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

Orange TeamRyan Null

CS 410 Orange Team19 November, 2008

Our Team

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

Professor Brunelle

DavidHardware Specialist

RyanProject Manager

AndrewFinance and Webmaster

SpencerSoftware and Market

NicoleSoftware Specialist

GenerosoSystems Specialist

Experts

Dr. Daniel Garland M.D.President of Pathologist

DepartmentObici Hospital

Suffolk

Mrs. Janet Jackson BSN RNHCMSDM Regulatory Compliance Manager

Amerigroup CorporationVirginia Beach

Overview

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


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

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

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-library/P06321

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


Current Rehabilitation System


Current Rehabilitation Results


Completion of Rehabilitation

20%

Survival Absent Rehabilitation

17%

Pre-Mature Death63%

Rehabilitation Outcomes

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-library/P06321[2] http://www.abc.net.au/rn/healthreport/stories/2007/2023663.htm

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


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.


Solution Overview


Modified Rehabilitation System


H.E.A.R.T. Logic


Client Rehabilitation Software


Client Software Report


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.


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


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.


Existing Technology Utilized

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

Technology Min Mean Max

Heart Sensor $5 $20 $50

Accelerometer $20 $25 $55

Battery $10 $10 $20

CPU $10 $14 $19

RAM $1.63 $3.27 $5.12

USB $0.19 $0.19 $0.19

Wednesday, November 19, 2008

Competition


Risks


ProbabilityNot Likely Low Moderate High Expected

ImpactExtreme T1 C1

High F1

Moderate T2 C2 T3 F2

Low

Negligible

Item

Technical Risks Probability Impact

T1 Hardware and Software Interoperability 2 5T2 Malfunction (Device and Software) 1 3T3 Hardware and Software Accuracy 3 3Item

Financial Risks Probability Impact

F1 Insurance Rejection 2 4F2 Market Competition 4 3Item

Customer Risks Probability Impact

C1 Proof of Benefit 3 5C2 Proper Utilization 2 3

Mitigations


Item Technical Risks MitigationT1 Hardware and Software Interoperability Exhaustive testing before trials and testingT2 Malfunction (Device and Software) Software diagnosisT3 Hardware and Software Accuracy Proper and thorough prototyping

Item Financial Risks MitigationF1 Insurance Rejection Inform insurance companies of positive impact and

return on investmentF2 Market Competition Price our product competitively

Item Customer Risks MitigationC1 Proof of Benefit Medical Trials and beta testingC2 Customer Understanding Instructions included with software, online resources,

and embedded help system.

ProbabilityNot Likely Low Moderate High Expected

ImpactExtreme T1 C1

High F1

Moderate T2 C2 T3 F2

Low

Negligible

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

[email protected]

H.E.A.R.T.Market Analysis



$977,421

$434,898

$67,931

$0

$200,000

$400,000

$600,000

$800,000

$1,000,000

$1,200,000

Pro

fit i

n D

olla

rs

Rehabilitation Market Analysis

Large Medium Small

Net Income:Large: >10 millionMedium: 5-10 millionSmall: <5 million

Percent of Industry:Large: 5%Medium: 42%Small: 53%

Estimated cost of Heart Disease in 2008:$156.4 billion


H.E.A.R.T.Resources, Staffing and Funding


Phase 0

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


Phase 1


Title Qty Salary Hours Hourly Rate TotalProject 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 40% Overhead $6,810Phase 1 = 6 month period Total Phase 1 Staffing Budget: $23,835

Budget BreakdownStaffing Requirements

Hardware Qty Unit Cost TotalHeart Rate Monitor 2 $100.00 $200.00Piezoelectric Accelerometer 4 $50.00 $200.00Software (QA) 1 $10.00 $10.00Receivers 2 $10.00 $20.00Transmitters 4 $10.00 $40.00Production 2 $10.00 $20.00Material (Box, Paper, assoc, etc) 2 $10.00 $20.00Assembly and Manufacturing 2 $30.00 $60.00Memory, Battery, cables, base station 4 $75.00 $300.00Labor and AV technicians 2 $300.00 $600.00Tax (8.8%) $53.24 $129.36

Total Phase 1 Hardware Budget $1,599.36

Hardware Requirements

Bottom Line$99,800

Phase 2


Budget Breakdown

Staffing Requirements

Hardware Requirements

Bottom Line$704,430

Title Qty Salary Hours Hourly TotalProject 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 $162,010Phase 2 = 2 year period Total Phase 2 Staffing Budget: $567,034

Hardware Quantity CpU Total CostHeart Rate Monitor 1,000 $45.00 $45,000.00Piezoelectric Accelerometer 2,000 $15.00 $30,000.00Receivers 2,000 $5.00 $10,000.00Transmitters 2,000 $5.00 $10,000.00Production 2,000 $5.00 $10,000.00Material (Box, Paper, assoc, etc) 2,000 $5.00 $10,000.00Assembly and Manufacturing 2,000 $10.00 $20,000.00Memory, Battery, cables, base station 2,000 $30.00 $60,000.00Training 45 $80.00 $3,600.00Testing 100 $150.00 $15,000.00Tax (8.8%) $30.80 $18,796.80


Phase 3


Budget Breakdown

Staffing and Hardware Requirements

Bottom Line$628,072

Hardware Qty CpU Total CostHeart Rate Monitor 1,500 $45.00 $67,500.00Piezoelectric Accelerometer 3,000 $15.00 $45,000.00Receivers 3,000 $5.00 $15,000.00Transmitters 3,000 $5.00 $15,000.00Production 3,000 $5.00 $15,000.00Material (Box, Paper, assoc, etc) 3,000 $5.00 $15,000.00Assembly and Manufacturing 3,000 $10.00 $30,000.00Memory, Battery, cables, base station 3,000 $30.00 $90,000.00Training 100 $80.00 $8,000.00Testing 500 $150.00 $75,000.00Tax (8.8%) $30.80 $33,044.00


Title Qty Salary Hours Hourly TotalProject 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 40% Overhead $103,437Phase 3 = Production Total Phase 3 Staffing Budget: $362,028

Budget Overview


Phase Staffing Resources Phase TotalPhase 1 (6 months) $23,835 $1,599 $99,800Phase 2 (Two Years) $567,034 $137,397 $704,430Phase 3 (Per Year) $362,028 $266,044 $628,072 Total Phases 1-3 $952,897 $405,040 $1,357,937

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)


Break Even Analysis


Variable Unit Cost = $200Fixed Cost = $266,044Expected Unit Sales = 1,500Price Per Unit = $500

Total Revenue = $750,000Total Variable Costs = $300,000Profit = $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 - $116 600 $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

Incentives

• Insurance Companies will experience:– Lower costs– Longer income

• Patients will experience– Lower premiums– Extended lifetime– Less hospitalization


H.E.A.R.T.Business Organization


Phase 0


Phase 1


Phase 2


Phase 3


H.E.A.R.T.Business Plans


Project Management


Management Plan

Marketing Plan Development Plan

Evaluation PlanStaffing Plan

Financial Plan Work Breakdown Structure

Funding Risk Management

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


Development Plan


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


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


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


• Phase 1

– Prototype design

– Functioning prototype

– Established algorithms

• Phase 2

– Successful market integration

– Save lives

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.



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

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