G2 Innovations Inc. The Wright Hand ® Development and Commercialization of a Novel Hand Prosthesis Raquel Lopez, Muris Mujagic, Michael Olsen, Albert Vette,
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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
BackgroundNeed for Prosthetic HandReview of Current Technology
The Wright Hand®
Electroactive Polymer Technology
Meeting Standards and Regulation
FDA Regulatory Process
Commercialization Market AssessmentProduct Valuation
Future Product PlatformsProduct 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
Tumours8.9%
Congenital anomalies
8.2%
Disease5.8% Traumatic
accidents77.0%
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
ACTUATOR ADVANTAGES DISADVANTAGES
DC Micromotor Minimize bulk and weight of conventional DC motors
Slow operating speed Noisy Weak grip force
Pneumatic
Artificial Muscle
Provide muscle-like characteristics
Contractile force ~ real muscle Light weight actuators
Short life cycle Speed of actuation slow Bulky equipment to produce
driving pressure
Thermally Activated Shape Memory Alloys
(SMA)
High strength:weight & strength:area ratio
Low cost
Heavy High power consumption Imprecise control High temperature required for
actuation
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®
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®
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
PerformancePerformance QualityQuality RiskRisk
• Functions• Reliability• Noise Levels• On/Off Time
Set Goals Meet Goals
• Design Control• Data Control• Review & Correct Nonconformities• Ensure Consistency
Estimate Risk
Using:
• Identified Hazards• Data from Previous/ Competitor’s Devices• Past Experience
IEC 60601 ISO 13485 ISO 14971
Identifying and Controlling Hazards
Meeting Standards and Regulations
Identify HazardsIdentify Hazards
High Voltage needed for Polymer Activation
Device Heating due to
Electrical Dissipation
Control System Malfunctioning
Skin Interfaces withMechanical Component
Implement ControlsImplement Controls
IEC/CSA ApprovedOptical Isolators
Wireless RF Processingof Sensory Signals
Restricted Use inHazardous 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®
Expenditure Cost
FDA approval process US $10,000
Testing & Clinical Trials $50,000
Overhead (facilities, staff, raw materials) $500,000 per year
Cost of Manufacture (fabrication, assembly) $9,000 per unit
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 The Wright HandHand®
1
Wrist Prosthesis
2
Whole Arm Prosthesis
3
Whole LegProsthesis
4
Spinoff Product Platform
Drug Delivery (Smart Pill)
Catheter-steering Element
Artificial Heart
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