Low Cost Modular Prosthetic System

Leg-O™

Landmines

Victims of Landmines

• Psychological trauma• Social exclusion• Struggle to make a living

Landmines worldwide

• Afghanistan• Angola• Bosnia-Herzegovina• Cambodia• Croatia• Iraq• Mozambique• Namibia• Somalia• Nicaragua• Sudan

• These 11 countries house 50% of remaining landmines

• Estimated 70,000,000 landmines still left in over 90 countries

• In Afghanistan, 150 people/month become victims

• More than 200,000 have been injured over the past two decades

Overview

1. Design1. Design

2. Testing 2. Testing

3. Business Model3. Business Model

4. Competitors 4. Competitors

Design Considerations

Availability

CostFunctions

Psychology

Social

Prosthetic Prosthetic LegLeg

Proposed Design

Axial resistance

Polymer socket

Height adjustable

Breathable gel liner

Reduce impact forcesStance locking

Orthonormal rotation

Economic and tough structure

Load-bearing

Shoe friendlyEsthetically

pleasing

Adjustable resistance

Modular design!

Performance Testing

InterviewData collection

InterviewData collection

Clinical testingin hospitals

Clinical testingin hospitals

Performance and structural testing

of lower-limb prostheses

Performance and structural testing

of lower-limb prostheses

Lab TestingLab Testing Patient StudyPatient Study Follow-up Studies

Follow-up Studies

~ 6 months 1 month 1 year

Lab Testing Validation of design•prototype development•finalize fabrication technique •finalize material selection. Static/ dynamic lower limb testing (using) single loading-module machine

Fatigue Testing Check for excessive deformation

Test typical compression loads •at different angles, momentary impact etc.•Evaluate individual components •evaluate entire assembly•Match and exceed ISO standards.

• Perform simulated endurance tests for 5-year (service life ;average # of hours of walking time per day)

Patient Testing

• Small group of volunteers • Fitting Protocol: Time, Complexity, Training, Education

• Patient Feedback & Interview

• Performance Testing, repair and improvement

• Examine wear, evaluate sockets, surveys of design

FDA

Step 1Establish if a medical device

Step 2Classification Identify the level of regulatory control (safety and effectiveness)

Step 3Submit a marketing application(development of data and/or information necessary)Meet pre-market & post market requirement

LegO requirements for FDA:

Step 1:Code 890 Physical Medicine

Step 2:Class I device with exemptions

Step 3Appropriate Marketing Application -Exempt from pre-market approval -Exempt from pre-market notification-Exempt from GMP (good manufacturing practice requirements)

Component Manufacturers

Require quality system regulation 820.180 & 820.198

-Require: Registration, listing, labeling

Business Outlook

Planning

TargetMarket

RevenuesInvestors Competitors

Target Market

• Low income individuals around the world

eg. Landmine victims, war victims, etc.

• This can include low income clients within North America as well.

TargetMarket

Business Outlook

Planning

TargetMarket

RevenuesInvestors Competitors

Investors

• Unlikely to find a typical investor:

- marginal/humanitarian markets

- tap into sources of funding that is free• UN• NGO’s (non-governmental organizations) • Foundations with money who can help • Collaboration with groups in Universities e.g.

Queens

TargetMarket

Investors

Business Outlook

Planning

TargetMarket

RevenuesInvestors Competitors

Revenues

• Prices we are targeting are:<$40Stainless Steel + metal components: $15Foot: $3Gel + polymer: $10

• Target production: 100,000/year• Breakdown of cost:

R&D: $150,000 (over 2 years)Other+ Overhead $500,000

Net Earnings = $12/legAnnual Revenues: $700 000/year

TargetMarket

InvestorsRevenues

Business Outlook

Planning

TargetMarket

RevenuesInvestors Competitors

Market Comparison

High End ModelsC-leg & RHEO Knee:

• >$30,000

•Customized designs

•Computer aided walk

•Complex functions

•Very few people can afford!

C-leg: US:300, Worldwide:2000

Market Comparison

Donated/Used Legs

Dr. Pearce’s design

•Low cost / free

•Uses materials found locally

•Low quality

Market Comparison

•$40

•Quality controlled

•Relatively comfortable

•Instant adjustment

•Long lasting

•Reliable

•Aesthetical

•$0.15/free

•No quality control

•Uncomfortable

•Cannot easily adjust

•Doesn’t last long

•$30,000+

•Complex functions

•High maintenance

cost

•$40

•Simple function

•Low maintenance

cost

Conclusions

• We have outlined:– The tremendous need for an inexpensive and

effective prosthetic leg– A design that meets the requirements of our

patients– A feasible business plan – A survey of our potential competitors

• Leg-O is an important and worthwhile venture