Bilateral Acoustic Sensing and Automated Breathing Segmentation for Remote Monitoring of Patients with COPD: A Longitudinal Study

Abstract: Chronic obstructive pulmonary disease (COPD) is one of the most costly and lethal chronic conditions, with a 23% readmission rate in the United States contributing over $52 billion in annual expenses. WearME—our patented wearable harness—addresses a gap in COPD care by allowing continuous, passive respiratory monitoring that does not rely on patient-initiated spirometric maneuvers. This innovative platform captures bilaterally segmented lung acoustics, cough frequency, and respiratory rhythms, enabling clinicians to detect early exacerbations and intervene preemptively. Our NIH- funded Fast-Track SBIR activities are designed to validate the device’s clinical performance, but successful commercialization also demands an evidence-based approach to market entry. Participation in the I-Corps program will allow our multidisciplinary team—comprising expertise in engineering, medicine, and entrepreneurship—to conduct extensive stakeholder engagement. Through at least 100 interviews, we will refine our assumptions about how best to distribute WearME (e.g., partnering with durable medical equipment distributors versus direct hospital sales), how to optimize payer reimbursement for remote patient monitoring codes, and whether to pursue a strategic acquisition by a major MedTech firm. This systematic discovery process is essential for honing WearME’s business model and ensuring its commercial viability. By the end of the program, we aim to finalize a blueprint for scaling WearME to broader markets, complete with validated pricing, market positioning, and distribution strategies, thereby fulfilling our vision of making continuous lung monitoring readily accessible to millions of COPD patients worldwide. 1