SBIR-STTR Award

Obstetricians measure fetal heartrate (FHR) and uterine contractions to evaluate fetal health during pregnancy and labor. This monitoring is performed to decrease the development of complications while minimizing the need for unnecessary obstetric interventions and is especially important for women with high-risk pregnancies. However, many women, especially in rural areas, do not have the time or resources to reach an obstetrician and the lack of monitoring increases the risk of morbidity, mortality, and poor infant outcomes. Thus, there is a significant need for improved access to specialized healthcare providers like obstetricians. Because FHR and contractions are detected in separate locations of the mother's abdomen, two separate devices are required- a tocometer to measure contractions and an FHR monitor. In the hospital, both are used to simultaneously measure contractions and FHR and the data is fed to and displayed on a large and separate machine called the cardiotocograph (CTG). Meanwhile, current monitors for home use can measure only 1 parameter because there is no method to simultaneously read data from 2 separate devices on an app. Additionally, these home devices are not approved for clinical decision-making. Fetal Life developed a patent- pending engineering design for a tocometer that is significantly smaller and more affordable than those in clinical use. To build upon this, Fetal Life will develop a portable and affordable system with its existing tocometer and an FHR monitor for at-home use that can send both sets of data to a hub that will be able to simultaneously send the data to an app on a commercial tablet to a remote obstetrician for real time monitoring. The development of the novel tocometer and the use of a tablet eliminates the need for a separate CTG, which will reduce overall cost and size. In addition to increasing access to necessary healthcare, this product will reduce cost and time required for healthy mothers and redirect resources to mothers with high-risk pregnancies. The goal of this Phase I STTR proposal is to develop the system of products and evaluate its usability for at- home use. This will be accomplished through the execution of 3 aims. In Aim 1, Fetal Life will repackage a consumer FHR monitor to be of similar size to the tocometer and incorporate a serial port onto each device that will send continuous data to a hub device through a cable and redesign the cases to be appropriate for use with a belt. In Aim 2, we will build a hub with two serial inputs to receive FHR and contraction data and develop its software to integrate the data and display it on a single app (iOS and Android) on commercial tablets. In Aim 3, we will perform a small proof-of-concept human subject to demonstrate feasibility with 5 pregnant women and evaluate its usability in an at-home context through surveys. This Phase I program will develop the prototype and provide necessary proof-of-concept data to support further development and a larger Phase II clinical trial that will center on its accuracy and efficacy.

Public Health Relevance Statement:
PROJECT NARRATIVE Measuring fetal heartrate and uterine contractions is a common procedure performed by obstetricians to ensure mother and fetal health during pregnancy and labor. However, many pregnant mothers, especially in rural areas, do not have the resources or time to reach an obstetrician and currently available at-home products are not used to make clinical decisions. Fetal Health will lower the barriers to healthcare access for rural mothers by developing a portable and affordable telemonitoring product that can measure fetal heartrate and uterine contractions and simultaneously send both sets of data to a remote doctor to make critical decisions in real time that will ultimately improve mother and fetal health.

Project Terms:
Abdomen; Abdominal; Clinical Research; Clinical Study; Data Display; Diabetes Mellitus; diabetes; Electronics; electronic device; Engineering; Fetal Monitoring; fetus monitoring; Goals; Gynecology; Health Personnel; Health Care Providers; Healthcare Providers; Healthcare worker; health care personnel; health care worker; health provider; health workforce; healthcare personnel; medical personnel; treatment provider; Hospitals; Housing; Methods; Morbidity - disease rate; Morbidity; mortality; Mothers; Discipline of obstetrics; Obstetrics; Outpatients; Out-patients; Legal patent; Patents; Patients; Personal Satisfaction; well-being; wellbeing; Pregnancy; Gestation; Pregnant Women; expectant mother; expecting mother; pregnant mothers; Resources; Research Resources; Risk; Risk Factors; Safety; Signal Transduction; Cell Communication and Signaling; Cell Signaling; Intracellular Communication and Signaling; Signal Transduction Systems; Signaling; biological signal transduction; Social Distance; Computer software; Software; Surveys; Survey Instrument; Tablets; Technology; Time; Triage; Ultrasonography; Echography; Echotomography; Medical Ultrasound; Ultrasonic Imaging; Ultrasonogram; Ultrasound Diagnosis; Ultrasound Medical Imaging; Ultrasound Test; diagnostic ultrasound; sonogram; sonography; sound measurement; ultrasound; ultrasound imaging; ultrasound scanning; United States; Universities; Uterine Contraction; Myometrial Contraction; Woman; County; Measures; health care; Healthcare; Rural Community; Dataset; Data Set; base; human subject; rural region; rural area; Ultrasound transducer; Ultrasonic Transducer; improved; Procedures; Clinical; Phase; Ensure; Rural; High-Risk Pregnancy; analog; Phase 2 Clinical Trials; phase II protocol; Phase II Clinical Trials; instrument; Life; programs; Home; Home environment; Clinic; System; Location; fetal; Services; novel; Devices; Reporting; develop software; developing computer software; software development; portability; Intervention Strategies; interventional strategy; Intervention; Skin; telehealth; Low income; Data; Improve Access; Patient outcome; Patient-Centered Outcomes; Patient-Focused Outcomes; STTR; Small Business Technology Transfer Research; Validation; Monitor; Modification; developmental; Development; pandemic; pandemic disease; cost; digital; designing; design; Coupled; innovate; innovative; innovation; infant outcome; wi-fi; wireless fidelity; usability; engineering design; prototype; clinical practice; clinical decision-making; improved outcome; access to health care; access to healthcare; accessibility of health care; accessibility to health care; accessibility to healthcare; health care access; health care service access; health care service availability; healthcare access; healthcare accessibility; healthcare availability; healthcare service access; healthcare service availability; health care availability; Android; rural health care; rural healthcare; recruit; Bluetooth; barrier to health care; barrier to healthcare; barrier to treatment; obstacle to care; obstacle to healthcare; barrier to care; remote care; remote healthcare; remote health care; Fetal health; realtime monitoring; real time monitoring; maternal healthcare; maternal health care

To ensure fetal well-being, obstetricians monitor fetal heartrate (FHR) and uterine contractions on a weekly to bi-weekly basis towards the end of pregnancy and during labor. Such monitoring is performed with an electronic fetal monitor (EFM) to decrease the development of complications while minimizing the need for unnecessary obstetric interventions. This is especially important for women with high-risk pregnancies. Inadequate monitoring increases the risk of morbidity, mortality, and poor infant outcomes. Unfortunately, many women, especially in rural and minority communities, face many barriers like sufficient time and resources to adequate prenatal care like EFM. Furthermore, EFMs used in hospitals are not portable and can be prohibitively expensive for mid- to low-resource communities. On the other hand, monitors for home use measure only 1 parameter and therefore not approved for clinical decision making. Fetal Life's solution is a novel EFM system based on a patent-pending engineering design. Our innovation enables us to manufacture an EFM system as accurate as a hospital EFM, but at a fraction of the cost, while maintaining a portable size with telemonitoring capabilities. Commercializing this system will increase accessibility to necessary healthcare by reducing the cost and time required for prenatal care for patients and healthcare providers. In a successful Phase I program, Fetal Life met all Phase I milestones resulting in: 1) development of a prototype of the system (devices plus patient-facing mobile app) and 2) confirmation that the system is usable by pregnant patients and can detect contraction and FHR signals. Completion of the Phase I program was critical to supporting the proposed Phase II program that will focus on completing and validating the EFM system with telemonitoring capabilities for 510(k) clearance. Phase II efforts will include completing the system with the addition of the healthcare provider-facing app and validating its accuracy with in vitro testing (Aim 1), manufacturing and completing standard safety testing (Aim 2), and validating accuracy and usability of the system in a statistically powered study with pregnant subjects (Aim 3). Successful completion of the Phase II program will provide critical performance and safety data necessary for a 510(k) filing, and key data supporting its use for telehealth, both of which are required for successful market deployment.

Public Health Relevance Statement:
PROJECT NARRATIVE Measuring fetal heartrate and uterine contractions is a common procedure performed by obstetricians to ensure mother and fetal health during pregnancy and labor. However, many pregnant mothers, especially in rural and minority communities, do not have the resources or time to reach an obstetrician and currently available at-home products are not used to make clinical decisions. Fetal Health will lower the barriers to healthcare access for rural mothers by developing a portable and affordable telemonitoring product that can measure fetal heartrate and uterine contractions and simultaneously send both sets of data to a remote doctor to make critical decisions in real time that will ultimately improve mother and fetal health.

Project Terms:
Appointment; Charge; Diabetes Mellitus; diabetes; Engineering; Face; faces; facial; Fetal Monitoring; fetus monitoring; Gel; Patient Care; Patient Care Delivery; Gynecology; Health Personnel; Health Care Providers; Healthcare Providers; Healthcare worker; health care personnel; health care worker; health provider; health workforce; healthcare personnel; medical personnel; treatment provider; Hospitals; In Vitro; Manikins; Mannequins; Maternal Health Services; health care for mothers; healthcare for mothers; maternal health care; maternal healthcare; mother health care; mother healthcare; Medical Device; Morbidity - disease rate; Morbidity; mortality; Mothers; NIH; National Institutes of Health; United States National Institutes of Health; Obstetrics; Discipline of obstetrics; Out-patients; Outpatients; Patents; Legal patent; Patients; well-being; wellbeing; Personal Satisfaction; Gestation; Pregnancy; complications during pregnancy; pregnancy-related complications; Pregnancy Complications; expectant mother; expecting mother; pregnant mothers; Pregnant Women; pregnancy care; prenatal appointment; prenatal checkup; prenatal visit; Prenatal care; healthcare quality; health care quality; Research Resources; Resources; Risk; Risk Factors; Safety; Cell Communication and Signaling; Cell Signaling; Intracellular Communication and Signaling; Signal Transduction Systems; Signaling; biological signal transduction; Signal Transduction; Software; Computer software; Survey Instrument; Surveys; Technology; Testing; Time; Universities; Uterine Contraction; Myometrial Contraction; Woman; County; Measures; Device Designs; Healthcare; health care; Rural Community; Data Set; Dataset; Caring; skin irritation; base; human subject; improved; Procedures; Clinical; Phase; Biological; biologic; Ensure; Evaluation; Rural; Measurement; High-Risk Pregnancy; Funding; Companions; Life; programs; Frequencies; Clinic; System; vibration; fetal; Services; biocompatibility; biomaterial compatibility; Lytotoxicity; cytotoxicity; monitoring device; Performance; cohort; novel; Participant; Study Subject; Devices; Coding System; Code; portability; Intervention Strategies; interventional strategy; Intervention; telehealth; Low income; Address; Data; Improve Access; Small Business Technology Transfer Research; STTR; Monitor; Development; developmental; cost; Minority; Coupled; innovation; innovate; innovative; infant outcome; usability; engineering design; prototype; commercialization; pregnant; in vitro testing; clinical practice; safety testing; data exchange; data transfer; data transmission; data sharing; clinical decision-making; 3D Print; 3-D print; 3-D printer; 3D printer; 3D printing; three dimensional printing; mobile application; mobile app; mobile device application; improved outcome; health care availability; access to health care; access to healthcare; accessibility of health care; accessibility to health care; accessibility to healthcare; health care access; health care service access; health care service availability; healthcare access; healthcare accessibility; healthcare availability; healthcare service access; healthcare service availability; minority communities; rural underserved; rural under served; barrier to care; barrier to health care; barrier to healthcare; barrier to treatment; obstacle to care; obstacle to healthcare; remote health care; remote care; remote healthcare; Fetal health; obstetric care; Rural Minority; remote monitoring; telemonitoring; underserved community; under served community; Home; Resource-limited setting; Low-resource area; Low-resource community; Low-resource environment; Low-resource region; Low-resource setting; Resource-constrained area; Resource-constrained community; Resource-constrained environment; Resource-constrained region; Resource-constrained setting; Resource-limited area; Resource-limited community; Resource-limited environment; Resource-limited region; Resource-poor area; Resource-poor community; Resource-poor environment; Resource-poor region; Resource-poor setting