Low Cost Modular Prosthetic System Leg-O ™. Landmines.
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Transcript of Low Cost Modular Prosthetic System Leg-O ™. Landmines.
![Page 1: Low Cost Modular Prosthetic System Leg-O ™. Landmines.](https://reader038.fdocuments.us/reader038/viewer/2022110210/56649eab5503460f94bb0aa3/html5/thumbnails/1.jpg)
Low Cost Modular Prosthetic System
Leg-O™
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Landmines
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Victims of Landmines
• Psychological trauma• Social exclusion• Struggle to make a living
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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
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Overview
1. Design1. Design
2. Testing 2. Testing
3. Business Model3. Business Model
4. Competitors 4. Competitors
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Design Considerations
Availability
CostFunctions
Psychology
Social
Prosthetic Prosthetic LegLeg
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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!
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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
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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)
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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
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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
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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
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Business Outlook
Planning
TargetMarket
RevenuesInvestors Competitors
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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
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Business Outlook
Planning
TargetMarket
RevenuesInvestors Competitors
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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
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Business Outlook
Planning
TargetMarket
RevenuesInvestors Competitors
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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
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Business Outlook
Planning
TargetMarket
RevenuesInvestors Competitors
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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
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Market Comparison
Donated/Used Legs
Dr. Pearce’s design
•Low cost / free
•Uses materials found locally
•Low quality
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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
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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