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?