Orange Team Ryan Null

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Orange TeamRyan Null

• CS 410 Orange Team
• 19 November, 2008

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Our Team
Professor Brunelle
Experts
Ryan Project Manager
Andrew Finance and Webmaster
Spencer Software and Market
Dr. Daniel Garland M.D. President of Pathologist
Department Obici Hospital Suffolk
David Hardware Specialist
Nicole Software Specialist
Generoso Systems Specialist
Mrs. Janet Jackson BSN RN HCMSDM Regulatory
Compliance Manager Amerigroup Corporation Virginia
Beach
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Overview

• Problem
• Customer
• Solution
• System Overview
• Risk and Benefit Analysis
• Market and Fiscal Analysis
• Conclusion

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Cardiac patients do not commit to the long-term
rehabilitation necessary to extend their life.
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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

1 Popular Science Magazine
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• 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

1 https//www.beaumonthospitals.com/health-libra
ry/P06321
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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

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Current Rehabilitation System
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Current Rehabilitation Results
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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

1 https//www.beaumonthospitals.com/health-libra
ry/P06321 2 http//www.abc.net.au/rn/healthrepor
t/stories/2007/2023663.htm
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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

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Heart Exercise Accelerometer Rehabilitation Tool

• 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.

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Solution Overview
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Modified Rehabilitation System
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H.E.A.R.T. Logic
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Client Rehabilitation Software
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Client Software Report
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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.

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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

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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.

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Existing Technology Utilized
Old Dominion University - Team Orange H.E.A.R.T.
- www.cs410.com
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Wednesday, November 19, 2008
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Competition
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  
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Risks
Probability Probability Probability Probability Probability
Not Likely Low Moderate High Expected
Impact Extreme T1 C1
Impact High F1
Impact Moderate T2 C2 T3 F2
Impact Low
Impact Negligible
Item Technical Risks Probability Impact
T1 Hardware and Software Interoperability 2 5
T2 Malfunction (Device and Software) 1 3
T3 Hardware and Software Accuracy 3 3
Item Financial Risks Probability Impact
F1 Insurance Rejection 2 4
F2 Market Competition 4 3
Item Customer Risks Probability Impact
C1 Proof of Benefit 3 5
C2 Proper Utilization 2 3
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Mitigations
Probability Probability Probability Probability Probability
Not Likely Low Moderate High Expected
Impact Extreme T1 C1
Impact High F1
Impact Moderate T2 C2 T3 F2
Impact Low
Impact Negligible
Item Technical Risks Mitigation
T1 Hardware and Software Interoperability Exhaustive testing before trials and testing
T2 Malfunction (Device and Software) Software diagnosis
T3 Hardware and Software Accuracy Proper and thorough prototyping
Item Financial Risks Mitigation
F1 Insurance Rejection Inform insurance companies of positive impact and return on investment
F2 Market Competition Price our product competitively
Item Customer Risks Mitigation
C1 Proof of Benefit Medical Trials and beta testing
C2 Customer Understanding Instructions included with software, online resources, and embedded help system.
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FDA
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_at_fda.hhs.gov
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H.E.A.R.T.

• Market Analysis

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Net Income Large gt10 million Medium 5-10
million Small lt5 million Percent of
Industry Large 5 Medium 42 Small 53
Estimated cost of Heart Disease in 2008 156.4
billion
Old Dominion University - Team Orange H.E.A.R.T.
- www.cs410.com
27
Wednesday, November 19, 2008
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H.E.A.R.T.

• Resources, Staffing and Funding

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Phase 0

• No budget is applicable, all work was done for
  free.

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Phase 1
Staffing Requirements
Budget Breakdown
Title Qty Salary Hours Hourly Rate Total
Project Manager 1 31,200 70 15 1,050
Software Manager 1 31,200 460 15 6,900
Hardware Manager 1 31,200 380 15 5,700
Financial Director 1 31,200 45 15 675
Marketing Director 1 31,200 65 15 975
Risk Director 1 31,200 60 15 900
Documentation Specialist 1 31,200 55 15 825
Webmaster 1 31,200 15 15 225
        Total Cost 17,025
All employees are Students  All employees are Students  All employees are Students    40 Overhead 6,810
Phase 1 6 month period    Total Phase 1 Staffing Budget  Total Phase 1 Staffing Budget  Total Phase 1 Staffing Budget 23,835
Hardware Requirements
Hardware Qty Unit Cost Total
Heart Rate Monitor 2 100.00 200.00
Piezoelectric Accelerometer 4 50.00 200.00
Software (QA) 1 10.00 10.00
Receivers 2 10.00 20.00
Transmitters 4 10.00 40.00
Production 2 10.00 20.00
Material (Box, Paper, assoc, etc) 2 10.00 20.00
Assembly and Manufacturing 2 30.00 60.00
Memory, Battery, cables, base station 4 75.00 300.00
Labor and AV technicians 2 300.00 600.00
Tax (8.8)   53.24 129.36
Total Phase 1 Hardware Budget     1,599.36
Bottom Line 99,800
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Phase 2
Staffing Requirements
Title Qty Salary Hours Hourly Total
Project Manager 1 87,000 1200 42 50,192
Software Engineer 2 71,000 2000 34 136,538
Hardware Engineer 2 81,000 1800 39 140,192
Financial Director 1 62,000 420 30 12,519
Marketing Director 1 44,000 460 21 9,731
Documentation Specialist 1 42,000 600 20 12,115
HR Manager 1 56,000 220 27 5,923
Technical Director 1 70,000 680 34 22,885
Software/Hardware Tester 1 69,000 450 33 14,928
Webmaster 1 40,000 160 19 3,077
        Total Cost 405,024
All employees are Full Time     40 Overhead 40 Overhead 162,010
Phase 2 2 year period  Total Phase 2 Staffing Budget  Total Phase 2 Staffing Budget  Total Phase 2 Staffing Budget  Total Phase 2 Staffing Budget 567,034
Budget Breakdown
Hardware Requirements
Hardware Quantity CpU Total Cost
Heart Rate Monitor 1,000 45.00 45,000.00
Piezoelectric Accelerometer 2,000 15.00 30,000.00
Receivers 2,000 5.00 10,000.00
Transmitters 2,000 5.00 10,000.00
Production 2,000 5.00 10,000.00
Material (Box, Paper, assoc, etc) 2,000 5.00 10,000.00
Assembly and Manufacturing 2,000 10.00 20,000.00
Memory, Battery, cables, base station 2,000 30.00 60,000.00
Training 45 80.00 3,600.00
Testing 100 150.00 15,000.00
Tax (8.8)   30.80 18,796.80
Total Phase 3 Hardware Budget     137,396.80
Bottom Line 704,430
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Phase 3
Staffing and Hardware Requirements
Title Qty Salary Hours Hourly Total
Project Manager 1 87,000 600 42 25,096
Software Engineer 1 71,000 1000 34 34,135
Hardware Engineer 1 81,000 800 39 31,154
Financial Director 1 62,000 450 30 13,413
Marketing Director 1 44,000 500 21 10,577
Documentation Specialist 1 42,000 400 20 8,077
HR Manager 1 56,000 170 27 4,577
Technical Director 1 70,000 440 34 14,808
Software/Hardware Tester 1 69,000 500 33 16,587
Lawyers 1 64,000 900 31 27,692
Procurement Manager 1 50,000 350 24 8,413
Customer Service 5 41,000 650 20 64,063
Webmaster 1 40,000 160 19 3,077
        Total Cost 258,591
All employees are Full Time  All employees are Full Time  All employees are Full Time  40 Overhead 40 Overhead 103,437
Phase 3 Production  Total Phase 3 Staffing Budget  Total Phase 3 Staffing Budget  Total Phase 3 Staffing Budget  Total Phase 3 Staffing Budget 362,028
Budget Breakdown
Hardware Qty CpU Total Cost
Heart Rate Monitor 1,500 45.00 67,500.00
Piezoelectric Accelerometer 3,000 15.00 45,000.00
Receivers 3,000 5.00 15,000.00
Transmitters 3,000 5.00 15,000.00
Production 3,000 5.00 15,000.00
Material (Box, Paper, assoc, etc) 3,000 5.00 15,000.00
Assembly and Manufacturing 3,000 10.00 30,000.00
Memory, Battery, cables, base station 3,000 30.00 90,000.00
Training 100 80.00 8,000.00
Testing 500 150.00 75,000.00
Tax (8.8)   30.80 33,044.00
Total Phase 2 Hardware Budget     266,044.00
Bottom Line 628,072
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Budget Overview
 Phase Staffing Resources Phase 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
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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

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Break Even Analysis
Phase 2

• 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
• Units Fixed Cost Total Cost Total Revenue Profit
• ------ ------------ ------------ ------------ ---
  ---------
• 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

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Incentives

• Insurance Companies will experience
• Lower costs
• Longer income
• Patients will experience
• Lower premiums
• Extended lifetime
• Less hospitalization

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H.E.A.R.T.

• Business Organization

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Phase 0
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Phase 1
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Phase 2
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Phase 3
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H.E.A.R.T.

• Business Plans

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Project Management
Management Plan
Marketing Plan
Development Plan
Evaluation Plan
Staffing Plan
Financial Plan
Work Breakdown Structure
Funding
Risk Management
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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

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Development Plan
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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

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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

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Evaluation Markers by Phase

• Phase 1
• Prototype design
• Functioning prototype
• Established algorithms
• Phase 2
• Successful market integration
• Save lives

• 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

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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