catheters

Animal Vaccinators

Intellectual

Property

IP is generated

during projects

for our customers

Product

Differentiation

• Over 30 issued patents

• Over 35 published applications

• Many other patents applied for and pending

• Designed to provide superior performance to

competitor products

• Better cost position through reduction of

components, tooling costs, and/or manufacturing

methods and materials

• Incorporate “nice to have” features with little to no

product cost increases such as smart packaging,

company brand information, etc.

Our Competitive Advantage

• Customer owns the created Intellectual Property

• Experience in the clinical environment and an understanding of user needs enables us to generate novel feasible product concepts

• An agile team of best-in-class talent accelerates product development cycles and customer response time

• Advanced engineering tools, proprietary prototyping methods, and manufacturing process expertise streamlines development

• Competence at mitigating risks ensures product quality and performance

• Our policy of accountability and open communication creates a strong and trusted product development partnership (detailed monthly reporting of time and regular updates on progress)

Delivering Innovative Solutions that Contribute to the Success of Our Customers

Innovation

Commercialized

www.gilero.com

gilero company overview 2013

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