SBIR Phase I: A Compact, Wireless Fetal Heart Monitor

This Small Business Innovation Research (SBIR) Phase I project will develop a compact wireless solution for the highly accurate monitoring of fetal and maternal health (comprising a stand-alone device and/or an add-on to an existing technology). The inexpensive and nonintrusive fetal heart monitor (FHM) will not only provide a new level of diagnostic accuracy for hospital and clinical use, but will enable instantaneous wireless transmission for monitoring at home and in resource limited situations (e.g. third world and military applications). In contrast to current technology, the FHM will monitor not only heart rate, but will also provide full electrocardiogram (ECG) traces of individual heart-beats. The ability to obtain individual traces is not matched by any existing technology. The continuous monitoring of ECG traces will provide essential diagnostic information, as well as statistically valuable scientific information on fetal development. The ability to monitor multiple gestations is likewise unmatched by any other technologies. Finally, the system will also provide valuable information on fetal positioning and motion. The broader impact/commercial potential of this project is that it addresses an urgent need for improved monitoring of problem pregnancies, especially in low-resource environments. By providing compact systems suitable for ambulatory off-site, clinic and hospital monitoring, the FHM will provide improved tools for prenatal and perinatal care that will enhance the health and well-being of mother and child. Adoption of FHM technologies will permit a more appropriate level of care (home, clinic, hospital) and allow timely intervention when required. The unique information provided by ECG traces will provide a more complete picture of fetal health and lead to a reduction in unnecessary surgical interventions. Consequently, the low-cost fetal heart monitor will improve health-care outcomes while reducing costs. Given the limitations of existing devices compared to the invention of this report, it is anticipated not only to capture a significant fraction of a rapidly growing market, but to create new diagnostic possibilities, and to access an addressable market of $139 million. The manufacturing, sales and support of the device will create jobs and enhance local economic vitality.