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

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

18. 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”

19. 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

20. 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

21. 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

22. 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)

23. Timeline

24. 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

25. 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%

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

27. Value Analysis WeightEvaluation (-1,0,1) Score Scientific Considerations Robustness 300 Development Stage 313 Scientific Competition 3-3 Total 90 Commercial Potential Market Size 500 Perceived Need 500 Freedom from Competition 5-5 Distance from Market 515 Time to Positive Cash Flow 300 Profit Margin of Product 515 Capital Required 4-4 Attractiveness to Investors 300 Exit Strategy 313 Total 384 WeightEvaluation (-1,0,1) Score Legal Considerations IP Position515 Defensibility of Patent212 Freedom to Practice414 Infringement Detection200 Absence of Regulatory Barriers414 Total 178 People Considerations Cooperative Nature515 Number of Stakeholders300 Balance of Skills300 Track Record2-2 Realistic Expectations500 Time/Willingness to Support300 Total 213 GRAND TOTAL 22

28. 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

29. Questions?