Validation of Auscultation Technologies using Objective and Clinical Comparisons

Technology is rapidly changing the health care industry. As new systems and devices are developed, validating their effectiveness in practice is not trivial, yet it is essential for assessing their technical and clinical capabilities. Digital auscultations are new technologies that are changing the landscape of diagnosis of lung and heart sounds and revamping the centuries old original design of the stethoscope. Here, we propose a methodology to validate a newly developed digital stethoscope, and compare its effectiveness against a market-accepted device, using a combination of signal properties and clinical assessments. Data from 100 pediatric patients is collected using both devices side by side in two clinical sites. Using the proposed methodology, we objectively compare the technical performance of the two devices, and identify clinical situations where performance of the two devices differs. The proposed methodology offers a general approach to verify a new digital auscultation device as clinically-viable; while highlighting the important consideration for clinical conditions in performing these evaluations.