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