Praesentation

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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
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Outline
Background Need for Prosthetic Hand Review of
Current Technology The Wright Hand Electroactive
Polymer Technology Meeting Standards and
Regulation FDA Regulatory Process Commercializati
on Market Assessment Product Valuation Future
Product Platforms Product Diversification
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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
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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
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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
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Actuator Technology Summary
How about Electroactive Polymers?
Background
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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
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G2 Innovations The Wright Hand
The Wright Hand
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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
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G2 Innovations The Wright Hand

• Advantages
• Compact structure with many DOF
• Light weight
• Noiseless
• Pliable
• Wide Temperature Range (-100ºC to 250ºC)

The Wright Hand
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G2 Innovations The Wright Hand
Complete The Wright Hand Package
Background
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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
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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

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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/
• Competitors Devices
• Past Experience

Meeting Standards and Regulations
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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
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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
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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 CDN300 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
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Product Valuation

• Wright Hand base unit 12,000
• 2-year service package 2,000
• Custom silicone covers 2,000-10,000
• Total Cost CDN12,000-24,000
• Cost comparable to Utah Arm ProControl System
• USD13,500-35,000

Commercialization
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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
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Future Wright Hand Product Platform
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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 !!