Systems and methods for improving production and/or calibration of biosensors are disclosed herein. The biosensors can be used for personal biomonitoring and providing personalized healthcare assessments. The manufacturing method can include gathering production data throughout production of the biosensors and using the production data to predict performance metrics for each biosensor. The predicted performance metrics can be generated using one or more models correlating the production data to the performance metrics. The predicted performance metrics can then be used by a biomonitoring system to adjust operating parameters of the biosensor before a user relies on the healthcare assessments from the biomonitoring system.

Skin-mounted or epidermal devices and methods for monitoring biofluids are disclosed. The devices comprise a functional substrate that is mechanically and/or thermally matched to skin to provide durable adhesion for long-term wear. The functional substrates allow for the microfluidic transport of biofluids from the skin to one or more sensors that measure and/or detect biological parameters, such as rate of biofluid production, biofluid volume, and biomarker concentration. Sensors within the devices may be mechanical, electrical or chemical, with colorimetric indicators being observable by the naked eye or with a portable electronic device (e.g., a smartphone). By monitoring changes in an individual's health state over time, the disclosed devices may provide early indications of abnormal conditions.

A system for detecting analytes in a biological subject, the system including at least one substrate including a plurality of microstructures configured to breach a stratum corneum of the subject, and wherein the one or more microstructures are responsive to a presence, absence, level or concentration of analytes to cause a change in appearance thereby indicating that a presence, absence, level or concentration of analytes has been detected.

A microsensor and method of manufacture for a microsensor, comprising an array of filaments, wherein each filament of the array of filaments comprises a substrate and a conductive layer coupled to the substrate and configured to facilitate analyte detection. Each filament of the array of filaments can further comprise an insulating layer configured to isolate regions defined by the conductive layer for analyte detection, a sensing layer coupled to the conductive layer, configured to enable transduction of an ionic concentration to an electronic voltage, and a selective coating coupled to the sensing layer, configured to facilitate detection of specific target analytes/ions. The microsensor facilitates detection of at least one analyte present in a body fluid of a user interfacing with the microsensor.

Devices and methods to mitigate the erroneous signal imparted by physical and/or chemical process incident upon analyte-selective electrochemical sensors that are non-analyte-related in origin are disclosed herein. A sensing system featuring at least one of an analyte-selective sensor and at least one of an analyte-invariant sensor.

The present invention generally relates, in certain aspects, to relatively small devices applied to the skin, modular systems, and methods of use thereof. In some aspects, the device is constructed and arranged to have more than one module. For instance, the device may have a module for delivering to and/or withdrawing fluid from the skin and/or beneath the skin of a subject and a module for transmitting a signal indicative of the fluid delivered to and/or withdrawn from the skin and/or beneath the skin of the subject, a module for analyzing a fluid withdrawn from the skin and/or beneath the skin of the subject, or the like. In some embodiments, the modules are connectable and/or detachable from each other, and in some cases, the connections and/or detachments may be performed while the device is in contact with the subject, e.g., while affixed to the subject. In some embodiments, the device may be repeatedly applicable to the skin of the subject to deliver to and/or withdraw fluid from the skin and/or beneath the skin of a subject, e.g., at the same location, or at different locations on the skin of the subject. In some aspects, the devices may be self-contained and/or have a relatively small size, and in some cases, the device may be sized such that it is wearable and/or able to be carried by a subject. For example, the device may have a mass and/or dimensions that allow the device to be carried or worn by a subject for various periods of time, e.g., at least about an hour, at least about a day, at least about a week, etc., or no more than about an hour, no more than about 10 min, etc.

An interstitial fluid sampling device with mechanical, electrical, and/or chemical components to mitigate sample quality issues and/or measure the quality of collected samples to alert of and/or correct for quality issues. The device includes at least one sensor that is specific to an analyte in the interstitial fluid, at least one wicking component, and at least one component to ensure the quality of collected interstitial fluid.

A wearable device utilizing flexible electronics is disclosed. The wearable device may comprise a flexible matrix material and may include sensors for measuring biometric measurements of an individual, an accelerometer for measuring an acceleration of a body part to which the wearable device is attached, a wireless transmitter, a flexible power source, and a microcontroller. During an activity, the microcontroller may receive signals from the sensors including the biometric measurements, and signals from the accelerometer including acceleration and force measurements associated with the individual. The microcontroller may convert the signals into digital signals and transmit the signals to a computing device for analysis. The computing device may analyze the digital signals to determine a performance metric for the individual. The performance metric may be compared to baseline data for the individual to determine a fatigue level, injury risk, or an adjustment to be made by the individual during the activity.

Aspects are directed to a reference electrode integrated on a surface of a substrate to facilitate functionalization of a working electrode. The reference electrode is used in the electrochemical deposition or electrodeposition of one or more functional layers on a working electrode. The working electrode may be a sensing element of an analyte-selective sensor. Additional aspects of the current subject matter are directed to a counter electrode integrated on a surface of a substrate.

Personal diagnostic devices including diagnostic patches (bio-patches) and interactive medical bracelets (bio-bracelets) are provided with a skin/patch interface, at least one analysis layer, a signal processing layer, and a user output interface. Embodiments of the interactive diagnostic devices may include micro-fluidic circuits with reaction chambers, analysis chambers, mixing cambers, and various pre-disposed chemistries or reagents for performing a wide verity of tests by transdermal transport of blood or perspiration. Sample collection chambers for the fluidic circuit may include minimally invasive tubules that penetrate the skin surface to acquire blood samples from capillaries near the epidermis. Alternate implementations of the personal diagnostic device may be equipped with logic processing, input/output devices, acoustic microphones, cryogenic circuits, embedded processors, electrical control circuitry, and battery current sources or photovoltaic sources of electrical power.