Pilot Clinical Assessment of the Diagnostic Capability, Usability, and Function of an Automatic Blood Pressure Monitor for Use in the Diagnosis and Management of Pre-eclampsia in a Low-resource Hospital
Phase: NA
Conditions: Pre Eclampsia
Sponsor: William Marsh Rice University

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A. Title  Preliminary evaluations of the accuracy, usability, and function of an automatic blood 
pressure monitor for use in the diagnosis and management of pre-eclampsia in low-resource 
hospitals 
 
B. Investigators 
 
Principal Investigator:          Dr. Ronald Mataya, College of Medicine, Blantyre, Malawi 
 
Co-Investigators: 
          
Rebecca Richards-Kortum, PhD, Dept of Bioengineering, Rice 
University, Houston, TX USA 
Maria Oden, PhD, Dept. of Bioengineering, Rice University, Houston, 
TX, USA 
Kelley Maynard, MSE, Rice 360 Institute, Houston, TX, USA 
Laura Causey, PhD, Rice 360 Institute, Houston, TX, USA 
 
Investigators’ CVs. Please see Appendix 1 
 
C. Institutions under whose umbrella the research project will be conducted 
 
College of Medicine, Blantyre, Malawi 
Rice University, Houston, TX, USA 
 
D. Executive Summary 
 
Pre-eclampsia and eclampsia pose a significant threat to the health of mothers globally. The 
WHO estimates that 50,000 women worldwide die annually as a result of pre-eclampsia or 
eclampsia [1], with the majority in developing countries. The research team at Rice University 
has developed Sphygmo, an automatic blood pressure monitor to be used for the monitoring 
and diagnosis of pre-eclampsia in pregnant women, particularly in low-resource settings where 
current blood pressure monitoring is limited. This study aims to evaluate the clinical monitoring 
and diagnostic capabilities of the device in the setting for which it was designed - a low-
resource hospital.  
 
This is a 3- phase clinical community trial. The first two phases are being completed by Rice 
University in Houston Texas. In phase 1, we will test the blood pressure monitor on healthy 
women followed by a secondary phase to test the monitor on pregnant women. Phase 3,  in 
Malawi, the study will compare the Sphygmo device to a commercially available automatic 
blood pressure monitor that has been previously validated for accuracy in pre-eclamptic 
women and  clinical ausculatory measurements taken by observers using a stethoscope and 
aneroid gauge  [2, 3]. The main objective of this study is to determine whether the Sphygmo 
device correctly identifies instances where systolic and diastolic blood pressures meet the 
diagnostic criteria for mild or severe pre-eclampsia during monitoring of at-risk mothers. 

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Additionally, this study aims to understand the occurrence and type of any complications 
associated with the usability and function of Sphygmo in a resource-limited clinical setting. 
 
The study will include 20 eligible and consenting women at QECH who are clinically identified as 
at-risk for pre-eclampsia or have already been diagnosed with pre-eclampsia. All participants 
will undergo the same protocol (monitoring with Sphygmo, the commercially available device, 
and using the ausculatory method). First, a nurse will fit a Sphygmo device cuff on one arm of 
the subject and the commerical cuff on the opposite arm. The nurse will program identical 
alarm thresholds and measurement intervals on the new device. A trained research assistant 
will be continuously on hand to assist the nurse in the device setup and record the blood 
pressure measurements and any alarm indications made by each device. Blood pressure 
measurements by Sphygmo and the commercial device will continue until monitoring is no 
longer clinically prescribed. All clinical decisions will be made according to the commercial 
device measurements.  In addition, every hour an observer will take a blood pressure reading 
using the clinical ausculatory method to confirm that the readings of both the commerical 
device and Sphygmo are accurate. 
 
 
 
 
The key results of the study will be the sensitivity and specificity of the Sphygmo device for 
identifying blood pressure levels corresponding to mild and severe pre-eclampsia. Additionally, 
a complication rate will be determined in regards to any user errors or device malfunction. 
These results will provide information on the performance, use, and usability of the device in its 
intended setting; this information will also alert the research team of any necessary design 
modifications for the device. The results of the study will be submitted for publication in a 
relevant research journal, such as the American Journal of Obstetrics and Gynecology. 
 
 
E. Background/Introduction 
Pre-eclampsia is characterized by hypertension and the presence of protein in urine of a 
pregnant woman and typically appears late in the pregnancy. Women with pre-eclampsia are at 
an elevated risk for stroke, organ dysfunction, blood clotting issues, pulmonary edema, and 
eclampsia [4]. Eclampsia is defined as the occurrence of seizures not attributed to other causes 
in women with pre-eclampsia [5]. 
 
The WHO estimates that 50,000 women worldwide die annually as a result of pre-eclampsia or 
eclampsia [1]. However, the vast majority of cases occur in developing countries where risk of 
dying from pre-eclampsia or eclampsia is 300 times higher than in the developed world [4].  
 
One major obstacle to the reduction of maternal deaths from pre-eclampsia complications or 
eclampsia is the difficulty of diagnosis. While the diagnostic criteria for pre-eclampsia are clear 
in the literature [6, 7], early detection is unavailable in many clinical settings in the developing 
world. The diagnosis and monitoring of pre-eclampsia relies on measurements of blood 
pressure and proteinuria [8]. Unfortunately, the repeated use of mercury sphygmomanometry 
to monitor pre-eclampsia is too time-intensive for most resource-constrained clinical settings. 

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In the absence of regular measurements to observe the effects of treatment and the condition 
of the patient, a mother’s safety may be compromised.  
 
Further, automatic monitors appropriate for hospital use are prohibitively expensive for the 
low-resource settings where they are most needed. Standard commercial devices such as the 
Dinamap ProCare monitor (GE Healthcare) is the only known monitor with an accuracy for pre-
eclamptic women that meets the standards of the British Hypertension Society (BHS) and is 
appropriate for hospital monitoring [2, 3]. Commercial hospital monitors are generally priced in 
the $1000-$2000 range. 
 
F. Justification 
 
Pregnancy-related hypertensive disorders cause 50,000 deaths annually, primarily in the 
developing world [1]. One major barrier to the diagnosis and management of pre-eclampsia is 
the time-intensive nature of conventional mercury sphygmomanometry, which is difficult in 
low-resource settings. There is a need for a blood pressure monitor that can independently 
monitor blood pressure and alarm if the pressure reaches the diagnostic criteria for mild or 
severe pre-eclampsia. This device must be shown to have a high level of accuracy and usability 
in low-resource settings. 
 
G. Objectives of the study 
 
Broad: 
A team of engineers from Rice University has recently developed Sphygmo, an ambulatory 
blood pressure monitor which costs only $50. This study aims to evaluate the ability of this 
device to monitor for the development of mild and severe pre-eclampsia in women in a 
resource-limited setting.  
 
Specific: 
- 
Primary Efficacy Objective: Determine whether the Sphygmo device correctly identifies 
instances where systolic and diastolic blood pressures meet the diagnostic criteria for 
mild or severe pre-eclampsia during monitoring of at-risk mothers. 
- 
Primary Usability Objective: Understand the occurrence and type of any complications 
associated with the usability and function of Sphygmo in a resource-limited clinical 
setting. 
  
H. Research Methodology/Materials and Methods 
 
 
i. Study Type 
 
This is a 3- phase clinical community trial. The first two phases are being completed by Rice 
University in Houston Texas. In phase 1, we will test the blood pressure monitor on healthy 
women followed by a secondary phase to test the monitor on pregnant women. Phase 3, in 

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Malawi, the study will compare the Sphygmo device to a commercially available automatic 
blood pressure monitor on women who are at-risk for pre-eclampsia or have already been 
diagnosed with pre-eclampsia. 
 
ii. Study Place 
 
After two initial testing phases conducted in Houston, Texas, we will conduct the pilot study at 
Queen Elizabeth’s Central Hospital in Blantyre, Malawi. Malawi represents an ideal location to 
conduct such a study as there are approximately 17,000 cases of pre-eclampsia annually.  
 
iii. Study Population 
 
The study will include 20 women in Malawi who are clinically identified as at-risk for pre-
eclampsia or have already been diagnosed with pre-eclampsia. These women will either be 
pregnant or up to 48 hours postpartum. All participants in the study will undergo the same 
protocol (monitoring with Sphygmo, the commercial device, and using the ausculatory 
method). All eligible and consenting women will be enrolled in the study if a Sphygmo device 
and the commercial monitor are available at the time of clinical need for blood pressure 
monitoring.  
 
iv. Study Period 
We anticipate that the clinical assessment in Malawi will take 1-4months to complete.  
 
v. Sample Size 
The Malawi study is a pilot study that is designed to provide data to be able to calculate the 
number of patients that would be needed in a full clinical trial to evaluate the efficacy of 
Sphygmo in diagnosing pre-eclampsia. As such, a sample of 10 participants would indicate how 
large of a sample would be required for the subsequent clinical trial. The sample size of 10 was 
suggested by collaborating clinical partners and feedback from statisticians. However, due to 
some patients potentially choosing to end study participation, the study team (researchers and 
clinical partners) will reques a sample size of 20 to ensure the appropriate amount of data is 
collected.  
 
The inclusion criteria for the clinical study in Malawi: 
- 
Women who have been identified as at-risk for pre-eclampsia or have been diagnosed 
with pre-eclampsia during a visit to QECH. 
- 
Women who have been clinically identified to benefit from continuous blood pressure 
monitoring. 
- 
Women ages 18 or older. 
 
The exclusion criteria for the clinical study in Malawi are as follows: 
- 
Pregnant women who have already developed eclampsia. 
- 
Women under age 18.  
 

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vi.  Data Collection 
Data will be collected on paper forms (Appendix 2) as is consistent with current clinical practice. 
Clinical and/or research personnel will record information, excluding personal identifiers, on a 
standardized patient monitoring form. After the patient’s participation is completed, the 
research coordinator will collect and scan the form.  
The following data points will be collected/processed:  
 
o Patient history variables: 
 Age 
 Gravidity 
 Estimated gestational age (or hours since delivery) 
 Mode of admission to hospital 
 Number of previous antenatal care visits  
 
o Threshold Accuracy: 
 True positive (TP): Control device and Sphygmo cross alarm threshold 
 True negative (TN): Control device and Sphygmo do not cross alarm 
threshold 
 False positive (FP): Control device does not cross alarm threshold but 
Sphygmo does 
 False negative (TN): Control device crosses alarm threshold but Sphygmo 
does not  
 Sensitivity: TP/(TP+FN) with confidence intervals  
 Specificity: TN/(TN+FP) with confidence intervals 
 
o Usability: 
 User error: dichotomous variable indicating incidence of nurse error (max 
1 per device interaction) 
 Total number of Sphygmo device interactions by nurse 
 Percent of error-free device interactions by nurses 
 
o Device Function: 
 Device malfunction: dichotomous variable indicating incidence of device 
malfunction (max 1 per device use) 
 Total number of device uses 
 Percent of malfunction-free device uses 
 
vii.  Data Management and Analysis 
 
Plan for Data Management: The data will be kept on a secure server accessible only to the 
study personnel. To ensure quality control of all data, we will strengthen the case 
managements audits that the program conducts to ensure completeness. A research team will 
be responsible for audits and completeness of the data. The research team will be conducting 
quarterly supportive supervision and meetings to validate the completeness and accuracy of 

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the data. For the purposes of our study, we also plan to compile scanned copies of the forms to 
perform intermittent checks on the accuracy of the database. No patient identifiers will be 
included when these forms are scanned. 
 
Plan for data analysis: The research team from Rice University will be responsible for all data 
analysis. Data will be entered stored in a database that will export to a CSV file.  We plan to 
analyze data using Excel and Matlab and associated statistics packages.  As a result of this 
analysis, we hope to calculate accuracy, usability, and functionality of the device during use in a 
low-resource hospital. The data will be presented as means, sensitivity/specificity, rates, and 
proportions. 
 
viii.  Results Presentation 
 
ix. Dissemination of the Results 
The results of this study will be made available to the Ministry of Health, COMREC, the College 
of Medicine Library, the Department of Paediatrics, and other partners working in maternal 
health. Findings will be published in academic journals and conference proceedings in an effort 
to disseminate results to potential end-users. The research findings of this study will be critical 
in the evaluation of future interventions. 
 
 
I.  Ethical Considerations 
 
Personal identifiers will be removed and confidentiality of the subjects will be strictly 
preserved. The data will be kept on a secure server accessible only to the study personnel. The 
study protocol will be approved by the University of Malawi COMREC and the Institutional 
Review Board of Rice University prior to initiation of the study.  A data and safety monitoring 
plan will also be established under the leadership of the PI at the College of Medicine – 
University of Malawi.  All investigators will be required to take the online Protecting Human 
Research Participants course provided by the NIH Office of Extramural Research.  Any loss of 
patient data will be reported to the University of Malawi COMREC through the PI and to the 
Institutional Review Board at Rice University. Information will be de-identified to ensure patient 
confidentiality and data integrity.   
 
Protection of Human Subjects:  
All studies involving human subjects will be conducted in a manner that will minimize the risk to 
the individual, utilize all patient materials for scientifically meaningful purposes, and protect 
individual rights to confidentiality. The associated clinical protocols will be approved by the 
University of Malawi COMREC, Blantyre, Malawi and by the Institutional Review Board of Rice 
University, Houston, TX. All researchers will conform to the standards set forth by the National 
Institutes of Health regarding experiments involving human subjects.  
 
Potential Benefits of the Proposed Research to Human Subjects and Others:   

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The primary benefit of this study is the information it will provide to aid in the development of 
an automatic blood pressure monitor for use in the developing world. Automated, periodic, 
long-term blood pressure measurement is essential for diagnosing hypertensive disorders such 
as eclampsia and pre-eclampsia in pregnant women. There is a great need for automatic 
monitors in very low resource settings to be able to perform this function given high patient 
volume and low hospital staff numbers. The subject will be simultaneously monitored with an 
FDA-approved automatic blood pressure monitor, which will inform all clinical decisions during 
the study.  
 
Recruitment and Informed Consent: 
The local PI will be the responsible investigator at the study site. The study protocol will be 
approved by the University of Malawi, College of Medicine, Research and Ethics Committee 
(COMREC) and the Institutional Review Board at Rice University prior to initiation of the study.  
 
Our study will use de-identified data. Signed informed consents will be obtained from the 
subjects prior to the start of any study procedures. 
 
Documentation of the consent process will include the following elements: 
 
• Date and time of consent; 
 
• Topics discussed with the subject (e.g. risk, benefits, etc.); and 
 
• Confirmation that the consent was reviewed, that the subject’s questions were answered, 
and that a signed copy of the consent was provided to the subject. 
 
The consent form will be updated or revised whenever important new safety information is 
available, whenever the protocol is amended, or whenever any new information becomes 
available that may affect participation in the study. All consent forms will be kept in a locked 
cabinet for protection of confidentiality.  
 
 
J. Possible Constraints 
 
The risks and discomfort associated with participation in this study are no greater than those 
ordinarily encountered during routine blood pressure monitoring. This includes minor 
discomfort while the pressure cuff is being inflated. 
 
There is the potential risk of the loss of confidentiality associated with participation in this 
study. No patient identifiers will be collected by the study. All patient data will be assigned a 
number to ensure subject confidentiality. All efforts will be made to maintain strict patient 
confidentiality.  
 
 

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K. Requirements  
The study will require the following: 
 
All supplies and equipment will be provided to QECH in Malawi. The commercial  monitor will 
be available for permanent use at the hospital after the study is complete. 
 
L. Budgetary Estimates 
 
Salary Description 
Cost 
Study Coordinator 
$3,500 
Nurse 
$2,000 
Total 
$5,500 
Direct Costs Total 
$ 5,500 
COMREC Fee (10%) 
$550 
Total 
$5,550 
 
 
M. Justification of Budget 
 
N. References 
1. World Health Organization. Priority Life-Saving Medicines for Women and Children. 2012; 
Geneva: WHO.  
2. Magee, L.A. et al. (2011). How to manage hypertension in pregnancy effectively. Br. J. Clin. 
Pharmacol. 2011; Vol. 72, Issue 3. 394-401. 
3. De Greef, A., Ghosh, D., Anthony, J., & Shennan, A. Accuracy Assessment of the Dinamap 
ProCare 400 in Pregnancy and Preeclampsia. Hypertens. Pregnancy 2010; Vol. 29. 198-
205. 
4. EngenderHealth. Balancing the Scales: Expanding Treatment for Pregnant Women with Life-
Threatening Hypertensive Conditions in Developing Countries. 2007; New York: 
EngenderHealth, 5. 
5. World Health Organization. WHO Recommendations for Prevention and Treatment of Pre-
Eclampsia and Eclampsia. 2011; Geneva: WHO. 
6. Wagner, L.K. Diagnosis and Management of Preeclampsia. Am. Fam. Phys. 2004; Vol. 70, 
Issue 12. 2317-2324. 
7. Turner, J.A. Diagnosis and Management of Pre-eclampsia: An Update. Int. J. Wom. Health 
2010; Vol. 2. 327-337.  
8. Dekker, G. & Sibai, B. Primary, secondary, and tertiary prevention of Pre-eclampsia. Lancet 
2001; Vol. 357. 209-15.  
 
 
 
 
 
 

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Appendix 1. Investigator’s CVs 
 
           Ronald H. Mataya, MD 
CONTACT INFORMATION: 
Home Address: 
26235 Cresthaven Court, 
Loma Linda, 
CA, 92354 
Phone: 909-799-7238 
 
Work Address: 
24951 North Circle Drive, 
Loma Linda, 
CA, 92350 
Email: rmataya@llu.edu 
Phone: 909-558-4902 
 
Nationality: USA 
 
Ron Mataya worked in Malawi as a clinician, teacher and manager in Obstetrics and 
Gynecology.  As a clinician, he introduced laparoscopic tubal ligation in Malawi having been 
trained by the Johns Hopkins Program for International Education in Gynecology and Obstetrics 
(JHPIEGO).  He was instrumental in training nurses in obstetrical ultrasonography in the 
country.   
 
As a member of staff in the Department of Obstetrics and Gynecology at the University of  
Malawi College of Medicine, he was in the team that introduced community based antenatal care 
by fielding medical students to rural health units.  As Medical Director of the Blantyre Adventist 
Hospital he led the staff in fund raising which resulted in the expansion of the hospital bed 
capacity from 25 to 50 beds making the hospital the first fully private tertiary care unit in the 
country.  As the Chairman of the National Health Sciences Committee within the Ministry of 
Health, Dr Mataya participated in policy development for family planning, HIV/AIDS/STIs, EPI, 
Malaria, TB and other national health issues. 
 
As Associate Director and then Director for Health Programs at the international head office of 
the Adventist Development and Relief Agency (ADRA) in the United States, Dr Mataya led in 
the institutionalization of reproductive health, family planning, maternal and child health and 

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HIV and AIDS programming in ADRA’s programs world wide. He led a team of public health 
experts in managing, implementing, monitoring and evaluating health programs in 15 countries.  
 
As Chair of the Department of Global Health (2005-2009) at Loma Linda University School of 
Public Health, Dr Mataya developed interdepartmental collaboration by establishing dual 
degrees in Global Epidemiology with the Department of Epidemiology and Biostatistics and 
Global Maternal and Child Health with the Department of Health Promotion and Education.  
 
He has consulted with  the Adventist Development and Relief Agency (ADRA) in Rwanda, 
Kenya, Zimbabwe Cambodia, Tanzania and Ghana, with the Academy for Educational 
Development (AED)/Africa 2010 Project  in Liberia, with the Global Fund in Guyana and 
Nigeria, with Compassion International in the Philippines. He served as an external consultant on 
the Zimbabwe Maternal and Perinatal Mortality and Morbidity Study (2006-2009), the results of 
which were presented at the 2009 conference of the International Federation of Obstetrics and 
Gynecology.  
 
He is Co-Principal Investigator on a five-year PEPFAR program  in a consortium composed of 
the Johns Hopkins/University of Malawi Research Center, the University of  North 
Carolina/Malawi Project and Loma Linda University School of Public Health “To Support the 
Scale-up of High Quality HIV Care and Treatment Programs in Malawi through a Strengthened 
Laboratory Infrastructure.” The total funding for the consortium is $12 million and Loma Linda 
University’s  portion is  $3.2 million. The program is managed by the Malawi College of 
Medicine. 
 
He is Principal Investigator on a CDC-funded Public Health Evaluation to determine the 
effectiveness of the use of dry blood samples collected by needle prick to measure viral loads in 
patients on anti-retroviral therapy in Malawi. This is a two-year evaluation research funded at 
$530,000 implemented in partnership with the University of North Carolina and the CDC.  
 
He was a consultant with the Liverpool Associates for Tropical Health (LATH) supporting the 
development of health assessment tools and their application in a district-based HIV/TB Program 
in three distinct regions of Uganda (south/west, east central and eastern). This project was jointly 
implemented by Management Sciences for Health (MSH) and LATH. In South Sudan, he served 
as a consultant in the development of tools to assess primary health care services in the country. 
In Libya, he was a consultant in supporting the development of policies and services for 
voluntary counseling and testing and the prevention of mother-to-child transmission of HIV. 
 
Loma Linda University seconded him to the University of Malawi College of Medicine where he 
currently serves as the head of the department of obstetrics and gynecology while providing 
support to the CDC/PEPFAR College of Medicine Laboratory Capacity Consortium.  
 
EDUCATION 
                                                                                                                                                      
Hubert Humphrey Fellow in International Health 
Policy, Planning and Management – Emory University Rollins 
School of Public Health  (non-degree)       
August 1996- 
August 1997 

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Specialized training in OBGYN  
Taiwan Adventist Hospital 
Taipei, Taiwan 
August, 1985 – 
August 1988 
Medical Doctor 
West Visayas State University 
Iloilo City, Philippines 
March, 1981 
Bachelors of Science in Biology 
Philippine Union College 
Manila, Philippines 
March, 1977 
 
 
EMPLOYMENT 
 
Loma Linda University School of Public Health, Loma Linda, California               July 1, 
2009-to present 
Associate Professor, Global Health Department 
Responsibilities: Teaching classes in maternal and child health, reproductive health, HIV and AIDS 
and women in development. Director of  the Global Maternal and Child Health program in the 
Department of Global Health 
Co-Principal Investigator Malawi College of Medicine Laboratory Capacity Consortium;  a 5-year 
grant funded by PEPFAR through the CDC implemented in partnership with the University of 
North Carolina, the Johns Hopkins University Malawi Research Center and the Malawi College of 
Medicine 
Senior Lecturer in Obstetrics and Gynecology, 2011 to present: under a special arrangement 
between the Loma Linda University and the University of Malawi College of Medicine 
Responsibilities: teaching medical students, training registrars and conducting research 
Head of the Department Obstetrics and Gynecology, February 2012:  
Responsibilities: the same responsibilities as above with the addition of leading a team of 10 
consultants,  50 nurse/midwives in a unit that delivers over 8,000 babies a  year.  
 
Loma Linda University School of Public Health, Loma Linda, California   
Chair and Assistant Professor, Global Health Department 
 
September 2005 
-  June 30, 2009 
 
Responsibilities:  Coordinating and leading in academic activities for both faculty and students, 
curriculum and course development, student advising, research, consultancies, class room teaching. 
 
Adventist Development and Relief (ADRA) International, Silver Spring MD 
Director for Health 
May 2002 - 
September 2005 
 
Responsibilities:  Worked with the health team in providing technical assistance to all USAID-
funded projects and upon request to DFID and DANIDA funded projects as well.  Worked with the 

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Planning Bureau and the health team in responding to requests for application (RFAs) released by 
USAID around the world.  Worked with the health team in planning and implementing funded 
projects around the world.  Made recommendations on policy to ADRA administration regarding 
ADRA’s response to Reproductive Health, Family Planning, HIV/AIDS and Child Survival.  
Served on the Africa Advisory Board for HIV/AIDS response.  Led the team in strategic planning 
for the health sector.  Conducted field trainings and workshops in reproductive health and family 
planning. Successfully expanded the health portfolio’s programs by being funded through the 
President’s Emergency Plan for AIDS Relief (PEPFAR) in Kenya and Tanzania. The project was 
funded for $10,000,000 and it became ADRA’s largest single project. 
 
 
 
Adventist Development and Relief (ADRA) International, Silver Spring MD 
Associate Director for Reproductive Health 
January 1999- 
May 2002 
 
Responsibilities: Under a USAID grant, developed policies and strategies for the integration of 
reproductive health and family planning into ADRA programs.  Developed strategies for 
monitoring and evaluating on-going reproductive health and family planning programs with the 
aim of strengthening them and introducing new methodologies for implementation.  Worked 
with the Reproductive Health Team, established a RH/FP learning group and a website for 
sharing with the ADRA Network the most recent information in the field.  Continue to provide 
technical assistance to new RH/FP projects funded by USAID through the NGO Networks for 
Health in Ethiopia, Cambodia, Nicaragua, Malawi, Nepal and Guinea-Conakry. 
 
Blantyre Adventist Hospital, Malawi 
OB/GYN Specialist and Medical Director 
 
January 1989 - 
July 1996 
 
Responsibilities: Specialty clinics in obstetrics and gynecology including out-patient and in-patient 
services such as antenatal care, deliveries, family planning and gynecological surgeries. 
Selected achievements: Establishment of a baby friendly unit at the Blantyre Adventist Hospital and 
the male friendly labor ward in which husbands were allowed to accompany their wives during the 
process of labor and delivery. 
 
Hubert Humphrey Fellow in Health Policy, Planning and Management 
Emory University Rollins School of Public Health  
August 1996 - 
July 1997 
 
Responsibilities: Studying Health Policy, Planning and Management in a non-degree program. 
 
College of Medicine, University of Malawi 
Part-time Senior Lecturer 
June, 1990-  
present 
 

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Responsibilities: Ran the OBGYN ultrasound clinic and teaching nurses to do ultrasound.  
Conducted teaching rounds as well as classroom tutorials.  
 
Blantyre Adventist Hospital, Malawi 
Clinical Practice and Medical Doctor 
January, 1989-
1996 
 
Responsibilities: As part of the clinical practice and medical director, performed general OB/GYN 
procedures and related services.  Was responsible for overseeing a 50-bed general hospital with over 
150 staff in all departments.  In addition, carried out functions related to human resource planning, 
recruitment and placement as well as involved in public relations and fund raising. 
 
 
 
 
Taiwan Adventist Hospital, Taiwan 
Residence Program in OBGYN 
August, 1985-1988 
 
Responsibilities:  As Chief Resident was responsible for preparing the residents’ duty roster and 
operating room and emergency room coverage.  
 
Blantyre Adventist Hospital, Malawi 
General Practice 
January 1982- 
August, 1985 
 
Responsibilities:  Out-patient and in-patient clinical services. 
 
Queen Elizabeth Central Hospital, Malawi 
House Officer  
 
July 1981 to 
December 1982 
 
Responsibilities: An eighteen-month rotation in all the departments at the hospital. 
 
MEMBERSHIPS IN PROFESSIONAL ORGANIZATIONS: 
1. Medical Association of Malawi  
2. Registered in the Specialists’ Registry of the Medical Council of Malawi 
3. American Public Health Association 
4. Christian Connections for International Health 
 
LANGUAGES: 
English as second language, Speaks Chinese, Shona (Zimbabwe) and Chichewa (Malawi) 
 

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COMMITTEES: 
1. Chairman of the Malawi Health Sciences Research Committee, 1993-1996, continued as 
member up to 1998 
2. Chairman of the National Cancer Society, 1994-1996 
3. Member of the Rotary Club of Limbe, 1994-1997 
4. Member of the International HIV and AIDS Committee of the General Conference of  the 
Seventh-Day Adventist   Church 2002 to present 
5. Member of the Rank, Tenure and Promotion Committee at the Loma Linda University School 
of Public Health 
 
INTERNATIONAL WORK EXPERIENCE: 
As Director for Health Programs at ADRA International,  supervised different health programs in 
the following countries: Indonesia (West Timor), Vietnam, Cambodia, Thailand, India, Nepal, 
Myanmar, Malawi, Kenya, Zambia, Zimbabwe, Uganda, South Africa, Ethiopia, Sudan, 
Somalia, Ghana, Guinea, Papua New Guinea, Madagascar, Azerbaijan, Armenia, Turkmenistan, 
Afghanistan, Honduras, Bolivia, Yemen, Peru and Nicaragua 
 
INTERNATIONAL SHORT TERM CONSULTANCIES: 
1. JSI Consultant, Mothercare Project Malawi, Uganda and Ghana 1994-1998 
2. Malawi Task Force on Safe Motherhood Consultant 1994- 1996. 
3. Malawi Task Force on  Syndromic Diagnosis and Treatment of STIs 
4. World Bank/KPMG Consultant, Cost Analysis of Health Services in Selected Private and 
Public Hospitals, Malawi, 1998 
5. November 2005 – Consultant to ADRA Rwanda – assessing the health components of a Title 
II Food Security Program 
6. Consultant to the Outdoor Therapy Program for post genocide young adults-ADRA Rwanda – 
November 2005 
7. February 2006 – Consultant to ADRA Sweden, assessing a training of trainers program in 
HIV and AIDS counseling and community support  in Kenya, Ghana and Zimbabwe 
8. From February 1, 2007 to 2009; consultant for a DFID-funded project at the University of 
Zimbabwe, Study of maternal and perinatal morbidity and mortality. This was probably the 
largest study of maternal and perinatal mortality morbidity ever done anywhere in the world. The 
results of this study were presented at the FIGO conference in Cape Town in 2009. 
 9. March 1, 2007, ADRA Australia: curriculum development for training of health care workers 
in Papua New Guinea on both clinical and syndromic diagnosis and treatment of sexually 
transmitted infections  
10. Member of the Academy for Education Development (AED) team to Liberia to assess health 
education and training institutions in the country. This was funded by USAID under the Africa 
2010 project. (April 2007) 
11. Member of the World Bank Monitoring and Evaluation Team for Health Facilities 
Assessment for Africa; 2007/2009 
12. Member of the Monitoring Systems Strengthening Team of the Global Fund to Role Back 
TB, AIDS and Malaria (trained as facilitator of the Monitoring Systems Strengthening Tool 
(MESST) developed by MEASURE Evaluation for use by the Global Fund, the President’s 
Malaria Initiative and the World Bank); 2007/2009 
13. Facilitated  MESST workshop in Guyana; January 2008 

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14. Facilitated MESST workshop in Nigeria; February 2008 
15. Assessment of Compassion International’s TB Program in the Philippines; July 2009 
16. Development of health facilities assessment tools of a USAID/PEPFAR-funded, MSH-
implemented project in Uganda;  2010 
17. Development of health facilities assessment tools of a USAID-funded project, implemented 
by LATH in South Sudan; 2010 
18. Team member on a USAID-commissioned review of the utilization of the health services 
provision assessment (HSPA) tools; 2010  
19. Consultant to the Reproductive Health Unit of the Malawi Government Ministry of Health on 
the Maternal Death Review. This is a current assignment. January to October 2013. 
20. Consultant to the MACRO-ICF International Health Services Delivery Assessment in 
Malawi: February to November 2013. This is a current assignment. 
 
INTERNATIONAL TEACHING EXPERIENCE: 
1. Taught reproductive health and safe motherhood courses  in the Masters in International 
Development for ADRA’s Professional Leadership Institute in Thailand, Costa Rica and Kenya 
(sponsored by Andrews University, Berrien Springs, Michigan) 
2. Under the NGO Networks for Health partnership in Vietnam, worked with the Than Hoa 
Regional Hospital to develop protocols for infection control in obstetrical care 
3. Taught reproductive health courses for the Loma Linda University School of Public Health 
off-campus program in Peru and Russia – 2007 and 2008 
4. Volunteered at the Blantyre Adventist Hospital in Malawi every year (1999-2008) 
5. Taught Integrated Community Development class; this is a Loma Linda University School of 
Public Health  MPH class taught in the Philippines and Peru every summer (students and faculty 
travel to the Philippines) (2006-2009) 
 
ACADEMIC REVIEWS: 
1. Proposal reviewer at the NIH in the Fogarty Center for International Programs: under the 
supervision of Dr Jean McDermott: 2003 
2. APHA International Health section reviewer of Reproductive Health, Family Planning and 
HIV and AIDS abstracts for presentation at the 2007 conference in Washington DC 
3. October 2006 – Reviewed two chapters, 8 and 9 in CORE’s Community Case Management 
manual  (The CORE Group is a USAID-funded consortium of US-based international NGOs that 
provides technical assistance to programs in child survival and maternal health) 
4. Systematic Review of the Effectiveness of Community-based Primary Health Care; 
commissioned by the Working Group on Community-based Primary Health Care, International 
Health Section, APHA: 2007 
5. Guest reviewer for the Journal of Women’s Issues published at the George Washington 
University 
6. Guest reviewer for the Journal of Cell and Animal Biology 
7. Guest reviewer for the Journal of AIDS and Education 
8. Reviewer of the 2010 APHA abstracts in the Reproductive Health, Family Planning and HIV 
and AIDS section for presentation at the Denver Conference. 
9. Reviewer of Naomi Baumslag’s 1994 text book “International Maternal and Child Health” to 
prepare for a new edition in 2011 
10. Guest reviewer of the Journal of Pediatric Infectious Diseases 

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11. Guest Reviewer of the BMC Public Health Journal “Prevalence and Correlates of School 
Truancy Among Pupils in Grades 7 to 10: Results from the 2004 Zambia Global School-based 
Health Survey”. 
12. Guest Reviewer of the Malawi Medical Journal 
13. Guest Reviewer of the SAHARA Journal 
 
 
 
PRESENTATIONS: 
1. Assessing the Impact of a Service Learning Program in an International Setting; by JC 
Belliard, A. Stromberg and RH Mataya; presented at the Service Learning Conference in 
Portland, Oregon, October 2006 
 
2. The role of Schools of Public Health in Health and Development: presented at the Adventist 
International Institute of Advanced Studies (AIIAS), Silang, Philippines, November 2006 
 
3. Adventist Responses through Health and Development in Africa: paper presented at a 
Consultation on Adventist work in Africa at Andrews University; sponsored by the Institute of 
World Missions, October 21, 2007 
 
4. HIV and AIDS prevention needs of Latinos and service providers in California; Stacy Morey, 
Rosalinda Cano-Hays, RN, Ann Fitzgerald, MPH, Ted C. Morrison, PhD, MPH, Enrique 
Gomez, MD, Thomas Donohoe BA, Joel Peisinger, Arturo Hernadez, MAS, Jaime Carillo, 
Allison Wolpoff, MPH, Blanca Lomeli, MD, Ronald Mataya, MD and Juan Carlos Belliard, 
PhD, MPH; presented at the 2008 APHA conference in San Diego, California 
 
5. Maternal mortality in Zimbabwe; a comparison between clinicians’ interpretation of  verbal 
autopsies and a computer generated probabilistic InterVA-M  model. Presented at the FIGO 
conference in October, 2009, in Cape Town, South Africa 
 
6. The role of Christian Health Associations in Health Care in African Countries: using Malawi 
as a case study. Presented at the Global Health Council in Washington DC on June 16, 2010. 
 
7. Prevention of maternal mortality in a developing country; using Malawi as a case study: 
presented to physicians at the JFK Memorial Hospital in Indio on April 20, 2011. 
 
8. Presentation at the Canadian Public Health Association Conference: The Malawi Laboratory 
Capacity Consortium; A Partnership of National and International Academic Institutions. June 
21, 2011, Montreal, Canada. 
 
9. A Systematic Assessment of Hospital-based Laboratories in Malawi: Poster presentation at the 
American Academy of Family Medicine, October 17, 2011, San Diego 
 
10. Performance of laboratories on the 12 sections of the SLIPTA checklist in Malawi by Kundai 
Moyo, Ronald Mataya, Deborah Kamwendo, Hannaniah Moyo, Visopo Harawa, Reuben 

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Mwenda, Abdoulaye Sarr, Carol Porter, Henry Limula, Isaac Chauwa: Presented at the African 
Society of Laboratory Medicine Conference in Cape Town, South Africa, December 1 to 7, 2012 
 
11. Lead Consultant on the Report on the Confidential Enquiry into Maternal Deaths in Malawi 
(2008-2012):presented  to the Malawi Ministry of Health on October17, 2013 at the Ministry of 
Health Reproductive Health Unit 
 
12. Long Term Outcomes for Women After Obstetric Fistula Repair in Malawi: a Qualitative 
Study by Laura Drew, Ronald Mataya, Jennifer Tang, Jeffrey Wilkinson; Poster presentation at 
the 5th Consortium of University for Global Health  Conference, May 10-12, 2014, Washington 
DC. 
 
 
 
 
 
 
PUBLICATIONS: (Peer reviewed) 
1. Muula AS, Ngulube TJ, Siziya S, Makupe CM, Umar E, Prozesky HW, Wiysonge CS, Mataya RH. 
Gender distribution of adult patients on highly active antiretroviral therapy (HAART) in Southern 
Africa: a systematic review. 
BMC Public Health. 2007 Apr 25;7(1):63 [Epub ahead of print]  
PMID: 17459154 [PubMed - as supplied by publisher] 
2. Muula AS, Prozesky HW, Mataya RH, Ikechebelu JI. 
Prevalence of complications of male circumcision in Anglophone Africa: a systematic review. 
BMC Urol. 2007 Mar 2;7:4. Review.  
PMID: 17335574 [PubMed - indexed for MEDLINE] 
3. Emmanuel Rudatsikira, Ronald H. Mataya, Seter Siziya, Adamson S. Muula 
The association between bullying and physical fighting among Filipino adolescents: results from the 
Global School-based  Health Survey 
Indian Journal of Pediatrics; October 2007 
4. Ronald Mataya 
The Worth of Malawian Women: A literature review of safe motherhood in Malawi 
Malawi Medical Journal; 19 (3): 116-117;  September, 2007 
5. Adamson Muula, Emmanuel Rudatsikira, Ronald H. Mataya, Seter Siziya, John Chipeta, Edward 
Kataika 
Human resources requirements for highly active anti-retroviral therapy scale-up in Malawi 
BMC Health Services Research 2007, 7:208 
6. Adamson Muula, Emmanuel Rudatsikira, Ronald H. Mataya, Seter Siziya 
Estimated financial and human resources requirements for the treatment of malaria in Malawi 

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Malaria Journal 2007, 6:168 
7. Adamson Muula, Emmanuel Rudatsikira, Ronald H. Mataya, Seter Siziya, Kondwani Chalulu, 
Joseph I. Ichekebelu, Tharwat Sulaiman 
An estimation of operative time requirements for the scaling-up of male circumcision in Malawi 
The New Iraqi Journal of Medicine 2008 4 (1) : 40-48 
8. Adamson Muula, Emmanuel Rudatsikira, Seter Siziya, Ronald H. Mataya 
Correlates of cigarette smoking among school-going adolescents in Thailand: findings from the Thai 
Global Youth Tobacco Survey 2005. 
International Archives of Medicine 2008, 1:8 
9. Seter Siziya, Adamson S. Muula, Emmanuel Rudatsikira, Ronald H. Mataya 
Correlates of HIV testing among women in Malawi: results from the Multiple Indicator Cluster Survey 
(MICS) Tropical Medicine and International Health, Volume 13, No. 11 pp 1-6     
10. Jamison, B., Gaede, D., Mataya, R., Belliard, J.  
Reflections on Public Health and Service-Learning. (2008). Academic Exchange Quarterly. 12(3), 
4134-4138. 
11.  Shalote Chipamaunga, Ronald Mataya, Adamson Muula 
An assessment of sex work in Swaziland: barriers to and opportunities for HIV prevention among sex 
workers, published in the Journal of Social Aspects of HIV/AIDS Research Alliance, Vol. 7 No. 3 
October 2010 
12. Taha Taha, Johnston Kumwenda, Ronald Mataya, Faustin Matchere, Newton Kumwenda 
Coverage of Highly Active Antiretroviral Therapy Among Postpartum Women in Malawi; accepted for 
publication on February 28, 2011, in the International Journal of STD and AIDS as manuscript ID 
IJSA-10-359-R1 
13. T.L. Magwali, R. Mataya, S.P. Munjanja, M. Chirehwa 
An Assessment of the Maternal Death Notification System in Zimbabwe-2006,  
Central African Journal of Medicine 2011;57 (1/4) 
14. Ronald Mataya, Don Mathanga, Jobiba Chinkhumba, Alinafe Chibwana, Kingsley Chikapupha, 
Jeanine Cardiello, 
A Qualitative Study Exploring the Knowledge, Attitudes and Practices of HIV Positive Who Stopped 
Breastfeeding at 6 Months to Prevent HIV Transmission to Their Children; submitted for publication in 
August 2012 to the Malawi Medical Journal: Accepted for publication in March 2013 
Non-peer reviewed publications: 
1. A Ministry of Compassion: Adventist Review, December 2004 

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2. A Time to Heal: International Adventist World Magazine, March 2007 
Funded Research and Service Grants: 
1. A Qualitative Study to Explore Attitudes and Perceptions of HIV Positive Women Who Are 
Advised to Stop Breastfeeding at 6 months.  Funded by the Loma Linda University School of 
Public Health Center for Health Research as a Seed Grant of $5,000 
2.  Supporting the Scale-up of High Quality HIV Care and Treatment Programs in Malawi through 
a Strengthened Laboratory Infrastructure.  Funding Opportunity Number CDC-RFA-PS09-969 
under the US Health and Human Services and the Center for Disease Control and Prevention 
(PEPFAR). Project funded for $12 million for five years to be implemented in a consortium 
made up of the Johns Hopkins/University of Malawi Research Center, the University of North 
Carolina/Malawi Project and the Loma Linda University School of Public Health. (35% time 
and effort) 
3. Validation of new technologies in the use of dry blood samples (DBS) for monitoring viral 
loads in patients on antiretroviral treatment in Malawi. This is funded separately (Grant number 
626110-3831) through the CDC’s Public Health Evaluation Program for $530,000 within the 
PEPFAR grant. (25% time and effort) 
4. Currently funded for 15% effort by the University of Malawi College of Medicine as senior 
lecturer in the Department of Obstetrics and Gynecology in Blantyre Malawi. This is through 
an arrangement between LLUSPH and the University of Malawi College of Medicine. 
Grant Proposals Submitted  
1. Acceptability and Impact of Option B+ for the Prevention of Mother to Child Transmission of 
HIV in Malawi. This was in response to Funding Opportunity Announcement # RFA-GH-12-
008. Principal Investigator; Dr Adamson Muula, Associate Professor of Epidemiology, 
University of Malawi College of Medicine, Department of Community Health, Co-PI; Ronald 
Mataya, Associate Professor, Loma Linda University School of Public Health, Global Health 
Department, Deborah Demster Kamwendo, Project Coordinator, University of North Carolina 
Malawi Project, Lilongwe Malawi. (Submitted in 2012, was not successful) 
2. Long Term Safety, Durability and Effectiveness of Option B+ ART Use in Malawi:R01 
application to NICHD/NIH in 2013: PI: Professor TahaTaha at the Bloomberg School of Public 
Health at Johns Hopkins University,Co-PIs: Ronald Mataya, Bonus Makanani, Frank Taulo. 
Received a score of 29;awaiting funding decision.  
 
 
 

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BIOGRAPHICAL SKETCH 
Provide the following information for the key personnel and other significant contributors in the order listed on Form Page 2. 
Follow this format for each person.  DO NOT EXCEED FOUR PAGES. 
 
NAME 
Rebecca Richards-Kortum 
POSITION TITLE 
Stanley C. Moore Professor of Bioengineering 
eRA COMMONS USER NAME 
rrrkortum 
EDUCATION/TRAINING  (Begin with baccalaureate or other initial professional education, such as nursing, and include postdoctoral training.) 
INSTITUTION AND LOCATION 
DEGREE 
(if applicable) 
YEAR(s) 
FIELD OF STUDY 
University of Nebraska 
BS 
1985 
Physics & Mathematics 
Massachusetts Institute of Technology 
MS 
1987 
Physics 
Massachusetts Institute of Technology 
PhD 
1990 
Medical Physics 
. 
 
A. Personal statement 
Dr. Richards-Kortum has extensive experience developing point-of-care diagnostic tests for 
early detection of cancer and infectious diseases.  In this project, she will participate as a 
training mentor to post graduate fellows receiving training in the development and 
assessment of point-of-care diagnostic tests for low-resource settings. 
B. Positions and Honors 
Current and Previous Academic Positions: 
Rice University, Dept. of Bioengineering, Professor, July, 2005 – present 
Rice University, Dept. of Bioengineering, Department Chair, July, 2005 – July, 2008 
University of Texas at Austin, Dept. of Biomedical Engineering, Professor, September 2001 – July 
2005 
Cockrell Family Endowed Chair in Engineering #10, September 2003 – Date 
Distinguished Teaching Professor, September 2001 - 2009 
University of Texas at Austin, Dept. of Electrical & Computer Eng. & Biomedical Engineering, 
Professor, 1999-2001 
University of Texas at Austin, Dept. of Electrical & Computer Engineering, Associate Professor, 
1995–1999 
University of Texas at Austin, Department of Electrical and Computer Engineering, Assistant 
Professor, 1990-1995 
 
Professional Registration: 
Licensed Professional Engineer, Texas SN89893 
 
Selected Honors and Awards: 
Presidential Young Investigator, National Science Foundation, 1991. 
Presidential Faculty Fellow, National Science Foundation, 1992. 
Becton Dickinson Career Achievement Award, Assoc. for Advancement of Medical Instrumentation, 
1992. 
Y.C. Fung Young Investigator Award, Bioengineering Division, Am. Soc. of Mechanical Engineers, 
1999. 
Fellow of the American Institute for Medical and Biological Engineering, 2000 
El Paso Energy Foundation Faculty Achievement Award for Teaching Excellence, 2000 
Chancellor’s Council Outstanding Teaching Award, University of Texas, 2002. 
Howard Hughes Medical Institute Professor, 2002, 2006 
Piper Professor, Minnie Stevens Piper Foundation, May 2004. 
ASEE Sharon Keillor Award for Women in Engineering Education, 2004. 
Chester F. Carlson Award, American Society for Engineering Education, June, 2007 
Member, National Academy of Engineering, 2008 
Fellow of the American Association for the Advancement of Science (AAAS), 2008 
IEEE Educational Activities Board Vice-President Recognition Award, 2008 

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21 
 
Fellow of the Biomedical Engineering Society, 2008 
 
C. Selected Peer Reviewed Publications (from total of >230): 
1. Thekkek, N., T. Muldoon, A. D. Polydorides, D. M. Maru, N. Harpaz, M. T. Harris, W. Hofstettor, S. P. 
Hiotis, S. A. Kim, A. J. Ky, S. Anandasabapathy, R. Richards-Kortum. Vital-dye enhanced 
fluorescence imaging of gastrointestinal mucosa: Metaplasia, neoplasia, and inflammation. 2012. 
Gastrointest Endosc. 75:4, 877-887. PMCID: PMC3336371. 
2. Vila PM, Park CW, Pierce MC, Goldstein GH, Levy L, Gurudutt VV, Polydorides AD, Godbold JH, 
Tenq MS, Genden EM, Miles BA, Anandasabapath S, Gillenwater AM, Richards-Kortum R, Sikora 
AG. Discrimination of benign and neoplastic mucosa with a high-resolution microendoscope (HRME) 
in Head and Neck Cancer. 2012. Ann Surg Oncol. Epub DOI: 10.1245/s10434-012-2351-1.  PubMed-
in process. 
 
3. Hellebust A and Richards-Kortum R.  Advances in molecular imaging: targeted optical contrast 
agents for cancer diagnostics.  Nanomedicine (Lond). Mar 2012; Vol 7(3): 429-45.  PMCID: 
PMC3327054. 
4. Richards-Kortum R, Gray LV, Oden M.  IBI*series winner.  Engaging undergraduates in global health 
technology innovation, Apr 2012, Science 336(6080): 430-431.  PMID: 22539712. 
5. Pierce MC, Schwarz RA, Bhattar VS, Mondrik S, Williams MD, Lee JJ, Richards-Kortum R, 
Gillenwater AM.  Accuracy of in vivo multi-modal optical imaging for detection of oral neoplasia. 2012.  
Cancer Prevention Research, 1 June 2012; Vol 5 (6):801-809. PMC in process. 
6. Lee MH, Buterbaugh K, Richards-Kortum R, Anandasabapathy S.  Advanced endoscopic imaging for 
Barrett’s Esophagus: current options and future directions. Curr Gastroenterol Rep. June 2012; Vol 
14 (3):216-225.  PMID: 22453701. 
7. Kelsey J. Rosbach, Michelle D. Williams, Ann M. Gillenwater, Rebecca R. Richards-Kortum; Optical 
Molecular Imaging of Multiple Biomarkers of Epithelial Neoplasia: EGFR Expression and Metabolic 
Activity in Oral Mucosa. Translational Oncology, June 2012; Vol 5 (3): 160-171.  PMCID: 
PMC3384270. 
8. Brittany Rohrman and Rebecca Richards-Kortum; A Paper and Plastic Device for Performing 
Recombinase Polymerase Amplification of HIV DNA. Lab on a Chip, 2012.  Vol 12 (17): 3082-3088.  
PubMed- in process. 
9. Renu Regunathan, MD; Jenny Woo, MD; Mark C Pierce, PhD; Alexandros D Polydorides, MD, PhD; 
Mohammad Raoufi, MD; Sasan Roayaie, MD; Myron Schwartz, MD; Daniel Labow, MD; Dongsuk 
Shin, BS; Rei Suzuki, MD; Manoop S Bhutani, MD; Lezlee G Coghlan, DVM; Rebecca Richards-
Kortum, PhD; Sharmila Anandasabapathy, MD; Michelle K Kim, MD; Feasibility and preliminary 
accuracy of high-resolution imaging of the liver and pancreas using FNA-compatible microendoscopy.  
Gastrointest Endosc.; August 2012, Vol 76(2):293-300.  PubMed- in process. 
10. Michael S. Cordray and Rebecca R. Richards-Kortum; Emerging nucleic acid based tests for the 
point-of-care detection of malaria.  American Journal of Tropical Medicine & Hygiene; August 2012; 
Vol 87 (2):223-30.  PMCID: PMC3414556. 
11. Lauren Levy, Peter Vila, Chan Park, Richard Schwarz, Alexandros Polydorides, Marita Teng, Vivek 
Gurudutt, Eric M. Genden, Brett A. Miles, Sharmila Anandasabapathy, Ann Gillenwater, R. R. 
Richards-Kortum and Andrew Sikora; High Resolution Optical Imaging of Benign and Malignant 
Mucosa in the Upper Aerodigestive Tract: An Atlas for Image-Guided Surgery; 2012. ISRN Minimally 
Invasive Surgery.  (in press).  
12. Mark C. Pierce, YaoYao Guan, Mary Kate Quinn, Xun Zhang, Wen-Hua Zhang, You-Lin Qiao, Philip 
Castle, Rebecca Richards-Kortum; A pilot study of low-cost, high-resolution microendoscopy as a tool 
for identifying women with cervical precancer.  Cancer Prevention Research, Sept 2012.  (Epub 
ahead of print). Pubmed in process. 
13. Noah Bedard, Timothy Quang, Kathleen Schmeler, Rebecca Richards-Kortum, and Tomasz S. 
Tkaczyk; Real-time video mosaicing with a high-resolution microendoscope.  Biomedical Optics 
Express, Sept 2012.  Vol 3 (10): 2428-2435.  PubMed- in process. 
14. Brittany Rohrman, Veronica Leautaud, Elizabeth Molyneux, and Rebecca Richards-Kortum; A lateral 
flow assay for quantitative detection of amplified HIV-1 RNA.  PLOS One, Sept 2012. Vol 7 (9): 
e45611. PubMed- in process. 

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15. Michael Cordray, Matthew Amdahl, and Rebecca Richards-Kortum; Gold nanopartical aggregation for 
quantification of oligonucleotides: optimization and increased dynamic range.  Analytical 
Biochemistry, Sept 2012. Pii: S0003-2697(12)00460-5, doi: 10.1016/j.ab.2012.09.013. PubMed – in 
process. 
 
  
D. Research Support 
Active 
Title: Point of Care Diagnostics of Human Immunodeficiency Virus (HIV) Viral Loads Using Nano-
based Reagents and Isothermal Amplification Studies 
Agency: NIH 
 
 
 
 
 
 
 
 
 
PI:  Rebecca 
Richards-Kortum 
Dates:  04/13/2010-03/31/2012 
We are developing an inexpensive, sensitive, and specific diagnostic test for determining type 1 HIV viral 
loads of seropositive patients in low-resource settings.  The proposed assay combines: target isolation, 
isothermal amplification and oligonucleotide targeted gold nanoparticle detection assay for detection of 
viral nucleic acids. After initial optimization, it will be tested in a clinical pilot study at a low resource 
setting. 
Title:  Med Into Grad Award 
Agency:  HHMI 56006766  
 
 
 
 
 
 
PI:  Rebecca Richards-
Kortum  
Dates: 4/01/2010-3/31/2014 
 
Rice University and the M.D. Anderson Cancer Center will develop a PhD training program integrating: (1) 
courses in cancer biology, clinical medicine, bioengineering and translational research; (2) internships in 
clinical cancer care and translational research and (3) jointly mentored inter-disciplinary PhD projects.   
Title: Low‐ Cost Respiratory Support: Reducing Early Neonatal Death in Rural Malawi 
Agency:  USAID 
 
 
 
 
 
 
 
 
PI: 
Rebecca 
Richards-Kortum 
Dates: 9/30/2011-9/29/2012 
In the developing world, oxygen therapy is often the only treatment option for babies who are suffering 
from respiratory distress.  Through a partnership between bioengineers at Rice University, pediatricians at 
the University of Malawi and Baylor College of Medicine, and industrial design engineers from 3rd Stone 
Design we will: (1)design and rigorously test the efficacy of a novel, rugged bCPAP system which can be 
made at a unit cost of only $160 at Queen Elizabeth Central Hospital in Blantyre, Malawi and refine it for 
use in rural district hospitals; (2) design a complementary training program for nurses and electromedical 
hospital staff; (3) engineer the bCPAP system for commercial manufacture; and (4) develop a country-
wide plan to implement bCPAP at all district hospitals in Malawi.   
Title:  Integrated Bi-FOV Endoscope for Detection of Precancer  
Agency:  NIH RO1CA124319 
   
 
 
 
 
PI:  Tomasz Tkaczyk (R. 
Richards-Kortum, co-PI) 
Dates: 10/01/07 to 09/30/12 
 
The major goal of this proposal is to build a dual FOV endoscope combining two: (1) high and (2) low 
resolution imaging systems. For the purpose of this proposal we call this instrument the “Bi-FOV 
Endoscope”. Using the Bi-FOV Endoscope will allow comprehensive study of molecular agents and 
streamline processes connected with (a) molecular drug development, (b) cancer screening and (c) and 
monitoring of guided drug therapy.  
Title:  Integrated Optical Needle (ION) for Cellular and Molecular Imaging of Cancer 
Agency:  NIH RO1EB007594 
   
 
 
 
 
PI:  R. Richards-Kortum  
Dates: 7/01/08 to 06/30/12 
 
The objective of this proposal is to develop and test a new optical imaging device for evaluation of 
neoplastic tumors.  Here, we propose the development of a new class of optical imaging device – the 
integrated optical needle (ION) - which can be inserted into a small gauge needle, acquiring images with 
sub-cellular resolution at the distal tip in real-time.   
Title:  Multi‐Modal Optical Imaging Systems for Early Detection of Oral Cancer 
Agency: Cancer Prevention Research Institute of Texas  PI:  R. Richards-Kortum 
Dates: 04/01/10 to 03/31/2013  

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23 
 
The goal of this proposal is to develop, optimize and validate a Multi-Modal Optical Imaging System 
(MMIS) which combines the high sensitivity of autofluorescence imaging together with the high specificity 
of high resolution imaging. Image analysis algorithms will display processed images in real time, providing 
automated diagnostic criteria for community-based oral screeners..  
Western Regional Center for Biodefense and Emerging Infectious Disease Research (WRCE)   
       
Agency:  NIH/NIAID  
 2 U54 A1057156-06 (Walker, DH) 
Subproject:  RP003.1  
 
 
 
 
 
 
PI:  A. Clinton White (R. 
Richards-Kortum, co-PI) 
Title:  Point-of-Care Diagnostics Test for Intestinal Protozoa 
Dates: 3/01/09 to 02/28/14 
 
The specific aim of this project is to develop an inexpensive, sensitive and specific diagnostic test that 
can be used for point-of-care diagnosis of cryptosporidiosis.  This is a major Research Project in the 
WRCE. 
Title: Fluorescence Spectroscopy to Detect Oral Neoplasia    
Agency: NCI/NIH  2RO1 CA095604-05A2 
 
 
PI: 
Ann 
Gillenwater 
 
(Richards-
Kortum,co-PI) 
Dates: 07/01/2009 to 06/30/2014 
 
The major goal of this proposal is to develop and test non-invasive diagnostic tools for oral dysplasia and 
early carcinoma of the oral cavity using the evolving technologies of fluorescence and reflectance 
spectroscopy. 
Title: The Role of HER2 Signaling in Early Stage Breast Cancer Initiation & Resistance to 
Tamoxifen Prevention 
Agency:  Komen Research Program KG091020  
PI: Dihua Yu (Richards-Kortum, Collaborator) 
Dates: 09/25/2009-9/24/2014 
 
We propose to (1) identify signaling pathways activated by HER2 during breast cancer initiation (2) 
determine the function of high HER2 expression and downstream signaling in transition from atypia to 
DCIS, and develop technology to image alterations in vivo, (3) test therapeutic strategies targeting HER2 
and the PI3K/Akt pathway, and (4) investigate whether signaling alterations accompanying high HER2 
expression can predict atypia progression and response to tamoxifen. 
Title: Harnessing the power of light to see and treat breast cancer  
Agency: DOD   
 
 
 
 
 
 
 
 
PI: Nirmala 
Ramanujam 
Dates: 07/01/10 to 06/30/2014  
Our objective is to exploit the wealth of physiological, metabolic, morphological and molecular sources of 
optical contrast to develop novel strategies that focus on two breast cancer applications: tumor margin 
assessment and prediction of response to neo-adjuvant therapy. 
Title:  Beyond Traditional Borders 
Agency: HHMI  
 
 
 
 
 
 
 
 
PI:  R. Richards-
Kortum  
Dates: 09/01/2010 to 08/31/2014 
The goal of this project is to expand a unique, multidisciplinary educational program - Beyond Traditional 
Borders - which will train a new generation of students to reach beyond traditional disciplinary and 
geographic borders to understand, address and solve global health disparities. 
Title: Academic-Industrial Partnership to Develop & Test Esophageal Cancer Imaging Tools 
Agency: NIH 
 
 
 
 
 
 
 
 
 
PI:  R. 
Richards-Kortum 
 
 
Dates: 08/16/2010 to 05/31/2015  
The goal of this proposal is to develop, optimize and validate novel multi-modal, multi-scale optical 
imaging 
platforms for non-invasive, early detection of esophageal neoplasia based on optical imaging. We will 
collaborate with colleagues at Pentax, Inc. to design and test multi-modal endoscopic imaging systems 
for 
early detection of neoplasia in Barrett’s esophagus.  
Title: Multimodal Optical Imaging for Cervical Cancer Screening in Developing Countries 
Agency: NIH 
 
 
 
 
 
 
 
 
 
PI:  R. 
Richards-Kortum 

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24 
 
Dates:   04/01/11 - 03/31/14 
The goal of this proposal is to integrate a series of collaborative studies to develop, test, and implement 
our optical imaging systems to improve cervical cancer screening in Botswana.   A wide‐field imaging 
system designed specifically to image the cervix will be constructed and tested. We will combine this 
system with a high‐resolution microendoscope developed by Dr. Richards‐Kortum under the parent NIH 
grant. Together, we will carry out a pilot clinical imaging study to test these systems in Botswana, 
collecting high‐resolution and wide‐field image data in reflectance and fluorescence modes. 
Title: Low-cost, high-sensitivity, reconfigurable optical sensing components for POC diagnostics 
Agency: Bill & Melinda Gates Foundation 
 
 
PI: R. Richards-Kortum  
Dates: 06/07/2011- 05/31/2014 
The goal of this proposal is to reduce the expense of the optical sensing component of a POC system by 
developing a high-performance Readout & Signal Transduction (ROST) component for POC devices at 
completely new scales of physical size (e.g., palm size) and cost (below US$10).   Our proposed ROST 
consists of a universal fixture designed to attach to the surfaces of a sample platform and interrogate 
signal at multiple points, arranged in any pattern.  
Title: Reagent-free, needle-free microscopy for malaria diagnosis 
Agency: Bill & Melinda Gates Foundation 
 
 
PI: R. Richards-Kortum 
Dates: 09/11/2012- 09/30/2014 
Our idea is to diagnose malaria by in vivo optical detection of the malaria parasite and its hemozoin 
crystal by-product. Our goal is to measure light scattered from infected red blood cells circulating in the 
superficial vasculature using a portable imaging device. This work will build upon the imaging techniques 
and instrumentation developed under Phase 1. Achieving this goal will provide a low cost, rapid 
diagnostic, free of biohazardous waste or the need for a trained technician, addressing key issues of 
conventional malaria diagnostics.  
Title: High Resolution Microendoscopy for the Detection of Esophageal Neoplasia 
Agency: NIH 
 
 
 
 
 
 
 
 
 
PI: Sharmila 
Anandasabapathy 
Dates: 9/07/2011-8/31/2013 
The goal of this proposal is to develop a low-cost, high resolution fiber-optic imaging system which can be 
combined with current white-light endoscopy.  Within this project, a high-resolution microendoscope 
(HRME) system will be designed, assembled, and tested for use alongside the standard endoscope.  We 
will train the clinical staff at the First University Hospital, Jilin, China in the use of the HRME, and in 
interpretation of the images acquired with the device.   
Title: Competitive Renewal: Optical Systems for In Vivo Molecular Imaging of Cancer 
Agency: NIH 
 
 
 
 
 
 
 
 
 
PI: Rebecca 
Richards-Kortum 
Dates: 09/23/2011-07/31/2016 
The goal of this proposal is to develop, optimize, and translate optical molecular imaging technologies to 
pilot clinical studies.  Our team will carry out work to improve: (1) molecular screening, (2) early diagnosis, 
and (3) treatment of early disease.  While this work has broad applicability for many types of cancers, we 
will develop and test systems for three organ sites, the oral cavity, esophagus, and lung, which together 
represent more than 25% of tumor mortality.   
 
Completed 
Title:  Beyond Traditional Borders 
Agency:  HHMI 52005885   
 
 
 
 
 
 
PI:  Rebecca Richards-
Kortum  
Dates: 9/01/06 to 08/30/10 
 
The goal of this project is to create a unique, multidisciplinary educational program - Beyond Traditional 
Borders - which will train a new generation of students to reach beyond traditional disciplinary and 
geographic borders to understand, address and solve global health disparities.   
Title: Reagent-free, needle-free microscopy for malaria diagnosis  
Agency:  Gates Foundation  
PI: Rebecca Richards-Kortum 
Dates: 11/01/09 to 10/31/2010  
Our goal is to develop a functional prototype instrument for in vivo detection of the optical signals specific 
to the malaria parasite and its hemozoin crystal by-product; this novel, rapid, and painless diagnostic 

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25 
 
does not require any consumable reagents, does not depend upon a trained operator, and does not 
generate any biohazardous waste.   
Title: Image Guided Robotic Ablation of Oropharyngeal Cancer 
Agency:  Intuitive Surgical 
 
 
 
 
 
 
PI: Rebecca Richards-
Kortum 
Dates: 06/27/2010 to 06/30/2011 
In this proposal, we will test the hypothesis that contrast-enhanced HRME, alone or in combination with 
wide-field refelectance imaging, can provide real-time discrimination between benign and malignant 
tissue during robotic tumor resection. 
Title: Multidisciplinary Investigation of Cellular & Microenvironment Alterations in Breast Cancer 
Initiation & Progression  
Agency:  DOD BC074699P7    
 
 
 
 
PI:  Dihua Yu (R. Richards-
Kortum, Co-PI) 
Dates: 05/01/08-09/21/2011 
 
 
The goal of this proposal is to study the interactions between transformed breast epithelial cells and their 
surrounding microenvironment, and to identify those interactions important in the initiation and 
progression of breast cancer.  
Title: Low-cost microscopy for diagnosis and drug-susceptibility testing of tuberculosis 
Agency: Virginia and L.E. Simmons Family Foundation PI: Rebecca Richards-Kortum 
Dates: 12/01/09 to 11/30/2011 
The objective of this project is to design and fabricate a compact array microscope comprising 24 
individual microscopes operating in parallel, enabling an entire sample to be siultaneously screened.  The 
system will be tested with mycobacterial culture and clinical specimens.  We will develop and apply image 
processing algorithms to automatically identify and quantify the presence of M. tuberculosis. 
 
 
 
 

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26 
 
 
 
Positions 
ACADEMIC APPOINTMENTS and EMPLOYMENT HISTORY: 
10/08 – present 
Professor in the Practice, Department of Bioengineering, RiceUniversity, Houston, TX 
7/08 – present 
Director, Oshman Engineering Design Kitchen, Brown School of Engineering, Rice University, 
Houston, TX 
1/04 – 7/08 
Lecturer and Laboratory Coordinator, Department of Bioengineering, RiceUniversity, 
Houston, TX 
12/00 – 03/04 
Senior Engineer, Sage-Crisp Engineering, Houston, TX 
07/99 – 07/00 
Visiting Assistant Professor, Department of Mechanical Engineering and Material Science, 
Rice University, Houston, TX 
11/98 – 10/00 
Assistant Professor of Orthopaedic Surgery, The University of Texas Medical School- 
Houston, Houston, TX 
07/97 – 11/98 
Instructor in Orthopedic Surgery, HarvardMedicalSchool, Boston, MA 
07/97 – 11/98 
Senior Research Associate, Department of Orthopedic Surgery, 
BethIsraelDeaconessMedicalCenter, Boston, MA 
08/94 – 07/97 
Research Fellow in Orthopedic Surgery, HarvardMedicalSchool, Boston, MA 
 
LICENSURE & CERTIFICATION: 
Engineer-in-Training 
 
PROFESSIONAL ORGANIZATIONS: 
1989-1992 
Biomedical Engineering Society 
1989-1992 
American Society of Mechanical Engineers 
1998-2001 
Orthopedic Research Society 
1990-2001 
American Society of Biomechanics 
2005-present 
Biomedical Engineering Society 
2006- present 
American Society of Engineering Education 
 
HONORS & AWARDS: 
2008 Cain Award for Communication Instruction, RiceUniversity 
BIOGRAPHICAL SKETCH 
Provide the following information for the key personnel and other significant contributors. 
Follow this format for each person.  DO NOT EXCEED FOUR PAGES. 
 
NAME 
                 Z. Maria Oden, Ph.D. 
POSITION TITLE 
        Professor in the Practice 
eRA COMMONS USER NAME 
MARIAODEN 
EDUCATION/TRAINING  (Begin with baccalaureate or other initial professional education, such as nursing, and include postdoctoral training.) 
INSTITUTION AND LOCATION 
DEGREE 
(if applicable) 
YEAR(s) 
FIELD OF STUDY 
TulaneUniversity, New Orleans, LA 
B.S.E. 
1989 
Biomedical Engineering 
TulaneUniversity, New Orleans, LA 
M.S. 
1991 
Biomedical Engineering 
TulaneUniversity, New Orleans, LA 
Ph.D. 
1994 
Biomedical Engineering 
HarvardMedicalSchool, Boston, MA 
Postdoctoral 
1994-1997 
Orthopedic Biomechanics 

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27 
 
1995 New Investigator Recognition Award, Orthopaedic Research Society 
1995  National Research Service Award (NRSA), National Institutes of Health 
1992   Student Paper Presentation Award, Twelfth Southern Biomedical Engineering Conference 
1992  Alpha Eta Mu Beta 
1991  Sigma Xi 
1989 
Student Paper Award, Louisiana Engineering Society 
1989 
Nissam Nathan Cohen Memorial Award for Contributions to the Class, to the School, and to the 
Profession of Biomedical Engineering, TulaneUniversity 
1989 
Dean James Marshall Robert Award for Leadership, Scholarship and Community Service, 
TulaneUniversity 
MENTORSHIP OF AWARD WINNING DESIGN TEAMS: 
2004-2005           Team Cobra (Austin Elam, Chris Gibson, ZeyadMetwalli, Roland Robb, Tom Rooney)  
o Revolutionary Aerospace Systems Concepts-Academic Linkage , Cape Canaveral, Florida 
May 2005, 1st place for Revolutionary Aerospace Systems Concepts Undergraduate 
Division 
o Texas Space Grant Consortium, Spring 2005, Best Project Model 
o Patent Awarded, Fall 2007 
2004-2005Space Owls (Allison Bean, Sriram Eleswarapu, Danika Hayman, Kim Hsu, Martin Kolnik) 
o Texas Space Grant Consortium, Spring Fall 2004, Best Project Model 
2006-2007 
HPN (Elaine Chan, Cynthia Chang, Alex Gordon, Eric Vu, Peter Yang) 
o RiceUniversity Research Symposium, Spring 2006, 1st Place-Engineering Division 
o Texas Space Grant Consortium, Spring 2006, Best Poster Presentation, Best Project 
Model 
o Revolutionary Aerospace Systems Concepts-Academic Linkage , Cape Canaveral, Florida 
May 2006, 1st place for Revolutionary Aerospace Systems Concepts, Forum Favorite 
Award 
o John L. McLucas Award for the study of space safety in recognition of outstanding work 
on the Osteonexus and efforts to provide for future Astronaut safety 
o Patent Application Filed, Fall 2006 
Thunderbirds (Jimmy Barnes, NehaDatta, Vishal Gupta, Laura Higbie, Lei Ji) 
o Texas Space Grant Consortium, Fall 2005, Best Oral Presentation, Best Project Model 
2006-2007 
MDS (Martin Bost, JennHowse, Ny-Ying Lam, ZavenSargsyan, Patrick Storer)  
o Texas Space Grant Consortium, Fall 2006, Best Oral Presentation 
Team GQ (Jesse Gill, Drew Bryant, Jon Martinez, Joe Valdez, Albert Yu)  
o Houston Society for Engineering in Medicine and Biology Student Design Competition, 
Spring2007, First Place 
Team Mongoose (Megan Jeans, Brian Schwab, Kim Bennett, Austin Ginnings)  
o Patent Application Filed, Fall 2008, Medicine Dosing Device 
Team ICE (Jon Ludwig, Christina Barry, Jonathan Hanson, Tim Josef, Mark Mendenhall)  
o Provisional Patent Application Filed, Spring 2007, Low Power Refrigeration for medicines 
in the developing world 
2007-2008             Team Phoenix (Shann Yu, Natalia Vasco, Eva Wang, Stacy Cheng, Kai Chu, Shuvro De) 
o Texas Space Grant Consortium, Optical immunoassay Device using Nanoshell 
Technology. Fall 2007, Best Oral Presentation, Best Paper, Best Poster, Best Overall 
Design Project 
o Texas Space Grant Consortium, Spring 2008, Best Oral Presentation, Best Poster, Best 
Paper, Best Overall Design Project 

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28 
 
Team Three Minute Mile  (WafaSoofi, Allen Chen, Mariko Wei)   
o Houston Society for Engineering in Medicine and Biology, February 2008,  First Place 
Student Design Showcase. 
Team IV Drip  (NehaKamat, Ketan Shah, Aaron Cottle, Tyler Barth, Chris Vaucher)   
o Houston Society for Engineering in Medicine and Biology, February 2008, Second 
Place Student Design Showcase. 
o Department of Electrical Engineering, May 2008,  Top Undergraduate Design 
Project 
2008-2009             Team Taurus (Charlie Foucar, Leslie Goldberg, Bodin Hon, Shannon Moore, Evan 
Williams) 
o Texas Space Grant Consortium, Bone Remodeling Monitor for Space Flight Fall 
2008, Spring 2009, Best Oral Presentation, Best Paper, Best Overall Design 
Project 
o NASA 2009 Exploration Systems Mission Directorate Systems Engineering Paper 
Competition, First Place, National Competition 
Team Heliotrope  (Jennifer Cieluch, CaterinaKaffes, Matthew Miller, Neel Shah, 
Steve Xu)   
o ASME iShow- Innovation Showcase, June 2009,  First Place, National Competition 
o RESNA Student Design Showcase, June 2009, One of five unranked finalists 
o Renamed to OrthoIntrinsics- finalist in 5 business plan competitions, earned 2nd 
place at University of Nebraska Business Plan Competition and 4th place overall 
at the Rice Business Plan Competition.  
o In Clinical Trials at present 
2009-2010             Team BabyBubbles (Jocelyn Brown, Haruka Maruyama, Joseph Chang, Kathleen 
Schnelle, Michael Pandya with MBA students David Tipps, Will Pike, Cynthia Hu, 
Martha Vega) 
o Rice Business Plan Competition Social Ventures Category, First Place 
ACCOMPLISHMENTS: 
2007-2009 Spearheaded the First and Second Houston Society for Engineering in Medicine and 
Biology- Student Design Showcase and Competition. This is an opportunity for student 
design teams from institutions from throughout Texas, Louisiana and other close states 
to demonstrate their student design to each other, industry and researchers. Secured 
funding from corporations to support this effort. 
2007-2010 Started the Rice/TMC Design Technology Forum with Dr. David McStravick (MECH). This 
forum is a quarterly series where surgeons from the TMC come together with 
researchers and students from RiceUniversity to discuss medical problems that may 
have technologic solutions.  
2007 
BME Summit. Coordinated nations-wide survey and workshop on trends and best 
practices in bioengineering design education for this national meeting of biomedical 
engineering educators.  
Selected publications  
1. Andrew R Miller, Gregory L Davis, Z Maria Oden, Mohamad Reza Razavi, AbolfazlFateh, 
MortezaGhazanfari, FaridAbdolrahimi, ShahinPoorazar, FatemehSakhaie, Randall J Olsen, 
Ahmad Reza Bahrmand, Mark C Pierce, Edward A Graviss, Rebecca Richards-Kortum “Portable, 
Battery-Operated, Low-Cost, Bright Field and Fluorescence Microscope” PLoSONE:  04 Aug 

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29 
 
2010.  
2. Oden, Maria, Mirabal, Yvette, Epstein, Marc, Richards-Kortum, Rebecca (2010) “Engaging 
Undergraduates to Solve Global Health Challenges: A New Approach Based on Bioengineering 
Design.” Annals of Biomedical Engineering, Vol. 38, No. 9,pp. 3031–3041. 
3. Oden, Z. Maria, Jeans, M., Schwab, B, Ginnings, A, Bennett, K., Schutze, G. “Adjustable-volume 
liquid dispensing pump.” Patent Application Filed, Feb, 8 2008.  
4. Oden, Z.Maria (2007)  “Finding Ideal Projects for the Bioengineering Design Course: BME-IDEA. 
5. Oden, Z. Maria ,  Mirabal, Yvette, Richards-Kortum, Rebecca (2007). “Global Health Technology 
Woven into Many Levels of Design Courses”  Transactions of Biomedical Engineering Society.  
6. Glauser CR, Oden ZM, Ambrose CG, Willits MB, Coupe KJ.(2003) Mechanical testing of small 
fracture implants for comparison of insertion and failure torques. Arch Orthop Trauma Surg 
Oct;123(8):388-91. 
7. Oden ZM, Selvitelli DM, Bouxsein ML. (1999) The effect of local density increases on the failure 
load of the proximal femur:  a finite element study.  Journal of Orthopaedic Research, 17(5):661-
667, 1999. 
8. Oden ZM, Selvitelli DM, Wolf RM, Myers ER. (1997) The effect of anisotropy on DXA based 
predictions of bone failure.  Calcified Tissue International, 63:67-73. 
9. Oden ZM, Hart RT. (1995) Correlation between mechanical parameters that represent bone’s 
mechanical milieu and control functional adaptation, in Bone Structure and Remodeling, edited 
by A. Adgaard and H. Weinans, World Scientific Publishing, London, 127-137. 
10. Hart RT, Oden ZM, Parrish SW, Burr DB. (1992). Computational methods for bone mechanics 
studies, The International Journal of Supercomputer Applications, (6)2:164-174. 
 
 
C.  Research Support 
Ongoing Research Support 
2008- 2010 
Brown Foundation Teaching Grant, Principal Investigator 
2004- 2010 
Texas Space Grant Consortium Undergraduate Design Initiative, Principal Investigator 
2009-2010 
NCIIA- eTeam Grant for OrthoIntrinsics, Principal Investigator 
2009-2011 
NCIIA – Course Development Grant, Co-PI 
2006-2010 
Beyond Traditional Borders USEP grant from Howard Hughes Medical Institute, co-PI 
2010-2012 
NCIIA- eTeam Grant for infantAir, Co-Principal Investigator 
 
Completed Research Support 
1989 
Pittsburgh Supercomputing Center Summer Institute, National Science Foundation 
1995-1997 
Pittsburgh Supercomputing Center Grant for Cray Time, Computational modeling proximal 
femur failure, Principal Investigator 
1995-1998 
National Institutes of Health, Predicting failure of human proximal femurs, (NRSA) Principal 
Investigator 
1997-1998 
Genetics Institute, The effect of local density increases on the failure load for the proximal 
femur, Principal Investigator 
1997-1998 
National Institutes of Health, Predicting hip fracture risk by QDR, (PI:  W.C. Hayes) 
Subcontract to Beth Israel Principal Investigator 
1997-1998 
National Space Biomedical Research Institute, Bone loss team; DEXA analysis, geometry and 
structure, finite element analysis, Co-Investigator with C. Ruff, T. Beck and D. Newman 

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30 
 
1998-2001 
Whitaker Foundation Biomedical Engineering Research Grant, The influence of 
bisphosphonate therapy on the density distribution and structural capacity of the human 
femur, Principal Investigator 
1999-2000 
Genetics Institute, The effect of local density increases on the failure load for the proximal 
femur, Principal Investigator 
1998-2000 
National Space Biomedical Research Institute Bone Team:  Skeletal structural consequences 
of bone loss, Co-Investigator. 
2005- 2007 
Brown Foundation Teaching Grant, Principal Investigator 
2005- 2008            
CBEN Educational Initiative funding for Design Projects, Principal Investigator 
 
 

 
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KELLEY MAYNARD 
2003 Southgate Blvd. Apt 3 Houston, TX 77030 
kmayn@rice.edu (517)-474-4222 
 
EDUCATION 
UNIVERSITY OF MICHIGAN 
2009-2011 
Master of Science in Biomedical Engineering 
Ann Arbor, MI
 
 GPA 7.97/9.00 
 
 Biomechanics Concentration 
 
 Graduate Design Program: performed complete biomedical product development process for a 
noninvasive device to detect internal bleeding after catheterizations 
 
 Social Venture Program: developed mass manufacturing, distribution, and field testing 
strategies for male circumcision device on Gates Grand Challenges Explorations Grant 
 
 Relevant Coursework: Global Health Design, Tissue Mechanics, Linear Programming, Applied 
Statistics, Biomedical Instrumentation  
 
2005-2009 
Bachelor of Science in Mechanical Engineering 
Ann Arbor, MI
 
 GPA 3.90/4.00 
 
 Engineering Global Leadership Honors Program 
 
 Minor in Spanish Language and Literature 
 
 Relevant Coursework: Design & Manufacturing I, II & III, Manufacturing System Design, 
Manufacturing and Supply Operations, Strategy at the Base of the Pyramid 
 
Summer 2008 
FACULTAD LATINOAMERICANA DE CIENCIAS SOCIALES 
 
Public Health Program 
Buenos Aires, Argentina
 
 Studied Public Health in Buenos Aires and engaged in a field placement in Mendoza to 
investigate community healthcare programs.  
 
EXPERIENCE 
RICE 360: INSTITUTE FOR GLOBAL HEALTH TECHNOLOGIES 
2013-present 
Director of Technology Development 
Houston, Texas
 
 Lead development of maternal and neonatal healthcare technologies, including optimization of 
device designs and benchtop validation tests. 
 
 Design and manage local and international clinical trials for maternal and neonatal healthcare 
technologies; communicate with regulatory boards concerning study and device approvals. 
 
2011-2012 
MEDICAL TECHNOLOGY TRANSFER AND SERVICES 
 
Biomedical Engineer, Whitaker International Fellow 
Hanoi, Vietnam
 
 Led design of patient breathing circuit and parameter control system for 
infant continuous positive air pressure device for use in low-resource 
hospitals in Asia. 
 
 Managed technical aspects of 3-phase clinical trial of phototherapy device 
for the treatment of neonatal jaundice.  
 
 Developed and tested closed-loop temperature control system for infant 
warmer device. 
 
 
2007-2011 
UNIVERSITY OF MICHIGAN BIOMECHANICS RESEARCH LAB 
 
Research Assistant, Advisor: James Ashton-Miller, Ph.D. 
Ann Arbor, MI
 
 Investigated the energy expenditure in childbirth by facilitating a human labor simulation study 
and building a 3-D computer model of muscles used in labor. 
 
 Performed dissection and biaxial material testing on pelvic floor tissues to determine 
the effects of pregnancy on the viscoelastic properties of these tissues. 
 
2009-2010 
UNIVERSITY OF MICHIGAN COLLEGE OF ENGINEERING 
 
Graduate Student Instructor 
Ann Arbor, MI
 
 Led help sessions, prepared homework, wrote exams, and graded exams (Mechanical 

 
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Behavior of Materials, Fall 2009 & Fall 2010). 
 
 Taught laboratory classes, led help sessions, wrote projects, and graded exams 
(Introduction to Computer Programming, Winter 2010). 
 
 
Summer 2010 
CARDINAL HEALTH, INC.  
 
Tauber Institute Team Project Intern 
Romulus, MI
 
 Developed service metrics to improve upon current metrics in capturing the true customer 
experience; validated metrics with interviews and electronic data analysis. 
 
 Uncovered inefficiencies and provided process improvement recommendations 
through collaboration on-site with a customer hospital. 
 
 Initiated strategic change in a multinational corporation through qualitative and quantitative 
reasoning; presented recommendations to Cardinal Health CEO.  
 
Summer 2009 
UNIVERSITY OF MICHIGAN DEPARTMENT OF COMPLEX SYSTEMS 
 
Research Leadership Team Intern 
La Union, Honduras
 
 Developed procedure, protocol and content for network analysis research; trained 20 
student researchers and 30 Honduran translators in research process; partnered with 
research team to collect network data for over 4000 subjects in over 30 villages. 
 
 Contributed to the development of partnerships and investments for the establishment of a 
rural microfinance institution. 
 
 
AWARDS 
 First Place, NCIIA BMEidea National Competition, $10K award (2011) 
 
 First Place, University of Michigan Biomedical Engineering Design Competition (2011) 
 
 Top Project, Innovative Design for Global Health (2010) 
 
 University of Michigan Alumnae Council Scholarship (2009, 2010) 
 
 Tauber Institute Academic Scholarship (2008, 2010)  
 
 Thomas M. Iden Scholarship (2009) 
 
 James B. Angell Scholar (2008) 
 
 
PRESENTATIONS Evaluation & Implementation of a Bubble Continuous Positive Airway Pressure System for 
Newborns, Second WHO Global Forum on Medical Devices (2013) 
 
 Infant Healthcare Technology Development in Southeast Asia, Whitaker Enrichment Seminar 
(2012) 
 
 Metric Development in Healthcare Operations, Tauber Spotlight Competition (2010) 
 
 SolarFocus Reflection System, University of Michigan Design Expo (2009) 
 
 Pneumatic Cycling Model, University of Michigan Design Expo (2007) 
 
 
PUBLICATIONS  Maynard K, Brincat C, DeLancey J, Ashton-Miller J. On the energetics of volitional pushing 
during a simulated second stage of labor. In preparation. 
 
 Sarvestani AS, Perosky J, Maynard K, Weist M, Jiang C, Sienko KH. Development of a Database 
for Global Health Medical Devices. Journal of Medical Devices 2011; 5(2):27532.  
 
 Contributor; Compendium of Medical Devices. World Health Organization 2011. 
 
 
SKILLS 
 Software: Unigraphics, Solidworks, Adams/View, 3DS Max, 3D Slicer, Mimics, Maple, 
MATLAB, LabVIEW, C/C++ programming, SPSS, R Statistics 
 
 Prototyping: mill, lathe, drill press, band saw, CNC, electronics assembly 
 
 Laboratory: small animal dissections, biaxial tissue testing 
 
 Lean Six Sigma (MoreStream Yellow Belt training at Cardinal Health) 
 
 
LANGUAGES 
 Professional working proficiency in written and spoken Spanish 
 
 Elementary proficiency in written and spoken Vietnamese 
 
 
ACTIVITIES 
 Blue Dragon Mentorship Program – English Tutor (2011-2012) 
 
 UM Center for Global Health, Technology Team – Member (2010-2011) 

 
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 Kiva Microfinance – Spanish Translator (2009-2011) 
 
 Michigan Health Engineered for All Lives – Member (2006-2011), Team Leader (2009) 
 
 Short-term field experience in Mexico (2005), Haiti (2007), Nicaragua (2010), India (2012), 
Philippines (2012), Myanmar (2012), Tanzania (2013), Malawi (2014) 

 
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Laura Causey Sandoval 
1615 Hermann Drive Apt 1315, Houston, TX 77004   704.287.5514   laura.causey@gmail.com 
 
EDUCATION 
 
Doctorate of Philosophy in Biomedical Engineering, December 2013 
The City College of New York, New York, NY 
Advisors: Distinguished Professors Sheldon Weinbaum, Ph.D. and Stephen Cowin, Ph.D. 
NASA Advisor: Beth Lewandowski, Ph.D. 
 
Masters of Science in Biomedical Engineering, May 2008 
Florida International University, Miami, FL 
Advisor: Anthony McGoron, Ph.D. 
 
Bachelors of Science in Chemical Engineering, May 2005 
University of Oklahoma, Norman, OK 
Minor in Spanish 
 
Study Abroad Program, Universidad Privada de Santa Cruz, Bolivia. Fall 2002 
 
EXPERIENCE 
 
Rice University, Program Associate, Houston, TX, January 2014-Present 
 
Research and development of a low-cost ambulatory pressure cuff designed to monitor pre-eclampsia in 
pregnant women living in developing countries 
 
Design will be tested in clinical trials in a hospital in Houston, TX as well as The Queen Elizabeth Central 
Hospital in Blantyre, Malawi 
 
The City College of New York, Research Assistant, New York, NY. August 2008-December 2013 
 
Theoretical applications of  the lymphatics system, muscle compressibility, and Starling’s Principle 
 
Predicted the pressure generated in skeletal muscle using theoretical calculations and simulations in MATLAB 
 
United Nations Headquarters, Supporting Officer, New York, NY. September 2013-November 2013 
 
Assisted with the first United Nations High Level Meeting on Disability and Development  
 
Managed social media (Facebook, Twitter, Thunderclap)  
 
Author of UN Enable Newsletter (September 2013 edition) 
 
Drafted the Secretary General Report, speeches, and letters to diplomats, including the former Vice President 
of Ecuador, Lenin Moreno 
 
NASA Glenn Research Center, Fellow, Cleveland, OH. August 2010-August 2013 
 
Mathematical modeling of the effects of microgravity and hypoxia on skeletal muscle of astronauts using 
MATLAB 
 
Presented work to scientists of various disciplines from Johnson Space Center and Glenn Research Center on a 
regular basis 
 
Worked at NASA Glenn for 10 weeks each year while supplementing the work of the "Digital Astronaut" 
project 
 
Florida International University, Research Assistant, Miami, FL. August 2006-May 2008 
 
Modified membranes using vapor and solution graft polymerization 
 
Investigated potential applications of membranes, including possible treatment of acute respiratory distress 
syndrome

 
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35 
 
Cardinal Engineering, Inc., Project Manager, Oklahoma City, OK. August 2005-August 2006 
 
Drafted regulatory plans for brick and material companies and power plants in OK, TX, KS, and GA 
 
Soil vapor extraction and ground-water remediation 
 
PUBLICATIONS 
 
L. Causey, B.E. Lewandowski, and W. Weinbaum. A mathematical model of oxygen transport in skeletal 
muscle during hindlimb unloading. NASA Technical Memorandum NASA/TM—2014-216631, March 
2014. 
 
L. Causey. Quantitative Model for Predicting Intramuscular Fluid Pressure and Skeletal Muscle 
Compressibility During Contraction and Stretch with Oxygen Transport Correlations. Ph.D. dissertation. 
The City College of New York, New York, 2013.  
 
L. Causey, S.C. Cowin, and W. Weinbaum. Quantitative model for predicting lymph formation and 
muscle compressibility in skeletal muscle during contraction and stretch. PNAS, 109.23: 9185-9190, June 
2012. 
 
L. Causey. Intravenous Oxygenator: Enhancement of Surface Properties to Minimize Bubble Size. M.S. 
thesis. Florida International University, Miami, 2008.  
 
CERTIFICATIONS AND SKILLS 
 
 
Engineer Intern Certification #13161, Oklahoma State Board of Registration for Professional 
Engineers and Land Surveyors, 2005 
 
Skilled in most major computer applications (expert in Microsoft Office, MATLAB, Abaqus FEA, 
SolidWorks, Adobe Photoshop and Illustrator, Code Composer Studio, Multisim, Ultiboard) 
 
GRANTS AND SCHOLARSHIPS 
 
 
NASA Graduate Student Research Fellowship (GSRP) – Independently submitted a research proposal 
that led to the support of stipend and research expenses for 3 years, 2010-2013 
 
National Science Foundation Scholar  – 7th International Summer School on Biocomplexity from 
System to Gene in Istanbul, 2008 
 
Laurance Reid Gas Conditioning Conference Scholarship Recipient, 2003 
 
ACTIVITIES AND HONORS 
 
P. Marathon Finisher – ING NYC Marathon, 2013 
Q. Distinguished student speaker – The 3rd US-Turkey Advanced Institute, Antalya, Turkey, 2012 
R. New York Junior League Advocate for Public Policy Committee, 2010-2012 
S. City Advocacy Co-coordinator – met with legislators to discuss Elder Evictions Legislation 
Int 0475-2011; organized volunteer training leadership courses to educate league members on 
local and state politics; met with legislators in Albany to discuss Domestic Survivors Justice 
Act 
T. Award for Outstanding Leadership – NIH Undergraduate Minority Mentor for CCNY Program, 2009-
2011 
U. Volunteer Tutor – Harlem Boys and Girls Club, 2009-2011 
V. Third place winner of the First Regional South Florida Technical Presentation, 2007 
W. Volunteer Tutor for Little Brother, Big Brothers/Big Sisters, 2007 

 
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Appendix 2.  Study Data Collection Form 
 
Subject number: 
 
 
 
 
__________  
Age: 
 
 
 
 
 
 
__________ 
Gravidity: 
 
 
 
 
 
__________ 
If pregnant, estimated gestational age: 
 
__________ 
If postpartum, hours since delivery:  
 
__________ 
Systolic alarm limits set: 
 
 
 
high: __________ low: __________ 
Diastolic alarm limits set: 
 
 
 
high: __________ low: __________ 
Time interval set: 
 
 
 
 
__________ 
Test device ID: 
 
 
 
 
__________ 
Nurse ID: 
 
 
 
 
 
__________ 
Time monitoring starts: 
 
 
 
__________ 
Time monitoring ends: 
 
 
 
__________ 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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37 
 
Blood Pressure Measurements 
 

 
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38 
 
Alarm Indications 
Time 
Device (control/test) 
Alarm type  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Errors/Questions by Nurses 
Time 
Nurse ID 
Description of Error/Resolution  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Device Malfunctions 
Time 
Device ID 
Description of Malfunction/Resolution