SBIR-STTR Award

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project aims to provide medical workers and consumers the utility of continuous blood pressure monitoring with an easy to use adhesive soft sensor, which can greatly improve personalized care and patient outcomes. While a patient is undergoing surgery, blood pressure is monitored because sudden drops have been linked to irreversible tissue and/or organ damage, resulting in post-operative complications and mortality. The traditional arm cuff blood pressure monitor is primarily used in surgical settings but while it is not invasive, the cuff doesn't capture sudden changes in blood pressure. There are more than 50 million surgeries are performed annually, > 85% of which rely on non-continuous blood pressure arm cuffs. This project will develop a new wearable medical device to non-invasively and continuously measure beat-to-beat blood pressure. This Small Business Innovation Research Phase 1 project will advance a new device for non-invasive and continuously blood pressure monitoring. Current devices are limited by their accuracy and temporal resolution. The proposed medical device is based on soft wearable pressure sensors that solves the cost, accuracy, and temporal resolution problem. The soft sensor adheres to the body wherever a pulse is palpable and measures the arterial expansion on the surface of the skin as a pulse wave traverses the artery. Soft sensor technology leverages the highly elastic properties of micro-nanostructure wrinkled electronic thin films developed using a novel shrinking fabrication process. Preliminary results using these soft wearable sensors established high correlation to the gold standard arterial line. This project will develop electronics to read and output signals wirelessly from multiple channels as well as highly pressure-sensitive multichannel sensors and a wristband form factor design. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is focused on providing real-time and continuous monitoring of blood pressure for patients in surgery and critical care. Currently, only 10-15% of patients undergoing surgery receive continuous blood pressure monitoring because such monitoring requires specialized skill to administer the invasive procedure and can also introduce potential complications. The remaining patients are monitored intermittently with a non-invasive blood pressure cuff, resulting in gaps in information between readings and potentially delayed response times. Rapid blood pressure drops are associated with poor patient outcomes such as organ damage/failure, post-surgical complications, and death. The success of this project has the potential to not only increase the number of surgical and critical care patients who receive continuous monitoring, improving quality of care and patient outcomes, but also to enable continuous blood pressure monitoring in other applications, such as in pre-eclampsia patients in obstetrics. This project also has commercial potential. With over 50 million surgeries performed in the US each year, the serviceable, addressable market is $2.5 billion per year. Expanded to the global market where over 230 million surgeries are performed annually, the total addressable market is over $11 billion._x000D_