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G2 Innovations Inc.

G2 Innovations Inc. The Wright Hand ® Development and Commercialization of a Novel Hand Prosthesis. Raquel Lopez, Muris Mujagic, Michael Olsen, Albert Vette, and Derek Wright. Outline. Background Need for Prosthetic Hand Review of Current Technology The Wright Hand ®

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G2 Innovations Inc.

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  1. G2 Innovations Inc. The Wright Hand® Development and Commercialization of a Novel Hand Prosthesis Raquel Lopez, Muris Mujagic, Michael Olsen, Albert Vette, and Derek Wright

  2. Outline Background Need for Prosthetic Hand Review of Current Technology The Wright Hand® Electroactive Polymer Technology Meeting Standards and Regulation FDA Regulatory Process Commercialization Market Assessment Product Valuation Future Product Platforms Product Diversification

  3. Need for Novel Prosthetic Hand • 1,250 new hand amputations per year in US • 50,000+ persons currently missing hand or entire arm in North America Causes of Amputation Background

  4. Current Prostheses • Prostheses: hooks, body-powered hands, electrically-powered hands • 30-50% of hand amputees do not use prosthetics regularly • Problems with current prosthetic hands: • Limited functionality • Too noisy • Uncomfortable • Takes too long to put on • Cosmetically unappealing Background

  5. Ideal Prosthetic Hand • Noiseless • Adaptive grasp • Increased degrees of freedom • Reflex and slip control • Sensory feedback • Easy control of movement • Light weight • Energy efficient • Fast response times • Affordable • Short ON/OFF time Goal: A prosthetic hand for amputation at the hand-wrist disarticulation level that best mimics the biological hand Background

  6. Actuator Technology Summary How about Electroactive Polymers? Background

  7. Electroactive Polymers (EAPs) • Function: • Change shape when subjected to stimulus • Can act as a sensor • EAP Types: • Ionic (wet) • Electronic (dry) – Dielectric Elastomer The Wright Hand®

  8. G2 Innovations: The Wright Hand® The Wright Hand®

  9. Human-Machine Interface • Myoelectric interface • Array of EMG detectors • Controller decodes desired muscle movement • Wireless communication between sensors and controller • Adhesive electrodes (one configuration each use) • (alt.) Permanent implant (one configuration total) The Wright Hand®

  10. G2 Innovations: The Wright Hand® • Advantages: • Compact structure with many DOF • Light weight • Noiseless • Pliable • Wide Temperature Range (-100ºC to 250ºC) The Wright Hand®

  11. G2 Innovations: The Wright Hand® Complete The Wright Hand® Package Background

  12. Patent Process: Patent protection filed through Canadian Intellectual Property Office (CIPO) Dec 8, 2003. Patent Cooperation Treaty (PCT) National Entry October 14, 2005. Registered patent 2520001 for “Wright Hand” hand prosthesis Funding: The Road to the Wright Hand® The Wright Hand®

  13. Meeting Standards and Regulations • Standards: • Goal is to assure safety and efficacy: • Performance Standards (IEC 60601) • Quality Management (ISO 13485) • Risk Management (ISO 14971) • Regulations: • Goal is to receive FDA approval: • 510K approval due to substantial equivalence

  14. Standards Compliance Process IEC 60601 ISO 13485 ISO 14971 Performance Quality Risk ISO 14971 Set Goals Meet Goals Estimate Risk • Functions • Reliability • Noise Levels • On/Off Time • Design Control • Data Control • Review & Correct • Nonconformities • Ensure Consistency • Using: • Identified Hazards • Data from Previous/ • Competitor’s Devices • Past Experience Meeting Standards and Regulations

  15. Implement Controls Wireless RF Processing of Sensory Signals IEC/CSA Approved Optical Isolators Use of Eudermic and Heat-Absorbing Materials Restricted Use in Hazardous Areas Identifying and Controlling Hazards Identify Hazards High Voltage needed for Polymer Activation Device Heating due to Electrical Dissipation Skin Interfaces with Mechanical Component Control System Malfunctioning Meeting Standards and Regulations

  16. Regulatory Approval by FDA • FDA Categorization (Sec. 890.3420): • Identification: External limb prosthetic component • Classification: Class I device • Regulatory Requirements: • Exempt from PMA (part 807E) • Exempt from GMP (part 820) • Documentation of records (part 820.180) • Documentation of complaint files (part 820.198) File a 510K for FDA Approval ! Meeting Standards and Regulations

  17. Potential user market: 50,000+ in North America Up to half of amputees are unhappy with or do not use prosthesis Potential market of CDN$300 Million Market Assessment Initial prototype study of 20 subjects: 85% indicated a marked improvement in functionality and ease of use over existing prostheses in one week trial

  18. Product Valuation Wright Hand base unit: $12,000 2-year service package: $2,000 Custom silicone covers: $2,000-$10,000 • Total Cost: CDN$12,000-$24,000 • Cost comparable to Utah Arm ProControl® System: USD$13,500-$35,000 Commercialization

  19. Cost to Develop the Wright Hand® • Investment Required : $1,200,000 • Projected Profit Margin: 40-60% • Estimated Units Sold in First Year: 500 • Estimated Market Share Increase: Y1: 1% Y2: 5% Y3: 12% Y4: 30% Y5: 50% • Time to Recover Initial Investment + 15%: 1 Year from FDA Approval Commercialization

  20. The Wright Hand® 1 Wrist Prosthesis 2 Whole Arm Prosthesis 3 Whole Leg Prosthesis 4 Future Wright Hand® Product Platform

  21. Spinoff Product Platform Robotic Surgical Instruments Drug Delivery (Smart Pill) Catheter-steering Element G2 Innovations Inc. Active Braille Display Active Audio Speakers Artificial Heart

  22. References & Acknowledgements • National Centre for Health Statistics • National Limb Loss Centre • Jet Propulsion Laboratory • PRISM Laboratory • Canadian Intellectual Property Office • Environmental Robots Inc. • Motion Control Inc. (www.UtahArm.com) !! Thank You !!

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