Science topic

Medical Devices - Science topic

Explore the latest publications in Medical Devices, and find Medical Devices experts.
Filters
All publications are displayed by default. Use this filter to view only publications with full-texts.
Publications related to Medical Devices (10,000)
Sorted by most recent
Article
Full-text available
The Internet of Things (IoT) is transforming the healthcare landscape by enabling innovative solutions that promote sustainability. This paper explores the role of IoT as a catalyst for sustainable healthcare through a case study approach. By examining various applications, including remote patient monitoring, smart medical devices, and energy-effi...
Article
Full-text available
This article is the first ethical review technical guideline in the field of oncology in China, compiled by the Medical Ethics Society of China Anti-Cancer Association and jointly completed by 104 national ethics review experts in accordance with a series of Chinese laws and regulations. The document, taking into account the national conditions of...
Article
Full-text available
Personalized Environmental Control Systems (PECS) enable occupants to locally adjust environmental parameters without affecting others. Rooted in the fields of thermal and air quality management, this approach is key for enhancing satisfaction and well-being in the built environment by empowering occupants to control their immediate surroundings. M...
Article
Full-text available
Real-time health monitoring systems (e.g., wearable ECG, pulse oximeters) demand ultra-low latency and robust security to protect sensitive patient data while ensuring timely clinical interventions. This study evaluates the performance-security trade-offs of TLS 1.3 versus TLS 1.2 in IoT-enabled medical devices, focusing on handshake latency, encry...
Article
Full-text available
This work emphasizes the potential of multifunctional NIR-active coatings for medical devices to enhance diagnostic accuracy and therapeutic effectiveness and reduce infection rates.
Article
Full-text available
Medical devices are most crucial segments of a country’s healthcare system. This paperfirstreviews and identifies the demand and supply side factors, encompasses of socio-economic, market-enabling, technological and policy instruments, that could drive the growth of the medical device industry and then highlights some key issues and challenges the...
Article
Full-text available
Internal marketing (IM) treats employees as customers, focusing on corresponding internal measures targeted at them. Yet, advertising to consumers is also an opportunity for employees to recognize the social impact of their work and change their mindset. Such activities are indeed observed in business. However, little is known about them in researc...
Preprint
Full-text available
Numerical simulations and clinical measurements of nasal resistance are in quantitative disagreement. Bias introduced by the design of medical devices has not been considered until now as a possible explanation. The aim of present paper is to study the effect of the location of the probe on the rhinomanometer that is meant to measure the ambient pr...
Article
Full-text available
This paper presents a propagation analysis of an implantable human body communication (IHBC) system for neurostimulators and a structural evaluation of simplified abdominal models. Modern medicine relies on implantable medical devices to provide advanced diagnostics and treatments for patients. Communication between such devices and external device...
Article
Full-text available
Objectives To explore physiotherapists’ knowledge and perception of exercise intensity and to identify factors influencing the attainment of recommended exercise intensity during rehabilitation sessions. Methods A qualitative study was conducted using semi-structured, face-to-face interviews with physiotherapists (PTs) who provide stroke rehabilit...
Preprint
Full-text available
We present a Lagrangian analysis of turbulent blood flow in the human left heart using high-fidelity simulations based on a patient-specific anatomical model. Leveraging a fully coupled fluid-structure-electrophysiology interaction (FSEI) framework, we track the motion of Lagrangian (passive) tracers to investigate the multiscale statistical proper...
Article
Full-text available
Patent rights are a part of Intellectual Property Rights (IPR) that provide legal protection for inventions in the field of technology. With the rapid development of the times and technological advancements, the protection of patent rights has become an increasingly crucial issue. This is due to the growing number of patent infringements, particula...
Article
Full-text available
Recent advances in minimally invasive surgical robotics and aerospace structural health monitoring have highlighted the critical need for optical fiber shape sensing systems. Current fiber‐optic shape sensing implementations have basic limits in single‐shot parallel measurement capabilities and further exploration into comprehensive error analysis...
Article
Full-text available
In the field of healthcare, artificial intelligence (AI)-assisted solutions can be viewed with anxiety or apprehension, thus transparency and trust-building are essential. AI is often invisible (and potentially undisclosed) to users, violating the ethical principle of transparency -- particularly with respect to informed disclosure. This Brief Tech...
Article
Full-text available
In 2014, the World Health Organization (WHO) published target product profiles (TPPs) which detailed minimal and optimal criteria to address high-priority TB diagnostic needs. Since then, the TB community’s needs have evolved; there has been a surge in new and innovative platforms suggesting use of alternative non-invasive specimens for TB diagnosi...
Conference Paper
Full-text available
This paper presents the development of an affordable, digital stethoscope-based Phonocardiogram (PCG) acquisition system designed for telemedicine applications. The proposed system utilizes modern DSP and ML techniques with low-cost hardware components to capture and analyze heart sounds, providing real-time data transmission to healthcare professi...
Article
Full-text available
Wire Electric Discharge Machining (WEDM) has become a prominent technique in the manufacturing industry for the precise cutting of conductive materials. This research paper provides an in-depth analysis of the latest developments, methodologies, and performance evaluations in WEDM. Through a systematic review of literature and empirical studies, th...
Article
Full-text available
Microneedle (MN) technology has emerged as a pivotal innovation for multiple distinct target organs drug delivery, with applications spanning drug administration, disease diagnostics, health monitoring, therapeutic interventions, and cosmetology. The efficacy of these applications is contingent upon the manufacturing techniques of MNs, their geomet...
Article
Full-text available
Technical thermoplastics offer beneficial properties, such as high strength‐to‐weight ratio, chemical resistance, and durability, that make them valuable in various industries, including automotive, aerospace, and electronics, and in applications such as medical devices. Some technical thermoplastics also offer superior tribological properties, alt...
Preprint
Full-text available
NABD is an AI-powered Remote Patient Monitoring System designed to enhance healthcare efficiency by continuously tracking patient health metrics in real time. The system integrates IoT-enabled medical devices to collect vital signs such as heart rate, oxygen levels, and temperature. These readings are processed using advanced AI algorithms to detec...
Article
Full-text available
The potential of a new research field is often estimated by its rapid growth in the previous decade; however, an equally steep decline can follow unless the scientific community makes a concerted effort to achieve the desired goal. Soft robots ranging from microscale (micron to submillimeter) to larger‐scale devices (millimeter to centimeter and be...
Article
Full-text available
Background: The chest radiograph remains one of the most performed examinations in radiology. It is mainly the first radiologic examination obtained in patients presenting with chest pain, shortness of breath, or cough. In the hospital environment, chest radiographs are typically performed in the emergency department or intensive care unit, and the...
Article
Full-text available
Background Looping blood vessels in robot-assisted surgery remains challenging because of limitations in instrument articulation, joint length, and the lack of tactile feedback. To address this critical issue, we developed the Vas Guide, a novel device, for safe blood vessel handling. This study aims to establish the efficacy, safety, and durabilit...
Article
Full-text available
Objectives Adolescents with life-limiting conditions are distinct from children or older adults in their palliative needs and developmental stage, yet, there is limited literature addressing this population. Our aim was to describe the characteristics of the adolescent population, aged 13–18, who have received specialist palliative care in the Repu...
Article
Full-text available
The dielectric properties of cholesteryl oleyl carbonate (COC) liquid crystal are investigated using the cavity perturbation method at a frequency of 20.9 GHz under heating conditions. This technique, known for its precision, is particularly effective for analysing small sample sizes. By applying Slater perturbation equations, shift in the resonant...
Article
Full-text available
Study objective The introduction of new medical devices into care units, or their replacement by new devices, is not always accompanied by implementation strategies that enable healthcare professionals to use them safely. Simulation is a relevant tool for reproducing critical care clinical situations without danger for the patients and providing tr...
Article
Full-text available
Marine environments offer a rich and diverse array of resources, including unique biomaterials with exceptional properties applicable in biomedicine. This review explores marine-derived functional biomaterials and their significance in biomedicine and drug delivery. Marine organisms have evolved unique characteristics to adapt to their environment,...
Article
Full-text available
This paper explores the emerging field of smart implants, focusing on the integration of sensor technology and data analytics to revolutionize patient care. By embedding miniature sensors within implantable medical devices, real-time physiological data can be collected, transmitted, and analyzed. This approach facilitates continuous monitoring of i...
Article
Full-text available
Modern healthcare environments require robust cybersecurity frameworks to protect patient data and maintain operational integrity. The integration of advanced security measures encompasses network architecture, identity and access management, privileged access management, unstructured data security, medical device protection, HIPAA compliance mecha...
Article
Full-text available
Graphene-based supercapacitors have emerged as promising candidates for next-generation energy storage due to their exceptional electrical conductivity, large surface area, and mechanical stability. This paper reviews innovative fabrication techniques such as rapid thermal annealing, hydrothermal reduction, and microwave-assisted synthesis, which e...
Article
Full-text available
This study introduces a novel and versatile application of neural networks (NNs) to enhance two distinct aspects of Wireless Power Transfer (WPT) systems. First, a compact NN architecture is presented for accurate distance estimation and automated impedance matching in a WPT system. Trained on either impedance measurements or scattering parameters...
Article
Full-text available
Background Rapid and early detection of SARS-CoV-2 infections, especially during the pre- or asymptomatic phase, could aid in reducing virus spread. Physiological parameters measured by wearable devices can be efficiently analysed to provide early detection of infections. The COVID-19 Remote Early Detection (COVID-RED) trial investigated the use of...
Article
Full-text available
Artificial intelligence is rapidly transforming healthcare, offering promising advancements in diagnosis, treatment, and patient outcomes. However, concerns regarding the regulatory oversight of artificial intelligence driven medical technologies have emerged, particularly with the U.S. Food and Drug Administration’s current approval processes. Thi...
Article
Full-text available
The Internet of Things (IoT) has emerged as a transformative technology in healthcare, revolutionizing patient care, diagnostics, and treatment processes. By connecting medical devices, sensors, and healthcare systems to the internet, IoT enables real-time monitoring, data analysis, and remote access to patient information. This innovation signific...
Article
Full-text available
The Internet of Things (IoMT) has revolutionized the global landscape by enabling the hierarchy of interconnectivity between medical devices, sensors, and healthcare applications. Significant limitations in terms of scalability, privacy, and security are associated with this connection. This study presents a scalable, lightweight hybrid authenticat...
Article
Full-text available
Objectives: To verify the feasibility of the Virtual Eggs Test (VET) and establish the ranges of fragilities of the Virtual Eggs (VEs) for assessing dexterity of stroke subjects and to collect feedback to improve its usability. Methods: An observational non-profit study, with a pre-market medical device. It was conducted at a hospital neurorehab...
Article
Full-text available
Cancer encompasses a heterogeneous set of diseases with specific etiology, natural history, prognosis, and anticancer drug treatments. Cancer (neoplastic malignancies) is a group of diseases that cause 10 million deaths worldwide each year. Fighting cancer in the initial stages (before metastasis) needs new and effective anticancer drugs. For examp...
Article
Full-text available
Complex flow patterns play a critical role in arterial thrombosis, yet the specific contribution of vorticity—the rotational component of fluid flow—remains poorly understood. An innovative microfluidic platform with systematically varied expansion angles (β = 30°‐150°) in a double stenosis design is developed to isolate vorticity's effects under c...
Article
Full-text available
This study proposes a hybrid CNN-LSTM model for FPGA-accelerated cardiac arrhythmia detection. Detecting cardiac arrhythmias is essential for early intervention, lowering heart disease risk. However, real-time detection necessitates efficient computing because ECG data processing is difficult. The suggested CNN-LSTM model is intended to satisfy the...
Article
Full-text available
Advanced medical devices serve an important role in modern medicine, particularly in orthopedics, by improving patients’ mobility and quality of life. However, the intricacy of devices such as joint replacements and spine implants raises hazards such as mechanical failures and biocompatibility difficulties. Materiovigilance, notably through India’...
Preprint
Full-text available
Soft robots have proven to outperform traditional robots in applications related to propagation in geometrically constrained environments. Designing these robots and their controllers is an intricate task, since their building materials exhibit non-linear properties. Human designs may be biased; hence, alternative designing processes should be cons...
Article
Full-text available
Introduction In the absence of sufficient constituent-specific dose-response toxicity data, threshold of toxicological concern (TTC) values are commonly used in toxicological risk assessment of medical device (MD) constituents. When experimental data or predictions suggest that a constituent is not likely to have genotoxic effects, categorizing the...
Article
Full-text available
Objectives Climate change is contributing to increased frequency and intensity of wildfires in California. This study evaluated the self-reported impacts of the California Oak Fire on the health of a medically at-risk population and identified their wildfire preparedness and information needs. Methods A cross-sectional mixed-methods survey was con...
Article
Full-text available
The speedy improvements in scientific gadgets have extensively transformed clinic architecture and internal practical layouts. This examine analyzes the relationship between technological tendencies in scientific gadget and the spatial and operational reconfiguration of health center departments. The studies hassle addressed is the inadequacy of co...
Preprint
Full-text available
Background: With the continuous advancement of technology and rapid development of precision medicine, precision medical devices are increasingly being utilized in clinical diagnosis and treatment. These devices play a crucial role in clinical practice. However, improper use accelerates instrument wear and tear, increases hospital costs, and jeopar...
Article
Full-text available
People can prevent illness and maintain their health in daily life through Wearable Medical Devices (WMDs), which continuously track health conditions. Low reliability, high battery consumption, and huge dimensions are just a few of the problems with wearables. One key challenge is to provide a reliable power supply. This paper presents a Multi-Sou...
Preprint
Full-text available
Background: Medical devices are essential for maintaining resilient health systems worldwide. However, their distribution does not reflect this, with as many as 76% of devices being used by 13% of the world’s population. Most devices, being designed for high-income countries and failing to consider the local needs of other settings, often fail when...
Article
Full-text available
Background Medical adhesives are frequently used during hospitalization to secure medical devices to the skin. Compared to adults, children are at a higher risk of developing medical adhesive‐related skin injuries (MARSI). Aim The aim of this study is to determine the incidence, characteristics and associated risk factors of MARSI in a Paediatric...
Article
Full-text available
Polyethylene is the most widely produced commodity plastic and is used in many applications, including packaging, insulation, and medical devices. However, the inertness of polyethylene makes chemical recycling inefficient and challenging. We report the conversion of oxidized high-density and low-density polyethylene, formed by direct, catalytic ox...
Article
Full-text available
Cold atmospheric plasma-aerosol (CAP-A) offers a promising alternative to conventional sterilisation and disinfection methods, which are often unsuitable for thermolabile medical devices due to high temperatures, toxic chemicals or radiation. CAP-A efficiently inactivates microorganisms and viruses without compromising the material integrity. Given...
Preprint
Full-text available
We develop a framework for the ergodic control of stochastic hybrid systems, integrating continuous-time dynamics with discrete switching modes under uncertainty. Motivated by real-world applications in robotics, smart energy, and safety-critical autonomy, we formulate hybrid systems whose long-term behavior is characterized by an invariant measure...
Article
Full-text available
This research aims to empirically test the influence of Good Corporate Governance and Profitability on Company Value (Case Study of Pharmaceutical Companies Listed on the IDX 2019-2023). From the results of the Pharmaceutical Research and Manufactures of America (PhRMA) study, it is known that the availability of new medicines in Indonesia is only...
Presentation
Full-text available
Safety-Critical Software Engineering Workshop by Tonex. Modern industries like aerospace, defense, automotive, and medical devices rely heavily on software-controlled systems where failure is simply not an option. The Safety-Critical Software Engineering Workshop by Tonex is designed to equip engineers, architects, and project stakeholders with the...
Article
Full-text available
An elastic bandage or tensor bandage is widely known as a flexible medical device made of polymer materials. It is usually made of cotton and reinforced with elastic yarns. Depending on the therapy and clinical picture, elastic bandages are used for compression treatment and as support bandages. The aim of this work was to carry out a washing proce...
Presentation
Full-text available
Model-Based Safety Analysis and Engineering (MBSAE) Essentials by Tonex. Rethinking safety in complex systems demands more than traditional analysis—it requires intelligent, model-driven precision. That’s exactly what Tonex delivers with its Model-Based Safety Analysis and Engineering (MBSAE) Essentials Training. This highly practical and expertly...
Presentation
Full-text available
Safety-Critical Software Development Workshop by Tonex. When systems simply cannot afford to fail, safety-critical software becomes the linchpin of success—or disaster. From aerospace and automotive to medical devices and industrial control systems, the software controlling these technologies must meet the highest standards for reliability, precisi...
Chapter
Full-text available
Biofilm-related infections pose significant challenges in modern medicine due to their chronic nature and resistance to conventional antimicrobial therapies. Biofilms, which are clusters of bacteria embedded in a self-produced extracellular matrix, often form on medical devices, tissues, and implants, protecting the bacteria from immune responses a...
Chapter
Full-text available
This chapter primarily focused on the scope of research on the bio-implant materials and their applications. The current demand for the bio-implant and their classification have been extensively discussed. The use of functional materials or responsive materials in biomaterials will add a novel direction in the development of futuristic medical-mate...
Article
Full-text available
Neglecting one's health is a major contributor to the decline in overall well-being, often resulting in the onset of various diseases and health issues. The avoidance of such complications becomes feasible with the introduction of a device capable of monitoring heart pulses at regular intervals, ideally every 60 seconds. The main goal of this artic...
Preprint
Full-text available
Despite their potential, digital therapeutics (DTx), software as a medical device, face adoption and use challenges partly due to insufficient economic evidence. This study investigates how researchers - including research engineers, health systems researchers, clinician-researchers, and practitioner-researchers - approach economic decision-making...
Article
Full-text available
Miniature Stirling cryocoolers based on SWaP-C (Size, Weight, Power Consumption, and Cost) objectives for HOT IR technology have grown their importance in the industries of defense, aerospace, medical devices, and small-scale cryogenic systems. The regenerator is the most essential component of the miniature Stirling cryocooler. The effective geome...
Article
Full-text available
Polyetheretherketone (PEEK) medical devices have been shown to perform well as permanent implants, but the hydrophobicity of PEEK limits its osseointegration ability. Postprocessing techniques are used to improve osseointegration, with ultraviolet (UV) light‐assisted functionalization being one possible method. We hypothesized that UV irradiation o...
Article
Full-text available
As artificial intelligence (AI) and machine learning (ML) become integral to modern healthcare, advanced predictive models are increasingly used to support clinical decision-making. These models offer the potential to enhance diagnostic accuracy, predict patient outcomes, and optimize resource allocation. However, their integration into healthcare...
Article
Full-text available
Ultra-reliable low-latency communication (URLLC) is a cornerstone of beyond 5G and future 6G networks, particularly for mission-critical applications such as the healthcare Internet of Things. In applications such as remote surgery, emergency services, and real-time health monitoring, it is imperative to ensure stringent latency and reliability req...
Article
Full-text available
Since we are still in the beginning stages of this technological revolution, a lot of people are holding out hope that artificial intelligence and machine learning will improve medical diagnosis, management, and treatment when they are initially released. On the other hand, there are a lot of challenges that might prevent the use of machine learnin...
Article
Full-text available
This project represents the first systematic assessment of the US Food and Drug Administration’s postmarket surveillance of legally marketed artificial intelligence and machine learning based medical devices. We focus on the Manufacturer and User Facility Device Experience database—the FDA’s central tool for tracking the safety of marketed AI/ML de...
Article
Full-text available
Objective This research aimed to identify the needs and priorities concerning structured and unstructured medical data of medical device companies engaged in developing medical software or hardware. Method The study was conducted between 23 March and 26 March 2023 and involved a survey of 76 managers, each of whom represented a single Korean medic...
Article
Full-text available
Background Regulation and postmarket surveillance of medical devices have been criticized for being too lenient as compared to drug regulation and postmarket surveillance. Little is known about the factors that determine which medical devices are chosen for implementation among similar medical devices. Objective Our aim was to systematically ident...
Article
Full-text available
Background Considering the challenges of providing nutrition care in resource‐limited settings (RLSs), the International Working Group for Patients' Right to Nutrition Care (WG) organized an expert meeting to propose recommendations and strategies to promote access to nutrition care and address disease‐related malnutrition (DRM). Methods An online...
Article
Full-text available
Featured Application Risk assessment for medical device design. Abstract Failure Mode and Effect Analysis (FMEA) is crucial for identifying risk reduction opportunities in design. This study aims to aid in the design of sophisticated medical devices by setting guidelines and addressing weaknesses in data collection and risk priority numbers (RPNs)...
Article
Full-text available
In a veterinary setting, incidents that involve medical devices that lead to harm or injury of an animal, or a member of veterinary staff, are rare. Nonetheless, it is important to be prepared and to learn from mistakes to minimise the likelihood of future incidents and reduce any future risk of harm. It is important to note that incidents may be c...
Article
Full-text available
Background The aim of our study was to investigate the epidemiology and risk factors of Klebsiella pneumoniae (KP) infection in immunocompromised patients and to compare the differences in prognosis among patients with different immune states in the extended-spectrum beta-lactamase KP (ESBL-KP), the carbapenem-resistant KP (CRKP), and the non-multi...
Article
Full-text available
Medical devices play a crucial role in modern healthcare, providing innovative solutions for diagnosing, preventing, monitoring, and treating ailments. Artificial Intelligence is transforming the field of medical devices, offering unprecedented opportunities through diagnostic accuracy, personalized treatment plans, and enhancing patient outcomes....
Article
Full-text available
In low-and middle-income countries, missed or delayed tuberculosis (TB) diagnoses contribute to avoidable morbidity, mortality, and transmission. Decentralized testing platforms, such as the Molbio Truenat, may offer solutions by providing accurate point-of-care testing, improving access, and lowering out-of-pocket costs. Despite these advantages,...
Research
Full-text available
PVC (Polyvinyl Chloride) film has found extensive applications in the medical field due to its versatile properties and exceptional performance characteristics. This synthetic polymer film is highly regarded for its transparency, flexibility, and cost-effectiveness, making it an ideal choice for various medical applications. PVC film for medical us...
Article
Full-text available
Photocurable functional block copolyesters are reported to engineer elastomeric scaffolds for biomedical applications. The polymer backbone is organized by soft and stiff blocks. The functional prepolymer is readily crosslinked by thiol‐yne click chemistry under ulraviolet light in the presence of a photo‐initiator to form a robust elastomer. The e...
Article
Full-text available
Background Enhanced Connected Care (ECC) monitoring, which fuses medical devices with continuous monitoring of patient vitals captured by a nursing dashboard, offers a better way to address patient safety and improve clinical outcomes. Nurses are the key players involved in the implementation of ECC, while their KAP towards the technology in place...
Article
Full-text available
This work presents a current-controlled CMOS ring oscillator (CCRO) optimized for ultra-low-voltage applications in next-generation energy-constrained systems. Leveraging bulk voltage tuning in 22 nm FDSOI differential inverter stages, the topology enables frequency adjustment while operating MOSFETs in the subthreshold region—critical for minimizi...
Conference Paper
Full-text available
Antibiotic-resistant biofilms pose a significant challenge to modern healthcare, complicating the treatment of infections associated with chronic diseases and medical devices. These biofilms provide bacteria with a protective barrier that shields them from antibiotics and immune responses, making infections difficult to treat. The development of no...
Preprint
Full-text available
Background- Preventing newborn deaths is possible with the right medical devices. However, in many countries, devices for small and sick newborn care (SSNC) are either unavailable, not fit for the environment, or broken. Newborn Essential Solutions and Technologies (NEST360) is a multicountry interdisciplinary alliance aimed at decreasing neonatal...
Article
Full-text available
Governor Vessel moxibustion, as a traditional external therapy, has obtained extensive clinical application and promotion in recent years. Through systematic collation of relevant literature, this paper conducts comprehensive analysis and elucidation regarding the theoretical foundations, historical origins, evolutionary trajectory, and characteris...
Article
Full-text available
The Indian Ministry of AYUSH has extensively embraced digital initiatives for the purpose of research and development. The use of advanced medical technologies and electronic communication in healthcare is the need of the hour. In Ayurveda, Roganidana highlights concepts propounding causative factors of disease and its pathology through the framewo...
Article
Full-text available
Administration of pulmonary surfactant is crucial for the treatment of respiratory distress syndrome (RDS) in preterm infants. The aim of this study is to evaluate the potential of Curosurf atomization via the Endosurf device, a recently developed spray technology, as a promising approach for surfactant delivery in infants with RDS. A comprehensive...
Article
Full-text available
Clinical applications of telemedicine using digital technology are in demand in Japan and continue to expand. However, with some exceptions, it would be difficult to say that the current situation is adequate in terms of encouraging research and development, formulating guidelines that need to be established before telemedicine can spread, and prov...
Article
Full-text available
This scoping review aims to identify regulator-approved ophthalmic image analysis artificial intelligence as a medical device (AIaMD) in three jurisdictions, examine their characteristics and regulatory approvals, and evaluate the available evidence underpinning them, as a step towards identifying best practice and areas for improvement. 36 AIaMDs...
Article
Full-text available
Background A substantial number of newborns face postdelivery respiratory issues annually. Current ventilation devices in immediate newborn care lack integrated sensors and supporting mechanisms for medical professionals. This is a potential field of improvement, as safe ventilation relies on accurate pressure administration in current t-piece resu...
Article
Full-text available
Artificial intelligence (AI) is rapidly transforming laboratory medicine, impacting medical devices and healthcare practices. Despite these advancements, AI-based medical device software (MDSW) introduces a new layer of complexity in regulatory compliance. This paper outlines the regulatory landscape for MDSW and AI-driven MDSW, clarifying the resp...
Article
Full-text available
Heart transplantation is indicated for advanced heart failure but its widespread application is limited by the lack of donors. The Organ Care System (OCS™) is a medical device that preserves the donor’s heart in an almost physiological state. Our institution requested a Hospital-Based Health Technology Assessment to enlighten their decision on the...
Article
Full-text available
This opinion piece employs a counter-factual thought experiment — a unilateral 150 percent tariff “embargo” on all imports to the US — to reveal the hidden costs of a US “trade-war victory.” It first imagines everyday Americans, from working mothers to professionals, forced to revert to home sewing and cross-border mall pilgrimages in the absence o...
Preprint
Full-text available
This reflection analyzes two pivotal team experiences from my career to explore the dynamics that contribute to high-and low-functioning teams. Drawing on contemporary concepts such as psychological safety, adaptive leadership, and team structure, I compare a high-performing, collaborative environment in a medical device company with a toxic, rigid...
Article
Full-text available
Urushiol, the principal bioactive component of natural lacquer, has emerged as a promising candidate for developing eco-friendly antimicrobial coatings due to its unique catechol structure and long alkyl chains. This review systematically elucidates the molecular mechanisms underpinning urushiol’s broad-spectrum antimicrobial activity, including me...
Article
Full-text available
Graphene, renowned for its exceptional thinness and strength, has sparked widespread interest due to its potential applications in medical technology, including drug delivery systems, biosensors, and advanced medical devices. This study aims to critically evaluate the rules and regulations surrounding the use of graphene in Malaysia's medical secto...
Article
Full-text available
Moisture absorption and outgassing are critical factors influencing the performance and reliability of flexible and rigid-flex printed circuit boards (PCBs), especially in high-reliability applications such as aerospace and medical devices. This study presents a comprehensive analysis combining experimental characterization and artificial intellige...
Article
Full-text available
In 2025, the U.S. healthcare and pharmaceutical sectors are grappling with significant challenges due to the imposition of new tariffs under the Trump administration. These tariffs, reaching up to 50% on European Union imports and 25% on goods from China, Mexico, and Canada, are disrupting global supply chains, increasing costs, and threatening the...
Article
Full-text available
Recent EU regulations recommend restriction of the use of medical devices in which cobalt content exceeds 0.1%. Commercially pure titanium (cpTi) and titanium alloys appear to be excellent alternatives to cobalt-based alloys in the fields of implantology and prosthodontics. The narrative review summarizes the structure and types of titanium alloys...
Article
Full-text available
Medical alloy materials play a crucial role in the manufacturing of medical devices and implants due to their unique physical, chemical, and biocompatible properties. However, the requirements for workpiece quality, surface accuracy, and surface integrity of different medical alloy materials used in different medical departments vary greatly. There...
Preprint
Full-text available
The reliability of polymer-encapsulated CMOS integrated circuits (ICs) is critical for the development of miniaturised active implantable medical devices (AIMDs). Traditional hermetic packaging methods become impractical as implant sizes decrease, necessitating alternative methods of protection from body fluids. This study evaluates the long-term s...
Preprint
Full-text available
The FDA classifies medical devices by risk, assigning each a Product Code (PC) that determines its regulatory pathway for clearance. Novel PCs are created when new technologies raise safety or efficacy questions not addressed by existing codes. This analysis examines whether novel PCs provide strategic or regulatory advantages to first-mover manufa...
Article
Full-text available
Technological advancements in healthcare have increased the demand for professionals in biomedical engineering. However, high school students' understanding of this field remains limited. This community service activity aimed to introduce the Biomedical Engineering study program, medical equipment, and related career prospects to senior high school...