Gadgetizificationeers Jibsy Jacob Howard Kim Christopher Moraes Jatinderpreet Singh Jean-Philippe...
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Transcript of Gadgetizificationeers Jibsy Jacob Howard Kim Christopher Moraes Jatinderpreet Singh Jean-Philippe...
Gadgetizificationeers
Jibsy JacobHoward Kim
Christopher MoraesJatinderpreet Singh
Jean-Philippe St-Pierre
Outline
Background & Target Market The problem Proposed Device: The Gadgematic FDA Approval Financial Analysis Conclusion
Background & Target Market
Loss of Limb– United States: 1.2 million amputees in 1996– United States: 16,000 new amputees / year– 30% are under 45
Biopsychosocial Model– Difficulty performing basic functions– Degradation in social & athletic participation– Psychological effects
*DATA SOURCE: National Health Interview Survey, Vital Statistics Report, Series 10, No. 200, 1996
The Problem
Inadequate Current Solutions Current R&D – requires many
years
Specialized Functionality– Cumbersome & impractical for daily
use– Minimal customizability available
Solution: The Gadgematic
Target Market– single forearm/hand amputees (below the elbow)
Single prosthetic ‘base unit’ Multiple functional & cosmetic attachments
– one attachment for one task
Quick & easy exchange of devices Facilitate personal & social development
Competitive Edge
Developed a platform for future growth
Possibility for ‘hands-free’ interchanging
Easily customizable attachments
• Work-related: single-finger typing, pen-holdingWork-related: single-finger typing, pen-holding
• Sporting equipment prosthesesSporting equipment prostheses
• Music & Entertainment-relatedMusic & Entertainment-related
• Hobby & Social activities: eating utensils, paintingHobby & Social activities: eating utensils, painting
FDA Approval: Classification
Request for FDA approval processed by the CDRH
The device of interest is classified as a physical medicine prosthetic device
In our design, the device must be divided in 2 parts that must be processed separately:
– 890.3420 External Limb Prosthetic Component Identification: “device intended for medical purposes that, when put
together with other appropriate components, constitutes a total prosthesis”
– 890.3025 Prosthetic & Orthotic Accessory Identification: “device intended for medical purposes to support,
protect, or aid in the use of… prosthesis”
Such parts are classified as Class I (General controls) medical devices based on:
– Their intended use– The limited risks to the user
These parts are exempt from premarket notification procedures (limitations in 890.9 do not apply)
They are also exempt from the Good Manufacturing Practices (GMP) Regulations with 2 exceptions:
– 820.180– 820.198
FDA Approval: Classification
FDA Approval: GMP Requirements
Sec. 820.180: – Addresses confidentiality and record retention period issues
Sec. 820.198:– Manufacturer needs to establish and maintain procedures for
receiving, reviewing, and evaluating complaints– Determine when an investigation is required– This must include the failure of the device, the labelling and the
packaging– It is crucial that the procedures established demonstrate an
understanding of the regulations and that decisions are made with regards to the safety of the user
FDA Approval: Other Requirements
Registration of the establishment– Has to be done within 30 days after starting activities requiring
registration– Form 2891– No fees required
Medical device listing– To keep the FDA advised of the generic category of the device– Form 2892– No fees required
Labelling requirements
Costs – 5 Year Forecast
Research, Development, & Testing ($2 M) Facilities ($3 M) Wages ($2.5 M) Materials ($1 M) Patents & Regulatory ($1 M) Marketing ($0.5 M)
Timeline
Marketing
Do we fit in the market? Utah Myoelectric Arm - $50 000 - 100 000 Standard Manual Arm ~ $5000 We’re right in the middle!
Who? 60% of arm amputees between ages of 21-64, 10% are younger
than 21 Insurance Companies, Un-insured Middle Class Workers
Marketing Strategy Advertising, Direct interaction with Doctors
Financials: Cash Flows
Selling Cost: $10 000–15 000/arm Our cost: $1000/arm
Average Salary: $45 000/year 16 000 new amputees per year in the US
10% Under 21 – Need Replacement
Market/year for first 5 years 1%, 2%, 5%, 7%, 10%
Cash flow for first 5 years of sale
02468
101214161820
1 2 3 4 5
Net SalesCost of SalesM
illi
on $
Year
Value Analysis
Weight Evaluation(-1,0,1)
Score
Scientific Considerations
Robustness 3 0 0
Development Stage 3 1 3
Scientific Competition 3 -1 -3
Total 9 0
Commercial Potential
Market Size 5 0 0
Perceived Need 5 0 0
Freedom from Competition 5 -1 -5
Distance from Market 5 1 5
Time to Positive Cash Flow 3 0 0
Profit Margin of Product 5 1 5
Capital Required 4 -1 -4
Attractiveness to Investors 3 0 0
Exit Strategy 3 1 3
Total 38 4
Weight Evaluation(-1,0,1)
Score
Legal Considerations
IP Position 5 1 5
Defensibility of Patent 2 1 2
Freedom to Practice 4 1 4
Infringement Detection 2 0 0
Absence of Regulatory Barriers 4 1 4
Total 17 8
People Considerations
Cooperative Nature 5 1 5
Number of Stakeholders 3 0 0
Balance of Skills 3 0 0
Track Record 2 -1 -2
Realistic Expectations 5 0 0
Time/Willingness to Support 3 0 0
Total 21 3
GRAND TOTAL 22
Conclusions
Developed a product– Addresses a need & has a market– Technologically possible today
Low risk of rejection by FDA Financially viable
Thank you for your time
Questions?