Point-of-Care Diagnostic Device Development and Patients, Providers, Payers, and Policy-Makers: If we build it, will they come?
Point-of-Care (POC) diagnostic devices have the potential to accelerate the delivery of high-quality healthcare to the right patient, at the right time, and with optimal clinical and public health outcomes. In particular, recent advances in genomic and precision medicine offer the additional potential to further personalize POC diagnostic devices and tools and maximize the desired health impact at the individual and population levels. Not surprisingly, these expectations have fueled tremendous advances in the science and technology of POC diagnostic device development. Since Tovar’s seminal description of a bedside agglutination test using whole blood for the rapid diagnosis of tularemia in 1946, the spectrum of diagnoses now enabled include other infectious, metabolic, hematologic, endocrine, cardiovascular, pulmonary, cerebrovascular, and other diseases. All of these advances have been possible because of dramatic improvements in the development of multiple substrate-specific biosensors and electrodes, multi-spectral imaging and monitoring, advances in miniaturization, and myriad enabling platforms and technologies. Concomitant with these advances, the number of scientific publications on POC diagnostic devices has grown exponentially, especially in the last decade (Figure 1). However, few of these studies address the important challenges of clinical acceptance, adoption, and adaptation with respect to providers, patients, and payers; provider and patient usage adherence; other implementation research outcomes; determinants of clinical meaningful use; cost-benefit and cost-effectiveness analyses; fidelity of POC device use in a variety of healthcare and real world settings; and strategies for dissemination and scale-up (Figure 2).
In particular, we lack evidence on how to use POC monitoring data to improve diagnosis and treatment options in the global environment and low-resourced settings. The evidence is also sparse on strategies to help integrate and use data and related analytics from POC devices in clinical and public health practice. To highlight these concerns, this lecture will present several caveats that challenge our assumptions on the potential advantages and contributions of POC diagnostic devices. It will also build on the successes of previous NIH/IEEE conference themes and specifically address the need for rigorous implementation research that can help inform clinical acceptance by providers and health systems; promote patient and community acceptance; and help advance clinical meaningful use of POC devices and tools. The lecture will also emphasize the importance of “beginning with the end in mind” and how implementation research within a context of active patient, community, and stakeholder engagement could inform early-stage translational research for POC diagnostic device development. The lecture will conclude with a discussion of POC diagnostic devices and implementation research in the NHLBI Strategic Vision for the next decade.
Dr. George Mensah is an accomplished clinician-scientist who currently serves as a senior advisor in the Office of the Director at the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health (NIH). He also serves as Director of the Center for Translation Research and Implementation Science (CTRIS) and Acting Director of the Division of Cardiovascular Sciences. In these positions, Dr. Mensah leads a trans-NHLBI effort to advance late-stage translational research in heart, lung, and blood diseases and sleep disorders. Dr. Mensah’s primary focus is the application of T4 translation research and implementation science approaches to address gaps in the prevention and treatment of heart, lung, and blood diseases and the elimination of health inequities. His goal is to maximize the population health impact of investments made in fundamental discovery science and pre-clinical or early-stage translational research in heart, lung, and blood diseases. Dr. Mensah trained in internal medicine and the subspecialty of cardiovascular diseases. His professional experience includes 20 years of public service between the U.S. Department of Veterans Affairs (VA), the Centers for Disease Control and Prevention (CDC), and the NIH. He has had management experience as a chief of cardiology; head of a clinical care department; and a past member of the Board of Governors of the American College of Cardiology as Governor for Public Health.