Innovation      Commercialized
About GileroA leading provider   •   Established in 2002of medical device         – Headquarters in Research Triangle Park...
Gilero Team                   Ted Mosler, P.E.          • 16+ years device development experienceManagement Team    Presid...
QualitySystemISO 13485 (BSI)certified QMSInternationallyrecognized standardfor design anddevelopment ofmedical devicesFlex...
Product Focus
Resourcesand ToolsSoftware             SolidWorks                     Pro/Engineer                     Ansys              ...
Gilero Design Center and Laboratory                                                    Conveniently                       ...
Product Development ServicesFrom initial concept tomanufacturing transfer,Gilero is a leading providerof pharmaceutical an...
Product Development Services Voice of Customer Understanding true latent clinical needs and product requirements  • Assess...
Product Development Services Concept Development Generation of feasible product concepts  • Utilization of voice of custom...
Product Development Services Prototyping Generation of representative conceptual products  • Allows early clinical feedbac...
Product Development Services Product/Package Design Products designed right the first time  • Up-front consultation with i...
Product Development Services Process Development Delivering confidence for the transition to full production  • Equipment ...
Product Development Services Product Testing Evaluation of product performance  • Competitor product testing  • Product ve...
Product Development Services Regulatory Services Development of unique regulatory strategy for your device  • Prepare and ...
Product Development Services Finished Devices Ensuring your innovation is commercialized  • Build and prove out processes ...
PortfolioExamplesIV Therapy       •   dedicated pump sets, needle-free & pre-pierced valves,                     pressure ...
PortfolioExamplesGeneral Hospital   •   ear curette, infant feeding system, stem cell collection,and Personal Use       fi...
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
IntellectualPropertyIP is generated     • Over 30 issued patentsduring projects     • Over 35 published applicationsfor ou...
Our Competitive Advantage•   Customer owns the created Intellectual Property•   Experience in the clinical environment and...
Innovation      Commercialized               www.gilero.com
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Gilero company overview 2013

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  • Add pic of conference room. Take better pics of labs, with people/things being tested.
  • Gilero company overview 2013

    1. 1. Innovation Commercialized
    2. 2. About GileroA leading provider • Established in 2002of medical device – Headquarters in Research Triangle Park, NCdesign & productdevelopment • Highly skilled team of best-in-class talentservices fromconcept to – Extensive clinical, design, engineering, andcommercialization 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
    3. 3. Gilero Team Ted Mosler, P.E. • 16+ years device development experienceManagement Team President & CTO • BSME, MBA focused on tech commercialization • 39 U.S., and multiple foreign patents issued/pending Tim Hopper, MBA • 19+ years medical device industry experience Chief Operating Officer • BBA Marketing, MBA Entrepreneurial Management • Senior sales, marketing and operations expertise Kristin Benokraitis • 13+ years manufacturing and quality engineering experience Director of Programs • BS Chemical Engineering & Quality Management • Manufacturing and product development expertise Andrew Corson • 16+ years medical device product development experience Director of Engineering • BS Mechanical Engineering • Manufacturing development and processes expertise Ed Browka • 9+ years medical/biotech product development experience Director of Design • MS Product Design Stanford University • Product design & entrepreneurial expertiseProduct • 13+ engineersDevelopment Team • Expertise in mechanical, biomedical, chemical, industrial and manufacturing engineering, and industrial design • Support staff in lab testing, office management, and accounting
    4. 4. QualitySystemISO 13485 (BSI)certified QMSInternationallyrecognized standardfor design anddevelopment ofmedical devicesFlexible systemallows to work underyour quality systemor ours
    5. 5. Product Focus
    6. 6. Resourcesand ToolsSoftware SolidWorks Pro/Engineer Ansys Corel Draw, Adobe Illustrator, SolidWorks (drawings & renderings) Vegas Pro, SolidWorks (video editing, animations) Web Conferencing for updates and inputRapid Prototyping Rapid Prototyping SLA, SLS Liquid silicone rubber (LSR) rapid prototyping Welding, bonding, film forming, packaging, and labeling Assembly equipmentInspection and Inspection and Testing LaboratoryTesting Laboratory Vision measurement Precision force testing Environmental chamber (accelerated aging) Custom fixture design and test method development
    7. 7. Gilero Design Center and Laboratory 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 collaborativeDesign and Engineering workspace with two large conference rooms.Process Development Lab Product Development Lab
    8. 8. Product Development ServicesFrom initial concept tomanufacturing transfer,Gilero is a leading providerof pharmaceutical and medicaldevice design and product Voice of Customer Concept Developmentdevelopment services. Prototyping Product/Package Design Process Development Product Testing Regulatory Services Finished Devices
    9. 9. 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
    10. 10. 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
    11. 11. 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
    12. 12. 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
    13. 13. 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
    14. 14. Product Development Services Product Testing Evaluation of product performance • Competitor product testing • Product verification and validation testing • Failure analysis
    15. 15. 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
    16. 16. 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
    17. 17. PortfolioExamplesIV Therapy • 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 setsPharmaceutical • 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 containerRespiratory • pulmonary hygiene devices, dry powder inhalers, filters/HME, humidification column, pressure indication & check valves, ventilation circuit componentry, airway intubation deviceOrthopedics • surgical lavage devices, prosthetic knee joint, orthotic brace component, finger/hands splints, meniscal repair device , cold therapy valve, arthroscopic fluid control valveOphthalmic • dry eye device, eyelid speculum, eye dropper, surgical assist device, contact lenses care kitCardiovascular • intravascular ultrasound catheter, surgical handle, ligation handle, ultrasound needle guidance system
    18. 18. PortfolioExamplesGeneral Hospital • ear curette, infant feeding system, stem cell collection,and Personal Use fibroid removal, cryogenic cord blood storageWound Care • tissue forceps, bariatric bedpan, negative pressure wound therapy, skin stretching apparatusDiagnostics • blood sampling, coagulation analyzer, monitor mounting system, cable enclosureOncology • radiation therapy immobilization, chemotherapy safe handling system, optical guided biopsyUrology • urinary catheter, male urinal, prostatic stent, incontinence devices, ostomy componentsDental • surgical suction deviceLabware • pipettes, cell affinity column, blood separation systemVeterinary • drug spike, animal vaccinatorSafety • drowning prevention device
    19. 19. DEVICE GALLERY
    20. 20. Safety IV Catheter(s)
    21. 21. Safety Drug Injection
    22. 22. Chemo Safe Handling
    23. 23. Infant Feeding
    24. 24. Drug Vial Access
    25. 25. Drug Reconstitution
    26. 26. Antiseptic Applicators
    27. 27. Urological Catheters
    28. 28. Animal Vaccinators
    29. 29. IntellectualPropertyIP is generated • Over 30 issued patentsduring projects • Over 35 published applicationsfor our customers • Many other patents applied for and pendingProduct • Designed to provide superior performance toDifferentiation 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.
    30. 30. 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
    31. 31. Innovation Commercialized www.gilero.com

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