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. Design 2. Testing 3. Business Model 4. Competitors

Design Considerations Availability Cost Functions Psychology Social Prosthetic Leg

Proposed Design Axial resistance Polymer socket Height adjustable Breathable gel liner Reduce impact forces Stance locking Orthonormal rotation Economic and tough structure Load-bearing Shoe friendly Esthetically pleasing Adjustable resistance Modular design!

Performance Testing Interview Data collection Interview Data collection Clinical testing in hospitals Clinical testing in hospitals Performance and structural testing of lower-limb prostheses Performance and structural testing of lower-limb prostheses Lab Testing Patient Study Follow-up Studies Follow-up Studies ~ 6 months 1 month1 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 1 Establish if a medical device Step 2 Classification Identify the level of regulatory control (safety and effectiveness) Step 3 Submit 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 3 Appropriate 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 & Require: Registration, listing, labeling

Business Outlook Planning Target Market RevenuesInvestorsCompetitors

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. Target Market

Business Outlook Planning Target Market RevenuesInvestorsCompetitors

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 Target Market Investors

Business Outlook Planning Target Market RevenuesInvestorsCompetitors

Revenues Prices we are targeting are: <$40 Stainless Steel + metal components: $15 Foot: $3 Gel + polymer: $10 Target production: 100,000/year Breakdown of cost: R&D: $150,000 (over 2 years) Other+ Overhead $500,000 Net Earnings = $12/leg Annual Revenues: $ /year Target Market Investors Revenues

Business Outlook Planning Target Market RevenuesInvestorsCompetitors

Market Comparison High End Models C-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