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

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®

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

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

G2 Innovations Inc. G2 Innovations Inc.

Robotic Surgical Instruments

Active Audio Speakers

Active BrailleDisplay

!! 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 !!