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Innovating Prosthetics: Introducing The Gadgematic for Amputee Empowerment

The Gadgematic is a groundbreaking prosthetic device designed for individuals with below-elbow amputations. This device addresses the inadequacies of current solutions by offering a customizable base unit with interchangeable attachments for various tasks. Targeting the 1.2 million amputees in the U.S., the Gadgematic facilitates personal and social development while enabling basic functions with agility. We aim for FDA approval as a Class I medical device, ensuring minimal risk to users. Financial analysis indicates a viable market opportunity. Join us in redefining prosthetic experience.

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Innovating Prosthetics: Introducing The Gadgematic for Amputee Empowerment

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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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