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Gilero Company Overview

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Gilero is a leading provider of pharmaceutical and medical device design & development services from concept to commercialization. We focus on understanding and meeting user needs to deliver …

Gilero is a leading provider of pharmaceutical and medical device design & development services from concept to commercialization. We focus on understanding and meeting user needs to deliver innovative solutions that contribute to the success of our customers. Gilero was formed in 2002 and we are located in Research Triangle Park, NC.

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  • 1. Innovation Commercialized Company Overview
  • 2. About Gilero Biomedical• Established in 2002 – Headquarters in Research Triangle Park, NC• Full-service medical device design & product development – From concept to commercialization• 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 2
  • 3. The Gilero Team• Management • 14+ years device development experience Ted Mosler, P.E. President & CTO • BSME, MBA focused on tech commercialization • 33 U.S., and multiple foreign patents issued/pending • 17+ years medical device industry experience Tim Hopper , MBA • BBA Marketing, MBA Entrepreneurial Management Chief Operating Officer • Senior sales, marketing and operations expertise Kristin Benokraitis • 10+ years in manufacturing, quality & device development Director of Quality/Programs • BSChE, BS Chemical Engineering • Quality & PM roles in developing Class I, II, & III devices • 14+ years in manufacturing & device development Andrew Corson Director of Engineering • BSME • 3 US patents, high volume manufacturing design focus• Product Development – 15+ engineers – Expertise in mechanical, biomedical, chemical, and industrial engineering as well as industrial design – Support staff in lab testing, office management, and accounting 3
  • 4. Product Focus Mechanical Design Single-Use Plastic & Class I & II Silicone Medical Materials Devices 4
  • 5. Tools and ResourcesSoftware • SolidWorks • Pro/Engineer • Ansys • Corel Draw and Vegas Pro (renderings and 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 5
  • 6. Gilero Design Center and Laboratory Product Development Lab Design and Engineering Process Development Lab 6
  • 7. Product Development ServicesVoice 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 7
  • 8. Product Development ServicesPrototyping• 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 simulationProduct/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 8
  • 9. Product Development ServicesProcess 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 systemsProduct Testing• Evaluation of product performance – Competitor product testing – Product verification and validation testing – Failure analysis 9
  • 10. Product Development ServicesRegulatory 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 FMEAsCommercialization Support• 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 network – Distribution networks, strategic partner & market channel recommendations 10
  • 11. Portfolio ExamplesIV Therapy – needle-free valves, IV safety catheters, anesthesia delivery, stopcocks, patient controlled drug delivery device with dose counter, infection control valvePharmaceutical – insulin delivery adapter, vial access devices, topical applicators, drug access and reconstitution systemRespiratory – dry inhalers, filters/HME, pressure indication & check valvesOncology – radiation therapy immobilization, chemotherapy safe handling systemUrology – urinary catheter, male urinal, incontinence devices, ostomy componentsCardiovascular – surgical handle, ligation handle, ultrasound needle guidanceDiagnostics – blood sampling, monitor mounting system, cable enclosure 11
  • 12. Portfolio ExamplesGeneral Hospital and Personal Use - ear curette, infant feeding system, stem cell collection, fibroid removal, cryogenic cord blood storageWound Care – tissue forceps, bariatric bedpan, negative pressure wound therapyProsthetics and Orthotics – prosthetic knee joint, orthotic brace componentOphthalmic – dry eye device, eyelid speculumDental – surgical suction deviceLabware – pipettesVeterinary – drug spike, animal vaccinatorSafety – drowning prevention device 12
  • 13. Device Gallery 13
  • 14. Intellectual Property• IP is generated during projects for our customers – Over 26 issued patents – Over 30+ published applications – Many other patents applied for and pending• Product differentiation – 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. 14
  • 15. Our Competitive Advantages• 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 15
  • 16. Innovation Commercializedwww.gilero.com