Form Approved Through 05/2004
Department of Health and Human Services
Public Health Services
OMB No. 0925-0001
LEAVE BLANK—FOR PHS USE ONLY.
Type
Activity
Number
Review Group
Formerly
Grant Application
Council/Board (Month, Year)
Do not exceed character length restrictions indicated.
1. TITLE OF PROJECT (Do not exceed 56 characters, including spaces and punctuation.)
Date Received
P3C Communicator
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)
No
NO
YES
Yes
Young, Zachary, Parker
3c. POSITION TITLE
3d. MAILING ADDRESS (Street, city, state, zip code)
Project Manager
7700 Hampton Blvd.
Norfolk, VA 23505
3e. DEPARTMENT, SERVICE, LABORATORY, OR EQUIVALENT
P3C Communicator
3f. MAJOR SUBDIVISION
P3C
E-MAIL ADDRESS:
3g. TELEPHONE AND FAX (Area code, number and extension)
TEL:
(757) 683-3653
FAX:
(757) 683-4900
4. HUMAN SUBJECTS 4a. Research Exempt
RESEARCH
If “Yes,” Exemption No.
No
4b. Human Subjects
Assurance No.
No
zyoung@cs.odu.edu
5. VERTEBRATE ANIMALS
Yes
4c. NIH-defined Phase III
5a. If “Yes,” IACUC
No
Yes
5b. Animal welfare assurance no.
6. DATES OF PROPOSED PERIOD OF
SUPPORT (month, day, year—MM/DD/YY)
approval Date
Clinical Trial
No
Yes
7. COSTS REQUESTED FOR INITIAL
BUDGET PERIOD
8. COSTS REQUESTED FOR PROPOSED
PERIOD OF SUPPORT
From
7a. Direct Costs ($)
7b. Total Costs ($)
8a. Direct Costs ($)
$390,130
$642,150
Yes
Through
7/1/2004
1/2/2006
$382,230
9. APPLICANT ORGANIZATION
Name
P3C
Address
8b. Total Costs ($)
$642,150
10. TYPE OF ORGANIZATION
7700 Hampton Blvd.
Norfolk, VA 23505
Public:

Federal
Private:

Private Nonprofit
For-profit: 
Woman-owned
General
State
Local
Small Business
Socially and Economically Disadvantaged
11. ENTITY IDENTIFICATION NUMBER
DUNS NO.
Institutional Profile File Number (if known)
Congressional District
12. ADMINISTRATIVE OFFICIAL TO BE NOTIFIED IF AWARD IS MADE
Name
Richard Strosahl
13. OFFICIAL SIGNING FOR APPLICANT ORGANIZATION
Name
Masudur Rashid
Title
Finance Specialist
Title
President
7700 Hampton Blvd.
Norfolk, VA 23505
Address
7700 Hampton Blvd.
Norfolk, VA 23505
Address
Tel:
(757) 683-3653
rstrosah@cs.odu.edu
FAX:
(757) 683-4900
Tel:
(757) 683-3653
FAX:
E-Mail: mrashid@cs.odu.edu
14. PRINCIPAL INVESTIGATOR/PROGRAM DIRECTOR ASSURANCE: I certify that the SIGNATURE OF PI/PD NAMED IN 3a.
statements herein are true, complete and accurate to the best of my knowledge. I am
(In ink. “Per” signature not acceptable.)
(757) 683-4900
E-Mail:
aware that any 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.
SIGNATURE OF OFFICIAL NAMED IN 13.
15. APPLICANT ORGANIZATION CERTIFICATION AND ACCEPTANCE: I certify that
the statements herein are true, complete and accurate to the best of my knowledge, and
(In ink. “Per” signature not acceptable.)
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.
PHS 398 (Rev. 05/01)
PHS 398/2590 (Rev. 05/01)
Face Page
Page 1
DATE
05/03/2004
DATE
05/03/2004
Form Page 1
Principal Investigator/Program Director (Last, First, Middle):
Young, Zachary, Parker
DESCRIPTION: State the application’s broad, long-term objectives and specific aims, making reference to the health relatedness of the project. Describe
concisely the research design and methods for achieving these goals. Avoid summaries of past accomplishments and the use of the first person. This abstract
is meant to serve as a succinct and accurate description of the proposed work when separated from the application. If the application is funded, this
description, as is, will become public information. Therefore, do not include proprietary/confidential information. DO NOT EXCEED THE SPACE
PROVIDED.
Over 30% of the people between the ages of 35 and 65 years old have been diagnosed with a
cardiovascular disease (CVD). These diseases, when left untreated, lead to cardiac events such as heart
attack, bypass surgery, angioplasty, and many others. After these events, rehabilitation is paramount. If a
patient takes all of his or her prescribed medication and makes recommended lifestyle changes the
individual will not only promote regression of his or her disease, the patient will decrease his or her chances
dying as a result of future cardiovascular problems by 20-30% according to the ACSM’s Guidelines for
Exercise Testing and Prescription.
Unfortunately, only 20% the patients who could benefit from cardiovascular rehabilitation participate. A
study published in 1996 cited many reasons for this lack of participation. Among the most common reasons
for lack of participation among patients were: lack of knowledge, lack of motivation, and lack of access to
care. Larger barriers to participation occurred in the medical community; these included: lack of resources
and facilities, time and economic constraints, poor communication between specialty and primary care
providers, and lack of policies and standards.
The primary objective of the P3C Communicator is to motivate individuals with cardiovascular diseases
to continue in taking a proactive approach to improving their well-being. We will achieve this objective by
providing users with analysis of their heart rate and blood pressure. The P3C Communicator will take
automatic readings of the user's blood pressure and heart rate through the use of a blood pressure/heart rate
monitor. The data will then be sent to our central server for analysis. The server will respond to the P3C
docking station with varied messages. If the user is doing well, the docking station will display a positive
message. If the user is possibly having problems, the docking station will display a warning or alert. The
goal of the P3C Communicator is to motivate an individual to maintain an exercise regiment that suits him or
her, while making sure that the user is not pushing his or her heart past a safe level.
PERFORMANCE SITE(S) (organization, city, state)
P3C Main Site, Norfolk, VA
Old Dominion University, Norfolk, Virginia
KEY PERSONNEL. See instructions. Use continuation pages as needed to provide the required information in the format shown below.
Start with Principal Investigator. List all other key personnel in alphabetical order, last name first.
Name
Organization
Role on Project
Young, Zachary
Haq, Rabia
Hollingsworth, Justin
Strosahl, Richard
Wong, Matthew
Young, John P.
Old Dominion University
Old Dominion University
Old Dominion University
Old Dominion University
Old Dominion University
Indiana University School of Medicine
Disclosure Permission Statement. Applicable to SBIR/STTR Only. See instructions.
PHS 398/2590 (Rev. 05/01)
Page 2
Yes
No
Project Manager
Webmaster
Prototype Design Specialist
Finanace Specialist
Tech. Document Specialist
Consultant
Principal Investigator/Program Director (Last, First, Middle):
Young, Zachary, Parker
The name of the principal investigator/program director must be provided at the top of each printed page and each continuation page.
RESEARCH GRANT
TABLE OF CONTENTS
Page Numbers
Face Page ..................................................................................................................................................
Description, Performance Sites, and Personnel ...................................................................................
Table of Contents .....................................................................................................................................
Detailed Budget for Initial Budget Period (or Modular Budget) ..........................................................
Budget for Entire Proposed Period of Support (not applicable with Modular Budget) .............................
Budgets Pertaining to Consortium/Contractual Arrangements (not applicable with Modular Budget)
Biographical Sketch – Principal Investigator/Program Director (Not to exceed four pages) ..................
Other Biographical Sketches (Not to exceed four pages for each – See instructions) .........................
Resources .................................................................................................................................................
7
8-12
13
Research Plan ...........................................................................................................................................
14-
1
2
3
4
5-6
Introduction to Revised Application (Not to exceed 3 pages) .........................................................................................................
Introduction to Supplemental Application (Not to exceed one page) ..............................................................................................
A. Specific Aims ......................................................................................................................................................................
B. Background and Significance .............................................................................................................................................
C. Preliminary Studies/Progress Report/
(Items A-D: not to exceed 25 pages*)
Phase
I Final
ReportReport
(SBIR/STTR),
or Phase II ONLY)
Phase
I Progress
(SBIR/STTR
* SBIR/STTR Phase I: Items A-D limited to 15 pages.
SBIR/STTR
Fast Track
Product...........................................................................................................................................
Development Plan ...........................................................................................................
D. Research
Design
and Methods
14
15-17
18-20
21-23
E. Human Subjects .................................................................................................................................................................
Protection of Human Subjects (Required if Item 4 on the Face Page is marked “Yes”) ...................................................
Inclusion of Women (Required if Item 4 on the Face Page is marked “Yes”) .................................................................
Inclusion of Minorities (Required if Item 4 on the Face Page is marked “Yes”) ...............................................................
Inclusion of Children (Required if Item 4 on the Face Page is marked “Yes”) .................................................................
Data and Safety Monitoring Plan (Required if Item 4 on the Face Page is marked “Yes” and a Phase I, II, or III clinical
trial is proposed ......................................................................................................................................................
F. Vertebrate Animals .............................................................................................................................................................
G. Literature Cited ...................................................................................................................................................................
H. Consortium/Contractual Arrangements ...............................................................................................................................
I. Letters of Support (e.g., Consultants) .................................................................................................................................
J. Product Development Plan (SBIR/STTR Phase II and Fast-Track ONLY) ..........................................................................
25-26
27-34
Checklist....................................................................................................................................................
35
Appendix (Five collated sets. No page numbering necessary for Appendix.)
Appendices NOT PERMITTED for Phase I SBIR/STTR unless specifically solicited. .............................................................
Number of publications and manuscripts accepted for publication (not to exceed 10)
Other items (list):
PHS 398/2590 (Rev. 05/01)
Page 3
24
Check if
Appendix is
Included
Principal Investigator/Program Director (Last, First, Middle):
Young, Zachary, Parker
DETAILED BUDGET FOR INITIAL BUDGET PERIOD
DIRECT COSTS ONLY
PERSONNEL (Applicant organization only)
FROM
THROUGH
7/1/2004
1/2/2006
TYPE
APPT.
(months)
%
EFFORT
ON
PROJ.
12
80.0
72,800
58,240
58,240
12
70.0
59,100
41,370
41,370
Programmer
6
60.0
52,600
15,780
15,780
Programmer
6
60.0
52,600
15,780
15,780
Programmer
6
60.0
52,600
15,780
15,780
Quality
Assurance
Quality
Assurance
Database
Analyst
Electric
Engineer
Electric
Engineer
Electric
Engineer
SUBTOTALS
2
60.0
52,400
5,240
5,240
2
60.0
52,400
5,240
5,240
3
100.0
71,400
17,850
17,850
6
50.0
56,600
14,150
14,150
6
50.0
56,600
14,150
14,150
6
50.0
56,600
14,150
14,150
217,730
217,730
ROLE ON
PROJECT
NAME
Principal
Investigator
Software
Engineer
DOLLAR AMOUNT REQUESTED (omit cents)
INST.
BASE
SALARY
SALARY
REQUESTED
FRINGE
BENEFITS
TOTAL
CONSULTANT COSTS
Dr. John Young
Dennis Ray
Medical Advisor
13,980
7,900
EQUIPMENT (Itemize)
Docking Station (7)
Heart Rate/ Blood Pressure Monitor (14)
5,250
7,000
SUPPLIES (Itemize by category)
Miscellaneous Disposable Costs
3,000
TRAVEL
Attend conferences / seminars
PATIENT CARE COSTS
INPATIENT
OUTPATIENT
1,000
0
0
NA
NA
ALTERATIONS AND RENOVATIONS (Itemize by category)
NA
0
OTHER EXPENSES (Itemize by category)
Personnel Overhead
87,100
SUBTOTAL DIRECT COSTS FOR INITIAL BUDGET PERIOD
$
CONSORTIUM/CONTRACTUAL COSTS
47,170
FACILITIES AND ADMINISTRATIVE COSTS
TOTAL DIRECT COSTS FOR INITIAL BUDGET PERIOD (Item 7a, Face Page)
SBIR/STTR Only: FEE REQUESTED
PHS 398/2590 (Rev. 05/01)
335,060
DIRECT COSTS
Page 4
$
382,230
Principal Investigator/Program Director (Last, First, Middle):
Young, Zachary, Parker
BUDGET FOR ENTIRE PROPOSED PROJECT PERIOD
DIRECT COSTS ONLY
BUDGET CATEGORY
TOTALS
PERSONNEL: Salary and
fringe benefits. Applicant
organization only.
INITIAL BUDGET
PERIOD
(from Form Page 4)
ADDITIONAL YEARS OF SUPPORT REQUESTED
2nd
3rd
217,730
145,430
CONSULTANT COSTS
21,880
21,880
EQUIPMENT
12,250
SUPPLIES
3,000
2,000
TRAVEL
1,000
1,000
87,100
58,170
342,960
228,480
47,170
23,540
390,130
252,020
PATIENT
CARE
COSTS
4th
5th
INPATIENT
OUTPATIENT
ALTERATIONS AND
RENOVATIONS
OTHER EXPENSES
SUBTOTAL DIRECT COSTS
CONSORTIUM/ DIRECT
CONTRACTUAL
COSTS
F&A
TOTAL DIRECT COSTS
TOTAL DIRECT COSTS FOR ENTIRE PROPOSED PROJECT PERIOD (Item 8a, Face Page)
––––– $
642,150
SBIR/STTR Only
Fee Requested
SBIR/STTR Only: Total Fee Requested for Entire Proposed Project Period
(Add Total Fee amount to “Total direct costs for entire proposed project period” above and Total F&A/indirect costs from Checklist
Form Page, and enter these as “Costs Requested for Proposed Period of Support on Face Page, Item 8b.)
$
JUSTIFICATION. Follow the budget justification instructions exactly. Use continuation pages as needed.
The principle investigator will oversee the design and development of the P3C system, facilitate
communication between team members, organize meetings, and keep track of the projects progress.
The software engineer will lead the development and evaluation of the computer engineering and
programming elements required for the P3C system. He will work with the database analyst to integrate the
database with the P3C system. He will participate in the design, writing, and testing of the P3C
Communicator’s software.
The programmers will design and develop the P3C Communicator’s software including the analysis software
and the Docking Station software.
The quality assurance experts will test the software. They will work with the software engineer ,
programmers, and database analyst to identify and fix bugs in the P3C Communicator’s software.
PHS 398/2590 (Rev. 05/01)
Page 5
Young, Zachary, Parker
Principal Investigator/Program Director (Last, First, Middle):
JUSTIFICATION. Follow the budget justification instructions exactly. Use continuation pages as needed.
The database analyst design will develop the P3C Communicator’s database. He will work with the
programmers and the software engineer to integrate the database.
The electrical engineer will design, develop, and participate in the testing the P3C Heart Rate/ Blood
Pressure monitor and the P3C docking station. They will work with the quality assurance experts to test P3C
Communicator systems.
Dr. John Young will assist in the development of the analysis software and validate tests, test cases, and test
results.
Dennis Ray will assist in the design and development of the P3C Communicator and help facilitate
communication between the P3C team and Old Dominion University.
PHS 398/2590 (Rev. 05/01)
Page 6
Principal Investigator/Program Director (Last, First, Middle):
Young, Zachary Parker
BIOGRAPHICAL SKETCH
Provide the following information for the key personnel in the order listed on Form Page 2.
Follow this format for each person. DO NOT EXCEED FOUR PAGES.
NAME
POSITION TITLE
Zachary Young
Principal Investigator / Project Manager
EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, and include postdoctoral training.)
DEGREE
INSTITUTION AND LOCATION
YEAR(s)
FIELD OF STUDY
(if applicable)
Old Dominion University, Norfolk, VA
B.S.
A. Positions and Honors
N/A
B. Selected peer-reviewed publications
N/A
C. Research Support
No sponsored research during the last three years.
PHS 398/2590 (Rev. 05/01)
Page 7
2001-2005
Computer Science
Principal Investigator/Program Director (Last, First, Middle):
Young, Zachary, Parker
BIOGRAPHICAL SKETCH
Provide the following information for the key personnel in the order listed on Form Page 2.
Follow this format for each person. DO NOT EXCEED FOUR PAGES.
NAME
POSITION TITLE
Rabia Haq
Webmaster
EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, and include postdoctoral training.)
INSTITUTION AND LOCATION
Old Dominion University, Norfolk, VA
Lahore University of Management and Sciences,
Lahore, Pakistan
DEGREE
(if applicable)
YEAR(s)
B.S.
2002-2004
Computer Science
2001-2002
Computer Science
FIELD OF STUDY
A. Positions and Honors
2003
2003
2003
2002-current
2001-2002
Member of the Association of Computing Machinery
Treasurer of Golden Key Honor Society
Member of the National Society of Black Engineers
Dean’s List – Fall- Old Dominion University
Dean’s List – Fall- Lahore University of Management and Sciences
B. Selected Peer Reviews
N/A
C. Research Support
Continuous research support provided to the Phase 3 Communicator Project Team for the design,
development and concept of the P3C Product.
Provided research on concept, design and development of the Medical Memory Assistance Project for
the Computer Productivity Initiative during the Fall 2003 semester at Old Dominion University.
PHS 398/2590 (Rev. 05/01)
Page 8
Principal Investigator/Program Director (Last, First, Middle):
Young, Zachary, Parker
BIOGRAPHICAL SKETCH
Provide the following information for the key personnel in the order listed on Form Page 2.
Follow this format for each person. DO NOT EXCEED FOUR PAGES.
NAME
POSITION TITLE
Justin W. Hollingsworth
Prototype Design Specialist
EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, and include postdoctoral training.)
INSTITUTION AND LOCATION
Old Dominion University, Norfolk, VA
A. Positions and Honors
B. Selected peer-reviewed publications
N/A
C. Research Support
No sponsored research during the last three years.
PHS 398 (Rev. 05/01)
Page 9
DEGREE
(if applicable)
YEAR(s)
B.S.
2000-2004
FIELD OF STUDY
Computer Science
Principal Investigator/Program Director (Last, First, Middle):
Young, Zachary
BIOGRAPHICAL SKETCH
Provide the following information for the key personnel in the order listed on Form Page 2.
Follow this format for each person. DO NOT EXCEED FOUR PAGES.
NAME
POSITION TITLE
Richard Strosahl
Finance Specialist
EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, and include postdoctoral training.)
INSTITUTION AND LOCATION
Old Dominion University, Norfolk, VA
A. Positions and Honors
B. Selected peer-reviewed publications
N/A
C. Research Support
No sponsored research during the last three years.
PHS 398 (Rev. 05/01)
Page 10
DEGREE
(if applicable)
YEAR(s)
B.S.
2001-2004
FIELD OF STUDY
Computer Science
Principal Investigator/Program Director (Last, First, Middle):
Young, Zachary Parker
BIOGRAPHICAL SKETCH
Provide the following information for the key personnel in the order listed on Form Page 2.
Follow this format for each person. DO NOT EXCEED FOUR PAGES.
NAME
POSITION TITLE
Matthew Wong
Technical Documentation Specialist
EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, and include postdoctoral training.)
DEGREE
INSTITUTION AND LOCATION
YEAR(s)
FIELD OF STUDY
(if applicable)
Old Dominion University, Norfolk, VA
B.S.
A. Positions and Honors
N/A
B. Selected peer-reviewed publications
N/A
C. Research Support
No sponsored research during the last three years.
PHS 398 (Rev. 05/01)
Page 11
2001-2005
Computer Science
Principal Investigator/Program Director (Last, First, Middle):
Young, Zachary, Parker
BIOGRAPHICAL SKETCH
Provide the following information for the key personnel in the order listed on Form Page 2.
Follow this format for each person. DO NOT EXCEED FOUR PAGES.
NAME
POSITION TITLE
John P. Young
Professor of Clinical Medicine
EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, and include postdoctoral training.)
INSTITUTION AND LOCATION
University of California, Berkeley, CA
University of California, San Francisco, CA
Albert Einstein College of Medicine, Bronx, NY
DEGREE
(if applicable)
YEAR(s)
B.A.
Ph.D
M.D.
1978
1983
1987
FIELD OF STUDY
Physiology
Physiology
Cardiology
A. Positions and Honors
1987-1992
1992-1993
1993-1998
1998-2000
2000-
Clinical Fellow in Medicine, Harvard Medical School
Instructor in Medicine, Harvard Medical School
Assistant Professor of Medicine (Cardiology), Georgetown University
Associate Professor of Medicine (Cardiology), Georgetown University
Present Professor of Clinical Medicine (Cardiology), Indiana University School of Medicine
B. Selected peer-reviewed publications
N/A
C. Research Support
No sponsored research during the last three years.
PHS 398 (Rev. 05/01)
Page 12
Young, Zachary, Parker
RESOURCES
Principal Investigator/Program Director (last, First, Middle):
FACILITIES: Specify the facilities to be used for the conduct of the proposed research. Indicate the performance sites and describe capacities,
pertinent capabilities, relative proximity, and extent of availability to the project. Under “Other,” identify support services such as machine shop,
electronics shop, and specify the extent to which they will be available to the project. Use continuation pages if necessary.
Laboratory:
NA
Clinical:
NA
Animal:
NA
Computer:
Three computers will be purchased to accommodate the increases in personnel from Phase I. This will bring
the total number of computers to 9.
Office:
1,100 sq. feet of office space will be rented for the duration of the project.
Other:
Old Dominion University provides supports, consultation, and research facilities. The campus is located only
a few blocks away from the P3C main site. The P3C Communicator team will work with Old Dominion
University’s Computer Productivity Initiative program in testing and evaluation of the functional prototype and
its components.
MAJOR EQUIPMENT: List the most important equipment items already available for this project, noting the location and pertinent capabilities of each.
The heart rate/blood pressure monitors and the parts needed to modify them will be purchased. The heart
rate/blood pressure monitors will be modified to serve as prototype models of the P3C Heart Rate/Blood
Pressure Monitors for the purpose of testing and development.
The prototype P3C docking stations will be assembled from commercial off the shelf components for the
purpose of testing and development.
PHS 398 (Rev. 05/01)
Page 13
A. Specific Aims
Individuals with cardiovascular diseases that are not motivated to continue in a proactive approach to
improving their well being are at a higher risk of having future cardiovascular problems. Our team plans to
solve this problem by providing a tool that will help to motivate individuals to continue in rehabilitation of some
form. The SBIR Phase II research and development effort will involve all aspects of the project that will need
to be completed in order to go to production.
Our proposed solution will achieve this goal by automatically monitor the user's blood pressure and heart
rate at set intervals throughout the day and providing feedback to the user based upon those readings. If
necessary, a health care professional of the user's choice will be contacted for follow-up. The solution will
involve a heart rate and blood pressure (HR/BP) monitor that will capture the raw data from the user, a docking
station that will download the data from the monitor and transmit the data to a central server, and a central
server that will provide analysis of the user's data and return a response to be displayed on the docking
station.
During SBIR Phase II, our primary goals will be the following:
o To determine the ideal monitoring system to use
o Make modifications to monitoring system if necessary
o To construct a functional docking station prototype
o To produce design specifications for the actual product
o To finalize the analysis algorithm and feedback system
We plan to achieve these goals by doing the following:
o Testing different methods of HR/BP monitoring
o Evaluate the features of different HR/BP monitors
o Employing engineers to consolidate different components into a docking station prototype
o Employing engineers to produce design specifications for the actual product
o Extensive testing with subject matter experts to verify and validate the analysis algorithm and
feedback system
At least three different blood pressure monitors will be tested. These include, a wrist cuff monitor, a typical
arm cuff monitor, and a arm cuff monitor that utilizes a technique of constantly monitoring blood pressure
called Ambulatory Blood Pressure Monitoring (ABPM.) Based on preliminary HR/BP monitor evaluation, P3C
is looking towards developing a device to capture data that takes the functionality of ABPM devices and
combines it with a smaller wrist held data receiver / recorder. Depending on the monitor we choose, our
analysis algorithm will have to be slightly modified. We also plan to employ the use of our consultant, Dr. John
P. Young in the validation and verification of our algorithm. In the testing of the product, we also plan to use
other subject matter experts including current cardiovascular disease patients and cardiologists to ensure the
validity of the P3C Communicator system.
The primary milestones towards the development product in Phase II will include the following:
o Selection of a monitoring system
o Completed construction of a docking station prototype
o Detailed design specifications for the actual product
o Verification and validation of the analysis algorithm and feedback system
The completion of the above major milestones will mark the end of SBIR Phase II and the beginning of our
production phase.
PHS 398 (Rev. 05/01)
Page 14
B. BACKGROUND AND SIGNIFICANCE OF THE PROBLEM
Currently, coronary atherosclerosis disease (CAD) and cardiovascular disease (CVD) are the leading
causes of death in industrialized countries. CAD and CVD are precursors to syndromes such as myocardial
infarctions (MI), angina pectoralis, sudden cardiac death syndrome, and heart failure. In America alone, over
60 million people are currently diagnosed with some form of CAD and nearly one million people died last year
as a result of CAD.
After a person has been diagnosed with a CVD, there are a number of ways to treat and prevent the
disease. Varying success has been realized with such methods as: lifestyle changes, cholesterol medication,
blood pressure medication, heart rhythm regulating medication, smoking cessation, coronary artery bypass
grafts (CABG), and counseling. Prevention is the best medicine. Whether or not a person has been
diagnosed with a CVD or CAD, it is possible to prevent further development of the disease by making specific
lifestyle changes. A controlled diet in conjunction with regular exercise can result in regression of
cardiovascular disease.
Our solution to the sufferers of CAD and CVD patients is to motivate them to maintain the preventive
methods prescribed by their physician. Our goal is to introduce a non-intrusive method of motivation that will
allow for monitoring the patient at regular intervals and maintains a history of the patient’s condition for
evaluation, and providing constant feedback to the patient.
There are several events that can occur that make an individual aware that preventive methods are
needed. A mild heart attack, angina attack, congestive heart failures, or simply mild blocking of arteries are
considered a cardiac event. Once a person has experienced a cardiac event, or been diagnosed with
cardiovascular disease, they will often be prescribed to begin cardiac rehabilitation. Cardiac rehabilitation is
generally broken down into three phases:

Phase I - In-patient Program: After a person has experienced a cardiac event or undergone surgery, he
or she will generally have a short stay in the hospital. During this stay, hospital staff will assist the
patient in getting out of bed and going for short walks to begin building cardiovascular endurance.
These walks get progressively longer until the person is discharged from hospital care.

Phase II - Rehabilitation: Generally, this phase is covered by a patient’s insurance and lasts about 12
weeks. During phase II, a patient will exercise approximately three times a week, starting at a low
intensity and building over the course of their 12-week stay. They will also undergo a small amount of
nutritional counseling. At this point, for the safety of the patients, all exercise takes place while the
person is attached to a 3-lead ECG (encephalocardiogram) that tracks electrical impulses across a
person’s heart. They also have resting, exercise, and post exercise blood pressures take at every visit.
Unfortunately, at the end of 12 weeks, most insurance plans will no longer provide assistance to
patients in cardiac rehabilitation. It is at this point that patients advance to phase III rehabilitation.

Phase III - Cardiac Rehabilitation: This is perhaps the most important phase. For all intents and
purposes, it is an effort to adopt a more proactive lifestyle to improve the patient’s health. It is a
relatively unsupervised exercise regime where a patient puts into practice what they learned in phase II.
In general, people who have enrolled in phase II rehabilitation are healthier than they were prior to their
cardiac event. During phase III it is their responsibility to maintain their health.
There are cardiac rehabilitation facilities that provide phase III support, but they often operate as gyms, where
memberships require a prescription from a doctor and a large monthly fee. More often though, patients will
join local recreation centers or cheaper gyms to gain access to some form of exercise expertise. It is
estimated that between 10-30% of all graduates of phase II rehabilitation begin and continue with phase III
rehabilitation.1 There are many barriers to continued participation in phase III rehabilitation; often cited on the
patient’s side are lack of motivation to exercise, lack of communication with their physicians, and lack of
1
American Journal of Cardiology Volume 79, Issue 1, January 1 1997
PHS 398 (Rev. 05/01)
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understanding the importance of exercise. Healthcare providers are often held responsible for not stressing
the importance of exercise, lack of communication with patients, and lack of communication between primary
care physicians and specialists.
Studies have shown that remote supervision along with continued communication with a health care
professional helps increase patient participation in phase III of cardiac rehabilitation. As a result, they help
decrease the incidences of recurrent cardiac complications. Support for a solution of this type was
demonstrated in a study conducted at Stanford University, where patients were monitored remotely via
telephone contact with a nurse case manager. The study revealed that communication was primary in keeping
85% of the patients motivated in maintaining their health, compared to an 80% dropout rate for patients not
participating in the program1 (see fig. 1). P3C can facilitate the success of such a program by utilizing
technology as a means to communicate, track, and educate.
When designed and developed correctly, the P3C HR / BP monitoring system should be able to do each of
the following:

Capture and store a time stamped heart rate and blood pressure of the user every 15 minutes

Transfer data through the monitor docking station to the P3C central server

Store and analyze the received readings in the P3C database

Serve as a communication tool between the users and the system

Provide appropriate feedback and motivation to the user on his or her readings, mitigating the patients’
reasons for lack of phase III participation

Help the users in monitoring their health care information and progress on a daily basis in phase III of
rehabilitation,

Provide graphs that show a patient’s daily, weekly and monthly progress,

Contact the patient’s health care provider in case most of the readings received are uncharacteristically
high or low
The result is a tool that will be of primary assistance to a cardiovascular disease patient to continually
monitor his or her health, with the aim or providing motivation and cost effective health care.
We propose to develop a prototype P3C system that will have the features listed in the previous paragraph.
This system will also work in case any history values of the user need to be added into the system for
consideration of overall performance, regardless of its source or the format in which it is stored. It is our intent
that this product will be designed to work effectively with anyone interested in using this product.
Control Group n = 300

Standard procedures for Phase III
patients

Assumed normal dropout rates
Experimental Group n = 300
 Received phone call from nurse
 Higher participation rates
Fig. 1
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The greatest benefit of using the P3C is the feedback with appropriate suggestions that a user will receive
in case their readings for a day have been uncharacteristically high or low.
The P3C team first sought to find a solution to the CAD and CVP problem. The research needed and
consisted of the following areas:
1. What are the reasons people suffer from heart disease?
The American Heart Association has identified a number of risk factors for developing CVD. The
major factors include age, family history, smoking, hypertension, hypercholesterolemia, diabetes
mellitus, and a sedentary lifestyle. Though not all of these causes are directly related to lack of
motivation, the implementation of a motivational tool will remind the wearer to take an active approach
to limit the chance of a cardiac event occurring.
2. What do current solutions address?
Currently, a few watches are available in the market that capture and store the users readings in
the monitor, with suggestions as to whether they are low or high when compared with standard
readings. This analysis is not personalized according to the patient’s health, nor does it consider the
patient’s past readings when making conclusions. Thus, watches in the market that provide feedback
are neither personalized, nor do they provide motivation to the user.
3. Research on the needed components for our system
Methods of taking blood pressure consist of the arm cuffs, the wrist cuffs, and ambulatory style.
This is the basis for our research for our components. We needed to examine the current methods and
identify the shortcomings of those products and make sure that the P3C will not suffer from the same
setbacks.
Currently, both Omron and Polar 5 watches perform methods of monitoring blood pressure and
heart rate information. In future phases, we intend to test these watches and similar products to
determine which commercial off the shelf (COTS) product will best meet our specification requirements.
We need a product that is durable and easy to use. For our product to be successful our product will
need not be intrusive to daily activities, but nevertheless change current lifestyles.
4. What problems does our product not solve?
Our product will not under any circumstance substitute information that is provided by the patients
physician or care provider. Our product is simply a tool that is used to help monitor and motivate
patients to actively participate in changing their lifestyle. The only way that our product can meet its
objectives and provide the assistance it needs is by continued cooperation from the wearer.
Bad habits can be hard to break. When those habits or behaviors become detrimental to one’s life,
it is imperative that patients take the necessary precautions to achieve a better lifestyle. The P3C
Communicator will be a continuous solution that will motivate, monitor and contribute to a healthier way
of life. While the issue of technical limitations exist to get our product developed, they are not
impossible to overcome. With technology progressing at such a brisk pace, the present technical
challenges that hinder the development of this product are minute in comparison to what the P3C will
provide. If our product succeeds then new innovative methods to combat CVD and CAD will continue
to grow as a result.
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C. Preliminary Studies / Progress Report
The P3C Team successfully completed the Phase I SBIR grant period begun on January 12, 2004 and
ending on May 3, 2004.
Key personnel for Phase I included (see figure 1):

Zachary Young - Zachary Young served as the project manager for the P3C team during
Phase I. Previously, he had served as the marketing manager of the team during a
preliminary research phase. He worked on the project from September 15, 2003 to May 3,
2004 for a total of 375 hours.

Matthew Wong - Matthew Wong served as the technical documentation specialist for the P3C
team. Matthew served on the team from January 12, 2004 to May 3, 2004. He worked on the
project during that time for a total of 340 hours.

Richard Strosahl served as the finance specialist on the P3C team. He worked on the project
between January 12, 2004 and May 3, 2004 for 325 hours.

Justin Hollingsworth served as the prototype design specialist for the P3C team. He worked
on this project from September 15, 2003 to May 3, 2004. During Phase I, he worked on the
project for a total of 340 hours. Prior to Phase I, he had served on the P3C team as the
finance manager during a preliminary research phase.

Rabia Haq served on the P3C team as the webmaster. She was also in charge of graphic
design for the team. She served on team from January 12, 2004 to May 3, 2004. During
Phase I, Rabia worked for a total of 300 hours.
Figure 1: organizational chart for Phase 1
The specific aims of Phase I were to:
1. Refine the problem statement and scope of the project
2. Determine the best solution to solve the given problem
3. Determine major risks to the product
4. Complete a revised budget and project plan
5. Complete a preliminary user manual
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In our preliminary research phase (phase zero), the team concluded that the best solution to our problem
would be a web-based communication tool between the health care community and individuals with
cardiovascular diseases. The user would input exercises performed, heart rate and blood pressure (optional
fields) and any notes. A health care professional would respond with e-mail or a phone call to motivate the
individual to continue their rehabilitation.
In Phase I, the P3C team determined that a web-based solution would not adequately solve the problem.
Individuals would have to have motivation to begin with in order to use such a solution. Also, by providing a
web-based solution, we immediately reduced the market size that we could sell the product to. Another
problem with the initial proposed solution is that it required the support of a local hospital or cardiovascular
rehabilitation facility in order to be successful. The product would be sold to the facility to use with their
patients. We determined that it was not feasible to assume that a large number of rehabilitation facilities would
be willing to use our product.
Instead of a web-based solution, the team decided that a better solution would be a system that would
automatically capture the user's heart rate and blood pressure, analyze the data, and return a response based
upon their condition. The ideal method to implement this solution, we decided, was to implement a three-part
system. The first module, a heart rate and blood pressure monitor, would capture the individual's heart rate
and blood pressure at regular intervals throughout the day. The second component, a docking station, would
download the data captured by the monitor and upload it to the third component, a central server. The central
server would analyze the data and return a response to the docking station. If a data reading were bad, a P3C
technician would be notified and would call the patient to alert them to a bad reading as well.
To develop this system, especially to implement the analysis code, we found it necessary to research more
about heart rate and blood pressure. Heart rate is measured in beats per minute and is a measure of how
many time a person's heart pumps. There are two types of blood pressure measures the pressure against the
walls of the arteries as the heart pumps. There are two kinds of blood pressure, systolic and diastolic. Systolic
blood pressure measures the maximum pressure while the heart is at work, while diastolic blood pressure
refers to the pressure in the arteries when the heart is resting. We also researched maximum and minimum
safe values for blood pressure and heart rate in order to implement the analysis. 2
Phase I included the design of a laboratory prototype. For the laboratory prototype it was necessary to
show a preliminary implementation of the critical product components. These components were identified as
the following:



Capturing Blood Pressure and Heart Rate (Heart Rate / Blood Pressure Monitor)
Transmitting Data from a Remote Device to a Computer (Docking Station)
Analysis of the Data (Central Server)
To show the capturing of an individual's heart rate and blood pressure, we chose to use an Omron HEM637. We chose this model for several reasons. First of all, it is capable of capturing the three types of data we
required: heart rate, systolic blood pressure, and diastolic blood pressure. Secondly, while the HEM-637 does
not, an upgraded version, the HEM-637IT does have the ability to connect to a computer.3 We saw this as an
important characteristic to show that, although our model did not have the ability to connect to a computer, the
same line of blood pressure monitors do come with that ability. The reason we did not purchase the HEM637IT was that it was out of our price range.
As we could not afford the HEM-637IT, we chose to use a Palm m100 to show the connection between a
computer and a remote device. We made a mock model of what our docking station would look like and
placed the connection cord inside the docking station. We inputted data into the Palm and then transmitted it
to the docking station computer.
2
3
American Heart Association. 2004. What is High Blood Pressure? http://www.americanheart.org/presenter.jhtml?identifier=2112
Omron. 2003. Omron HEM-637IT instruction manual. <http://www.omronhealthcare.com/site_3/fil/fil_120.pdf>
PHS 398 (Rev. 05/01)
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Two computers were used in the prototype demonstration. The first computer served as the client docking
station. It accepted file input as well as manual input and connected to the central server computer through a
network. The second computer served as the central server and performed the analysis of the data. It
returned a response to the first computer, which it displayed.
The prototype demonstration showed that we could:
1.
2.
3.
4.
Capture the Data Needed
Transmit the Data
Analyze the Data
Send and Display a Status Message
The revised budget for Phase II was determined to be $642,000.00. Although the project changed
considerably, the project plan did not, as we were able to simply move much of our resources from software
development to hardware development.
The two largest risks for the project were determined to be
 Finding a good heart rate and blood pressure monitor that would fulfill our requirements
 Faulty analysis code
We will be able to mitigate the first risk by considering several options for a monitor. We found that
wrist held blood pressure monitors were hard to use and had to be held at heart level to get an accurate
reading. Therefore, we chose to expand our options to include monitors with arm cuffs. We are also
considering using a current method of blood pressure monitoring called Ambulatory Blood Pressure Monitor
(ABPM.) With ABPM, blood pressure is monitored at regular intervals throughout the day. The only problem
with this method is that it is only available with arm cuffs. One possible option for us is to try to integrate ABPM
into a wrist cuff monitor.4
Erring on the side of caution will mitigate the latter risk. It is better to warn an individual about a reading
that may have been acceptable than to fail to warn an individual about a bad reading. Also, we plan to
extensively test our analysis software utilizing a cardiovascular expert, Dr. John P. Young to assist in the
validation and verification of our algorithm. Before our product reaches to general public, we plan to have
tested it thoroughly with test groups.
The group preliminary user manual was completed on April 23, 2004. While the document will certainly
change in Phase II and III, it provides us with a good foundation on which to build our final user manual.
4
Netdoctor.co.uk. 1998. Blood pressure measurement. <http://www.netdoctor.co.uk/
health_advice/examinations/measuringbloodpressure.htm>
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D. RESEARCH & DEVELOPMENT DESIGNS AND METHODS
With the conclusion of creating and testing the laboratory prototype in Phase I, the P3C team will start
Phase II, the development of a fully functional prototype. In Phase II, we will evaluate different heart rate /
blood pressure (HR/BP) monitors, determine the best components to use for our docking station, and develop
software, including an optimal analysis algorithm. The P3C team will then begin integration to ensure whether
or not the system functions cooperatively as designed. Each of these major objectives will be conducted
concurrently at both the P3C main site as well as Old Dominion University research facilities.
All of the major components of the P3C Communicator System currently exist as commercial of the
shelf products (COTS). It is our goal in research to find the optimal components to use and then combine them
into a streamlined, comprehensive package.
Much of the product specification data will already be provided to us with COTS product
documentation. With the aid of our medical advisor Dr. John P. Young, the P3C research and development
(R&D) team will do its own testing to ensure compatibility with given specifications. Consumer product test and
approval by the FDA and other third party organizations will serve as further research materials.
Hardware Evaluation
In order to determine the best HR/BP monitors to use, the P3C R&D team will evaluate the following
criteria: ease of use for the consumer, accuracy, durability, precision, size, ease of modification, ease of data
transmission to a separate device, and price.
The different types of HR/BP monitors we will evaluate are arm cuff style, wrist cuff style, and ambulatory
monitor style.
Arm cuff style is the most common HR/BP monitoring method; clinic blood pressure is taken with this
method. The readings from this kind tend to be the most accurate due to the fact that the cuff is positioned at
the same level as the heart.
Wrist cuff style tends to be the least accurate, due to varying positions of the cuff. Because the cuff is
applied to the wrist, leveling the device to the heart with consistency can be somewhat difficult. Devices do
exist that can aid in finding the "sweet spot" where the readings are most accurate; however, repeating this
process can wear thin on the user. 5 This could be especially problematic for our product because the device
we are to develop will take readings in regular intervals.
Ambulatory monitor devices combine an arm cuff with a separate recording device, which is typically
worn at the hip. These devices are specifically designed to take readings at regular intervals. Average
daytime readings tend to be lower than with arm cuff style readings taken in a clinical setting.6
The purpose that our selected HR/BP monitor will serve to fulfill is to provide a device that can measure
and capture heart rate and blood pressure data accurately at regular intervals (i.e.: every fifteen minutes) as
unobtrusively and as simple for the user as possible.
The components of the docking station consist of a TFT color flat screen display, power supply,
recharging module, data port, a 56k modem, a microprocessor, circuit boards, and a plastic casing. To
determine the best components for the docking station we must evaluate durability, reliability, size,
compatibility among components, and price. The docking station P3C is to develop will function to download /
synchronize data from the HR/BP monitor, transmit the new data to our central servers, and receive feedback
from our servers.
5
6
Omron. 2003. Omron HEM-637 instruction manual. <http://www.omronhealthcare.com/site_3/fil/fil_125.pdf>
The Second Australian Blood Pressure Study. 1997. <http://www.health.adelaide.
edu.au/ANBP2/abpm.htm>
PHS 398 (Rev. 05/01)
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Once we have an idea of the range of available devices and components, we can better determine the
exact specifications that are reasonable and suitable for our intended use. With comparative data in hand, the
P3C R&D team will then be able to select the components and COTS items that we will use to develop a
functional prototype.
Hardware Development
Once the P3C R&D team selects a HR/BP monitor and the components of the docking station, our team of
electrical engineers will begin work on shrinking down the HR/BP monitor and putting the components of the
docking station together, respectively.
Though many HR/BP monitors on the market today tend to be rather bulky, much of the bulk is attributed to
the size of the display screen rather than internal computational units.7 As evidenced by many modern digital
watches, small liquid crystal displays (LCDs) are capable of displaying readable alphanumeric characters. We
should be able to implement these smaller LCDs without losing other functional capabilities of the HR/BP
monitors. Because the general state of technology and electronics is that most everything becomes smaller,
our electrical engineers should be able to find COTS components to replace existing HR/BP components
should the need arise.
Depending on the HR/BP monitor model that our team of electrical engineers chooses, this team may
also have to tweak or add the ability to transmit data to a separate device.
With respect to the docking station, the P3C team must make all the docking station components
interoperate correctly as well as make it compatible with our selected HR/BP monitor. Tasks to accomplish
this objective may include soldering, writing / adapting an operating system, and writing / adapting drivers. Our
software engineers will develop any necessary code to run the operating system.
Software Development
While our team of electrical engineers works on finding suitable physical components of the P3C
Communicator system, our programmers and software engineer will work in tandem with our medical advisor,
John P Young, to develop an accurate, reliable analysis methodology. With Dr. Young's expertise in the field
of cardiology, he can direct our team in the right direction. While it is widely known that blood pressure and
heart rate are key indicators of health, Dr. Young will elaborate on the nuances and difficulties in using blood
pressure and heart rate data taken with such frequency.
The basic layout of our analysis entails comparing new user data to history data to determine if the new
readings are out of the norm. To assure that our analysis delivers relative, useful information to the end user,
we must refine our algorithm to take into account not only the user’s history data, but also the accuracy of
given readings, varying activity by the user, and any other factors the P3C research team discovers.
Once we develop an algorithm to analyze HR/BP data, the P3C software development team will write the
analysis software. This team is also responsible for graphical user interfaces (GUI) for the docking station
(client side application). They will also be working with our database analyst to develop the P3C database,
which includes a back end for internal management and a front end so that our customer service
representatives have appropriate access to the database.
In addition to mathematical algorithms and coding, the P3C analysis development team must then
decide on how exactly to provide feedback to users. Feedback must take into account how users will react.
The aesthetic appeal of visual feedback via the docking station screen such as text messages, colors, and
layout can have a significant impact on how users will perceive the usefulness of the P3C system. Phone calls
7
Omron. 2003. Omron HEM-637 instruction manual. <http://www.omronhealthcare.com/site_3/fil/fil_125.pdf>
PHS 398 (Rev. 05/01)
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from P3C technicians to end users must follow a carefully crafted script. Because the main goal of the P3C
system is to instill motivation in the user, research in human response to stimuli is critical.
Integration and Testing
When the three components of the P3C Communicator System are complete, we will commence
integration of the HR / BP monitor, docking station, and analysis software. Once integration is complete, we
will verify that the system functions properly by running it through a series of tests. After in-house testing and
backing for functionality, we will proceed to conduct field testing with cardiovascular disease (CVD) patients to
gauge the system’s effectiveness in capturing data, synchronizing data with the docking station, and providing
accurate analysis, feedback, and motivation.
The P3C quality assurance (QA) team will collect and manually analyze data collected from CVD patients
via our P3C HR/BP monitor. They will then compare their manual analysis with our automated analysis
software (the algorithms for manual and automated will be the same). The QA team will also heed any
suggestions and problems that stem from CVD patient usage of the P3C Communicator system.
Final Functional Prototype Development Review
Upon completion of integration and testing, the functional prototype will go under final scrutiny. The entire
P3C team will determine if we had indeed met the technical design goals and specifications. More importantly,
the P3C team will decide whether or not our product has adequately fulfilled its role as a motivator for CVD
patients to develop and maintain a healthier lifestyle. Upon approval, final specifications for mass-production
will be set.
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G. LITERATURE CITED
1. American Journal of Cardiology. January 1 1997. Volume 79, Issue 1
2. American Heart Association. 2004. What is High Blood Pressure?
< http://www.americanheart.org/presenter.jhtml?identifier=2112>
3. Omron. 2003. Omron HEM-637IT instruction manual. <http://www.omronhealthcare.com/site_3/fil/fil_120.pdf>
4. Netdoctor.co.uk. 1998. Blood pressure measurement. <http://www.netdoctor.co.uk/
health_advice/examinations/measuringbloodpressure.htm>
5. Omron. 2003. Omron HEM-637 instruction manual. <http://www.omronhealthcare.com/site_3/fil/fil_125.pdf>
6. The Second Australian Blood Pressure Study. 1997. <http://www.health.adelaide.
edu.au/ANBP2/abpm.htm>
7. ACSM. 2003. Resource Manual for Guidelines for Exercise Testing and Prescription, Third Edition
8. Center for Disease Control. 2000 Health people 2010: Heart Disease and Stroke
<http://www.cdc.gov/cvh/hp2010/pdf/HP2010.pdf>
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I. CONSULTANTS
Zachary Young
P3C Communicator Principal Investigator
7700 Hampton Blvd.
Norfolk, VA 23505
Mr. Zachary Young:
Old Dominion University (ODU) agrees to enter into a consortium agreement with P3C. ODU will act as a
research institute collaborating with P3C in the SBIR Phase II design and development of the functional
prototype of the P3C Communicator. P3C will provide me [Dennis Ray] with $7,900 for consulting costs over
the span of SBIR Phase II. Research development and aid will be supplied to P3C through ODU’s Computer
Productivity Initiative program.
The appropriate programmatic and administrative personnel of each organization involved in this grant
application are aware of the NIH consortium grant policy and are prepared to establish the necessary interinstitutional agreement(s) consistent with that policy.
Sincerely,
Dennis Ray
Authorized Official
Old Dominion University
Norfolk, VA 23505
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Page 25
Zachary Young
P3C Communicator Principal Investigator
7700 Hampton Blvd.
Norfolk, VA 23505
Mr. Zachary Young:
I certainly welcome the invitation and agree to serve as a medical consultant for your phase II SBIR grant,
proposal to create the P3C Communicator. It is my understanding that this device will be used to monitor a
user’s heart rate and blood pressure, and to provide a means for analysis, feedback, and motivation. As you
are well aware, lack of motivation is one of the most significant factors causing regression among those
suffering from cardiovascular diseases. I think that it is great that a device is being conceived that will address
this problem, and will gladly provide any support that I can. Cardiovascular disease is a grim problem in
society, and any device that genuinely seeks to fight back against the number one killer of Americans deserves
serious consideration. You obviously have the tools and people to succeed in this important endeavor; I wish
you the best of luck in your application and I believe that it deserves strong support.
Sincerely,
John Young,
Professor of Clinical Medicine
Georgetown University
Washington, D.C.
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J. PRODUCT DEVELOPMENT / COMMERCIALIZATION PLAN
VALUE OF THE SBIR/STTR PROJECT, EXPECTED OUTCOMES, AND IMPACT
The primary objective of the P3C Communicator is to motivate individuals with cardiovascular diseases to
continue in taking a proactive approach to improving their well-being. We will achieve this objective by
providing users with analysis of his or her heart rate and blood pressure. The P3C Communicator will take
automatic readings of the user's blood pressure and heart rate through the use of a blood pressure / heart rate
monitor. The data will then be sent to our central server for analysis. The server will then respond to the P3C
docking station with varied messages. If the user is doing well, the docking station will display a positive
message. If the user is possibly having problems, the docking station will display a warning or alert. The goal
of the P3C Communicator is to motivate people to maintain an exercise regiment that suits him or her, while
making sure that the user is not pushing his or her body past a safe level.
The primary technological objectives of the project are as follows:



Merge Ambulatory Blood Pressure Monitoring with a Wrist Cuff Design
Construct a Docking Station
Develop Analysis Algorithm
Currently, the only solutions that provides adequate motivation for cardiovascular disease patients is
enrollment in a cardiovascular rehabilitation program for phase III cardiovascular disease patients or joining a
gym. Insurance usually will not pay for this phase of rehabilitation, and so, many people are either unable or
unwilling to pay for such a service. Participation in phase III cardiac rehabilitation is between 10% and 20%.
Those who do participate are 20% to 30% less likely to die from a cardiac issue8. Joining a gym is a cheaper
alternative, however, one does not receive with it all the expertise available at a rehabilitation facility.
Our solution will address the weaknesses in the current approaches by providing a lower cost, easy to use
product that can be used almost anywhere. The heart rate / blood pressure monitor is designed to be worn
during the entire day, wherever the user goes. When he or she comes home, the user simply plugs the
monitor into the docking station and the docking station will download the data and transmit it to the central
server.
The cost of the product will be much cheaper than current solutions. Our current plan is to sell the P3C
Communicator package for $295.00. We will also charge a monthly fee of ten dollars. We hope to be able to
reduce the initial price of the package, but we are not yet sure if that will be possible, as it depends on what
kind of price we will be able to negotiate for the monitors.
The technical innovation in this product will be:


The analysis of the user's current readings with historical values as well as accepted norms to generate
a personalized analysis
The merging of ambulatory blood pressure monitoring with a wrist cuff blood pressure monitor
The benefits of these technical innovations would be important in developing future systems that monitor an
individual's blood pressure and heart rate.
The goal of the project is to develop a product that will save people's lives. If an individual uses the product
and in turn becomes more aware of his or her health conditions, it is hoped that the individual will take a
greater interest in improving or maintaining his or her health.
8ACSM’s Resource Manual for Guidelines for Exercise Testing and Prescription, Third Edition, 2003.
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This SBIR project integrates with the overall business plan of the company mentioned in the next section.
The SBIR project acts as any other project in the company. All of the performance assessment and quality
reviews that are part of the companies other projects are included in the P3C Communicator Project.
Figure 1
Figure 2
The completion of the project will be completed in accordance with the project management plan
(Figure 1) and work breakdown structure (Figure 2).
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COMPANY
The Company
The P3C company was founded by Masudur Rashid in 1992 with the goal of providing medical
solutions for cardiovascular disease patients.
The present size of the company is 38 individuals. Last year, our annual sales were $17,402,659.40.
Included in those sales are the results of three past SBIR NIH grants.
President Rashid has very optimistic goals for the future. He hopes to expand to 100 employees and
$170,000,000.00 in sales by 2012. To encourage innovation, he has been very willing to fund innovative
products with the company’s own funds. One such project is the P3C Communicator.
The P3C Communicator Team
The P3C Communicator project team began in September of 2003 as an investigative research group.
The project team is committed to provide the best value by developing COTS systems and by utilizing
existing technology that is field proven.
The P3C Communicator project team office will maintain the project master schedule. The
master schedule contains each work breakdown structure (WBS) element and will be used to track the
progress of each element. Any variations from the master schedule must be coordinated with the project
office. It is the responsibility of each team member to call attention to possible schedule deviations as
soon as possible. The project will be developed in phases; within each phase, formal reviews will play an
important role in monitoring project progress. All formal reviews will be announced a month in advance of
the meeting date.
Progress Performance Assessment
All P3C Communicator Team members will participate in monthly progress reports. P3C will track the
technical and financial progress of the project. Reviews will be held monthly unless if there is reason to
schedule progress meetings more frequently. At each progress assessment meeting the following will be
discussed:

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


Progress to Date
Present Work
Present Status of Deliverables
Future Plans and Coordination Efforts
Technical Issues and Other Problems
Before the meetings, the P3C Communicator Project Manager will determine the current status on
all present activities with reference to the schedule and budget. Quality reviews of all project
documentation and modules will be held periodically. In addition to these progress reports, the team will
also provide reports in the following categories:
Technical Progress and Reporting
The schedule for the project 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 project progress and is
reviewed at least quarterly during the team review.
PHS 398 (Rev. 05/01)
Page 29
Financial Management and Reporting
The financial profile for the Project is established during the planning phase and monitored throughout the
performance period. 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 project spending profile represents a summary of phase
spending profiles.
The Project Manager provides an information package that identifies the phase numbers assigned
to each activity, the corresponding budgets and schedules, the overall spending profile for the project, and
a synopsis of all major deliverables and milestones specified in the contract. The Project Manager uses
this information, combined with an on-line financial summary of the project to track its financial status on a
weekly basis. The Contracts Administrator will provide an updated spending profile on a monthly basis or
upon request from the Project Manager. The Project Manager uses the financial summary in conjunction
with his assessments of technical progress to track the overall status of the efforts.
Quality Process and Reporting
Quality management on the project will be a team effort. The Project Manager is ultimately responsible
for the development and implementation of the System Quality Project Plan (SQPP). The SQPP is an
umbrella plan that incorporates the quality projects of the project 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 project 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 project reviews. All planned quality project activities and quality evaluations
(internal audits) are submitted to the Project Manager for review.
Monthly Progress Report
P3C Communicator Project will submit a monthly progress reports to P3C. The report will cover the
following:







Progress Summary
Critical Path Analysis
Milestone Deliverables, Planned, Actual, and Forecast
Risk Status Update
Resource/Budget Profile
Milestone/Deliverables Planned, Actual, and Forecast
Quality Actions (Reviews, audits)
Reviews
Reviews will play an important part in the management and monitoring of all phases of the P3C
Communicator Project. Informal reviews with the project team members will be held at all levels on a
weekly basis to ensure that the project stays on track. Formal technical reviews will be held once a month
to ensure that the project is proceeding as planned. The types of reviews, their purpose and presented
information are addressed in the following paragraphs.
PHS 398 (Rev. 05/01)
Page 30
Technical Reviews
Formal technical reviews will be conducted on the dates specified in the master schedule. The
reviews will be held jointly with P3C, P3C Communicator project team members and sub-suppliers as
necessary. An agenda and review material will be submitted to P3C two weeks 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.
Quality Reviews
The Project Manager 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 project 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 project team. As part of the quality
activities for the project, the quality team will conduct informal reviews to:





Evaluate the processes used by the project team members to perform project tasks
Evaluate deliverable products for compliance with contract requirements
Evaluate work in process during engineering reviews
Document results of each evaluation
Recommend corrective and preventive actions if necessary
MARKET, CUSTOMER, AND COMPETITION
The P3C Communicator will target primarily cardiovascular disease patients. Our main focus is patients
between the ages of 35 and 60. Over 21 million of these individuals have a cardiovascular disease (Figure 3.)
Figure 3: CVD Percentages by Age
Individuals who display a high risk for a cardiovascular disease account for 50 to 70 percent of all
cardiovascular diseases patients.9 The P3C Communicator will provide these individuals with a detailed
analysis of heart rate and blood pressure readings with the goal of preventing future cardiovascular problems.
Currently, our competition is enrollment in a cardiovascular rehabilitation program, or other heart rate
and blood pressure monitors. Cardiovascular rehabilitation programs are expensive and are usually done at
9
Center for Disease Control. 2000 Health people 2010: Heart Disease and Stroke
<http://www.cdc.gov/cvh/hp2010/pdf/HP2010.pdf>
PHS 398 (Rev. 05/01)
Page 31
the rehabilitation facility, but they provide patients with motivation and advice. Other monitors on the market
capture data and some analyze, but none provide personalized analysis and human involvement if necessary.
This is where the P3C Communicator is unique. It provides the user with a less expensive way to get
personalized analysis of heart rate and blood pressure data, while not costing what a membership fee at a
cardiovascular rehabilitation center would cost.
In order for potential customers to be willing to use our product, we must prove two things primarily. First
of all, we must show that our product will not intrude on their life. We must show that the monitor is not going
to single them out as a victim of cardiovascular disease. Secondly, it is also important to show that the
analysis will be accurate and will not be shared with other organizations unless if the patient requests it.
INTELLECTUAL PROPERTY (IP) PROTECTION
Any intellectual property produced by the P3C Communicator team will be protected by requiring all
individuals working on the project to sign an agreement not to disclose any information about the project to any
outside sources without prior approval of the company.
FINANCE PLAN
Following the successful completion of Phase II, the P3C Communicator has acquired company
funding for Phase III of development. The president of our company has allocated $500,000 for us to produce
1,000 units of the P3C Communicator.
President M. Rashid
P3C
7700 Hampton Boulevard
Norfolk, Virginia 23505
April 29, 2004
Mr. Zachary Young
P3C Communicator Principle Investigator
7700 Hampton Boulevard
Norfolk, Virginia 23505
Mr. Young:
I am always pleased to see innovation in the proposals for this company. The P3C Communicator is one of
the best ideas I have ever seen. I will allocate your group $500,000.00 to put the first 1,000 units on the
market. Once the unit has infiltrated the market, we will discuss the allocation of more funds to your project.
Sincerely,
Masudur Rashid
PHS 398 (Rev. 05/01)
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P3C President
PRODUCTION AND MARKETING PLAN
Production
P3C Communicator will be produced by a contracted manufacturer. During SBIR Phase II of
development, we will determine the manufacturer to use for both parts of the P3C Communicator system.
For production of the P3C Heart Rate / Blood Pressure Monitor, we are currently looking at Polar and
Omron. Both companies currently make heart rate and blood pressure devices. We have not yet found a
company suitable to mass-produce the P3C Docking Station.
Marketing
In Phase III of development, we plan to utilize the Commonwealth of Virginia's Center for Innovation
Technology (CIT) for marketing assistance. P3C has also dedicated funds to be used for marketing in the
event that CIT does not work. The P3C Communicator will be licensed to P3C. The product will be sold
primarily in brick and mortar stores. Offline, it will be available in stores with which we will negotiate sales
contracts. P3C has not yet determined whether we will sell the product online.
REVENUE STREAM
P3C plans to produce a revenue stream for the company by manufacturing and selling the P3C
Communicator. Additional revenue will be generated by a monthly service charge that will be billed to the
customers of the P3C Communicator. Currently the P3C Communicator team is planning to sell the P3C
Communicator for around $295.00. The monthly service fee will be ten dollars a month.
Following the completion of Phase II, our staffing will be reduced to the minimum. Once the first product is
ready to be sold, we will hire additional customer service representatives and sales representatives. As more
units of the P3C Communicator enter the market, our database will grow, and we will be forced to hire
additional staffing to maintain the customer accounts.
PHS 398 (Rev. 05/01)
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Young, Zachary, Parker
CHECKLIST
Principal Investigator/Program Director (last, First, Middle):
TYPE OF APPLICATION (Check all that apply.)
NEW application. (This application is being submitted to the PHS for the first time.)
SBIR Phase I
SBIR Phase II: SBIR Phase I Grant No.
SBIR Fast Track
STTR Phase I
STTR Phase II: STTR Phase I Grant No.
STTR Fast Track
REVISION of application number:
(This application replaces a prior unfunded version of a new, competing continuation, or supplemental application.)
INVENTIONS AND PATENTS
(Competing continuation appl. and Phase II only)
COMPETING CONTINUATION of grant number:
(This application is to extend a funded grant beyond its current project period.)
No
Previously reported
SUPPLEMENT to grant number:
Yes. If “Yes,”
Not previously reported
(This application is for additional funds to supplement a currently funded grant.)
CHANGE of principal investigator/program director.
Brunelle, Janet
Name of former principal investigator/program director:
FOREIGN application or significant foreign component.
1. PROGRAM INCOME (See instructions.)
All applications must indicate whether program income is anticipated during the period(s) for which grant support is request. If program income is
anticipated, use the format below to reflect the amount and source(s).
Budget Period
Anticipated Amount
Source(s)
2. ASSURANCES/CERTIFICATIONS (See instructions.)
The following assurances/certifications are made and verified by the
signature of the Official Signing for Applicant Organization on the Face
Page of the application. Descriptions of individual assurances/
certifications are provided in Section III. If unable to certify compliance,
where applicable, provide an explanation and place it after this page.
•Debarment and Suspension; •Drug- Free Workplace (applicable to new
[Type 1] or revised [Type 1] applications only); •Lobbying; •NonDelinquency on Federal Debt; •Research Misconduct; •Civil Rights
(Form HHS 441 or HHS 690); •Handicapped Individuals (Form HHS 641
or HHS 690); •Sex Discrimination (Form HHS 639-A or HHS 690); •Age
Discrimination (Form HHS 680 or HHS 690); •Recombinant DNA and
•Human Subjects; •Research Using Human Embryonic Stem Cells•
Human Gene Transfer Research; •Financial Conflict of Interest (except
•Research on Transplantation of Human Fetal Tissue •Women and
Phase I SBIR/STTR) •STTR ONLY: Certification of Research Institution
Minority Inclusion Policy •Inclusion of Children Policy• Vertebrate Animals• Participation.
3. FACILITIES AND ADMINSTRATIVE COSTS (F&A)/ INDIRECT COSTS. See specific instructions.
DHHS Agreement dated:
No Facilities And Administrative Costs Requested.
DHHS Agreement being negotiated with
Regional Office.
No DHHS Agreement, but rate established with
Financial Specialist
Date
5/3/2004
CALCULATION* (The entire grant application, including the Checklist, will be reproduced and provided to peer reviewers as confidential information.)
15.00 % = F&A costs
12.00 % = F&A costs
$
Amount of base $
304,830 x Rate applied
203,600 x Rate applied
c. 03 year
Amount of base $
x Rate applied
% = F&A costs
$
d. 04 year
Amount of base $
x Rate applied
% = F&A costs
$
e. 05 year
Amount of base $
x Rate applied
% = F&A costs
$
TOTAL F&A Costs
$
a. Initial budget period:
Amount of base $
b. 02 year
$
47,170
23,540
70,710
*Check appropriate box(es):
Salary and wages base
Modified total direct cost base
Other base (Explain)
Off-site, other special rate, or more than one rate involved (Explain)
Explanation (Attach separate sheet, if necessary.):
4. SMOKE-FREE WORKPLACE
PHS 398 (Rev. 05/01)
Yes
No (The response to this question has no impact on the review or funding of this application.)
Page 34