Low Cost Modular Prosthetic System

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29 Νοε 2013 (πριν από 3 χρόνια και 19 μέρες)

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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

Clinical testing

in hospitals


Performance and

structural testing


of lower
-
limb

prostheses

Lab Testing

Patient Study

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 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 820.180 & 820.198

-
Require: Registration, listing, labeling



Business Outlook

Planning

Target

Market

Revenues

Investors

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.


Target

Market

Business Outlook

Planning

Target

Market

Revenues

Investors

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

Target

Market

Investors

Business Outlook

Planning

Target

Market

Revenues

Investors

Competitors

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: $700 000/year

Target

Market

Investors

Revenues

Business Outlook

Planning

Target

Market

Revenues

Investors

Competitors

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