1. Orange Team Ryan Null CS 410 Orange Team 19 November, 2008

2. Our Team 19 November, 20082 Old Dominion University: Computer Science CS 410 Orange Team - HEART 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

3. Overview Problem Customer Solution System Overview Risk and Benefit Analysis Market and Fiscal Analysis Conclusion 19 November, 20083 Old Dominion University: Computer Science CS 410 Orange Team - HEART

4. Cardiac patients do not commit to the long-term rehabilitation necessary to extend their life. 19 November, 2008 Old Dominion University: Computer Science CS 410 Orange Team - HEART 4

5. Cardiac Rehabilitation 22 million people in the United States experience some form of heart failure. 50% of 22 million will die within 5 years. [1] 19 November, 20085 Old Dominion University: Computer Science CS 410 Orange Team - HEART [1] Popular Science Magazine

6. The goal of cardiac rehabilitation is to help the patient return to the highest level of function and independence possible, while improving the overall quality of life - physically, emotionally, and socially. [1] 19 November, 2008 Old Dominion University: Computer Science CS 410 Orange Team - HEART 6 [1] https://www.beaumonthospitals.com/health-library/P06321

7. Importance of Rehabilitation Doctor prescribed exercises are essential to successful rehabilitation Increased heart strength and mobility Lower blood pressure, cholesterol, and BMI Reduced emotional stress, depression, and anxiety 19 November, 20087 Old Dominion University: Computer Science CS 410 Orange Team - HEART

8. Current Rehabilitation System 19 November, 20088 Old Dominion University: Computer Science CS 410 Orange Team - HEART

9. Current Rehabilitation Results 19 November, 2008 Old Dominion University: Computer Science CS 410 Orange Team - HEART 9

10. Involvement of Rehabilitation Patients According to Beaumont Hospitals: “Active involvement of the patient and family is vital to the success of the program.” [1] Also: “[…] If the patient is actively engaged […] they feel like they have some control over what they will do and how they will do it.” [2] 19 November, 2008 Old Dominion University: Computer Science CS 410 Orange Team - HEART 10 [1] https://www.beaumonthospitals.com/health-library/P06321 [2] http://www.abc.net.au/rn/healthreport/stories/2007/2023663.htm

11. Goals of Solution Lifestyle Education: – Increase involvement in rehabilitation process – Illustrate concrete benefits of changes through historical data Support: – Provide accountability and control of exercise regimen – Provide feedback on progress 19 November, 200811 Old Dominion University: Computer Science CS 410 Orange Team - HEART

12. H eart E xercise A ccelerometer R ehabilitation T ool Contains 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 introduced during rehab and be utilized during patient follow-ups. Be non-intrusive and not substantially modify current established rehabilitation process. 19 November, 200812 Old Dominion University: Computer Science CS 410 Orange Team - HEART

13. Solution Overview 19 November, 200813 Old Dominion University: Computer Science CS 410 Orange Team - HEART

14. Modified Rehabilitation System 19 November, 200814 Old Dominion University: Computer Science CS 410 Orange Team - HEART

15. H.E.A.R.T. Logic 19 November, 2008 Old Dominion University: Computer Science CS 410 Orange Team - HEART 15

16. Client Rehabilitation Software 19 November, 200816 Old Dominion University: Computer Science CS 410 Orange Team - HEART

17. Client Software Report 19 November, 200817 Old Dominion University: Computer Science CS 410 Orange Team - HEART

18. H.E.A.R.T. Effects The patient will: Be involved in managing their rehabilitation through feedback on progress. Develop and maintain positive long-term lifestyle changes as recommended by their rehabilitation specialists. Be educated and accountable for their long term exercise and rehabilitation regimen. 19 November, 200818 Old Dominion University: Computer Science CS 410 Orange Team - HEART

19. Capabilities of H.E.A.R.T. Provide historical data on exercises and heart rate. Offer immediate alerts regarding safe rehabilitation recommendations. Be extensible to other medical and athletic applications 19 November, 200819 Old Dominion University: Computer Science CS 410 Orange Team - HEART

20. H.E.A.R.T. Problems The system will not be beneficial to the patient and the rehabilitation system, unless the doctor, rehabilitation specialist, and patient properly utilize the system. 19 November, 2008 Old Dominion University: Computer Science CS 410 Orange Team - HEART 20

21. Existing Technology Utilized Old Dominion University - Team Orange H.E.A.R.T. - www.cs410.com 21 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

22. Competition 19 November, 200822 Old Dominion University: Computer Science CS 410 Orange Team - HEART H.E.A.R.T. Inquiry In Home Rehab Only SenseWear Mobile X X Long-Term X X X Cost Effective X X X Involvement X X X X X Nonintrusive X X X X X Historical Data X X X Extensible X X X X Heart Rate Data X X X Exercise Type Discrimination X X X X Exercise Count X X X

23. Risks 19 November, 200823 Old Dominion University: Computer Science CS 410 Orange Team - HEART Probability Not LikelyLowModerateHighExpected Impact ExtremeT1C1 HighF1 ModerateT2C2T3F2 Low Negligible Ite m Technical RisksProbabilityImpact T1Hardware and Software Interoperability25 T2Malfunction (Device and Software)13 T3Hardware and Software Accuracy33 Ite m Financial RisksProbabilityImpact F1Insurance Rejection24 F2Market Competition43 Ite m Customer RisksProbabilityImpact C1Proof of Benefit35 C2Proper Utilization23

24. Mitigations 19 November, 200824 Old Dominion University: Computer Science CS 410 Orange Team - HEART ItemTechnical RisksMitigation T1Hardware and Software InteroperabilityExhaustive testing before trials and testing T2Malfunction (Device and Software)Software diagnosis T3Hardware and Software AccuracyProper and thorough prototyping ItemFinancial RisksMitigation F1Insurance Rejection Inform insurance companies of positive impact and return on investment F2Market CompetitionPrice our product competitively ItemCustomer RisksMitigation C1Proof of BenefitMedical Trials and beta testing C2Customer UnderstandingInstructions included with software, online resources, and embedded help system. Probability Not LikelyLowModerateHighExpected Impact ExtremeT1C1 HighF1 ModerateT2C2T3F2 Low Negligible

25. FDA 19 November, 200825 Old Dominion University: Computer Science CS 410 Orange Team - HEART 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

26. H.E.A.R.T. Market Analysis 19 November, 2008 Old Dominion University: Computer Science CS 410 Orange Team - HEART 26

27. Old Dominion University - Team Orange H.E.A.R.T. - www.cs410.com 27 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

28. H.E.A.R.T. Resources, Staffing and Funding 19 November, 2008 Old Dominion University: Computer Science CS 410 Orange Team - HEART 28

29. Phase 0 No budget is applicable, all work was done for free. 19 November, 200829 Old Dominion University: Computer Science CS 410 Orange Team - HEART

30. Phase 1 19 November, 200830 Old Dominion University: Computer Science CS 410 Orange Team - HEART TitleQtySalaryHoursHourly RateTotal Project Manager1$31,20070$15$1,050 Software Manager1$31,200460$15$6,900 Hardware Manager1$31,200380$15$5,700 Financial Director1$31,20045$15$675 Marketing Director1$31,20065$15$975 Risk Director1$31,20060$15$900 Documentation Specialist1$31,20055$15$825 Webmaster1$31,20015$15$225 Total Cost$17,025 All employees are Students 40% Overhead$6,810 Phase 1 = 6 month period Total Phase 1 Staffing Budget:$23,835 Budget Breakdown Staffing Requirements HardwareQty Unit Cost Total Heart Rate Monitor2$100.00$200.00 Piezoelectric Accelerometer4$50.00$200.00 Software (QA)1$10.00 Receivers2$10.00$20.00 Transmitters4$10.00$40.00 Production2$10.00$20.00 Material (Box, Paper, assoc, etc)2$10.00$20.00 Assembly and Manufacturing2$30.00$60.00 Memory, Battery, cables, base station4$75.00$300.00 Labor and AV technicians2$300.00$600.00 Tax (8.8%) $53.24$129.36 Total Phase 1 Hardware Budget $1,599.36 Hardware Requirements Bottom Line $99,800

31. Phase 2 19 November, 200831 Old Dominion University: Computer Science CS 410 Orange Team - HEART Budget Breakdown Staffing Requirements Hardware Requirements Bottom Line $704,430 TitleQtySalaryHoursHourlyTotal Project Manager1$87,0001200$42$50,192 Software Engineer2$71,0002000$34$136,538 Hardware Engineer2$81,0001800$39$140,192 Financial Director1$62,000420$30$12,519 Marketing Director1$44,000460$21$9,731 Documentation Specialist1$42,000600$20$12,115 HR Manager1$56,000220$27$5,923 Technical Director1$70,000680$34$22,885 Software/Hardware Tester1$69,000450$33$14,928 Webmaster1$40,000160$19$3,077 Total Cost$405,024 All employees are Full Time 40% Overhead$162,010 Phase 2 = 2 year period Total Phase 2 Staffing Budget:$567,034 HardwareQuantityCpUTotal Cost Heart Rate Monitor1,000$45.00$45,000.00 Piezoelectric Accelerometer2,000$15.00$30,000.00 Receivers2,000$5.00$10,000.00 Transmitters2,000$5.00$10,000.00 Production2,000$5.00$10,000.00 Material (Box, Paper, assoc, etc)2,000$5.00$10,000.00 Assembly and Manufacturing2,000$10.00$20,000.00 Memory, Battery, cables, base station2,000$30.00$60,000.00 Training45$80.00$3,600.00 Testing100$150.00$15,000.00 Tax (8.8%) $30.80$18,796.80 Total Phase 3 Hardware Budget $137,396.80

32. Phase 3 19 November, 200832 Old Dominion University: Computer Science CS 410 Orange Team - HEART Budget Breakdown Staffing and Hardware Requirements Bottom Line $628,072 HardwareQtyCpUTotal Cost Heart Rate Monitor1,500$45.00$67,500.00 Piezoelectric Accelerometer3,000$15.00$45,000.00 Receivers3,000$5.00$15,000.00 Transmitters3,000$5.00$15,000.00 Production3,000$5.00$15,000.00 Material (Box, Paper, assoc, etc)3,000$5.00$15,000.00 Assembly and Manufacturing3,000$10.00$30,000.00 Memory, Battery, cables, base station3,000$30.00$90,000.00 Training100$80.00$8,000.00 Testing500$150.00$75,000.00 Tax (8.8%) $30.80$33,044.00 Total Phase 2 Hardware Budget $266,044.00 TitleQtySalaryHoursHourlyTotal Project Manager1$87,000600$42$25,096 Software Engineer1$71,0001000$34$34,135 Hardware Engineer1$81,000800$39$31,154 Financial Director1$62,000450$30$13,413 Marketing Director1$44,000500$21$10,577 Documentation Specialist1$42,000400$20$8,077 HR Manager1$56,000170$27$4,577 Technical Director1$70,000440$34$14,808 Software/Hardware Tester1$69,000500$33$16,587 Lawyers1$64,000900$31$27,692 Procurement Manager1$50,000350$24$8,413 Customer Service5$41,000650$20$64,063 Webmaster1$40,000160$19$3,077 Total Cost$258,591 All employees are Full Time 40% Overhead$103,437 Phase 3 = Production Total Phase 3 Staffing Budget:$362,028

33. Budget Overview 19 November, 2008 Old Dominion University: Computer Science CS 410 Orange Team - HEART 33 PhaseStaffingResourcesPhase Total Phase 1 (6 months)$23,835$1,599$99,800 Phase 2 (Two Years)$567,034$137,397$704,430 Phase 3 (Per Year)$362,028$266,044$628,072 Total Phases 1-3$952,897$405,040$1,357,937

34. Funding Phase 1 – National Science Foundation – Grants.gov Research Experiences for Undergraduate – Funding of $33,000,000 Improving Heart Failure Disease Management – Up to $250,000 Cardiac Translational Research Implementation Program – Up to $500,000 Phase 2 – US Small Business Administration SBIR Grants – Up to $750,000 SBIR Loans – US Department of Commerce Phase 3 – Various Investor Groups National Venture Capital Association Funding Universe U.S. Angel Investors Vision 2 Reality (v2r.com) 19 November, 2008 Old Dominion University: Computer Science CS 410 Orange Team - HEART 34

35. Break Even Analysis 19 November, 200835 Old Dominion University: Computer Science CS 410 Orange Team - HEART Variable Unit Cost = $200 Fixed Cost = $266,044 Expected Unit Sales = 1,500 Price Per Unit = $500 Total Revenue = $750,000 Total Variable Costs = $300,000 Profit = $183,956 Break-Even at 886 Units UnitsFixed CostTotal CostTotal RevenueProfit ------------------------------------------------------ 0$266$266$0- $266 100$266$286$50- $236 200$266$306$100- $206 300$266$326$150- $176 400$266$346$200- $146 500$266$366$250- $116 600$266$386$300- $86 700$266$406$350- $56 800$266$426$400- $26 900$266$446$450 $3.95 1000$266$466$500$33 1100$266$486$550$63 1200$266$506$600$93 1300$266$526$650$123 1400$266$546$700$153 1500$266$566$750$183 Phase 2

36. Incentives Insurance Companies will experience: – Lower costs – Longer income Patients will experience – Lower premiums – Extended lifetime – Less hospitalization 19 November, 2008 Old Dominion University: Computer Science CS 410 Orange Team - HEART 36

37. H.E.A.R.T. Business Organization 19 November, 2008 Old Dominion University: Computer Science CS 410 Orange Team - HEART 37

38. Phase 0 19 November, 2008 Old Dominion University: Computer Science CS 410 Orange Team - HEART 38

39. 19 November, 2008 Old Dominion University: Computer Science CS 410 Orange Team - HEART 39

40. Phase 1 19 November, 2008 Old Dominion University: Computer Science CS 410 Orange Team - HEART 40

41. 19 November, 2008 Old Dominion University: Computer Science CS 410 Orange Team - HEART 41

42. Phase 2 19 November, 2008 Old Dominion University: Computer Science CS 410 Orange Team - HEART 42

43. 19 November, 2008 Old Dominion University: Computer Science CS 410 Orange Team - HEART 43

44. Phase 3 19 November, 2008 Old Dominion University: Computer Science CS 410 Orange Team - HEART 44

45. 19 November, 2008 Old Dominion University: Computer Science CS 410 Orange Team - HEART 45

46. H.E.A.R.T. Business Plans 19 November, 2008 Old Dominion University: Computer Science CS 410 Orange Team - HEART 46

47. Project Management 19 November, 2008 Old Dominion University: Computer Science CS 410 Orange Team - HEART 47 Management Plan Marketing PlanDevelopment Plan Evaluation PlanStaffing Plan Financial PlanWork Breakdown Structure FundingRisk Management

48. Major Milestones Phase 0 – Established solution – Established website – SBIR – Funding acquisition Phase 2 – Medical trials – Exhaustive testing – Expansion of capabilities Phase 1 – Exercise discrimination – Logging and processing – Technical documentation – Prototype Phase 3 – First sale – First life extended 19 November, 2008 Old Dominion University: Computer Science CS 410 Orange Team - HEART 48

49. Development Plan 19 November, 2008 Old Dominion University: Computer Science CS 410 Orange Team - HEART 49

50. Risk Management Plan Identify and categorize risks according to severity and probability. Mitigate the impact of risks by preventing the cause or alleviate current risks. Continually re-examine risks throughout all phases. Anticipate and beware of new risks 19 November, 200850 Old Dominion University: Computer Science CS 410 Orange Team - HEART

51. Evaluation Plan Scope – Close observation of new cardiac incidents and rehabilitation market Duration – Measured against original allocated time Cost – Compared to estimations by phase Quality – Observe and respond to customer feedback 19 November, 200851 Old Dominion University: Computer Science CS 410 Orange Team - HEART

52. Evaluation Markers by Phase Phase 0 – Mature idea – Funding established – Project website established Phase 2 – Expansion of algorithms – Completion of client software – Successful medical trials – System ready to box and sell 19 November, 2008 Old Dominion University: Computer Science CS 410 Orange Team - HEART 52 Phase 1 – Prototype design – Functioning prototype – Established algorithms Phase 2 – Successful market integration – Save lives

53. H.E.A.R.T. Results: 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 53 Wednesday, November 19, 2008