SBIR Phase I: Real-time Continuous Sensor-based Objective Scoring and Reporting of Acute Pain

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is the development of a non-invasive device to objectively measure acute pain. This pain measurement sensor will monitor patients? pain continuously and in real-time thus replacing or complementing the subjective pain measurement and scoring that is practiced today. When patients are able to communicate, pain levels are subjectively reported by the patients. When patients are unable to effectively communicate, pain levels are subjectively measured by a clinician using proxies such as vital signs and facial expressions. Such non-responsive patients include individuals in the acute care units, pediatrics, or patients suffering from neurological disorders such as stroke and dementia. Up to 10 million patients are admitted to acute care every year with an average length of stay (LOS) over 10 days. Improved pain monitoring could reduce LOS and decrease complications associated with over medication. A decrease in LOS of just 0.25 days could save over $5 billion/year. In addition, inefficient pain management is recognized as one of the major reasons patients become addicted to opiates. Opioid abuse in the US costs over $55.7 billion. An estimated market/revenue opportunity for this device is $450 million with limited adoption. The proposed project entails the development of the real-time acute pain scoring and reporting software platform. It will provide development of a platform to enable real-time pain scoring and reporting, a major effort to prove that the technology can be deployed in clinical settings where a physician can make good use of pain level diagnosis and apply a therapy plan. Feasibility of the platform has been indicated by studies aimed to prove the link between pain-evoked cortical activity of the brain and corresponding hemodynamic responses. In this project, the bio-signals extraction, signal conditioning, and real-time pain scoring algorithms will be developed utilizing real-time objective pain assessment in addition to developing a usability mobile app. In addition, we will perform validation studies of the developed platform. Successful development of the proposed platform will contribute to improving patient?s pain management significantly by lowering costs related to pain management and length of stay. The goal of phase II of the project is to miniaturize the system and enhance the user interface, an essential step towards commercialization.