SensaMove ArmSensaMove Technologies
Irena Barbulovic-NadStefanie Blain
Geneviève GaviganRohini Gupta
Jennifer KohlenbergGolnaz Vahedi
November 30th, 2005
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
Objective Develop a prosthetic that improves upon:
Functionality
Weight
Audible noise
Ease of use
Outline Highlights of technology Biopsychosocial implications FDA approval Commercialization Questions
The SensaMove Arm
MMG electrodes
Artificial muscles
90º ROM elbow
Electroactive Polymer sensors
Supinating / pronating wrist
Open / close hand
User-trainedMicroprocessor
Sensors
Finger pressure sensors
Grip pressure sensor
EAP locationsGrip
Artificial Muscles
E.A. Moschou et al. / Sensors and Actuators B xxx (2005) xxx–xxx
Hydrogel
Artificial muscle
Muscle conformation
Training
Artificial Neural Network
User
Elbow
HandWrist
ICF Model
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
Competitors:
Motion Control, Inc.
Otto Bock HealthCare
T.R.S., Inc
Variety Ability Systems Inc.
Can we commercialize?
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
Commercialization: The ‘So-So’ R&D:
New techniques in preliminary research
Legal: Concepts: Artificial muscle, MMG, EAP
Commercial: Acceptance – New training
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
Start Up Company
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
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
Technology that FeelsQuestions ?