Presentation on theme: "G2 Innovations Inc. The Wright Hand ® Development and Commercialization of a Novel Hand Prosthesis Raquel Lopez, Muris Mujagic, Michael Olsen, Albert Vette,"— Presentation transcript:
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
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 Outline
1,250 new hand amputations per year in US 50,000+ persons currently missing hand or entire arm in North America Need for Novel Prosthetic Hand Background Causes of Amputation
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
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
Actuator Technology Summary Background How about Electroactive Polymers?
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 ®
G2 Innovations: The Wright Hand ® The Wright Hand ®
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 ®
Advantages: Compact structure with many DOF Light weight Noiseless Pliable Wide Temperature Range (-100ºC to 250ºC) The Wright Hand ® G2 Innovations: The Wright Hand ®
Complete The Wright Hand ® Package Background G2 Innovations: The Wright Hand ®
The Road to the Wright Hand ® 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 Wright Hand ®
Standards: Goal is to assure safety and efficacy: Performance Standards (IEC 60601) Quality Management (ISO 13485) Risk Management (ISO 14971) Meeting Standards and Regulations Regulations: Goal is to receive FDA approval: 510K approval due to substantial equivalence
Standards Compliance Process Meeting Standards and Regulations ISO 14971 PerformanceQualityRisk Functions Reliability Noise Levels On/Off Time Set GoalsMeet Goals Design Control Data Control Review & Correct Nonconformities Ensure Consistency Estimate Risk Using: Identified Hazards Data from Previous/ Competitor’s Devices Past Experience IEC 60601ISO 13485ISO 14971
Identifying and Controlling Hazards Meeting Standards and Regulations Identify Hazards High Voltage needed for Polymer Activation Device Heating due to Electrical Dissipation Control System Malfunctioning Skin Interfaces with Mechanical Component Implement Controls IEC/CSA Approved Optical Isolators Wireless RF Processing of Sensory Signals Restricted Use in Hazardous Areas Use of Eudermic and Heat-Absorbing Materials
Regulatory Approval by FDA FDA Categorization (Sec. 890.3420): Identification: External limb prosthetic component Classification: Class I device Meeting Standards and Regulations 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 !
Market Assessment 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 Initial prototype study of 20 subjects: 85% indicated a marked improvement in functionality and ease of use over existing prostheses in one week trial
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
Cost to Develop the Wright Hand ® Commercialization 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
Future Wright Hand ® Product Platform The Wright Hand Hand ® 1 Wrist Prosthesis 2 Whole Arm Prosthesis 3 Whole Leg Prosthesis 4
Spinoff Product Platform Drug Delivery (Smart Pill) Catheter-steering Element Artificial Heart G2 Innovations Inc. Robotic Surgical Instruments Active Audio Speakers Active Braille Display
!! Thank 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) References & Acknowledgements You !!