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SensaMove Arm SensaMove Technologies Irena Barbulovic-Nad Stefanie Blain Geneviève Gavigan Rohini Gupta Jennifer Kohlenberg Golnaz Vahedi November 30 th, 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-trained Microprocessor
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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 Hand Wrist
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ICF Model
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Get to Market: FDA Approval Step 1 defined by 201(h) in FD&C Act Step 2 no substantially equivalent PMA $90,910 “de novo” process as Class II under 513(f)(2) 510(k) $3,066 Step 3 performance standards clinical performance data patient registries post market surveillance guidelines Step 1Step 2Step 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: PhaseMilestone6 mnth1 yr2 yr3 yr Research and DesignDetail Design Prototype constructionPrototype arm TestingClient use CommercialProduction capability
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Money Money Money NPV = $7.5 M Investment = $1.5 M
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Technology that Feels Questions ?
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