The outgoing FDA commissioner’s comments on the slow integration of data from mobile platforms into clinical research highlight the challenges facing real-world applications of wearables.
Focus on wearable sensors
Wearable technologies have the potential to transform our ability to monitor physiology not only in the clinical trial and outpatient settings, but also in the context of health and wellness. These replace monitoring available only in a hospital setting with minimally invasive devices that can be worn and are capable of high-frequency and/or continuous sampling. But only a handful of analytes are known to be faithfully measureable from easily accessible sites, and most of these analytes are relevant to monitoring physical exertion in athletes rather than to broader applications or to disease (see Review by Heikenfeld et al.). Engineers, bioinformaticians, clinicians and biologists are working to develop sensors that access bodily fluids to detect important biomarkers while interfacing seamlessly with skin (see Perspective by Someya and Amagai).
Although wearable biosensors as a whole have not yet been widely successful commercially or been incorporated into clinical decision-making, the promise of measuring analytes such as glucose continuously (see News Feature) and non-invasively continue to drive investment, intellectual property (see Patent Table) and technological development in the field (see Review by Kim et al.). They will also need to overcome several economic, technological and cultural challenges in handling data from these devices, including data analysis, management, security and privacy (see Editorial).
Realizing the dream of noninvasive glucose monitoring
Reviews and Perspectives
Assessing progress towards designing reliable wearable biosensors reveals the challenges remaining before the promise of clinical translation can be realized.
Heikenfeld et al. survey the range of biochemical analytes that can be sensed in dermal interstitial fluid, saliva and sweat, and outline criteria for tailoring sensor design to address the right analyte in the right body site for the right disease or wellness application.
Recent patents related to wearable devices and systems for monitoring glucose levels and other health conditions.