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Gadgetizificationeers

Gadgetizificationeers. Jibsy Jacob Howard Kim Christopher Moraes Jatinderpreet 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

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Gadgetizificationeers

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  1. Gadgetizificationeers Jibsy Jacob Howard Kim Christopher Moraes Jatinderpreet Singh Jean-Philippe St-Pierre

  2. Outline • Background & Target Market • The problem • Proposed Device: The Gadgematic • FDA Approval • Financial Analysis • Conclusion

  3. 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

  4. The Problem • Inadequate Current Solutions • Current R&D – requires many years • Specialized Functionality • Cumbersome & impractical for daily use • Minimal customizability available

  5. 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

  6. Competitive Edge • Developed a platform for future growth • Possibility for ‘hands-free’ interchanging • Easily customizable attachments • Work-related: single-finger typing, pen-holding • Hobby & Social activities: eating utensils, painting • Sporting equipment prostheses • Music & Entertainment-related

  7. 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”

  8. FDA Approval: Classification • 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

  9. 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

  10. 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

  11. 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)

  12. Timeline

  13. 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

  14. 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%

  15. Million $ Year Cash flow for first 5 years of sale

  16. Value Analysis

  17. 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

  18. Questions?

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