sensamove arm sensamove technologies irena barbulovic-nad stefanie blain geneviève gavigan rohini...
TRANSCRIPT
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SensaMove ArmSensaMove Technologies
Irena Barbulovic-NadStefanie Blain
Geneviève GaviganRohini Gupta
Jennifer KohlenbergGolnaz Vahedi
November 30th, 2005
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Where’s my change? Problems with current prosthetics (suggested from literature
and by individual who uses four prosthetic limbs)
Weight Audible noise Unnatural appearance Durability Temperature Speed of arm’s movement Ease of Use Functionality
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Objective Develop a prosthetic that improves upon:
Functionality
Weight
Audible noise
Ease of use
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Outline Highlights of technology Biopsychosocial implications FDA approval Commercialization Questions
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The SensaMove Arm
MMG electrodes
Artificial muscles
90º ROM elbow
Electroactive Polymer sensors
Supinating / pronating wrist
Open / close hand
User-trainedMicroprocessor
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Sensors
Finger pressure sensors
Grip pressure sensor
EAP locationsGrip
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Artificial Muscles
E.A. Moschou et al. / Sensors and Actuators B xxx (2005) xxx–xxx
Hydrogel
Artificial muscle
Muscle conformation
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Training
Artificial Neural Network
User
Elbow
HandWrist
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ICF Model
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Get to Market: FDA Approval
Step 1defined by 201(h) in FD&C Act
Step 2no substantially equivalent PMA $90,910“de novo” process as Class II under 513(f)(2) 510(k) $3,066
Step 3performance standardsclinical performance datapatient registriespost market surveillanceguidelines
Step 1 Step 2 Step 3“Medical Device”
Classify Device
Data for Market
Submission
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Competitors:
Motion Control, Inc.
Otto Bock HealthCare
T.R.S., Inc
Variety Ability Systems Inc.
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Can we commercialize?
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Commercialization: Market (USA data)
350,000 amputees - 30% upper limb loss
50,000 new amputations/yr - 20% upper limb
Target Clients: 100,000
Market increase from $5.2 billion in 2005 to $6.8 billion in 2010 (AAGR of 5.5%)
Source: BCC, Inc
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Commercialization: The ‘So-So’ R&D:
New techniques in preliminary research
Legal: Concepts: Artificial muscle, MMG, EAP
Commercial: Acceptance – New training
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Commercialization: The ‘Good’ Legal:
Patentable: Pressure Sensor, Complete arm People:
Dynamic team Skilled and Resourceful
Commercial: Address unmet needs for prosthetics Reach market in 3 yrs High market potential
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Start Up Company
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SensaMove Prosthetics
Lead Product: SensaMove Arm Platform Technology: Feedback Sensors Timeline:
Phase Milestone 6 mnth 1 yr 2 yr 3 yr
Research and Design Detail Design
Prototype construction Prototype arm
Testing Client use
Commercial Production capability
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Total Units Sold 637Cost of Capital 8%Net Present Value $7,514,471.41
Year 1 2 3 4 5 … 10
Growth Rate 50% 50%No. of People Mng. 6 6 6 8 8 10Units Sold 0 0 0 20 30 225Patent Costs -$50,000Legal Fees, Insurance -$20,000 -$20,000 -$20,000 -$20,000 -$20,000 -$20,000Rent & Oprt. Cost -$100,000 -$100,000 -$100,000Equipment -$500,000 -$10,000 -$10,000 -$10,000Material -$50,000 -$280,000 -$420,000 -$3,150,0001 Prototype, 2 Demos -$100,000Marketing -$20,000 -$20,000 -$40,000 -$40,000 -$40,000R&D (subcontracting) -$20,000 -$20,000 -$20,000 -$20,000 -$20,000FDA Approval -$100,000Total Sale* $0 $0 $0 $1,400,000 $2,100,000 $15,750,000
Salaries $0 $0 $0 -$960,000 -$960,000 -$1,200,000Sales Cost (%10) -$140,000 -$210,000 -$1,575,000Tech. Support (%5) -$70,000 -$105,000 -$787,500Training (%3) -$42,000 -$63,000 -$472,500Warranty (5%) -$70,000 -$105,000 -$787,500Net Cash Flow -$120,000 -$160,000 -$660,000 -$352,000 $47,000 $7,587,500
*Price/Unit $70,000; Material Cost/Unit 20%;
Money Money Money
NPV = $7.5 MInvestment = $1.5 M
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Technology that FeelsQuestions ?