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

这个小企业创新研究（SBIR）第一阶段项目的更广泛的影响/商业潜力在于它能够为临床医生提供一种新的工具，用于围手术期，术后和慢性疼痛管理。该技术支持增强患者安全性，提高术后恢复的国际标准，降低成瘾可能性和阿片类药物节省，减少临床医生和医疗资源的负担，降低医疗服务成本，并通过培训提高临床医生的能力。商业影响存在于医疗保健的各个方面，包括围手术期程序，住院降压和恢复，门诊手术中心程序和慢性疼痛管理。它有潜力扩展到其他临床市场，包括军事和急救人员。这项技术可以通过为前线受伤的部队提供先进的护理能力，并通过康复来支持国家的国防。该解决方案也适用于在国家，州和地方危机期间使用，并且随着家庭医院趋势的增加，可以追求该市场。最终，商业影响存在于全球范围内的使用，并在未来十年内促进区域区块使用的整体预计增长。这一小企业创新研究（SBIR）第一阶段项目将技术应用于130多年来尚未解决的医疗应用。 基于临床需求，开发了一种最小可行装置（MVP），并制作了原型，可客观量化神经阻滞。该项目提高了MVP的能力，并提供了有关神经阻滞的实时体内状态的信息。其目的是确保器械在具有挑战性的临床条件下，对于不同的神经阻滞类型和生理上不同的患者人群的稳健性。实现这些目标的计划是将人为因素和设计工程标准应用于MVP，以确保：a）用户显示易于理解，以适当的形式和格式提供预期信息，并支持所需的临床过程和程序; B）用户控件执行所需功能，完整，反映临床环境的适当术语，并支持所需的临床过程和程序;以及c）监视器可靠、制造精良、对患者和用户安全，并完全支持相关数据的采集、处理、显示和记录。该奖项反映了NSF的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。

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.