1. Heart Exercise Accelerometer Rehabilitation Tool CS 410 Orange Team November 19, 2008 Old Dominion University - Team Orange H.E.A.R.T. - www.cs410.com 1 Wednesday, November 19, 2008

2. Team Information Old Dominion University - Team Orange H.E.A.R.T. - www.cs410.com 2 Professor Brunelle David Hardware Specialist Ryan Project Manager Andrew Finance and Webmaster Spencer Software and Market Nicole Software Specialist Generoso Systems Specialist Experts Dr. Daniel Garland M.D. President of Pathologist Department Obici Hospital Suffolk Mrs. Janet Jackson BSN RN HCMSDM Regulatory Compliance Manager Amerigroup Corporation Virginia Beach Wednesday, November 19, 2008

3. Overview Old Dominion University - Team Orange H.E.A.R.T. - www.cs410.com 3 Problem Customer Solution System Overview Risk and Benefit Analysis Market and Financial Analysis Conclusion Wednesday, November 19, 2008

4. Cardiac-patients do not commit to the long-term rehabilitation necessary to extend their life. Old Dominion University - Team Orange H.E.A.R.T. - www.cs410.com 4 Wednesday, November 19, 2008

5. Short Term Rehabilitation Goals A medical evaluation done by health professionals is used to determine appropriate exercise goals and procedures. Exercise: FITT – Frequency: 3 – 5 times a week. – Intensity: Target heart rate – Time: 30 – 60 min per session – Type: Aerobic Old Dominion University - Team Orange H.E.A.R.T. - www.cs410.com 5 Wednesday, November 19, 2008

6. Long Term Rehabilitation Goals Lifestyle Education: – Increase involvement in rehabilitation process – Illustrate concrete benefits of lifestyle change Support: – Provide accountability and control of exercise regimen – Provide feedback on progress Old Dominion University - Team Orange H.E.A.R.T. - www.cs410.com 6 Wednesday, November 19, 2008

7. Benefits of Long-Term Rehabilitation Lifestyle Changes for patient: Increased Involvement: Education on concrete benefits of managing their own long term rehabilitation Accountable for choices they make Improve Quality of Life: Increased Heart Strength and Mobility Lower Blood Pressure, Cholesterol, and BMI Decreased emotional stress, depression, and anxiety Old Dominion University - Team Orange H.E.A.R.T. - www.cs410.com 7 Wednesday, November 19, 2008

8. Current Morbidity Data Representation of 5 million people currently living with a heart condition. Wednesday, November 19, 2008 Old Dominion University - Team Orange H.E.A.R.T. - www.cs410.com 8

9. Current Rehabilitation System Old Dominion University - Team Orange H.E.A.R.T. - www.cs410.com 9 Wednesday, November 19, 2008

10. Modified Rehabilitation System Old Dominion University - Team Orange H.E.A.R.T. - www.cs410.com 10 Wednesday, November 19, 2008

11. Heart Exercise Accelerometer Rehabilitation Tool A multi-sensor system utilizing piezoelectric accelerometers on a primary band and multiple optional secondary bands connected to the primary band via a wireless technology. Old Dominion University - Team Orange H.E.A.R.T. - www.cs410.com 11 Wednesday, November 19, 2008

12. H.E.A.R.T. The solution will: Contain mechanics to monitor and record patients’ heart rate, exercise type, intensity, and duration each time they exercise. Reinforce positive progress with reports and analysis of future potential benefits. Be utilized during rehabilitation patient follow- ups. Be non-intrusive and not substantially modify current established rehabilitation process. Old Dominion University - Team Orange H.E.A.R.T. - www.cs410.com 12 Wednesday, November 19, 2008

13. H.E.A.R.T. Component Diagram Old Dominion University - Team Orange H.E.A.R.T. - www.cs410.com 13 Wednesday, November 19, 2008

14. Device Process Flow Old Dominion University - Team Orange H.E.A.R.T. - www.cs410.com 14 Wednesday, November 19, 2008

15. Client Software Output Old Dominion University - Team Orange H.E.A.R.T. - www.cs410.com 15 Wednesday, November 19, 2008

16. H.E.A.R.T. Effects The patient will: Develop and maintain positive long-term lifestyle changes for activity as recommended by the rehabilitation specialists. Be involved in managing their rehabilitation through feedback on progress. Be educated and accountable for their long term exercise and rehabilitation regimen. Old Dominion University - Team Orange H.E.A.R.T. - www.cs410.com 16 Wednesday, November 19, 2008

17. Capabilities of H.E.A.R.T. Capable Involve the patient. Illustrate concrete benefits through feedback on progress. Provide historical data on exercise and heart rate progress. Offer immediate alerts. Extensible to other exercise applications. Incapable Provide Dr. referral. Force attendance. Provide transportation. Old Dominion University - Team Orange H.E.A.R.T. - www.cs410.com 17 Wednesday, November 19, 2008

18. Competition Old Dominion University - Team Orange H.E.A.R.T. - www.cs410.com 18 Wednesday, November 19, 2008

19. Existing Technology Utilized Old Dominion University - Team Orange H.E.A.R.T. - www.cs410.com 19 TechnologyMinMeanMax Heart Sensor$5$20$50 Accelerometer$20$25$55 Battery$10 $20 CPU$10$14$19 RAM$1.63$3.27$5.12 USB$0.19 Wednesday, November 19, 2008

20. Risk Analysis Chart Old Dominion University - Team Orange H.E.A.R.T. - www.cs410.com 20 Wednesday, November 19, 2008

21. FDA approval This is in response to your email below to the U.S. Food and Drug Administration (FDA) requesting information on a medical product. If this product makes a medical claim, then it would be considered a medical device. For more information on what a manufacturer of a device must do to get a medical device cleared by the FDA for marketing, please visit our Device Advice web site at http://www.fda.gov/cdrh/devadvice/ Please feel free to email me back directly if you have any further questions. Good luck with your project. Sincerely, Bonnie J. Alderton Consumer Staff Division of Small Manufacturers, International and Consumer Assistance Center for Devices and Radiological Health U.S. Food and Drug Administration bonnie.alderton@fda.hhs.gov 21 Old Dominion University - Team Orange H.E.A.R.T. - www.cs410.com Wednesday, November 19, 2008

22. Old Dominion University - Team Orange H.E.A.R.T. - www.cs410.com 22 Net Income: Large: >10 million Medium: 5-10 million Small: <5 million Percent of Industry: Large: 5% Medium: 42% Small: 53% Estimated cost of Heart Disease in 2008: $156.4 billion Wednesday, November 19, 2008

23. Budget Old Dominion University - Team Orange H.E.A.R.T. - www.cs410.com 23 Wednesday, November 19, 2008

24. Two-year Fiscal Analysis Old Dominion University - Team Orange H.E.A.R.T. - www.cs410.com 24 IncomeExpenditure Device sales3,745,000Device construction3,155,000 Initial investment500,000 Operation cost380,000 3,745,0004,035,000 First Year: 290,000 Loss IncomeExpenditure Device sales3,745,000Device construction3,155,000 Operation cost380,000 3,745,0003,535,000 Second Year: 210,000 Profit Wednesday, November 19, 2008

25. H.E.A.R.T. Benefits Patient involvement in rehabilitation leading to positive long term lifestyle changes and a longer, healthier life. Reduced insurance premiums due to decreased hospitalization. Minimal impact on currently established rehabilitation procedures. Old Dominion University - Team Orange H.E.A.R.T. - www.cs410.com 25 Wednesday, November 19, 2008

26. Team Management Old Dominion University - Team Orange H.E.A.R.T. - www.cs410.com 26 Our primary tool for team coordination is Dot Project. This tool allows us to collaborate online and assign tasks to each other. It also contains a forum and allows us to maintain a versioned file repository. We meet every Thursday at 6pm, and as needed. Dot Project Team based active collaboration software. Word Press HTML Templating Engine. Tools Utilizing Wednesday, November 19, 2008

27. Funding Plan National Science Foundation Grant Proposals Application Guide Forms and Applications Grants.gov Research Experiences for Undergraduates : Total Funding = $33,000,000Research Experiences for Undergraduates Improving Heart Failure Disease Management : up to $250,000Improving Heart Failure Disease Management Cardiac Translational Research Implementation Program (C-TRIP) : up to $500,000Cardiac Translational Research Implementation Program (C-TRIP) Mechanisms of Functional Recovery After Stroke : up to $250,000Mechanisms of Functional Recovery After Stroke Phase 1 US Small Business Administration SBIR Overview Loan Eligibility SBA Loans US Department of Commerce Loans & Grants Phase 2 Various Investor Groups National Venture Capital Association (NVCA) Venture Capital and Angel Investors Funding Universe U.S. Angel Investors U.S. Angel Investors Phase 3 Wednesday, November 19, 2008 Old Dominion University - Team Orange H.E.A.R.T. - www.cs410.com 27

28. Budget: Phase 1 Wednesday, November 19, 2008 Old Dominion University - Team Orange H.E.A.R.T. - www.cs410.com 28

29. Budget: Phase 2 Old Dominion University - Team Orange H.E.A.R.T. - www.cs410.com Wednesday, November 19, 2008 29

30. Budget: Phase 3 Wednesday, November 19, 2008 Old Dominion University - Team Orange H.E.A.R.T. - www.cs410.com 30

31. Budget Recap Wednesday, November 19, 2008

32. Phase 0 Organization Wednesday, November 19, 2008