7. Team
• Proven Control
System
• Highly
collaborative
• Have Provided Design
Input
• Helping with Market
Research
• Main distributor
of the Southeast
for orthopedics
• Providing input from a
clinical setting
Chris Lake
CEO/CPO
• ISO 9001/13485
• Design and Mfg
services
• Get cGMP in place
• Design / Mfg integrated
9. Traction
• Lake Prosthetics
wants 10 units
• Main distributor of
the Southeast for
orthopedics
• Providing input from a
clinical setting
Chris Lake
CEO/CPO
• Part of a soft launch
with his channel
• Currently working
on Northeast area
12. The Sprints
Risk Mitigation:
$10k to $15k (1 year)
• Provisional Patent (3 weeks)
• Final Patent/PCT continuation
(1 year from start)
Production Setup:
$75k (4 months)
• Final Design by Contract Mfg.
• Prototype fleet for partner review
Channel Development:
$100k ( 1 year)
• Prototype fitting and support for
early adopters
First Article Batch:
$25k (3 months)
• First production batch to satisfy
demand
Bottom Line:
• $215k
• 8 months to market
13. Five Year Plan
• Year 1: Device DFM and Launch
• Year 2: Tradeshow Appearances and Workshops to improve
sales, Full Patent Filed
• Year 3: Full Patent Filed, Device 2 redesign starts for next
market segment (lower limb)
• Year 4: Sales of Device 1, 510k submission of Device 2
• Year 5: Active Sales Push for Device 2 and 510k Approval
14. The Mission
• Increase access to exoskeleton therapy for the handicapped
• Enable @ home occupational therapy
• Bring to market a low cost, high performance exoskeleton
platform
Editor's Notes
Stroke
Most expensive
Coming in at 2% of the population, patients carry this all their lives
The only sure-fire way is increased therapy, they need at least double what they currently have, 60% of the time they are alone and unable to care HUGE RISK
Adds $1.3 Billion in additional costs each year, Up to $16.7BB
Total Market for TBI in 2015, $22.5 Billion
Reword End-user
Traction
Myopro 510k submission K062631 calls out three predicates
For the active motor component they use the Boston elbow
Boston Elbow is covered by powered exercise equipment 890.5380, therefore it is class I cGMP exempt with an exception to complaint reporting and record keeping