"Device development"

BACKGROUND: This industry survey was conducted to gain insight into the ways structured Benefit-Risk assessment (sBRA) of medical products is approached across drug or medical device developing companies, including frameworks and methods that are currently used and areas where future work is being planned. METHODS: A survey containing 28 questions covering five key areas of sBRA was set-up and shared with representatives from the participating companies. Each company was asked to complete a single survey response including inputs across the company's multidisciplinary key representatives involved in benefit-risk assessment...

Plant species like the Venus flytrap possess unique abilities to intelligently respond to various external stimuli, ensuring successful prey capture. Their nerve-devoided structure provides valuable insights for exploring natural intelligence and constructing intelligent systems solely from materials, but limited knowledge is currently available and the engineering realization of such concept remains a significant challenge. Drawing upon the flytrap's action potential resulting from ion diffusion, we propose a signal accumulation/attenuation model and a corresponding liquid metal-based logic module, which operates on the basis of the shape change of liquid metal within a sodium hydroxide buffer solution...

A novel strategy was employed to create supramolecular metallogels incorporating Tb(iii) and Eu(iii) ions using benzene-1,3,5-tricarboxylic acid (TA) as a gelator in N , N -dimethylformamide (DMF). Rheological analysis demonstrated their mechanical robustness under varying stress levels and angular frequencies. FESEM imaging revealed a flake-like hierarchical network for Tb-TA and a rod-shaped architecture for Eu-TA. EDX analysis confirmed essential chemical constituents within the metallogels. FT-IR, PXRD, Raman spectroscopy, and thermogravimetric analysis assessed their gelation process and material properties, showing semiconducting characteristics, validated by optical band-gap measurements...

We describe our first experience with the Triolifter (Fuji Systems, Yokohama, Japan) in cardiac surgery. The Triolifter is a less expensive, novel organ fixation device developed as a fixation indenter mainly for traction of the lung under video-assisted surgery and is now available in Japan. An 84-year-old man diagnosed with unstable angina pectoris underwent emergency coronary artery bypass grafting (CABG) under cardiac arrest. Following the declamping of the aorta and the resumption of the beating heart, bleeding from the left anterior descending artery (LAD) anastomosis site was observed...

AIMS/HYPOTHESIS: This study compares the efficacy and safety of a tubeless, on-body automated insulin delivery (AID) system with that of a tubeless, on-body sensor-augmented pump (SAP). METHODS: This multicentre, parallel-group, RCT was conducted at 13 tertiary medical centres in South Korea. Adults aged 19-69 years with type 1 diabetes who had HbA1c levels of <85.8 mmol/mol (<10.0%) were eligible. The participants were assigned at a 1:1 ratio to receive a tubeless, on-body AID system (intervention group) or a tubeless, on-body SAP (control group) for 12 weeks...

CONTEXT: Medical devices fall under the broad topic encompass everything from basic hardware to integrated software systems. The integration of software into hardware devices is not simple due to requirements of regional regulatory bodies. Therefore, medical businesses need to oversee not only the creation of devices but also the observance of guidelines and standards established by regulatory bodies. While plan-driven methodologies prevented software from evolving or changing, agile methodologies have inherent characteristics of insufficient planning and documentation...

INTRODUCTION: Patients with congenital hyperinsulinism (HI) require constant glucose monitoring to detect and treat recurrent and severe hypoglycemia. Historically, this has been achieved with intermittent self-monitoring blood glucose (SMBG), but patients are increasingly using continuous glucose monitoring (CGM). Given the rapidity of CGM device development, and increasing calls for CGM use from HI families, it is vital that new devices are evaluated early. METHODS: We provided two months of supplies for the new Dexcom G7 CGM device to 10 patients with HI who had recently finished using the Dexcom G6...

In soft electronics, anisotropic conductive adhesive films (ACFs) are the trending interconnecting approach due to their substantial softness and superior bondability to flexible substrates. However, low bonding pressure (≤1 MPa) and fine-pitch interconnections of ACFs become challenging while being extended in advanced device developments such as wafer-level packaging and three-dimensional multi-layer integrated circuit board assembly. To overcome these difficulties, we studied two types of ACFs with distinct conductive filler sizes (ACF-1: ~20 μm and ACF-2: ~5 μm)...

BACKGROUND: Cell-derived sheets are of global interest for regenerative therapy. Transplanting a sheet for abdominal organs requires a device for laparoscopic delivery to minimize invasiveness. Here, using a porcine model, we aimed to confirm the feasibility of a device developed to deliver sheets to the thoracic cavity in a laparoscopic transplantation procedure. MATERIAL AND METHODS: We used the device to transplant human skeletal myoblast cell sheets onto the liver and measured extra-corporeal, intra-abdominal, and total procedure times for sheet transplantation...

Metallic bioresorbable orthopaedic implants based on magnesium, iron and zinc-based alloys that provide rigid internal fixation without foreign-body complications associated with permanent implants have great potential as next-generation orthopaedic devices. Magnesium (Mg) based alloys exhibit excellent biocompatibility. However, the mechanical performance of such implants for orthopaedic applications is contingent on limiting the rate of corrosion in vivo throughout the bone healing process. Additionally, the surgical procedure for the implantation of internal bone fixation devices may impart plastic deformation to the device, potentially altering the corrosion rate of the device...

Bacterial infections frequently occur within or near the vascular network as the vascular network connects organ systems and is essential in delivering and removing blood, essential nutrients, and waste products to and from organs. In turn, the vasculature plays a key role in the host immune response to bacterial infections. Technological advancements in microfluidic device design and development have yielded increasingly sophisticated and physiologically relevant models of the vasculature including vasculature-on-a-chip and organ-on-a-chip models...

OBJECTIVE: Pedicle screw stabilization (PSS) surgeries for spinal instability are still the most effective treatment approach. The use of preoperative planning can minimize the complications related to transpedicular screw (TPS) misplacement. The study aimed to evaluate the surgical outcomes of a guide device developed to improve the accuracy of the free-hand technique using three-dimensional planning in PSS. PATIENTS AND METHODS: Patients with degenerative spinal diseases who underwent open PSS between 2019 and 2022 were evaluated retrospectively...

A rigid fluorophore unit of Julolidine/coumarin fused with an indolium-conjugated system was built for the immediate and effective recognition of cyanide ions in a 90 % aq. DMSO solution. The probes are capable of displaying better sensitivity/selectivity for the cyanide ion over a wide range of other interfering ions. The probe JI showed an instant colorimetric variation, whereas the modified probe JCI showed both colorimetric and fluorimetric variation with cyanide ion. The observed detection limit values indicated excellent sensitivity of the probe to the cyanide ion...

The remote monitoring of vital signs and healthcare provision has become an urgent necessity due to the impact of the COVID-19 pandemic on the world. Blood oxygen level, heart rate, and body temperature data are crucial for managing the disease and ensuring timely medical care. This study proposes a low-cost wearable device employing non-contact sensors to monitor, process, and visualize critical variables, focusing on body temperature measurement as a key health indicator. The wearable device developed offers a non-invasive and continuous method to gather wrist and forehead temperature data...

An innovative mobile lidar device, developed to monitor volcanic plumes during explosive eruptions at Mt. Etna (Italy) and to analyse the optical properties of volcanic particles, was upgraded in October 2023 with the aim of improving volcanic plume retrievals. The new configuration of the lidar allows it to obtain new data on both the optical and the microphysical properties of the atmospheric aerosol. In fact, after the upgrade, the lidar is able to measure three backscattering coefficients, two extinction coefficients and two depolarisation ratios in a configuration defined as "state-of-the-art lidar", where properties such as particle size distribution and the refractive index can be derived...

This article summarises some of the outstanding sessions that were (co)organised by the Allied Respiratory Professionals Assembly during the 2023 European Respiratory Society International Congress. Two sessions from each Assembly group are outlined, covering the following topics: Group 9.01 focuses on respiratory physiology techniques, specifically on predicted values and reference equations, device development and novel applications of cardiopulmonary exercise tests; Group 9.02 presents an overview of the talks given at the mini-symposium on exercise training, physical activity and self-management at home and outlines some of the best abstracts in respiratory physiotherapy; Group 9...

Singlet fission (SF) is a process where a singlet state splits into two triplet states, which is essential for enhancing optoelectronic devices. Macrocyclic structures allow for precise control of chromophore orientation and facilitate singlet fission in solutions. However, the behavior of these structures in thin films, crucial for solid-state device optimization, remains underexplored. This study examines the aggregation and singlet fission processes of bipentacene macrocycles (BPc) in thin films using molecular dynamics simulations and electronic structure calculations...

In the context of the global energy crisis, the development of high-performance heat transport devices within nano scales has become increasingly important. Theoretical discovery and evaluation of novel structures with high performance in thermal conductivity by affordable calculations could provide significant instructions for experimental studies focusing on thermoelectric device development. For 2-dimensional (2D) functional materials, their heat transport efficiency is correlated with their electronic properties and structural features...

BACKGROUND: Emergency airway management in resource-limited settings presents multifaceted challenges due to shortages in essential medical resources, healthcare professionals, and infrastructure. METHODS: We conducted a literature search using keywords "Emergency Airway Management" "Low Resource" "Africa" "Asia" from databases such as Pubmed, and Google Scholar, from where we extracted relevant literature for our study. FINDINGS: These limitations resulted in delayed interventions, suboptimal care, and higher complication rates during intubation procedures...

BACKGROUND: Treatment and care of patients in intensive care units require the use of many medical and technological instruments. Pressure injuries occur when medical devices, which are used more in intensive care patients and are in direct or indirect contact with the skin, cause focal and localized forces on the superficial or deep tissues. OBJECTIVE: In this study, it was aimed to examine the risk factors, incidence and characteristics of medical device-related pressure injuries in intensive care patients...