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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. Where’s my change?.

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sensamove arm

SensaMove Arm

SensaMove Technologies

Irena Barbulovic-Nad

Stefanie Blain

Geneviève Gavigan

Rohini Gupta

Jennifer Kohlenberg

Golnaz Vahedi

November 30th, 2005

where s my change
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
Objective
  • Develop a prosthetic that improves upon:

Functionality

Weight

Audible noise

Ease of use

outline
Outline
  • Highlights of technology
  • Biopsychosocial implications
  • FDA approval
  • Commercialization
  • Questions
the sensamove arm

MMG electrodes

User-trained

Microprocessor

Supinating / pronatingwrist

90º ROM elbow

Artificial muscles

Electroactive

Polymer sensors

Open / close hand

The SensaMove Arm
sensors
Sensors

Grip pressure sensor

Grip

EAP locations

Finger pressure sensors

artificial muscles
Artificial Muscles

Hydrogel

Muscle

conformation

Artificial

muscle

E.A. Moschou et al. / Sensors and Actuators B xxx (2005) xxx–xxx

training
Training

User

Elbow

Artificial Neural Network

Hand

Wrist

get to market fda approval
Get to Market: FDA Approval

Data for Market Submission

“Medical Device”

Classify Device

Step 1

Step 2

Step 3

  • 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
competitors
Competitors:
  • Motion Control, Inc.
  • Otto Bock HealthCare
  • T.R.S., Inc
  • Variety Ability Systems Inc.
commercialization market usa data

Source: BCC, Inc

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%)
commercialization the so so
Commercialization: The ‘So-So’
  • R&D:
    • New techniques in preliminary research
  • Legal:
    • Concepts: Artificial muscle, MMG, EAP
  • Commercial:
    • Acceptance – New training
commercialization the good
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
sensamove prosthetics
SensaMove Prosthetics
  • Lead Product: SensaMove Arm
  • Platform Technology: Feedback Sensors
  • Timeline: