Enhancing the Commercialization Readiness of a Noninvasive Total Hemoglobin Monitor

Abstract It is a rare event when new and useful medical parameters can be added to the suite of monitoring and diagnostic tests available in a clinical setting. Of particular importance is the ability to measure crucial physiological parameters or analytes in a continuous and noninvasive manner—evidenced by the importance of noninvasive vital signs monitoring—because it reduces expense, eliminates delays in diagnosis, and removes the potential for exposure to blood-borne pathogens. This SBIR Commercialization Readiness Pilot (CRP) program proposal is being submitted to further the regulatory plan, intellectual property strategy, manufacturing readiness, and market launch plan for a new patient monitor capable of accurate, noninvasive, and continuous measurements of total hemoglobin (tHb) and oxygen saturation (SpO2). The measurement of total hemoglobin is a crucial and frequently performed blood test used in nearly all areas of healthcare. The accurate measurement of this parameter is particularly important for patients potentially requiring a transfusion, receiving rapid administration of fluids, undergoing a surgical procedure, or having experienced trauma that has resulted in significant blood loss. Total hemoglobin must also be measured for anemia screening prior to blood donation. The new monitor will look much like a conventional pulse oximeter, the ubiquitous vital-signs monitor that has been in widespread clinical use since the 1980s and which uses a clothespin-like sensor to “shine” red and infrared light through the finger and report a measure of the oxygen level in the arterial blood. The product realized from the current research will not only provide a noninvasive and continuous measurement of total hemoglobin but also noninvasively measure oxygen saturation with unprecedented precision and accuracy. Successful completion of the proposed work will improve the commercial readiness of a pulse oximeter capable of total hemoglobin and oxygen saturation measurements. It is the culmination of the Companyandapos;s efforts to prove that the high measurement precision provided by the use of narrow- band lasers can make possible accurate noninvasive measurement of tHb on human subjects over the full clinically-relevant tHb range. Availability of a noninvasive total hemoglobin monitor will help diagnose anemic patients sooner and contribute to the judicious use of blood transfusions, all with less pain or risk of infection while reducing the time burden on caregivers and costs to the healthcare system. It could also eliminate the need for the painful fingersticks associated with blood donation.Narrative An important part of medical care is the use of tests that help clinicians diagnose disease or other medical conditions, but often these tests require that blood or other samples be drawn from the body and sent to a central hospital laboratory. The proposed work has the goal of creating a monitor that can measure the levels of hemoglobin, the oxygen carrying protein in a patientandapos;s blood, without the need to draw a blood sample. This will ease patient distress and risk of infection, speed diagnosis, and result in improved patient outcomes and reduced healthcare costs.