SBIR Phase I: Neural Blockade Monitor Technology for Precision Pain Management

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The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is found in its ability to provide a novel tool for clinicians for perioperative, post-surgical, and chronic pain management. This technology supports enhanced patient safety, international standards for enhanced recovery after surgery, reduced addiction potential and opioid sparing, reduced loading on clinicians and healthcare resources, reduced cost of healthcare services, and advanced capability of clinicians through training. The commercial impact exists in all facets of healthcare, including perioperative procedures, in-hospital step-down and recovery, ambulatory surgery center procedures, and chronic pain management. The potential exists to expand into other clinical markets including the military and first responders. This technology can support the national defense of the country by providing advanced care capability for wounded troops on the front lines, in recovery, and through rehabilitation. The solution also applies to use during times of national, state, and local crisis, and, as the hospital-at-home trend increases, that market can be pursued. Ultimately, the commercial impact exists in both worldwide use and in contributing to the overall projected increase in use of regional blocks in the coming decade.This Small Business Innovation Research (SBIR) Phase I project applies technology to a medical application that has not been addressed for over 130 years. Based on clinical needs, a minimally viable device (MVP) has been developed and prototyped that objectively quantifies neural blockades. This project advances the capability of the MVP and advances information about the real-time in vivo status of a neural blockade. The goal is to assure device robustness under challenging clinical conditions, for different neural blockade types, and for physiologically diverse patient populations. The plan to reach these goals is to apply human factors and design engineering standards to the MVP to assure that: a) the user displays are readily understood, provide the expected information in an appropriate form and format, and support the required clinical processes and procedures; b) the user controls perform the required functions, are complete, reflect the appropriate nomenclature for the clinical environment, and support the required clinical processes and procedures; and c) the monitor is reliable, well fabricated, safe for the patient and user, and completely supports the acquisition, processing, display, and recording of pertinent data. The resulting technology will be a robust patient monitoring device that assures patient safety and optimized treatment.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.