Post on 04-Jul-2015
transcript
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
Product Development Services
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
Product Development Services
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 Development Services
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
Product Development Services
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 Development Services
Product Testing
Evaluation of product performance
• Competitor product testing
• Product verification and validation testing
• Failure analysis
Product Development Services
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
Product Development Services
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
Product Development Services
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