SensaMove Arm SensaMove Technologies Irena Barbulovic-Nad Stefanie Blain Geneviève Gavigan Rohini Gupta Jennifer Kohlenberg Golnaz Vahedi November 30 th, 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-trained Microprocessor
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 Hand Wrist
ICF Model
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
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: PhaseMilestone6 mnth1 yr2 yr3 yr Research and DesignDetail Design Prototype constructionPrototype arm TestingClient use CommercialProduction capability
Money Money Money NPV = $7.5 M Investment = $1.5 M
Technology that Feels Questions ?