Generic Device Research Articles

In silico medical device testing of anatomically and mechanically conforming patient-specific spinal fusion cages designed by full-scale topology optimisation.

A full-scale topology optimisation formulation has been developed to automate the design of cages used in instrumented transforaminal lumbar interbody fusion. The method incorporates the mechanical response of the adjacent bone structures in the optimisation process, yielding patient-specific spinal fusion cages that both anatomically and mechanically conform to the patient, effectively mitigating subsidence risk compared to generic, off-the-shelf cages and patient-specific devices. In this study, in silico medical device testing on a cohort of seven patients was performed to investigate the effectiveness of the anatomically and mechanically conforming devices using titanium and PEEK implant materials. A median reduction in the subsidence risk by 89% for titanium and 94% for PEEK implant materials was demonstrated compared to an off-the-shelf implant. A median reduction of 75% was achieved for a PEEK implant material compared to an anatomically conforming implant. A credibility assessment of the computational model used to predict the subsidence risk was provided according to the ASME V&V40-2018 standard.

Pre-ANDA strategy and Human Factors activities to de-risk pharmaceutical companies ANDA submission of drug–device combination products: case study of a formative Comparative Use Human Factors study

ABSTRACT Background This article presents a strategy that a Drug Delivery Device Developer (DDDD) has adopted to support Abbreviated New Drug Application (ANDA) submissions of drug–device combination products. As per the related FDA guidance, a threshold analysis should be compiled. If ‘other differences’ between the Reference Listed Drug (RLD) and the generic drug devices are identified, a Comparative Use Human Factors (CUHF) study may be requested. Methods The DDDD performed task analysis and physical comparison to assess the pen injector design differences. Then, a formative CUHF study with 25 participants simulating injections using both RLD and the generic pen injectors was conducted. Results After each participant completed four simulated injections, similar type and rates of use error between the RLD (0.70) and generic (0.68) pen injectors were observed. Conclusion DDDDs can support pharmaceutical companies in the ANDA submission strategy of their drug–device combination product by initiating comparative task analysis and physical comparison of the device as inputs for the threshold analysis. If ‘other differences’ are identified, a formative CUHF study can be performed. As shown in our case study, this approach can be leveraged to support the sample size calculation and non-inferiority margin determination for a CUHF study with the final combination product.

Automating the Identification of Safety Events Involving Machine Learning-Enabled Medical Devices.

With growing use of machine learning (ML)-enabled medical devices by clinicians and consumers safety events involving these systems are emerging. Current analysis of safety events heavily relies on retrospective review by experts, which is time consuming and cost ineffective. This study develops automated text classifiers and evaluates their potential to identify rare ML safety events from the US FDA's MAUDE. Four stratified classifiers were evaluated using a real-world data distribution with different feature sets: report text; text and device brand name; text and generic device type; and all information combined. We found that stratified classifiers using the generic type of devices were the most effective technique when tested on both stratified (F1-score=85%) and external datasets (precision=100%). All true positives on the external dataset were consistently identified by the three stratified classifiers, indicating the ensemble results from them can be used directly to monitor ML events reported to MAUDE.

Let Us Manage BP Monitor Data Using WordPress Server and C#

Purpose: Nowadays, due to our unhealthy lifestyle, hypertension is a common and serious issue. We visit the doctor for a regular checkup at specific intervals. The doctor asks for a record of BP to review the medicine. Generally, we write our BP records on paper and carry them to show the doctor. There are a couple of disadvantages in this procedure. At first, most of the time, we did not find our paper at the time of the doctor's visit. Sometimes, the doctor is not able to read the handwriting. The doctor needs more time to estimate the high, low, and average BP record till the last visit. Sometimes, doctors prefer the BP curve. However, this procedure is more challenging. If any one of the events does not happen as expected, the treatment might go wrong. We need a good solution for the above all. We have the strength of various matured technologies. Applying those, we can solve the above situation quickly. Design/Methodology/Approach: Now, the solution is to record our BP data electronically rather than handwritten so that doctors can understand it easily. To store the bp data, we use a database. We will use a cloud database so that it can be accessible from anywhere. We can use a PC or mobile application to enter the BP data. We must enter the current reading whenever we measure BP using the apps. That is it. The application does the rest of the process. Findings/Result: As we describe, the procedure is primarily hectic. To enter bp data by opening is a time-consuming task. However, once familiar to us, it has excellent benefits. Once they adopt it, it will become a user-friendly tool to manage the BP data. Originality/Value: Several procedures are available to store and display the BP record. The smartwatch is a generic device that stores the data inside the application and then displays it according to our needs. However, it has serious drawbacks; in some ranges ( as observed in the high range), it does not provide an accurate value. Here, we are capturing the bp data from a dedicated bp instrument, which we can consider a reliable data source. Our application aims to provide as accurate data as possible to the doctors who need information. So, the application provides actual value to the user. Paper Type: Conceptual Research.

Generic model of IoT Edge device for object monitoring via LoRaWAN

This article deals with the generic model for object monitoring and tracking in an industrial environment and manufacturing. We focus on the design of generic IoT Edge device model that enables the integration of various LoRa sensors independently on vendor solutions for common use cases. Our model is based on the MQTT protocol, which is proven for sensor applications and gives needed independency on proprietary protocols. The model was implemented in Node-RED software and subsequently validated with sensors of different vendors to confirm the generic approach and base for independent object tracking solutions. The proposed Edge device model supports independent object tracking, such as object status monitoring, localization and triggered events, giving independent approach for tailored solutions and wide application portfolio based on combined different sensors and devices.

Feasibility of eolian sound for urban wind speed estimation

AbstractWind‐speed measurement is crucial in designing wind‐resistant buildings and controlling the wind environment in urban areas. However, the current methods of measuring wind speed, such as anemometers and Doppler lidar, are associated with high costs. This study investigated an alternative approach to measuring wind speed using the eolian sound emitted from cylindrical objects in urban settings, such as electrical cables. The proposed method relies on a relationship between the frequency of Karman vortex generation, which gives rise to eolian sound, and wind speed, considering the diameter of a cylindrical object. This study addressed 2 research questions: (1) the possibility of capturing and identifying the eolian sound emitted from a cylindrical object using a generic recording device and whether the peak frequency of the recorded sound aligns with the theoretically predicted frequency; (2) the feasibility of estimating the direction of the eolian sound source to identify the object responsible for the sound emission. The authors conducted a series of experiments involving artificially generated eolian sound in an outdoor environment and analyzed the recorded sound signals. The analysis results were encouraging, confirming positive responses to both research questions. These results indicate the potential for a novel method capable of estimating wind speed.

Potential application of a non-contact tool using measurable autofluorescence in oral leukoplakia

ObjectiveA fluorescence-based mouth-observation device has recently been developed, which shines the oral mucosa with blue excitation light to visualize oral mucosal lesions; this visualization is based on the differences in autofluorescence between oral lesions and healthy mucosa. In recent years, it has received renewed attention in terms of infection control because of its non-contact protocol. This study used IllumiScan® (Shofu, Japan), a fluorescence device similar to a generic fluorescence visualization device, for the analysis of oral mucosal lesions. The study aimed to compare the relationship between the histopathological findings of leukoplakia and those obtained using IllumiScan®. MethodsFifty patients with a clinical diagnosis of oral leukoplakia and a histopathological diagnosis of epithelial dysplasia or hyperkeratosis were included. The brightness of leukoplakia was reported as G values and was compared with those of tissue images. The G values were obtained using IllumiScan® and used for further analysis. ResultsThe G values of areas surrounding the white lesions on the oral mucosa with epithelial dysplasia were significantly lower than those of areas surrounding white hyperkeratotic lesions and healthy mucosa. ConclusionsBy observing oral leukoplakia with the Illumiscan®, we were able to diagnose leukoplakia noninvasively by comparing G values in and around white lesions and applying fluorescence visualization retention and fluorescence visualization loss intensities.

Key Device Attributes for Injectable Somatostatin Receptor Ligand Therapy in Acromegaly and Neuroendocrine Tumours.

People living with acromegaly and neuroendocrine tumours (NETs) may be treated with injectable somatostatin receptor ligands (SRLs), administered by either a caregiver or as self-injection via a proprietary or generic device. Injection device attributes that contribute to ease of use and storage, minimise preparation requirements, and reduce injection pain are associated with improved adherence and more favourable therapeutic outcomes. The aim of this study was to assess current opinion surrounding favourable SRL device attributes for people living with acromegaly and NETs as well as that of their caregivers. Participants (healthcare professionals [HCPs] and patients/non-HCP caregivers) from 11 countries were invited to answer survey questions related to their demographic, experience, and preferences as they relate to the real-world use of injectable SRL devices. Questions were developed based on review of available literature and meetings with a Scientific Committee. Device attributes preferred by the patient/non-HCP caregiver group (n = 211) included confidence that the correct drug amount is delivered (76%), quick administration with minimal pain/discomfort (68%), and device safety (needle-safety and low risk of contamination; 53%). Device attributes preferred by HCPs (n = 52) were quick administration with minimal pain/discomfort (69%), correct use is easy to learn, confidence in handling the device (63%), and confidence that the correct drug amount is delivered (62%). The results identified key features of injection devices for SRL therapy which merit consideration for optimal management and underscore the importance of patient partnership in treatment decisions.

Automated CO2 and CH4 monitoring system for continuous estimation of degassing related to hydropower

Reliable measurement of greenhouse gas emissions from reservoirs is essential for estimating the carbon footprint of the hydropower industry. Among the different emission pathways, degassing downstream of the turbines and spillway is poorly documented mainly because of the safety stakes related to sampling up and downstream the power plants. The alternative being to sample the water from the turbine inside the station, this study aimed to assemble a custom automated CO2 and CH4 monitoring system (SAGES), especially designed for long-term surveys in hydropower facilities, with a special focus on low maintenance requirements. The SAGES combines infrared and laser technologies with a modular programming approach and run with a specifically designed plexiglass equilibration system (PES) that maintain a permanent headspace and avoid clogging by suspended solids. Although the SAGES is based on commercially available devices, it is the first time they are combined and used with the gas equilibrator. To ensure the reliability of the mounting and to control the quality of the readings, the system was tested in laboratory prior to its installation in generating stations. SAGES and PES performances were compared with those of generic devices available on the market although less adapted to the specific deployments targeted. The SAGES gas partial pressure measurements were accurate and linear in the entire range tested: 0 to 5,000 ppm for pCO2 and 0 to 600 and 10,000 ppm for pCH4. Gas PP measurements were comparable to the reference CO2/CH4 sensor and there was no drift during long term deployment. The SAGES/PES installed in 2021 in cascading generating stations of the Romaine complex collected more than 28,000 data points over a 10-month period and required only two maintenances. Results show that the SAGES is a reliable tool that provide long-term CO2 and CH4 dataset in generating stations while requiring minimal energy, care and maintenance. The data collected in turbine water and the recent use of the SAGES in peat land by a collaborative team demonstrate how the SAGES systems can efficiently contribute to the understanding of reservoir carbon cycles.

Generic dynamic molecular devices by quantitative non-steady-state proton/water-coupled electron transport kinetics

Dynamic molecular devices operating with time- and history-dependent performance raised new challenges for the fundamental study of microscopic non-steady-state charge transport as well as functionalities that are not achievable by steady-state devices. In this study, we reported a generic dynamic mode of molecular devices by addressing the transient redox state of ubiquitous quinone molecules in the junction by proton/water transfer. The diffusion limited slow proton/water transfer-modulated fast electron transport, leading to a non-steady-state transport process, as manifested by the negative differential resistance, dynamic hysteresis, and memory-like behavior. A quantitative paradigm for the study of the non-steady-state charge transport kinetics was further developed by combining the theoretical model and transient state characterization, and the principle of the dynamic device can be revealed by the numerical simulator. On applying pulse stimulation, the dynamic device emulated the neuron synaptic response with frequency-dependent depression and facilitation, implying a great potential for future nonlinear and brain-inspired devices.

Anisotropic leaky-like perturbation with subwavelength gratings enables zero crosstalk

Electromagnetic coupling via an evanescent field or radiative wave is a primary characteristic of light, allowing optical signal/power transfer in a photonic circuit but limiting integration density. A leaky mode, which combines both evanescent field and radiative wave, causes stronger coupling and is thus considered not ideal for dense integration. Here we show that a leaky oscillation with anisotropic perturbation rather can achieve completely zero crosstalk realized by subwavelength grating (SWG) metamaterials. The oscillating fields in the SWGs enable coupling coefficients in each direction to counteract each other, resulting in completely zero crosstalk. We experimentally demonstrate such an extraordinarily low coupling between closely spaced identical leaky SWG waveguides, suppressing the crosstalk by ≈40 dB compared to conventional strip waveguides, corresponding to ≈100 times longer coupling length. This leaky-SWG suppresses the crosstalk of transverse–magnetic (TM) mode, which is challenging due to its low confinement, and marks a novel approach in electromagnetic coupling applicable to other spectral regimes and generic devices.

Cooperative Multiband Spectrum Sensing Using Radio Environment Maps and Neural Networks.

Cogitive radio networks (CRNs) require high capacity and accuracy to detect the presence of licensed or primary users (PUs) in the sensed spectrum. In addition, they must correctly locate the spectral opportunities (holes) in order to be available to nonlicensed or secondary users (SUs). In this research, a centralized network of cognitive radios for monitoring a multiband spectrum in real time is proposed and implemented in a real wireless communication environment through generic communication devices such as software-defined radios (SDRs). Locally, each SU uses a monitoring technique based on sample entropy to determine spectrum occupancy. The determined features (power, bandwidth, and central frequency) of detected PUs are uploaded to a database. The uploaded data are then processed by a central entity. The objective of this work was to determine the number of PUs, their carrier frequency, bandwidth, and the spectral gaps in the sensed spectrum in a specific area through the construction of radioelectric environment maps (REMs). To this end, we compared the results of classical digital signal processing methods and neural networks performed by the central entity. Results show that both proposed cognitive networks (one working with a central entity using typical signal processing and one performing with neural networks) accurately locate PUs and give information to SUs to transmit, avoiding the hidden terminal problem. However, the best-performing cognitive radio network was the one working with neural networks to accurately detect PUs on both carrier frequency and bandwidth.

WiscSort: External Sorting for Byte-Addressable Storage

We present WiscSort, a new approach to high-performance concurrent sorting for existing and future byte-addressable storage (BAS) devices. WiscSort carefully reduces writes, exploits random reads by splitting keys and values during sorting, and performs interference-aware scheduling with thread pool sizing to avoid I/O bandwidth degradation. We introduce the BRAID model which encompasses the unique characteristics of BAS devices. Many state-of-the-art sorting systems do not comply with the BRAID model and deliver sub-optimal performance, whereas WiscSort demonstrates the effectiveness of complying with BRAID. We show that WiscSort is 2-7 x faster than competing approaches on a standard sort benchmark. We evaluate the effectiveness of key-value separation on different key-value sizes and compare our concurrency optimizations with various other concurrency models. Finally, we emulate generic BAS devices and show how our techniques perform well with various combinations of hardware properties.

Evaluation of Dynamic Flashing Yellow Arrow Decision Support System in the Field Using Before and After Real-Time Data

A permissive left turn is one of the most dangerous movements a driver can make because the driver travels across opposing traffic lanes. In recent years, flashing yellow arrow (FYA) signals have been proven to help drivers make safer left turns. The four-section signal display with FYA permissive left-turn indication creates an opportunity to enhance the left-turn phase with a variable mode that can change on demand. A challenge to using this system is knowing the best times of day to apply the FYA indication. The authors developed an exclusive hardware platform: first, to provide a generic device compatible with the different controller types used by different jurisdictions and, second, to automate selection of the FYA left-turn modes based on available gaps in the opposing traffic at intersections acquired in real time from existing sensors in the field. Phase IV provided conclusive field testing and evaluation of the decision support system (DSS), by switching between red and FYA modes in a rational manner consistent with driver expectations and left-turning gap acceptance thresholds. It was also concluded that coordinated signals with long cycle lengths, 3 min and longer, help provide adequate gaps even in heavy traffic patterns since most of the vehicle arrivals are in platoons and at the beginning of the cycle. The analysis showed that the utilization factor for the DSS recommendations for all the intersections ranged between 65% and 75% during peak conditions on weekdays and between 90% and 95% during off-peak conditions and weekends. The total delay in the before study for all the intersections amounted to 737 vehicle-hours and in the after-study was 440 vehicle-hours of delay. An overall reduction of about 40% in delay which confirms the operational benefit of the dynamic FYA DSS. The developed platform is applicable at any four-section head configuration to maximize safety and efficiency of the intersections.

The effect of dead volumes on the performance of magnetic refrigerators

Regenerative magnetic refrigeration at room temperature has the potential to overcome various problems affecting vapor compression devices while providing competitive performance, but the effects of several loss mechanisms must be evaluated and accounted for. In actual devices, inactive sections in the regenerator originate dead volumes leading to possible non-optimal exploitation of the magnetocaloric material and the associated loss mechanism. While magnetic refrigeration gained attention, few studies have systematically investigated the effects of dead volume on system performance. In this work, a one-dimensional model valid for a generic magnetic refrigerator device (either linearly reciprocating or with continuous, or discontinuous, rotary motion) is used to study the effect of the dead volume. The device performance was assessed by comparing the characteristic curves (cooling power, and COP) of an ideal device (zero dead volume) to the corresponding characteristic curves for different dead volume ratios. The performance is negatively affected if the device is operated under the same working conditions and control parameter settings used in the ideal device. This effect is higher for higher temperature spans. Nevertheless, the device could approximate the ideal performance by adjusting its control parameters. The main measures to mitigate the negative effects of dead volumes can be summarized in the necessity to operate at lower frequencies, higher fluid mass flow rates, and higher torque. The results of this study prove that the proper control of such operative parameters is able to maximize the device performance and mitigate the performance losses due to the dead volume effects.

Technological socialities: The impact of information and communication technologies on belonging among deaf and hard‐of‐hearing people

AbstractThis review article examines how different types of communication technologies, from the specialized medical to generic social devices, influence belonging and sociality among deaf and hard‐of‐hearing (DHH) people. The emphasis is on DHH adolescents and young adults who may be impacted differently across countries, given state‐specific policies regarding the status of sign language and deaf education, and based on different availability, affordability, and accessibility of communication technologies. We introduce different perspectives on deafness, ranging from pathological to cultural, a heuristic on which we build to explore DHH socialities as complex and evolving. We then analytically review ethnographic research on how cochlear implants impact DHH people's belonging to the “deaf world” and/or the “hearing world,” and how they navigate between these worlds. Then we move on to technologies such as text messages and social media, which enable DHH people to extend their socialities beyond local communities. Belonging is a fluid phenomenon, and technologies which are in a constant process of innovation and development may influence it in complex ways. We argue that to explore questions of belonging, identity, and sociality among DHH people, and how they are shaped by technologies, (visual) ethnographic methods are particularly productive.

A microfluidic mechano-chemostat for tissues and organisms reveals that confined growth is accompanied with increased macromolecular crowding.

Conventional culture conditions are oftentimes insufficient to study tissues, organisms, or 3D multicellular assemblies. They lack both dynamic chemical and mechanical control over the microenvironment. While specific microfluidic devices have been developed to address chemical control, they often do not allow the control of compressive forces emerging when cells proliferate in a confined environment. Here, we present a generic microfluidic device to control both chemical and mechanical compressive forces. This device relies on the use of sliding elements consisting of microfabricated rods that can be inserted inside a microfluidic device. Sliding elements enable the creation of reconfigurable closed culture chambers for the study of whole organisms or model micro-tissues. By confining the micro-tissues, we studied the biophysical impact of growth-induced pressure and showed that this mechanical stress is associated with an increase in macromolecular crowding, shedding light on this understudied type of mechanical stress. Our mechano-chemostat allows the long-term culture of biological samples and can be used to study both the impact of specific conditions as well as the consequences of mechanical compression.

Improving the performance of a generic fisheye as a secondary bycatch reduction device in a south-eastern Australian penaeid-trawl fishery

The utility of a generic device (termed a ‘fisheye’) and its simple modification for cumulatively reducing bycatch in penaeid trawls was assessed during two experiments in a south-eastern Australian fishery. In the first experiment, conventional trawls (with no fisheye) were compared to simultaneously towed, identical trawls installed with a typical fisheye (termed ‘mesh fisheye’) comprising an open triangular frame terminating in a semi-elliptical vertical opening (350 × 150 mm) in the top of the trawl extension at 1.1 m anterior to the codend drawstring. Trawls with the mesh fisheye maintained catches of penaeids (mostly school prawns, Metapenaeus macleayi) but retained significantly less total bycatch (by 39 %) and fewer unwanted southern herring, Herklotsichthys castelnaui (by 60 %) and tailor, Pomatomus saltatrix (by 52 %). During the second experiment, trawls with the mesh fisheye were simultaneously compared to those with a modified design comprising a solid panel of aluminium in the lower half of the triangular frame (termed the ‘solid fisheye’). The solid fisheye excluded significantly more bycatch (by 52 %) and small southern herring (by 47 %), and also the numbers of several other species, including mulloway (by 38–41 %) without affecting penaeid catches. The improved performance of the solid fisheye was attributed to its greater anterior displacement of water and posterior area of lower perceived flow for fish. The results and simplicity of the fisheye modification support not only its regional use, but also testing in other national and international fisheries.

A predictive computational platform for optimizing the design of bioartificial pancreas devices

The delivery of encapsulated islets or stem cell-derived insulin-producing cells (i.e., bioartificial pancreas devices) may achieve a functional cure for type 1 diabetes, but their efficacy is limited by mass transport constraints. Modeling such constraints is thus desirable, but previous efforts invoke simplifications which limit the utility of their insights. Herein, we present a computational platform for investigating the therapeutic capacity of generic and user-programmable bioartificial pancreas devices, which accounts for highly influential stochastic properties including the size distribution and random localization of the cells. We first apply the platform in a study which finds that endogenous islet size distribution variance significantly influences device potency. Then we pursue optimizations, determining ideal device structures and estimates of the curative cell dose. Finally, we propose a new, device-specific islet equivalence conversion table, and develop a surrogate machine learning model, hosted on a web application, to rapidly produce these coefficients for user-defined devices.

Numerical modeling for efficiency and endurance assessment of an indirect mitral annuloplasty device

In recent years, several transcatheter systems have been introduced for treatment of common mitral regurgitation (MR). Such a system that is based on indirect mitral annuloplasty (IMA) is currently indicated for functional MR. Very few clinical studies have been performed to assess the efficiency and durability of such devices, despite their high risk of fracture resulting from ongoing exposure to large cyclic deformations. In this study, numerical models of moderate primary MR were created to test the implantation procedure of a customized IMA device and its sealing efficiency. The ability of the implanted device to reduce systolic leakage was evaluated and affirmed with a model of a more generic device. The long-term durability of the device was tested using a range of Nickel Titanium material properties. Our results demonstrated a considerable reduction in leakage for both the simplified generic device and the more detailed customized device models. The device met different fatigue criteria, confirming its resiliency and safety even after 10 years, even under the harsher conditions of primary MR. This is the first study to assess the performance and fatigue risk of IMA devices for the treatment of more complicated MR conditions. These findings may pave the way for further research to ultimately consider the device in selective cases of PMR.