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Low Cost Modular Prosthetic System

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.

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Low Cost Modular Prosthetic System

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  1. Low Cost Modular Prosthetic System Leg-O™

  2. Landmines

  3. Victims of Landmines • Psychological trauma • Social exclusion • Struggle to make a living

  4. 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

  5. Overview 1. Design 2. Testing 3. Business Model 4. Competitors

  6. Design Considerations Cost Functions Prosthetic Leg Availability Psychology Social

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

  8. Performance Testing Lab Testing Patient Study Follow-up Studies Performance and structural testing of lower-limb prostheses Clinical testing in hospitals Interview Data collection ~ 6 months 1 month 1 year

  9. 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)

  10. 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

  11. 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

  12. 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 820.180 & 820.198 -Require: Registration, listing, labeling

  13. Business Outlook Planning Target Market Investors Revenues Competitors

  14. 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 Target Market

  15. Business Outlook Planning Target Market Investors Revenues Competitors

  16. 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 Investors Target Market Investors

  17. Business Outlook Planning Target Market Investors Revenues Competitors

  18. 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: $700 000/year Revenues Target Market Investors Revenues

  19. Business Outlook Planning Target Market Investors Revenues Competitors

  20. Market Comparison • C-leg & RHEO Knee: • >$30,000 • Customized designs • Computer aided walk • Complex functions • Very few people can afford! • C-leg: US:300, Worldwide:2000 High End Models

  21. Market Comparison • Donated/Used Legs • Dr. Pearce’s design • Low cost / free • Uses materials found locally • Low quality

  22. Market Comparison

  23. 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

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