Prepared by: Michele Majchrowski
ENHANCED DIABETIC MANAGER
Last Updated: Tuesday, July 26, 2016
2008 ODU CS 410 Green
SBIR Grant Proposal
Page 2 of 43
Prepared by: Michele Majchrowski
ENHANCED DIABETIC MANAGER
2008 ODU CS 410 Green
SBIR Grant Proposal
FORMATTED BY MICHELE MAJCHROWSKI
2008 ODU GREEN PROJECT MANAGER
6 May 2008
Last Updated: Tuesday, July 26, 2016
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Prepared by: Michele Majchrowski
ENHANCED DIABETIC MANAGER
2008 ODU CS 410 Green
SBIR Grant Proposal
ABSTRACT
The Enhanced Diabetic Manager will be a tool targeted initially towards new diabetics in the United
States. This tool will provide historical information about how a diabetic’s body processes different foods
from different places. It will also assist them with estimating how much insulin should be injected according
to the estimated calculation of carbohydrates. The calculation for carbohydrate estimation will be obtained
from past history of glucose levels and insulin dosages required when a particular meal was eaten. Suggested
insulin dosages will be determined by past carbohydrate intake for their meal and current glucose levels.
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Prepared by: Michele Majchrowski
ENHANCED DIABETIC MANAGER
2008 ODU CS 410 Green
SBIR Grant Proposal
TABLE OF CONTENTS
ABSTRACT ....................................................................................................................................................................... 2
............................................................................................................................................................................................ 5
1 GRANT PROPOSAL ...................................................................................................................................................... 5
1.1 GRANT APPLICATION .................................................................................................................................................. 5
2 OVERVIEW .................................................................................................................................................................... 7
2.1 INSULIN TYPES ............................................................................................................................................................ 8
3 BACKGROUND INFORMATION ............................................................................................................................... 9
4 GOALS ........................................................................................................................................................................... 11
5 PROGRAM MANAGEMENT PLAN ......................................................................................................................... 11
5.1 PROGRAM IDENTIFICATION ....................................................................................................................................... 11
5.2 PROGRAM MANAGEMENT OVERVIEW ....................................................................................................................... 11
5.3 CORPORATE STRUCTURE ........................................................................................................................................... 13
5.4 MANAGEMENT APPROACH ........................................................................................................................................ 13
5.5 PROJECT TEAM ......................................................................................................................................................... 13
5.6 PROGRAM DURATION ................................................................................................................................................ 14
6 QUALITY PROCESS AND REPORTING................................................................................................................. 14
6.1 WORK BREAKDOWN STRUCTURE .............................................................................................................................. 14
6.1.1 Phase 0.............................................................................................................................................................. 15
6.1.2 Phase 1.............................................................................................................................................................. 16
6.1.3 Phase 2.............................................................................................................................................................. 16
6.1.4 Phase 3.............................................................................................................................................................. 17
6.2 PLANS ....................................................................................................................................................................... 17
6.2.1 Evaluation Plan ................................................................................................................................................ 17
6.2.2 Funding Plan .................................................................................................................................................... 18
6.2.3 Marketing Plan ................................................................................................................................................. 18
6.2.4 Prototype Plan .................................................................................................................................................. 18
6.2.5 Resource Plan .................................................................................................................................................. 18
6.2.6 Risk Management Plan ..................................................................................................................................... 19
6.2.7 Staffing Plan ..................................................................................................................................................... 19
7 PROGRAM PLANNING ............................................................................................................................................. 19
8 PROGRESS PERFORMANCE ASSESSMENT ........................................................................................................ 19
8.1 TECHNICAL PROGRESS AND REPORTING ................................................................................................................... 20
8.2 FINANCIAL MANAGEMENT AND REPORTING ............................................................................................................. 20
8.3 EARNED VALUE ........................................................................................................................................................ 20
8.4 QUALITY PROCESS AND REPORTING ......................................................................................................................... 21
8.5 MONTHLY PROGRESS REPORT .................................................................................................................................. 21
9 REVIEWS ...................................................................................................................................................................... 22
9.1 PROGRAM MANAGEMENT REVIEWS .......................................................................................................................... 22
9.2 TECHNICAL REVIEWS ................................................................................................................................................ 22
9.3 QUALITY REVIEWS .................................................................................................................................................... 23
10 BIOGRAPHIES ........................................................................................................................................................... 23
10.1 MICHELE MAJCHROWSKI ........................................................................................................................................ 23
10.2 MEREDITH WILHELM .............................................................................................................................................. 24
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Prepared by: Michele Majchrowski
ENHANCED DIABETIC MANAGER
2008 ODU CS 410 Green
SBIR Grant Proposal
10.3 ADAM HAMER ......................................................................................................................................................... 24
10.4 FRANCIS PRUTER..................................................................................................................................................... 24
10.5 DEREK ALLEN ......................................................................................................................................................... 24
10.6 ERIC SCHULTZ......................................................................................................................................................... 24
11 CONCLUSION ........................................................................................................................................................... 24
12 APPENDIX .................................................................................................................................................................. 25
12.1 APPENDIX A – EVALUATION PLAN ...................................................................................................................... 25
12.2 APPENDIX B – FUNDING PLAN ............................................................................................................................. 31
12.3 APPENDIX C – MARKETING PLAN ........................................................................................................................ 32
12.4 APPENDIX D – PROTOTYPE PLAN ......................................................................................................................... 35
12.5 APPENDIX E – RESOURCE PLAN ........................................................................................................................... 37
12.6 APPENDIX F – RISK MANAGEMENT PLAN ............................................................................................................ 39
12.7 APPENDIX G – STAFFING PLAN ........................................................................................................................... 40
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Prepared by: Michele Majchrowski
ENHANCED DIABETIC MANAGER
1
2008 ODU CS 410 Green
SBIR Grant Proposal
GRANT PROPOSAL
Form Approved Through 05/2004
OMB No. 0925-0001
LEAVE BLANK—FOR PHS USE ONLY.
Type
Activity
Number
Review Group
Formerly
Department of Health and Human Services
Public Health Services
1.1
Grant Application
Council/Board (Month, Year)
Do not exceed character length restrictions indicated.
Date Received
1. TITLE OF PROJECT (Do not exceed 56 characters, including spaces and punctuation.)
Enhanced Diabetic Manager (eDM)
2. RESPONSE TO SPECIFIC REQUEST FOR APPLICATIONS OR PROGRAM ANNOUNCEMENT OR SOLICITATION
(If “Yes,” state number and title)
Number:
Title:
3. PRINCIPAL INVESTIGATOR/PROGRAM DIRECTOR
New Investigator
3a. NAME (Last, first, middle)
3b. DEGREE(S)
Majchrowski, Michele M
No
NO
YES
Yes
AS
3c. POSITION TITLE
3d. MAILING ADDRESS (Street, city, state, zip code)
Project Manager
Old Dominion University, Computer Science Dept.
Hampton Boulevard
Norfolk, Va. 23529
3e. DEPARTMENT, SERVICE, LABORATORY, OR EQUIVALENT
Old Dominion University
3f. MAJOR SUBDIVISION
Computer Science
3g. TELEPHONE AND FAX (Area code, number and extension)
E-MAIL ADDRESS:
TEL: 757-495-2059
4. HUMAN SUBJECTS
RESEARCH
5. VERTEBRATE ANIMALS
FAX:
757-683-4900
4a. Research Exempt
No
jmayor@cs.odu.edu
Yes
No
4c. NIH-defined Phase III
4b. Human Subjects
Assurance No.
Yes
No
Yes
If “Yes,” Exemption No.
Clinical Trial
No
5a. If “Yes,” IACUC
approval Date
5b. Animal welfare assurance no.
Yes
6. DATES OF PROPOSED PERIOD OF
SUPPORT (month, day, year—MM/DD/YY)
7. COSTS REQUESTED FOR INITIAL
BUDGET PERIOD
8. COSTS REQUESTED FOR PROPOSED
PERIOD OF SUPPORT
From
Through
7a. Direct Costs ($)
7b. Total Costs ($)
8a. Direct Costs ($)
8b. Total Costs ($)
5/6/08
5/6/09
100,000
100,000
100,000
100,000
9. APPLICANT ORGANIZATION
Name
Enhancement Services
Address
10. TYPE OF ORGANIZATION
,000.00
Division (eSD)
Old Dominion University, Computer Science Dept.
Hampton Boulevard
Norfolk, Va 23529
Public:
Federal
Private:
Private Nonprofit
For-profit:
General
State
Local
Small Business
Woman-owned
Socially and Economically Disadvantaged
11. ENTITY IDENTIFICATION NUMBER
DUNS NO.
2
Institutional Profile File Number (if known)
Congressional District
12. ADMINISTRATIVE OFFICIAL TO BE NOTIFIED IF AWARD IS MADE
Name
Janet Brunelle
13. OFFICIAL SIGNING FOR APPLICANT ORGANIZATION
Name
Janet Brunelle
Title
eSD
Title
PCS-HRMS President
Old Dominion University, Computer Science Dept.
Hampton Boulevard
Norfolk, Va 23529
Address
Old Dominion University, CS Dept.
Hampton Boulevard
Norfolk, Va 23528
Address
Tel:
757-683-4415
brunelle@cs.odu.edu
FAX:
E-Mail:
Last Updated: Tuesday, July 26, 2016
757-683-4900
Tel:
FAX: 757-683-4900
757-683-4415
brunelle@cs.odu.edu
E-Mail:
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Prepared by: Michele Majchrowski
ENHANCED DIABETIC MANAGER
2008 ODU CS 410 Green
SBIR Grant Proposal
SIGNATURE OF PI/PD NAMED IN 3a.
14. PRINCIPAL INVESTIGATOR/PROGRAM DIRECTOR ASSURANCE: I certify that the
statements herein are true, complete and accurate to the best of my knowledge. I am aware that any (In ink. “Per” signature not acceptable.)
false, fictitious, or fraudulent statements or claims may subject me to criminal, civil, or
administrative penalties. I agree to accept responsibility for the scientific conduct of the project and
to provide the required progress reports if a grant is awarded as a result of this application.
15. APPLICANT ORGANIZATION CERTIFICATION AND ACCEPTANCE: I certify that the
statements herein are true, complete and accurate to the best of my knowledge, and accept the
obligation to comply with Public Health Services terms and conditions if a grant is awarded as a
result of this application. I am aware that any false, fictitious, or fraudulent statements or claims
may subject me to criminal, civil, or administrative penalties.
Last Updated: Tuesday, July 26, 2016
SIGNATURE OF OFFICIAL NAMED IN 13.
(In ink. “Per” signature not acceptable.)
DATE
DATE
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Prepared by: Michele Majchrowski
ENHANCED DIABETIC MANAGER
2
2008 ODU CS 410 Green
SBIR Grant Proposal
OVERVIEW
By Michele Majchrowski
Different forms of diabetes affects over 75 million people in the United States alone. One and a half million
or 8% of new diabetics are diagnosed every year yet 4% of the population is still undiagnosed. There are 54
million pre-diabetics. This makes 25% of the population diabetic or pre-diabetic.
Diabetics 25%
U.S. Population
Those with Type I Diabetes must undergo daily insulin injections to process glucose otherwise known as
sugars. This type of diabetes causes a persons body to destroy natural insulin produced by the body. Diabetes
results from the body's failure to produce insulin, the hormone that "unlocks" the cells of the body, allowing
glucose to enter and fuel them.
Pre-diabetes is a condition that occurs when a person's blood glucose levels are higher than normal but not
high enough for a diagnosis of type 2 diabetes. There are 54 million Americans who have pre-diabetes, in
addition to the 21 million with diabetes.
Type I 6%
Type II 20%
Pre Diabetic 72%
Undiagnosed 1%
Gestational <1%
About 80% of all diabetics are Type II diabetics. Some Type II diabetics can sometimes control their disease
by diet alone but most require some form of insulin regimen. Type I diabetics account for 13% of the
diabetics and require daily insulin injections to survive. So this makes 93% of all diabetics requiring some
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Prepared by: Michele Majchrowski
ENHANCED DIABETIC MANAGER
2008 ODU CS 410 Green
SBIR Grant Proposal
form of insulin management. Gestational and pre-diabetics are a small percentage of the overall total. Yet
both of these types are early signs of the possibility of becoming a true diabetic (Public Health Advocacy ).
Type I 6%
Type II 20%
Pre Diabetic 72%
Undiagnosed 1%
Gestational <1%
Types of Diabetes
Type 1 diabetes Results from the body's failure to produce insulin, the hormone that "unlocks" the cells of
the body, allowing glucose to enter and fuel them. It is estimated that 5-10% of Americans who are diagnosed
with diabetes have type 1 diabetes. This disease cannot be prevented and requires daily insulin treatments.
Type 2 diabetes Results from insulin resistance (a condition in which the body fails to properly use insulin),
combined with relative insulin deficiency. Most Americans who are diagnosed with diabetes have type 2
diabetes.
Can be prevented or delayed with a healthy lifestyle, including maintaining a healthy weight, eating sensibly,
and exercising regularly.
Gestational diabetes Gestational diabetes affects about 4% of all pregnant women - about 135,000 cases in
the United States each year.
Gestational diabetes affects about 4% of all pregnant women.
Pre-diabetes Pre-diabetes is a condition that occurs when a person's blood glucose levels are higher than
normal but not high enough for a diagnosis of type 2 diabetes. There are 54 million Americans who have prediabetes, in addition to the 21 million with diabetes.
Information obtained from American Diabetes Association and Healthwise, Incorporated
2.1
Insulin Types
There are different types of insulin used for different purposes. Nobody's metabolism is exactly the same
which makes it necessary to have to have different brands and types of basal and bolus insulins. Basal doses
are doses that distribute insulin for a half or an entire day. Bolus doses are doses that are necessary after food
consumption.
Insulin Type
Last Updated: Tuesday, July 26, 2016
Technical
Onset
Duration
Peak
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Prepared by: Michele Majchrowski
ENHANCED DIABETIC MANAGER
2008 ODU CS 410 Green
SBIR Grant Proposal
(hours) (up to X hours) (hours)
Short Acting
Soluble
1/2 - 1
8
1 -3
Intermediate Acting
Isophane
Protamine
1/2 - 3
24
2 - 16
Intermediate Acting
Zinc Suspension
1/2 - 3
24
2 - 16
Long Acting
Zinc Suspension
2-6
36
8 - 24
1/2
24
1 - 12
Short + Intermediate Acting Biphasic Isophane
Long Acting
Lantus
Glargine
N/A
24
None
Rapid Acting
Humalog
Lispro
1/4
20
N/A
Information obtained from AIDA
3
BACKGROUND INFORMATION
By Michele Majchrowski
One of the most challenging feats of a diabetic’s day is keeping their blood glucose levels within the
normal range of 70 – 150 mg since their bodies either do not produce enough insulin or any at all. If the
normal range is not managed properly it can cause serious complications.






High Blood Pressure
Nerve Damage
Amputation
Heart Disease and Stroke
Kidney Damage
Eye Disease
Over 50% of all diabetics of Type I and Type II form some type of chronic complications. The longer their
disease is unmanaged; the more the risk of experiencing a
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Prepared by: Michele Majchrowski
ENHANCED DIABETIC MANAGER
2008 ODU CS 410 Green
SBIR Grant Proposal
complication.
These complications need to be managed properly. With proper management, complications are reduced
by 50%. This is why it is essential to teach new diabetics the proper way to manage their disease so they
can prevent amputations and death.
16
14
12
High BP
Nerve Damage
Amputation
Heart Disease & Stroke
Kidney
Eye
10
8
6
4
2
0
Improper Mgm
4
Proper Mgm
GOALS
One of our goals is to provide historical insight on how the diabetic’s metabolism reacts to different
foods from different places. This process can utilize existing insulin pumps and glucose monitors.
The insulin pumps will provide data about the amount of bolus injections based on total
carbohydrates consumed. Glucose monitors will provide information on blood sugar levels for a
particular time of the day. Another goals is to assist in the calculation of carbohydrates by allowing
for customization of what, where and how much was consumed.
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ENHANCED DIABETIC MANAGER
5
2008 ODU CS 410 Green
SBIR Grant Proposal
PROGRAM MANAGEMENT PLAN
By Michele Majchrowski
5.1
Program Identification
This Program Management Plan (PMP) is for the ENHANCED DIABETIC MANAGER SOFTWARE (EDMS). The
program will deliver the EDMS hardware, software and documentation for the EDMS. ODU GREEN TEAM
is responsible for the integration, acceptance testing and training of the Software Package.
5.2
Program Management Overview
Execution of the Program will be performed in accordance with the procedures defined by the set of planning
documents. These documents include Program Management Plan*, System Quality Program Plan (SQPP),
Software Management Plan (SMP), Configuration Management Plan (CMP), Engineering Management Plan
(EMP), Manufacturing Plan (MP), and Risk Management Plan (RMP) (see Figure 1). The responsibilities of
the Program Team, the capabilities of the system, and the Program deliverables are detailed under the
contractual provisions, as well as ODU GREEN TEAM’s technical, management, and cost proposals.
* This Program Management Plan shall be deemed to meet the contractual requirement of a Project
Management Plan.
Figure 1. Program Management
This Program Management Plan describes the management philosophy, program organization, schedule, and
major milestones that serve as the guide for execution of the Program. The PMP also provides the customer
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Prepared by: Michele Majchrowski
ENHANCED DIABETIC MANAGER
2008 ODU CS 410 Green
SBIR Grant Proposal
and the quality team with the information they need to monitor and evaluate the progress of the effort. This plan
provides the following pertinent information:







Corporate Organization
Program Team Organization With Areas of Responsibility
Work Breakdown Structure
Program Planning
Progress Reporting and Team Management
Detailed Program Schedule and Milestones
Program Reviews
The Program Management Plan provides guidance for the content and execution of the following plans:







5.3
Evaluation
Funding
Marketing
Prototype
Resource
Risk Management
Staffing
Corporate Structure
The entirety of ODU GREEN TEAM Corporation supports the EDMS Program. In 2008, ODU GREEN
TEAM made a commitment to transition its command and control systems to COTS hardware and software.
This commitment will result in the development of management system for diabetics. This system will be
installed, successfully tested, and operational. The following is ODU GREEN TEAM EDMS Corporate
organizational structure:



5.4
CEO & President, ODU GREEN TEAM Corporation.
Group Vice President.
EDMS Program Office. EDMS Program Office will execute the program and provide day-to-day
senior management supervision, management, engineering, and administrative resources necessary to
manage and administer the EDMS program.
Management Approach
ODU GREEN TEAM’s management goal is to work closely with the diabetic community to fully understand
their needs. The system requirements will allow for fielding a system that meets those requirements. The
management approach to executing contracts at ODU GREEN TEAM is based on the philosophy that successful
Programs are delivered by goal-oriented teams. A Program Manager (PM) will lead the ODU GREEN TEAM.
The PM is responsible for overseeing team efforts to include planning, programmatic, technical, and financial
aspects of the program. The PM is the primary Point of Contact (POC) for the customer. The primary duties
include supervision of planning, scheduling, financial, and technical activities, and customer liaison. The PM is
responsible for all Program-related decisions and commitments with approval, as required, from the Corporate
Management Team.
A key element of ODU GREEN TEAM’s program management approach is customer involvement. ODU
GREEN TEAM encourages the customer to retain an active role in monitoring the progress of all aspects of the
Program. The customer is encouraged to discuss technical details directly with members of the Program team,
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ENHANCED DIABETIC MANAGER
2008 ODU CS 410 Green
SBIR Grant Proposal
provide planning and schedule recommendations, and assist in resolution of technical and programmatic issues.
In order to facilitate customer involvement, ODU GREEN TEAM will provide access to program information
including, but not limited to:





5.5
Program Plans and Schedules and Status
Earned Value
Formal Review Material
Action Items
System Drawings and Documentation
Project Team
The Program Team is committed to provide the best value by delivering COTS, open architecture, and lowrisk systems at the lowest cost. This commitment is attainable because it is based on the re-use of existing
technology that is field-proven. Through strategic teaming and an extensive system selection process, ODU
GREEN TEAM has assembled a cohesive Program Team that is experienced with the implementation of each
component that will comprise the EDMS Total Ship Computing Environment.
Program Manager/Team Leader. Overall management responsibility for EDMS is assigned to a Program
Manager who is responsible for planning and coordination of the day-to-day technical, contractual, and
financial aspects of the program. She is responsible for the generation and management of program schedules,
coordination of program staff assignments and for coordinating all program activities. Another task she is
assigned is to be the domain expert. Her principal assistants are:









Development Manager. The Development Manager is responsible for determining risk and staff
requirements. He is responsible for evaluation of all system risks during all phases of components to
reduce performance degradation of the system. He also determines the staff required to complete the
project. (Eric)
Quality/Process Manager. The Quality/Process Manager is responsible for evaluating and
determination of the target market for the program and to collect and deliver the operator manuals,
system manuals, and training material. (Francis)
Planning Manager. The Planning Manager administers the budget and is the primary point of
contact between ODU GREEN TEAM and subcontractors for contract matters. In addition to
supporting the Program Manager, the PM is responsible for coordinating all contractual aspects of the
program, including financial deliverables and milestone payments. (Derek)
Support Manager. The SM provides overall technical direction for the Program Team. The SM is
assigned responsibility to provide technical oversight. She is the senior engineer and will directly
determine hardware and software technologies required. She is also responsible for evaluating our
product against the competition. Several senior engineers in the areas of software design,
development, and production will assist the SM. (Meredith)
Systems Engineer. The System Engineer is responsible for system-level activities to ensure system
meets the specification requirements. He is responsible for the development and maintenance of the
product web site, system MFCDs, design documents and interface documents. (Adam)
Lawyer. Our lawyer will provide legal disclaimers necessary to prevent lawsuits.
Medical Expert. The medical expert will assist with the accuracy of our estimated calculations.
Technical Writer/Editor. The Technical writer will design, create, maintain, and update technical
documentation—including online help, user guides, white papers, design specifications, and other
documents. The technical writer will also provide editing and formatting.
Accountant. The accountant will provide financial assistance.
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ENHANCED DIABETIC MANAGER
5.6
2008 ODU CS 410 Green
SBIR Grant Proposal
Program Duration
The EDMS program is a 1 year project through delivery of the first vessel. The Flight 0 schedule consists of a
preliminary design down selection milestone in third quarter FY-08, and award of up to three contracts to
product competing final designs. This evaluation period will complete in second quarter FY-08 followed by
development in the third and fourth quarters of FY-08. Development will require approximately 1 year.
Delivery of the first prototype will occur in fourth quarter of FY-08.
6
QUALITY PROCESS AND REPORTING
Quality management on the program will be a team effort. Each team member is required to submit forms
which track their work progress on a biweekly basis.
6.1
Work Breakdown Structure
By Michele Majchrowski
The program Work Breakdown Structure (WBS) reflects the budgeted cost versus resources required to
complete each task. The WBS phase numbers are integrated as part of the master program schedule. Budgets
for work planned are entered into ODU GREEN TEAM’s financial tracking system for each WBS element,
actual costs and estimates to complete are managed by the Planning Manager. The WBS element numbers
will be structured according to the Contract Statement of Work and will be used to track program costs,
progress, earned value and progress relative to the master program schedule. The WBS management tools that
the ODU GREEN TEAM will utilize are Microsoft Project 2007 and Visio.
6.1.1 Phase 0
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ENHANCED DIABETIC MANAGER
2008 ODU CS 410 Green
SBIR Grant Proposal
6.1.2 Phase 1
6.1.3 Phase 2
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ENHANCED DIABETIC MANAGER
2008 ODU CS 410 Green
SBIR Grant Proposal
6.1.4 Phase 3
6.2
Plans
6.2.1 Evaluation Plan
By Meredith Wilhelm
The Evaluation Plan developed by eDM software development team will be ongoing throughout the
development and implementation of eDM. Every major milestone will be intensely evaluated to ensure a
quality product.
The Evaluation Plan’s initial goal is to strictly follow the schedule set forth by the WBS in order to ensure
that we are accomplishing our goals in a timely manner. The evaluation plan is aware that the WBS is only an
estimate of how long each phase will take but will not allow for extreme differences in dates. Therefore, if
calculations show that the development team is working at more than a 10% difference then the time set forth
by the WBS the group must reevaluate their performance while developing the product. It has been designed
to integrate easily with every phase of the project.
Due to the wide range of evaluations that need to be performed the entire team must be involved. The
Evaluation Plan will work hand in hand with the testing of our device, “3 Phases of Testing”. The evaluation
and testing of our product will ensure that we have a thoroughly tested product, which was achieved in a
systematic manner.
The group will ensure that throughout the “3 Phases of Evaluation” and through the complete development of
the product they:


Monitor current status in regards to defined schedule and budget
Make necessary adjustments if the group falls too far off task
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ENHANCED DIABETIC MANAGER



2008 ODU CS 410 Green
SBIR Grant Proposal
Evaluate product and areas for improvement
Monitor Customer Feedback
Make and document adjustments where necessary
Full plan details in Appendix A
6.2.2 Funding Plan
By Derek Allen
To fund the product, “enhanced Diabetes Manager”, Green Team Spring 2008 will submit a SBIR grant
application to the National Science Foundation. Additional funding will be acquired through business loans in
order to get through phase II. Once Phase III starts our product should be self-sufficient, requiring no further
funding.
Full plan details in Appendix B
6.2.3 Marketing Plan
By Francis Pruter
Our product will primarily be targeted to newly diagnosed Diabetics since this transition can be frightening
and is essential for living a longer healthier life. Over 20 million people have been diagnosed with some form
of diabetes in America alone and that number is on the rise. There is an estimated 6 percent growth rate of the
disease. Without accurate and constant monitoring of glucose levels and caloric intake, Diabetes will suffer
from both acute and chronic conditions.
Full plan details in Appendix C
6.2.4 Prototype Plan
By Eric Schultz
Create a PDA that can suggest insulin amounts and when to take the insulin. This is based on the insulin
delivery method, the insulin used, the person's current glucose level, and their activity level planned for the
next few hours and what food the person will be eating in the next 30 minutes. The data can then be displayed
and analyzed on a PC.
Full plan details in Appendix D
6.2.5 Resource Plan
By Adam Hamer
This document defines the hard resources associated with the project per phase. The purpose of this
document is to define what hard resources are necessary per phase and to explain their purpose. Each phase
defines new hard resources that are introduced; however it should be assumed by the reader that any hard
resource that is used in a previous phase will be used for the same purpose in subsequent phases unless
otherwise noted.
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ENHANCED DIABETIC MANAGER
2008 ODU CS 410 Green
SBIR Grant Proposal
Although human resources are in integral part of the resource plan, these resources have been addressed in the
separate document, Staffing Plan, contained within this SBIR. The reader is referred to the funding plan for
any detailed financial information.
Full plan details in Appendix E
6.2.6 Risk Management Plan
By Eric Schultz
While risks are involved in every project, the creation of a risk management plan can effectively help manage
and reduce the threat caused by risks because of proper foresight and planning. The purpose of this document
is to help guide the spring 2008 Green Team in planning, coordination and decision making.
Full plan details in Appendix F
6.2.7 Staffing Plan
By Meredith Wilhelm
This plan defines details for each phase of development. It defines the staff necessary to complete the phase.
Full plan details in Appendix G
7
PROGRAM PLANNING
By Michele Majchrowski
The ODU GREEN TEAM Program Team will maintain the program master schedule. The master schedule
contains a line item for each WBS element and will be used to track the progress of each element. All
deviations from the master schedule must be coordinated with the program office. It is the responsibility of
each team member to call attention to possible schedule deviations at the earliest opportunity. The program
office will coordinate the program schedule with EDMS. The program will be developed in phases; within
each phase, formal reviews will play an integral part in monitoring program progress. All formal reviews will
be announced one week in advance of the starting date.
ODU GREEN TEAM will take a “top down approach” to the Program Schedule, meaning that we will pace
our workload to fit the overall Program requirements. Particular attention will be given to timely milestone
completions. It is recognized that the schedule is particularly tight, containing critical program milestones
during the three months, and adequate personnel will be available in order to keep the program moving
forward.
8
PROGRESS PERFORMANCE ASSESSMENT
All ODU GREEN TEAM members will participate in progress reporting and team management. ODU
GREEN TEAM will track technical and financial progress of the program. Reviews will be held weekly or as
mutually agreeable between ODU GREEN TEAM and EDMS.




Report on progress to date
Present work to be performed during the next week
Present status of all deliverables and review planned delivery dates
Present status of all received items
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Prepared by: Michele Majchrowski
ENHANCED DIABETIC MANAGER


2008 ODU CS 410 Green
SBIR Grant Proposal
Plan and coordinate activities
Discuss technical or programmatic issues as necessary.
In preparation for the meetings the ODU GREEN TEAM Program Manager will collect the current status data
on relevant on-going activities, progress against schedule and budget, and planned activity for the next
reporting period. Quality reviews of all program documentation and procedures will be held periodically. In
particular, the quality program will be involved with program deliveries and milestones and will work off of
the master program schedule to plan program audits. Technical, financial and quality progress and status
reporting will be conducted according to the following general guidelines.
8.1
Technical Progress and Reporting
The schedule for the program is established during the planning phase and monitored throughout the
performance period. The schedule contains an entry for each WBS element. The percentage of completion for
each WBS element is determined as necessary to manage program progress and is reviewed at least quarterly
during the General Manager’s review.
8.2
Financial Management and Reporting
The financial profile for the Program is established during the planning phase and monitored throughout the
performance period. This profile is generated by assigning accounting phase numbers to every Program activity
that has been identified as a scheduled event. A budget representing labor costs, materials purchase, and other
expenditures (such as travel expenses) is then prepared for every phase. The schedule and budgets are then
integrated to provide a spending profile for the phase. The Program spending profile represents a summary of
phase spending profiles.
The Program Manager (PM) is provided an information package that identifies the phase numbers assigned to
each activity, the corresponding budgets and schedules, the overall spending profile for the program, and a
synopsis of all major deliverables and milestones specified in the contract. The PM uses this information,
combined with an on-line financial summary of the Program to track its financial status on a weekly basis. An
updated spending profile is provided automatically by the Planning Manager on a weekly basis, or upon request
from the PM. The PM uses the financial summary in conjunction with his assessments of technical progress to
track the overall status of the efforts.
8.3
Earned Value
By Derek Allen and Francis Pruter
Earned Value Ratios will be reported as required. At a minimum, ODU GREEN TEAM will determine earned
value monthly at the overall Program level and will report at the 2nd level of WBS indenture in order to
provide additional information.
Ratios will be reported in the form of the Schedule Performance Index (SPI) and the Cost Performance Index
(CPI). Ratios below 0.90 will be explained in further detail.
SPI is to be calculated as follows:
SPI =
BCWP (Budgeted Cost of Work Performed)
BCWS (Budgeted Cost of Work Scheduled)
CPI is to be calculated as follows:
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Prepared by: Michele Majchrowski
ENHANCED DIABETIC MANAGER
2008 ODU CS 410 Green
SBIR Grant Proposal
CPI = BCWP (Budgeted Cost of Work Performed)
ACWP (Actual Cost of Work Performed)
ODU GREEN TEAM will use a combination of Microsoft Project and Microsoft Excel in order to calculate
the ratios. On a weekly basis, actual costs will be entered. A baseline of work to be performed will be
established in Microsoft Project and will provide the BCWS. Milestones will be applied against the various
WBS elements, and % complete status of the milestones will be updated on a monthly basis. Based upon %
complete, Microsoft Project will calculate BCWP, or earned value, at the individual WBS level and determine
the earned value at the overall program level.
8.4
Quality Process and Reporting
Quality management on the program will be a team effort. The Quality System Manager will coordinate
conduct, quality reviews, and audits. The PM is ultimately responsible for the development and implementation
of the System Quality Program Plan. The SQPP is an umbrella plan which incorporates the quality programs of
the program team members. The SQPP describes a team quality concept, including Process Coordination and
Quality Evaluators. Team members are responsible for performing the processes required to complete Program
tasks. Quality Evaluators are responsible for verifying that the development, production, and handling of all
documentation, software, and hardware are performed in accordance with the SQPP and its component
processes. The team is also responsible for conducting periodic reviews and evaluations of work-in-process;
attending in-house test events, and supporting in-house Program reviews. All planned quality program activities
and quality evaluations (internal audits) are submitted to the PM for review.
8.5
Monthly Progress Report
ODU GREEN TEAM will submit a monthly progress reports. The report shall cover, at a minimum, the
following:















9
Progress Summary;
The variance statement;
Critical Path Analysis;
Milestone Deliverables, planned actual and forecast;
Earned Value Schedule and Cost Performance Indices;
Dependencies: a ‘critical items list’ of all items, whether or not the Contractor’s direct responsibility,
which could jeopardize timely completion of the work or any significant parts of the programme;
Risk Status: update of risk register;
Look Ahead (Future action and Forecast);
Resource Profile;
Work Package/Activities planned, actual & forecast status;
Milestone/Deliverables planned, actual & forecast status;
Configuration Change Control issues;
Quality Actions (Reviews, audits);
One Page Plans and Reports summarising the above for inclusion in the Purchaser’s monthly report;
Commercial: amendments to Contract status report; No later than meeting + 5 working days.
REVIEWS
Reviews will play an integral part in the management and monitoring of all phases of the EDMS Program.
Informal reviews with the Program team members will be held at all levels on a weekly basis to ensure that
the program stays on track. Formal technical reviews will be held to ensure that the program is proceeding as
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Prepared by: Michele Majchrowski
ENHANCED DIABETIC MANAGER
2008 ODU CS 410 Green
SBIR Grant Proposal
planned. The types of reviews, their purpose and presented information are addressed in the following
paragraphs.
9.1
Program Management Reviews
Program Management Reviews (PMRs) will be conducted in May 2008; thereafter reviews will take place biweekly. The PMRs are scheduled to discuss programmatic issues related to the development and
implementation of the Program. The reviews will provide the opportunity to review the progress of the effort; as
well as to conduct milestone reviews of deliverables, and identifies and resolves any issues that may arise during
the execution of the tasking.
The PM will ensure that all program-related information required to meet the objectives of the review are
prepared and delivered not later than one week prior to the scheduled review date. The PM will also be
responsible for identifying the ODU GREEN TEAM EDMS Program Team personnel who will attend the
review. The PM will attend all Program Management Reviews. The following information will be prepared in
support of each PMR. Recorded during the review and delivered before the completion of the review.
9.2
Technical Reviews
Formal technical reviews will be conducted on the dates specified in the master schedule. The reviews will be
held jointly with EDMS, ODU GREEN TEAM members and sub-suppliers as necessary. An agenda and
review material will be submitted to EDMS one week prior to the scheduled meeting. Review meeting
minutes will be delivered before the completion of the review. The objectives for each review are outlined
below.
Reviews will be held to validate the direction taken for the design, development and test of the system. The
System Requirements Review (SRR), Preliminary Design Review (PDR), and Critical Design Review (CDR)
will be formal reviews held at ODU GREEN TEAM’s facility. The Test Readiness Reviews (TRR) will be
formal reviews held prior to HAT & SAT.
System Requirements Review is conducted to ensure that the Program team fully understands the system
performance requirements specified in the System/Segment Specification. A detailed review of requirements for
the system and each subsystem will be reviewed. The System/Segment Specification (Technical Specification)
will be used in the review.
System Design Review is conducted to present and review the system design. System requirement allocation to
each system component will be discussed. The general approach to be taken for the integration of each system
component will be presented. The documents listed below will be used in the review. This will be an informal
review. The data will be included in the PDR.


System/Segment Design Document
System Interface Design Document
Software Requirements Review is conducted to review the software specification and interface requirement
specifications. This review will be conducted as part of the PDR.
Preliminary Design Review is conducted to present the preliminary design of the Program System. The
functional requirements of each subsystem will be discussed in detail. The following documents will be used in
the review:
Critical Design Review is conducted to review system integration issues. In particular the review will focus on
system interfaces in preparation for next phase.
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Prepared by: Michele Majchrowski
ENHANCED DIABETIC MANAGER
2008 ODU CS 410 Green
SBIR Grant Proposal
Test Readiness Reviews are held to determine if the system is ready to proceed to the next level of test. Test
configurations and results from the previous test efforts will be presented. The test report from the previous test
will be used in the review.
9.3
Quality Reviews
The PM supported by the quality process manager (QPM) will establish the time and identify attendees for all
formal reviews. He will also coordinate with the appropriate managers to conduct quality reviews at key
program milestones, and in preparation for formal reviews with the customer. Informal peer review and
engineering planning meetings will also be held at the discretion of each subsystem manager to discuss technical
issues, conduct internal comment reviews, and provide technical guidance to members of the Program team. As
part of the quality activities for the program, the quality team will conduct informal reviews to:





Evaluate the processes used by the Program team members to perform program tasks;
Evaluate deliverable products for compliance with contract requirements;
Evaluate work-in-process during engineering reviews;
Document results of each evaluation; and
Recommend corrective and preventive actions if necessary.
10 BIOGRAPHIES
10.1 Michele Majchrowski
I have been working in the technology field for over 10 years. I started my journey for my career back in 1994
at Thomas Nelson Community College (TNCC). From TNCC, I earned an A.A.S. in Information Systems
with Specialization in Programming and later an A.S. in Computer Science. Prior to obtaining my A.A.S, I
got a job in my career field in 1998 and I have been with this same company since.
Our company started out as a small contracting company for the government. In 2005, we were bought out by
CIBER which made us formerly known as Remtech Services (RSI) part of a large corporation. The buyout
was beneficial since they have a tuition reimbursement program!
I started as a contractor for the government at Fort Eustis. I was mostly a C++ programmer on a UNIX
system. Since then, I have programmed applications more in the Windows environment in Visual Basic,
JAVA, Javascript, classic ASP, Fox Pro, VB.NET and ASP.NET.
Currently, I work as a contractor at Fort Monroe. I am currently the primary IIS and DB Administrator as well
as a webmaster for the office which I am contracted with. Other experiences that I have obtained are from
application and server software installation and configuration such as Microsoft Project Server, Microsoft
Sharepoint Services and Microsoft Office Sharepoint Server.
10.2 Meredith Wilhelm
Meredith graduated from the University of Virginia in the spring of 2006, with a Bachelor's Degree in
History. She is currently pursuing a second bachelor's degree in Computer Science at Old Dominion
University and expects to graduate in the spring of 2009. Meredith is interested in web development and
networking and she has gained experience with C++, Java, UNIX, CSS and Html.
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ENHANCED DIABETIC MANAGER
2008 ODU CS 410 Green
SBIR Grant Proposal
10.3 Adam Hamer
10.4 Francis Pruter
10.5 Derek Allen
Derek Allen has been in the ODU CS department since 2005. He expects to graduate in fall 2008, with a
Bachelor’s in CS and a minor in CE. He has extensive experience in networking and IT thanks to Branscome,
Inc.
10.6 Eric Schultz
In spring of 2006 I graduated from TCC with an Associates Degree in Computer Science. Currently I'm
extending that knowledge at ODU and gaining new knowledge working for the Systems Group. Currently I
am focusing on Solaris and Windows Server Administration.
11
CONCLUSION
eDM will give new diabetics control over their lives. It will take the daily nightmares that are encountered
from every decision and put them all in perspective in one place. This in turn will teach new diabetics how to
manage their blood glucose levels quicker than ever before. eDM will make a difference. eDM is the answer.
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Prepared by: Michele Majchrowski
ENHANCED DIABETIC MANAGER
2008 ODU CS 410 Green
SBIR Grant Proposal
12 APPENDIX
12.1 APPENDIX A – Evaluation Plan
By Meredith Wilhelm
Enhanced Diabetic Manager
Evaluation Plan
The eDM project life cycle will be evaluated based on the individual and overall results of the four project
phases. In order for this project to be deemed successful every phase of the project must be evaluated based
on the WBS. The evaluation plan will adapt to accommodate changes during the life of the project. The
evaluation plan focuses on the technical, marketing, financial, personnel, and administrative aspects of the
project. To ensure quality standards are met, any deviation from the evaluation plan will be brought to the
attention of the project manager for approval. A phase is successful when all the items for that phase are
completed. Evaluation will occur whenever necessary, but no less often than every four months. The
evaluation plan chart (figure 2) will be used as a template in evaluating all the phases of this project.
Each phase will be evaluated based on the evaluation checklist for that phase. Evaluation will occur every
3 months or as deemed necessary by the Project Manager. The evaluation checklist consists of five
subcategories. They are as follows:





Personnel Factor: each member of the team will be evaluated based on technical, communication,
management (if applicable), and overall impact to the group.
Administrative Factor: scheduling and task breakdown analysis is included in this evaluation factor.
Financial Factor: the scheduled budget for the current phase will be evaluated for cost efficiency,
and funding allocation.
Marketing Factor: the current target market and an updated list of competitors will be validated.
Technical Factor: the components of the software, interface and hardware compatibility will be
evaluated for completion, testing, and integration.
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Prepared by: Michele Majchrowski
ENHANCED DIABETIC MANAGER
Phase 0
2008 ODU CS 410 Green
SBIR Grant Proposal
Phase 1
Phase 2
Phase 3
Evaluation Checklist
(Phase 0, 1, 2 or 3)
Technical
Factor
Personnel
Factor
Marketing
Factor
Administrative
Factor
Financial
Factor
Phase I
Personnel Factor
Although a team is evaluated by its overall results rather than individual team member’s results, the team’s
success is limited by the least contributing team member. In order to meet the set quality standards, each
member of the team will be evaluated based on technical, communication, management (if applicable), and
overall impact to the group.
Success is when the following are obtained:

Cooperation between members

Communication between member’s

Each members’ contributions are satisfactory
Administrative Factor
Project development can cause some legal and medical concerns. This guideline will focus on satisfying those
concerns as well as patent protection.
This is also where scheduling and task breakdown analysis are performed.
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Prepared by: Michele Majchrowski
ENHANCED DIABETIC MANAGER
2008 ODU CS 410 Green
SBIR Grant Proposal
Success is when the following are obtained:

Schedule for meetings

Every meeting is documented
Financial Factor
One of the most important resources in project development is money. Without it, a project will most likely
not survive the next phase. The evaluation guideline will include the net present value of the investment,
impact on cash flow, and time until break-even. Delays in project delivery date can strain the project funds;
the availability of financial resources will be measured. Forecasting of the overall funding needed for the
project delay will be determined for smooth project continuance.
Success is when the following are obtained:

Budget that meets the SBIR funding allocated (if budget is over, another funding agency is
needed to help cover the cost)

Budget broken down by phase

Breakeven point
Marketing Factor
Although the marketing aspect is not of significant concern for Phase I, it should still be evaluated based on
the approaches in market penetration.
Success is when the following are obtained:

Target Market is still valid

Competition still exists
Technical Factor
There are two components in determining the technical success of the project: software, and interfacing.
Software:
Software will be managed and evaluated under industry standards for performance. Testing will be
performed whenever new features are added to ensure functionality. Integration testing will be
performed at every level of development.
Interfacing:
The software will be tested to insure it is compatible with a variety of hardware devices such as pdas
and insulin pumps. Rigorous in-house testing will be performed on a regular basis and in fact may
encapsulate both the hardware and software testing once both facets of the project are sufficiently
complete.
In addition to in-house testing, we plan on incorporating a beta testing program in the field itself.
eDM will be given to select doctors to test on their diabetic patients. This would allow us to see how
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Prepared by: Michele Majchrowski
ENHANCED DIABETIC MANAGER
2008 ODU CS 410 Green
SBIR Grant Proposal
well our software works and how much trust patients can give to eDM in determining their insulin
levels. In beta testing, doctors and patients would be instructed not to rely solely on eDM for their
insulin data to ensure the safety of all patients.
Beta testing plan
The following will be tested:



Product’s functionality
Product’s user-friendliness
User documentation
Each doctor/patient will receive the following:



Basic instructions
User Manual
o Will include troubleshooting instructions
o Designed in a user-friendly format
Feedback and Comment Form
Acceptance Criteria
Industry and medical standards will dictate the acceptance of our software components. Our integrated
system will have to pass rigorous in-house testing as well as beta testing with doctors and patients. In regards
to the beta tests, 75% of patients in doctors must respond positively and there must be no incidents where our
software could have caused serious injury or death because of incorrect suggestions.
Success is when the following are obtained:




Functional prototype software
Functional integration of software and external devices
Technical documentation for software
Secured SBIR grant for Phase I and Phase II
Phase II
Personnel Factor
Similar to Phase I, except this phase will involve professionals hired to code and construct the product.
Success is when the following are obtained:

Cooperation and communication between members

eDM is produced and working properly

Each members’ contributions are satisfactory
Administrative Factor
Project development can cause some legal, environmental and safety concerns. This guideline will focus on
satisfying those concerns as well as patent and trade secret protection.
This is also where scheduling and task breakdown analysis are performed.
Success is when the following are obtained:
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Prepared by: Michele Majchrowski
ENHANCED DIABETIC MANAGER

Schedule for meetings

Every meeting is documented
2008 ODU CS 410 Green
SBIR Grant Proposal
Financial Factor
One of the most important resources in project development is money. Without it, a project will most likely
not survive the next phase. The evaluation guideline will include the net present value of the investment,
impact on cash flow, and time until break-even. Delays in project delivery date can strain the project funds;
the availability of financial resources will be measured. Forecasting of the overall funding needed for the
project delay will be determined for smooth project continuance.
Success is when the following are obtained:

Budget that meets the SBIR funding allocated which is this phase is $750,000 (if budget is
over, another funding agency is needed to help cover the cost)

Budget broken down by phase

Breakeven point
Marketing Factor
Marketing is more important in phase II than in phase I. While the product is still under development, beta
testing will continue and the target market will begin to be evaluated.
Success is when the following are obtained:

Target Market is still valid

Competition still exists
Technical Factor
There are two components in determining the technical success of the project: software, and interfacing.
Software:
Software will be managed and evaluated under industry standards for performance. Testing will be
performed whenever new features are added to ensure functionality. Integration testing will be
performed at every level of development.
Interfacing:
The software will be tested to insure it is compatible with a variety of hardware devices such as pdas
and insulin pumps. Rigorous in-house testing will be performed on a regular basis and in fact may
encapsulate both the hardware and software testing once both facets of the project are sufficiently
complete.
Beta testing will continue in this phase. Results will begin to be evaluated from doctors and patients.
Any serious flaws will need to be addressed before mass distribution begins.
Beta testing plan
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Page 30 of 43
Prepared by: Michele Majchrowski
ENHANCED DIABETIC MANAGER
2008 ODU CS 410 Green
SBIR Grant Proposal
The following will be tested:



Product’s functionality
Product’s user-friendliness
User documentation
Each doctor/patient will receive the following:



Basic instructions
User Manual
o Will include troubleshooting instructions
o Designed in a user-friendly format
Feedback and Comment Form
Acceptance Criteria
Industry and medical standards will dictate the acceptance of our software components. Our integrated
system will have to pass rigorous in-house testing as well as beta testing with doctors and patients. In regards
to the beta tests, 75% of patients in doctors must respond positively and there must be no incidents where our
software could have caused serious injury or death because of incorrect suggestions.
Success is when the following are obtained:



Functional software for eDM
Functional integration of software and external devices
Technical documentation for software
Phase III
Personnel Factor
Only support staff will remain to provide assistance and take calls. One or two in-house software engineers
will remain to take care of any problems that arise. At this stage a lawyer will be on call to deal with any legal
disputes.
Success is when the following are obtained:

Adequate support is provided for eDM

Any issues with the software can be resolved by the remaining personnel
Administrative Factor
Communication with eDM’s on call lawyer will help settle any legal disputes. Administration will be
necessary to monitor the support staff to ensure that the quality of help given is high.
Financial Factor
One of the most important resources in project development is money. Without it, a project will most likely
not survive the next phase. The evaluation guideline will include the net present value of the investment,
impact on cash flow, and time until break-even. Delays in project delivery date can strain the project funds;
the availability of financial resources will be measured. Forecasting of the overall funding needed for the
project delay will be determined for smooth project continuance.
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Prepared by: Michele Majchrowski
ENHANCED DIABETIC MANAGER
2008 ODU CS 410 Green
SBIR Grant Proposal
Success is when the following are obtained:

eDM reaches the breakeven point when estimated

Profit is eventually gained.
Marketing Factor
Marketing is important in phase III to ensure that eDM’s sales are as high as possible and the correct market
is targeted.
Success is when the following are obtained:

Target Market is still valid

Competition still exists or eDM is vastly superior
Technical Factor
This is less important in this phase as production and design will be completed. It will still be important for
eDM to be supported by existing hardware and adaptable as technical improvements are made.
Acceptance Criteria
eDM must continue to sell at a rate which will eventually approach the breakeven point. The software must be
successful in aiding diabetics to manage their daily lives without causing any serious injury or death.
Success is when the following are obtained:


eDM gains a satisfactory percent of the target market
eDM continues to be supported by new hardware technologies
12.2 APPENDIX B – Funding Plan
By Derek Allen
Enhanced Diabetic Manager
Funding Plan
To fund the product, “enhanced Diabetes Manager”, Green Team Spring 2008 will submit a SBIR grant
application to the National Science Foundation. Additional funding will be acquired through business loans in
order to get through phase II. Once Phase III starts our product should be self-sufficient, requiring no further
funding.
The SBIR program distributes funds in increments of $100,000 and $750,000 for two different phases of
development. Phase I will be eDM’s prototyping phase, and will require the full $100,000 from the SBIR
grant. Green team does not anticipate any overage during this phase.
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Prepared by: Michele Majchrowski
ENHANCED DIABETIC MANAGER
2008 ODU CS 410 Green
SBIR Grant Proposal
eDM will run into budgetary concerns midway through Phase II, even with the maximum award of $750,000
from the SBIR grant. Therefore, additional grants and loans for businesses will be used in order to make it
through to Phase III. Phase II costs are estimated to be $1,461,500, or $711,500 over the SBIR grant.
Phase III costs are estimated to be $1.74 in materials per unit made and $16,800 in salary per week. Product
sales will be needed to offset this continued cost of operation, in addition to paying down earlier loans.
For details on how money will be spent, see the Staff and Resource Plans.
12.3 APPENDIX C – Marketing Plan
By Francis Pruter
Enhanced Diabetic Manager
Marketing Plan
Our Target Market:
Our product will primarily be targeted to newly diagnosed Diabetics since this transition can be
frightening and is essential for living a longer healthier life. Over 20 million people have been diagnosed
with some form of diabetes in America alone and that number is on the rise. There is an estimated 6 percent
growth rate of the disease. Without accurate and constant monitoring of glucose levels and caloric intake,
Diabetes will suffer from both acute and chronic conditions.
Cost:
In order to cover the cost of development and keeping our product affordable to the end user, our
product is will cost the client approximately $50. Since our product is software, the client must have a PDA
and/or a desktop.
Break Even Analysis:
In order to get out of debt from the development phase, we need to sell 26,486 units at a price of $50.
The chart below also takes in consideration the weekly salary of the staff. Also, the chart below assumes that
we will sell at least 50,000 units in the first year which should be achievable with potential market of 1.5
million newly diagnosed diabetics.
sold/week
1
1000
Last Updated: Tuesday, July 26, 2016
gross profit
48260
weekly
salary
12600
profit/week
35660
Profit
($620,200.00)
Page 33 of 43
Prepared by: Michele Majchrowski
ENHANCED DIABETIC MANAGER
2008 ODU CS 410 Green
SBIR Grant Proposal
2
1000
48260
12600
35660
($584,540.00)
3
1000
48260
12600
35660
($548,880.00)
4
1000
48260
12600
35660
($513,220.00)
5
1000
48260
12600
35660
($477,560.00)
6
1000
48260
12600
35660
($441,900.00)
7
1000
48260
12600
35660
($406,240.00)
8
1000
48260
12600
35660
($370,580.00)
9
1000
48260
12600
35660
($334,920.00)
10
1000
48260
12600
35660
($299,260.00)
11
1000
48260
12600
35660
($263,600.00)
12
1000
48260
12600
35660
($227,940.00)
13
1000
48260
12600
35660
($192,280.00)
14
1000
48260
12600
35660
($156,620.00)
15
1000
48260
12600
35660
($120,960.00)
16
1000
48260
12600
35660
($85,300.00)
17
1000
48260
12600
35660
($49,640.00)
18
1000
48260
12600
35660
($13,980.00)
19
1000
48260
12600
35660
$21,680.00
20
1000
48260
12600
35660
$57,340.00
21
1000
48260
12600
35660
$93,000.00
22
1000
48260
12600
35660
$128,660.00
23
1000
48260
12600
35660
$164,320.00
24
1000
48260
12600
35660
$199,980.00
25
1000
48260
12600
35660
$235,640.00
26
1000
48260
12600
35660
$271,300.00
27
1000
48260
12600
35660
$306,960.00
28
1000
48260
12600
35660
$342,620.00
29
1000
48260
12600
35660
$378,280.00
Last Updated: Tuesday, July 26, 2016
Page 34 of 43
Prepared by: Michele Majchrowski
ENHANCED DIABETIC MANAGER
2008 ODU CS 410 Green
SBIR Grant Proposal
30
1000
48260
12600
35660
$413,940.00
31
1000
48260
12600
35660
$449,600.00
32
1000
48260
12600
35660
$485,260.00
33
1000
48260
12600
35660
$520,920.00
34
1000
48260
12600
35660
$556,580.00
35
1000
48260
12600
35660
$592,240.00
36
1000
48260
12600
35660
$627,900.00
37
1000
48260
12600
35660
$663,560.00
38
1000
48260
12600
35660
$699,220.00
39
1000
48260
12600
35660
$734,880.00
40
1000
48260
12600
35660
$770,540.00
41
1000
48260
12600
35660
$806,200.00
42
1000
48260
12600
35660
$841,860.00
43
1000
48260
12600
35660
$877,520.00
44
1000
48260
12600
35660
$913,180.00
45
1000
48260
12600
35660
$948,840.00
46
1000
48260
12600
35660
$984,500.00
47
1000
48260
12600
35660
$1,020,160.00
48
1000
48260
12600
35660
$1,055,820.00
49
1000
48260
12600
35660
$1,091,480.00
50
1000
48260
12600
35660
$1,127,140.00
Advertising:
Initially, our product will be exposed to the market via doctor recommendations. We will being
giving doctors samples of our product to ensure that they understand its features and capabilities to allow
them to accurately recommend our product that meets the needs of their clients.
After we have received doctor’s endorsements, we plan to begin marketing on the internet as well as
medical magazines such as the AARP. This will allow our product to be exposed to a larger market.
Last Updated: Tuesday, July 26, 2016
Page 35 of 43
Prepared by: Michele Majchrowski
ENHANCED DIABETIC MANAGER
2008 ODU CS 410 Green
SBIR Grant Proposal
Competition Matrix:
Although products exist that help manage the disease, our product will incorporate all the features into on
bundle. Below is a matrix of our competitors.
SiDiary
OneTouch
Diabetic
ezManager
GlucoPilot
eDM
Monitor
Database
X
Of
Foods
Manages Carbs X
X
X
X
Well
Graphs
and X
X
X
X
Charts
Activity Level
Interface
X
X
X
X
with X
X
X
X
X
X
trend X
X
X
X
X
X
X
X
X
X
Data X
X
devices
Glucose
Monitoring
Meal-related
X
patterns
Easy
X
X
X
X
management
Customer
X
X
X
support
12.4 APPENDIX D – Prototype Plan
By Eric Schultz
Enhanced Diabetic Manager
Last Updated: Tuesday, July 26, 2016
Page 36 of 43
Prepared by: Michele Majchrowski
ENHANCED DIABETIC MANAGER
2008 ODU CS 410 Green
SBIR Grant Proposal
Guide to Prototype Production
Overview of Project:
Create a PDA that can suggest insulin amounts and when to take the insulin. This is based on the insulin
delivery method, the insulin used, the person's current glucose level, and their activity level planned for the
next few hours and what food the person will be eating in the next 30 minutes. The data can then be displayed
and analyzed on a PC.
Requirements for actual product:
PDA
Insulin pump
Glucose monitoring device (can come with pump, litmus test, etc.) Personal Computer *
* = optional
Requirements for prototype
Personal Computer
-Database (for list of foods)
-Compiler/libraries for chosen programming language (c++/java/etc.)
Prototype Program Overview
The high cost of product development means that developing a prototype is an expensive and time consuming
endeavor. During a prototyping phase, a product can be changed drastically. In order to keep initial costs at
minimum and to quickly and effectively change with the product's requirements, the decision to simulate the
product in its initial phases was agreed upon.
Prototype Design
The program's design will be made up of three different parts.
1. Part one would consist of a simple program that reflects a human bodies' current insulin levels, the
gradual lowering of glucose levels, glucose levels after injection and the person's activity level.
2. Part two consists of a database that contains a list of foods, their calories and how much insulin to
inject, how soon to inject insulin when about to consume the selected food.
3. Part three would simulate our device. The features here would include accepting input based on the
database, adding to the database, editing items in the database, storing/updating/displaying a user's
settings, getting data from the 1st part of the program, and sending insulin amounts to the 1st part of
the program.
Last Updated: Tuesday, July 26, 2016
Page 37 of 43
Prepared by: Michele Majchrowski
ENHANCED DIABETIC MANAGER
2008 ODU CS 410 Green
SBIR Grant Proposal
12.5 APPENDIX E – Resource Plan
By Adam Hamer
Enhanced Diabetic Manager
Resource Plan
Purpose
This document defines the hard resources associated with the project per phase. The purpose of this
document is to define what hard resources are necessary per phase and to explain their purpose. Each phase
defines new hard resources that are introduced; however it should be assumed by the reader that any hard
resource that is used in a previous phase will be used for the same purpose in subsequent phases unless
otherwise noted.
Although human resources are in integral part of the resource plan, these resources have been addressed in the
separate document, Staffing Plan, contained within this SBIR. The reader is referred to the funding plan for
any detailed financial information.
Phase 0
In this phase the initial SBIR proposal is created along with a proposal presentation and product website.
Since this phase only involves research and the proof of concept, no hard resources are required.
Phase 1
In this phase a lab prototype will be developed and the SBIR Phase 2 proposal will be developed. Success
will be measured by the successful completion of those two deliverables.
Resource
Quantity
Cost
Database Software (mySQL)
1
$
Laptop(Toshiba Satellite
L355D)
2
$ 800
$1,600
Router(Linksys WRT54GS
Wireless-G broadband
router)
1
$ 100
$ 100
Ethernet Cables(10 ft. CAT5)
3
Workstation
1
$
0
10
Total
$
$
0
30
$1,200
$1,200
Total Resource Cost (Phase 1)
$2,930
The following hard resources are needed for Phase 1:
1. Database Software (mySQL) – This software will allow us to write eDM's database that will contain
a wide assortment of food types, as well as, data collected based on our eDM's glucose management
software.
Last Updated: Tuesday, July 26, 2016
Page 38 of 43
Prepared by: Michele Majchrowski
ENHANCED DIABETIC MANAGER
2008 ODU CS 410 Green
SBIR Grant Proposal
2. Laptops – These will act as our portable devices in testing our transfer of data between multiple
devices.
3. Router – The router is needed so that we can transfer information to the other computers.
4. Ethernet Cables – This will act as the median in which we will connect the laptop computers and
workstation, to the router, in tern to one another.
5. Workstation – The workstation is needed so that we can have a central area to upload modules of our
project EDM, as well as act at a non portable device.
Phase 2
In this phase the actual prototype of the product will be developed.
The following hard resources are needed for Phase 2:
Resource
Quantity
Cost
Total
Laptop(Toshiba
Satellite L355D)
4
$ 800
$3,200
Workstation (2GB
Ram, 120 GB
Harddrive)
1
$1,000
$1,000
Glucose Monitor with
download capability
1
$ 100
$ 100
Insulin Pump with
wireless device or
download capability
1
$1,200
$1,200
Device Software
INC
CDs (100 pack)
5
$
$
0
20
$ 100
Total Resource Cost (Phase 2)
$5,500.00
6. Database Software (mySQL) – This software will allow us to write eDM's database that will contain
a wide assortment of food types, as well as, data collected based on our eDM's glucose management
software.
7. Laptops – These computers will be needed as we increase the number of people working on the
project to meet deadlines.
8. Workstation – The workstation will be needed for back up of information.
9. Glucose Monitor - This will be need when we continue testing our software will be able to
communicate with a portable monitoring system.
10. Insulin Pump – This will be needed when we continue testing our software will be able to
communicate with an Insulin pump that sends out information, to create a better analysis of the
diabetic’s health.
11. eDM – This software will be needed to be loaded onto the devices to show its functionality.
12. CD's – will be needed so that we can with the assistance of a Doctor distribute our device as a
possible way to manage Diabetes.
Phase 3
Last Updated: Tuesday, July 26, 2016
Page 39 of 43
Prepared by: Michele Majchrowski
ENHANCED DIABETIC MANAGER
2008 ODU CS 410 Green
SBIR Grant Proposal
This phase is the main rollout of the product. In this phase the warehouse and manufacturer is secured and
actual production begins. The marketing campaign also begins in this phase.
The following hard resources are needed for Phase 3:
Resource
Quantity
Cost
Total
Database Software
(SQL Server)
1
$1,900
$ 1,900
Laptop(Toshiba
Satellite L355D)
4
$ 800
$ 3,200
IIS & DB Servers
(Dell PowerEdge 2900
III)
2
$10,000
$20,000
$24,100
Total Resource Cost (Phase 3)
13. Database Software – This software will be needed so that we can insure database integrity of
information needed for the user to input information to the device with our software.
14. Laptops – These computers will be needed as we increase the number of people working on the
project, and maintenance of the server.
15. IIS & DB Server – These will be act as the device that will utilize the Database Software and
services.
Out Years
The phase is the functional and support phase of the project. The tasks in this phase are ongoing and are not
part of the project.
Since Out Years maintains and supports the products that are created in the project, any hard resources needed
for that support would have been identified and setup in Phase 3. Therefore there are no hard resources
defined specifically for Out Years the Out Years hard resources come from previous phases.
12.6 APPENDIX F – Risk Management Plan
By Eric Schultz
Enhanced Diabetic Manager
Risk Management Plan
Overview:
While risks are involved in every project, the creation of a risk management plan can effectively help manage
and reduce the threat caused by risks because of proper foresight and planning. The purpose of this document
is to help guide the spring 2008 Green Team in planning, coordination and decision making.
Management Plan:
1. Identify the risk.
2. Identify what project area is responsible for dealing with the risk
Last Updated: Tuesday, July 26, 2016
Page 40 of 43
Prepared by: Michele Majchrowski
ENHANCED DIABETIC MANAGER
2008 ODU CS 410 Green
SBIR Grant Proposal
3. Input the risk into our risk list
4. Calculate the risk's probability and impact
5. Determine the best plan for overcoming the risk *
6. Execute the plan
7. Track the risk for the affected product life cycle
* Plan for overcoming risks:
Accept the risk - Leave the project as is in hopes that the benefits from leaving features in will out weigh the
benefits from spending resources to resolve the issue.
Add/subtract features from the product - Change features in the product to eliminate or decrease the impact or
probability of the risk.
Receive a solution from a 3rd party - Consult a 3rd party to devise or create a solution.
Risks and their Mitigation
FDA Approval/ Law Suits – from an early stage we will seek out medical advice from a competent doctor.
Incompatible Pumps – These risks are mitigated by our recruitment of competent employees.
Competition – We plan on having our target audience by gaining doctor’s approval first. This will establish
our product as an authority in the fields and then establish marketing strategy focused on the customer.
Someone loses their PDA/Insecure PDA – The medical data will be stored in an encrypted format
Cure for Diabetes – Once the probability increases, our marketing division will focus on applying our pump
to areas other that diabetes (for example chemotherapy or pain relief).
User settings change - When the user inputs a new insulin container, the device will ask for the updated
information regarding insulin type.
PC Used to view enhancements – In addition to graphical displays, when ever possible; a text display mode
will be viewable to the user on the PDA.
Tedious to use – Right from the initial test phase, the program will be designed with an easy to navigate user
interface.
12.7 APPENDIX G – Staffing Plan
By Meredith Wilhelm
Enhanced Diabetic Manager
Staffing Plan
Last Updated: Tuesday, July 26, 2016
Page 41 of 43
Prepared by: Michele Majchrowski
ENHANCED DIABETIC MANAGER
2008 ODU CS 410 Green
SBIR Grant Proposal
ODU Green Team Spring 2008
Phase 0
Phase 0 will be staffed by six Old Dominion University Students, forming the Green Team. These students
will develop the concept and details for the Diabetic Management software. All labor will be unpaid in this
phase.
Phase I
Phase 1 will be staffed by the same six students as well as one medical expert. The students will be paid at an
intern rate for this phase.
Intern Salary: $25,000/year - $12.50/hour for 4 months.
Expert Salary: $100,000/year - $50/hour for 4 months.
Phase II
Specialists will be hired to develop our product.
Manager: Will assign tasks and insure that all deliverables produced are of high quality.
Personnel needed: 1
Salary: $100,000/ year – $50/hour for 6 months..
Software Engineer: Will design and implement code for the software portion of the project. Experience with
MySQL or other database languages is required.
Personnel needed: 5
Salary: $75,000/ year – $37.50/hour for 6 months.
Software Assistants: Will aid the software engineers in coding and debugging. Assistants are paid at an
intern rate.
Personnel needed: 1-2
Salary: $30,000/year – $17.00/hour for 6 months.
Hardware Engineer: Will ensure that the PDA device is compatible with the Diabetic Management software
and any insulin pumps or PC programs that it will interface with.
Personnel needed: 1
Salary: $75,000/year – $37.50/hour for 6 months.
Finance Specialist: Will be responsible for the cost of all parts of the solution. The finance specialist must
ensure that the project stays within the giving budget and may be responsible for obtaining additional funding
in future phases.
Personnel needed: 1
Last Updated: Tuesday, July 26, 2016
Page 42 of 43
Prepared by: Michele Majchrowski
ENHANCED DIABETIC MANAGER
2008 ODU CS 410 Green
SBIR Grant Proposal
Salary: $25,000/year – $15.00/hour for 6 months.
40% overhead will be used to pay for any administrative and non-production staff.
Phase III
Staff for this phase will be hired for existing product support and maintenance.
Software Engineer: Will remain on call for any changes or debugging needed for the code.
Personnel needed: 2
Salary: $75,000/ year – $37.50/hour for 10 years.
Support Center Staff: Will be responsible for handling customer complaints and issues. Will take calls and
forward any issues to the on-call Software Engineer.
Personnel needed: 5
Salary: $25,000/year – $12.50/hour for 10 years
Administrative Assistant: Will be responsible for maintaining the office environment for the support center
and communications.
Personnel needed: 1
Salary: $31,000/year – $15.00/hour for 10 years.
Lawyer: Will be on call to handle any legal issues and mediate potential lawsuits.
Personnel needed: 1
Salary: $200/hour-8 hours consult/week over 10 years.
Last Updated: Tuesday, July 26, 2016
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