Search Results (211)

Background/Objectives: Decision-analytic Bayesian approaches are ideally suited for designing clinical trials. They have been used increasingly over the last 30 years in developing medical devices and drugs. A prototype trial is a bandit problem in which treating participants is as important as treating patients in clinical practice after the trial. Methods: This article chronicles the use of the Bayesian approach in clinical trials motivated by bandit problems. It provides a comprehensive historical and practical review of Bayesian adaptive trials, with a focus on bandit-inspired designs. Results: The 20th century saw advances in Bayesian methodology involving computer simulation. In the 21st century, methods motivated by bandit problems have been applied in designing scores of actual clinical trials. Fifteen such trials are described. By far the most important Bayesian contributions in clinical trials are the abilities to observe the accumulating results and to modify the future course of the trial on the basis of these observations. In the spirit of artificial intelligence, algorithms are programmed to learn the optimal treatment assignments over the remainder of the trial. Conclusions: Bayesian trials are still nascent and represent a small minority of clinical trials, but their existence is changing the way investigators, regulators, and government and industry sponsors view innovation in clinical trials. Full article

This article presents a comprehensive review of assistive devices for synovial joints, addressing their definitions, classifications, and technological advancements. The historical evolution of artificial exoskeletons, orthoses, prostheses, and splints is analyzed, emphasizing their impact on rehabilitation and the enhancement of human mobility. Through a systematic compilation of scientific literature, patents, and medical regulations, the study clarifies terminology and classifications that have often been imprecisely used in scientific discourse. The review examines the biomechanical principles of the musculoskeletal system and the kinematics of synovial joints, providing a reference framework for the optimization and design of these devices. Furthermore, it explores the various types of artificial exoskeletons, and their classification based on structure, mobility, power source, and control system, as well as their applications in medical, industrial, and military domains. Finally, this study highlights the necessity of a systematic approach in the design and categorization of these technologies to facilitate their development, comparison, and effective implementation, ultimately improving users’ quality of life. Full article

The increasing integration of digital technologies in healthcare has expanded the attack surface for privacy violations in critical systems such as electronic health records (EHRs), telehealth platforms, and medical device software. However, current vulnerability detection datasets lack domain-specific privacy annotations essential for compliance with healthcare regulations like HIPAA and GDPR. This study presents C3-VULMAP, a novel and large-scale dataset explicitly designed for privacy-aware vulnerability detection in healthcare software. The dataset comprises over 30,000 vulnerable and 7.8 million non-vulnerable C/C++ functions, annotated with CWE categories and systematically mapped to LINDDUN privacy threat types. The objective is to support the development of automated, privacy-focused detection systems that can identify fine-grained software vulnerabilities in healthcare environments. To achieve this, we developed a hybrid construction methodology combining manual threat modeling, LLM-assisted synthetic generation, and multi-source aggregation. We then conducted comprehensive evaluations using traditional machine learning algorithms (Support Vector Machines, XGBoost), graph neural networks (Devign, Reveal), and transformer-based models (CodeBERT, RoBERTa, CodeT5). The results demonstrate that transformer models, such as RoBERTa, achieve high detection performance (F1 = 0.987), while Reveal leads GNN-based methods (F1 = 0.993), with different models excelling across specific privacy threat categories. These findings validate C3-VULMAP as a powerful benchmarking resource and show its potential to guide the development of privacy-preserving, secure-by-design software in embedded and electronic healthcare systems. The dataset fills a critical gap in privacy threat modeling and vulnerability detection and is positioned to support future research in cybersecurity and intelligent electronic systems for healthcare. Full article

Medical simulators have revolutionized clinical training, particularly in teaching skills such as cardiac auscultation. This review synthesizes recent advances in the technological design and implementation of cardiac simulators for medical education, alongside scientometric and patentometric analyses. The focus is on innovations enhancing efficacy, safety, and accessibility. Analyses included 69 patents published over the past five years, sourced from Google Patents, Patentscope, Espacenet, and The Lens. A bibliometric analysis was performed using 52 scientific reports from PubMed, ScienceDirect, and The Lens within the same timeframe. Key findings indicate an 8% increase in AI-integrated cardiac auscultation devices compared to conventional equipment. Furthermore, 85% of the studies reported compliance with applicable regulations of at least 90%, reflecting improved regulatory alignment. This analysis provides a foundation for future research and the development of more accurate and accessible educational tools for cardiac auscultation training. Full article

Internet of Things (IoT) technology in healthcare has enabled innovative services that enhance patient monitoring, diagnostics and medical data management. However, securing sensitive health data while maintaining system efficiency of resource-constrained IoT devices remains a critical challenge. This work presents a comprehensive end-to-end IoT security framework for healthcare environments, addressing encryption at two key levels: lightweight encryption at the edge for resource-constrained devices and robust end-to-end encryption when transmitting data to the cloud via MQTT cloud brokers. The proposed system leverages multi-broker MQTT architecture to optimize resource utilization and enhance message reliability. At the edge, lightweight cryptographic techniques ensure low-latency encryption before transmitting data via a secure MQTT broker hosted within the hospital infrastructure. To safeguard data as it moves beyond the hospital to the cloud, stronger end-to-end encryption are applied to ensure end-to-end security, such as AES-256 and TLS 1.3, to ensure confidentiality and resilience over untrusted networks. A proof-of-concept Python 3.10 -based MQTT implementation is developed using open-source technologies. Security and performance evaluations demonstrate the feasibility of the multi-layer encryption approach, effectively balancing computational overhead with data protection. Security and performance evaluations demonstrate that our novel HECS4MQTT (Health Edge Cloud Security for MQTT) framework achieves a unique balance between efficiency and security. Unlike existing solutions that either impose high computational overhead at the edge or rely solely on transport-layer protection, HECS4MQTT introduces a layered encryption strategy that decouples edge and cloud security requirements. This design minimizes processing delays on constrained devices while maintaining strong cryptographic protection when data crosses trust boundaries. The framework also introduces a lightweight bridge component for re-encryption and integrity enforcement, thereby reducing broker compromise risk and supporting compliance with healthcare security regulations. Our HECS4MQTT framework offers a scalable, adaptable, and trust-separated security model, ensuring enhanced confidentiality, integrity, and availability of healthcare data while remaining suitable for deployment in real-world, latency-sensitive, and resource-limited medical environments. Full article

This study introduces a rigid–flexible coupled constant force actuator integrated with Active Disturbance Rejection Control (ADRC) to tackle the rigidity–compliance trade-off in precision force-sensitive applications. The actuator utilizes compliant hinges to decrease contact stiffness by three orders of magnitude (${10}^6\to {10}^3 \mathrm{N}/\mathrm{m}$), facilitating effective force management through millimeter-scale placement (0.1∼1 mm) and inherently mitigating high-frequency disturbances. The ADRC framework, augmented by an Extended State Observer (ESO), dynamically assesses and compensates for internal nonlinearities (such as friction hysteresis) and external disturbances without necessitating accurate system models. Experimental results indicate enhanced performance compared to PID control: under dynamic disturbances, force deviations are limited to $\pm 0.2 \mathrm{N}$ with a 98.5% reduction in mean absolute error, a 96.3% increase in settling speed, and 99% suppression of oscillations. The co-design of mechanical compliance with model-free control addresses the constraints of traditional high-stiffness systems, providing a scalable solution for industrial robots, compliant material processing, and medical device operations. Validation of the prototype under sinusoidal perturbations demonstrates reliable force regulation (settling time $<0.56 \mathrm{s}$, errors $<0.5 \mathrm{N}$), underscoring its relevance in dynamic situations. This study integrates theoretical innovation with experimental precision, enhancing intelligent manufacturing systems via adaptive control and structural synergy. Full article

Cardiac pacemakers are standard implantable medical devices that regulate and treat heart rhythm disorders, primarily aiming to improve patient health outcomes. This study presents the systematic design, implementation, and simulation-based validation of a novel fuzzy-immune adaptive Fractional-Order Linear Quadratic Integral (FO-LQI) control strategy for heart rate (HR) regulation using cardiac pacemakers. Unlike the conventional LQI controller, the proposed approach replaces the integer-order integrator with a fractional-order integral operator to enhance the controller’s design flexibility and dynamic response. To address the implementation challenges of fixed fractional exponents, a fuzzy-immune adaptation mechanism is introduced to modulate the fractional order in real time. This adaptive scheme improves the controller’s robustness across varying physiological states, enabling more responsive HR adaptation to the patient’s metabolic demands. The proposed controller is modeled and simulated in MATLAB/Simulink using physiologically relevant test cases. Comparative simulation results show that the fuzzy-immune adaptive FO-LQI controller outperforms the baseline LQI and fixed FO-LQI controllers in achieving time-optimal HR regulation. These findings validate the reliability and enhanced robustness of the proposed control scheme for simulating cardiac behavior under diverse physiological conditions. Full article

Functional and safety requirements for medical devices are increasing with the continuous advancement of medical technology. To improve the therapeutic effect and safety of medical devices and patients, researchers are constantly exploring new materials and processes. Among them, the preparation of functional surfaces has become an important means to improve the performance of medical devices. This paper provides a comprehensive and critical review of recent advancements in laser processing technologies for the fabrication of functional surfaces in medical devices. Leveraging the unique capabilities of laser-based techniques to precisely tailor micro- and nanoscale surface structures, these methods have demonstrated remarkable potential in enhancing the therapeutic efficacy, biocompatibility, and overall safety of medical implants and surgical instruments. Such innovations are paving the way for the development of next-generation medical devices with multifunctional surface properties, meeting the increasing demands of modern clinical applications. The review focuses on the key applications, including cell function regulation, antibacterial properties, corrosion resistance, friction characteristics, and anti-adhesion properties. It also explores the considerable potential of laser processing technology, while addressing the challenges associated with multifunctional surface design and material selection. Looking ahead, the paper discusses future directions for the application of laser processing in novel materials and complex biomimetic structures. Full article

Orthopedic implant technology has historically seen difficulties in attaining long-term stability and biological integration, leading to complications such as implant loosening, wear debris production, and heightened infection risk. Nanotechnology provides a revolutionary method for addressing these constraints through the introduction of materials characterized by exceptional biocompatibility, durability, and integration potential. Nanomaterials (NMs), characterized by distinctive surface topographies and elevated surface area-to-volume ratios, facilitate improved osseointegration and provide regulated medication release, thereby creating a localized therapeutic milieu surrounding the implant site. To overcome the long-standing constraints of conventional implants, such as poor osseointegration, low mechanical fixation, immunological rejection, and implant-related infections, nanotechnology is causing a revolution in the field of orthopedic research. NMs are ideally suited for orthopedic applications due to their exceptional features, including increased tribology, wear resistance, prolonged drug administration, and excellent tissue regeneration. Because of their nanoscale size, they can imitate the hierarchical structure of real bone, which in turn encourages the proliferation of cells, lowers the risk of infection, and helps with the mending of bone fractures. This article will investigate the wide-ranging possibilities of nanostructured ceramics, polymers, metals, and carbon materials in bone tissue engineering, diagnostics, and the treatment of implant-related infections, bone malignancies, and bone healing. In addition, this paper will provide a basic overview of the most recent discoveries in nanotechnology driving the future of translational orthopedic research. It will also highlight safety evaluations and regulatory requirements for orthopedic devices. Full article

This paper introduces a high-efficiency buck converter designed for a wide load range, targeting low-power applications in medical devices, smart homes, wearables, IoT, and technology utilizing WiFi and Bluetooth. To achieve high efficiency across varying loads, the proposed converter employs a low-power adaptive on-time (AOT) controller that ensures output voltage stability and seamless mode transitions. An adaptive comparator (ACP) with variable output impedance is introduced, offering a variable DC gain and bandwidth to be suitable for different load conditions. A negative-level shifter (NLS) circuit, with its swing ranging from −0.5 V to the battery voltage (V_BAT), is proposed to control the smaller power p-MOS transistors. By using an NLS, the chip area, which is mostly occupied by power CMOS transistors, is reduced while the power efficiency is improved, particularly under a heavy load. A status time detector (STD) block which provides control signals to the ACP and NLS for optimized power consumption is added to identify load conditions (heavy, light, ultra-light). By employing a 180 nm CMOS technology, the active chip area occupies about 0.31 mm². With an input voltage range of 2.8–3.3 V, the controller’s current consumption ranges from 1.2 μA to 16 μA, corresponding to the output load current varying from 12 μA to 120 mA. Although the output load can vary, the output voltage is regulated at 1.2 V with a ripple between 3 and 12 mV. The proposed design achieves a peak efficiency of 96.2% under a heavy load with a switching frequency of 1.3 MHz. Full article

Cybersecurity is an essential component for preserving the integrity of healthcare systems, particularly in the face of the increasing adoption of interconnected medical devices, which significantly expands cyber risk exposure. A critical issue in this context is the fragmentation of knowledge regarding the security of these devices. The absence of a unified framework hampers the systematic identification of vulnerabilities and the effective implementation of protective measures. This study highlights such fragmentation by requiring the integration of seven ISO standards, nine NIST controls, one HIPAA regulation, one ENISA directive, one GDPR regulation, and one HITRUST framework, along with the review of 47 scientific articles and analysis of 27 documented vulnerabilities (CVEs). The need to consult this broad range of sources reflects both the complexity of the regulatory landscape and the lack of standardization in medical device security. Based on this review, key pillars were defined to support an integral and adaptable security model. This model provides a practical tool to strengthen digital healthcare infrastructures, facilitate continuous audits, and mitigate emerging threats, all while aligning with international standards. Furthermore, it promotes the consolidation of fragmented knowledge, helping to close security gaps and enhance the resilience of healthcare systems in a globalized environment. Full article

The regulation of clinical trials for medicinal products and medical devices has undergone numerous changes in recent years in the European Union, challenging manufacturers and national regulatory agencies as well. With the introduction of combined drug–device products, the regulatory landscape has been drastically changed to adapt to novel technological advancements and innovations. A comparative analysis has not yet been published highlighting the main differences and common elements of these two medicinal products, which took up almost all of the market in the pharmaceutical sector. Due to stricter regulations in the field of medical devices, the process from application up until post-market surveillance became more difficult, but a correlation between the regulation of drug trials can also be found. The main differences lie in the risk management systems, where, regardless of the background knowledge of a drug, it is always strict and mandatory structured progress, while in the case of medical devices, it is more flexible based on the risk category of the product. Generally, the utilization of e-health opportunities, transparency, and data accessibility have been improved in both fields. Via the adaptation of the mentioned regulation in the EU, the safety of patients and the efficacy of trials have been greatly increased. This manuscript aims to compare the specific regulations of these two types of medicinal products with a brief outlook on the non-EU sector as well. Full article

Background and Objective: Innovation is a key enabler of patient-centered care in cardiology, with new medical devices and digital health technologies offering the potential to improve outcomes and efficiency. However, the evaluation of these innovations poses challenges for clinicians, regulators, and procurement stakeholders, particularly within the complex European healthcare landscape. This review aims to explore the current state of health technology assessment (HTA) for cardiology-related medical devices in Europe, offering a clinical perspective. Material and Methods: Three independent scoping reviews were conducted following the PRISMA-ScR guidelines. Keywords included “innovation”, “health technology assessment”, and “cardiology”. The search was supplemented by the relevant literature on European HTA policies, regulatory directives, and emerging technologies. Results: The review identified three central themes: (1) the evolving role of clinicians in HTA processes, (2) the integration of innovative technologies such as digital tools and artificial intelligence within HTA frameworks, and (3) the considerable variation in HTA practices and policies across EU member states. Conclusions: HTA in Europe is undergoing a transformation, with increasing emphasis on interdisciplinary collaboration and frameworks that support innovation. While the goal of harmonization across the EU remains a work in progress, new regulatory efforts, such as the HTA Regulation (HTAR), offer promising avenues for aligning clinical practice with evidence-based assessment and reimbursement decisions. Full article

Objective: Current good manufacturing practice (cGMP) guidance for positron emission tomography (PET) drugs has been established in Europe and the United States. In Japan, the Pharmaceuticals and Medical Devices Agency (PMDA) approved the use of radiosynthesizers as medical devices for the in-house manufacturing of PET drugs in hospitals and clinics, regardless of the cGMP environment. Without adequate facilities, equipment, and personnel required by cGMP regulations, the quality assurance (QA) and clinical effectiveness of PET drugs largely depend on the radiosynthesizers themselves. To bridge the gap between radiochemistry standardization and site qualification, the Japanese Society of Nuclear Medicine (JSNM) has issued guidance for the in-house manufacturing of small-scale PET drugs under academic GMP (a-GMP) environments. The goals of cGMP and a-GMP are different: cGMP focuses on process optimization, certification, and commercialization, while a-GMP facilitates the small-scale, in-house production of PET drugs for clinical trials and patient-specific standard of care. Among PET isotopes, N-13 has a short half-life (10 min) and must be synthesized on site. [¹³N]Ammonia ([¹³N]NH₃) is used for myocardial perfusion imaging under the Japan Health Insurance System (JHIS) and was thus selected as a working example for the manufacturing of PET drugs in an a-GMP environment. Methods: A [¹³N]NH₃-radiosynthesizer was installed in a hot cell within an a-GMP-compliant radiopharmacy unit. To comply with a-GMP regulations, the air flow was adjusted through HEPA filters. All cabinets and cells were disinfected to ensure sterility once a month. Standard operating procedures (SOPs) were applied, including analytical methods. Batch records, QA data, and radiation exposure to staff in the synthesis of [¹³N]NH₃ were measured and documented. Results: 2.52 GBq of [¹³N]NH₃ end-of-synthesis (EOS) was obtained in an average of 13.5 min in 15 production runs. The radiochemical purity was more than 99%. Exposure doses were 11 µSv for one production run and 22 µSv for two production runs. The pre-irradiation background dose rate was 0.12 µSv/h. After irradiation, the exposed dosage in the front of the hot cell was 0.15 µSv/h. The leakage dosage measured at the bench was 0.16 µSv/h. The exposure and leakage dosages in the manufacturing of [¹³N]NH₃ were similar to the background level as measured by radiation monitoring systems in an a-GMP environments. All QAs, environmental data, bacteria assays, and particulates met a-GMP compliance standards. Conclusions: In-house a-GMP environments require dedicated radiosynthesizers, documentation for batch records, validation schedules, radiation protection monitoring, air and particulate systems, and accountable personnel. In this study, the in-house manufacturing of [¹³N]NH₃ under a-GMP conditions was successfully demonstrated. These findings support the international harmonization of small-scale PET drug manufacturing in hospitals and clinics for future multi-center clinical trials and the development of a standard of care. Full article

Supplier selection in the medical device manufacturing (MDM) industry significantly affects quality, operational efficiency, and overall organizational performance. Due to the industry’s dependence on advanced technologies and rigorous regulatory standards, identifying critical success factors (CSF) for selecting suppliers is essential. This study aims to analyze relationships among critical success factors (CSF) influencing supplier selection and their influence on supplier quality and the performance outcomes of MDM companies. A structured survey was conducted among MDM companies in Mexico, and the collected data were analyzed through exploratory and confirmatory factor analysis. Structural equation modeling (SEM) was used to quantify the relationships identified. Results indicate that information technology, reliable delivery, Industry 4.0 adoption, resilience, and environmental and social responsibility positively influence supplier quality, which subsequently enhances MDM firm performance. Supplier quality emerges as a critical mediator between supplier selection factors and company performance. Findings emphasize that prioritizing supplier quality, reinforced through Industry 4.0 technologies and resilient practices, ensures operational continuity, enhances competitive advantage, and supports sustainability. Companies incorporating these critical success factors into their supplier selection processes are better equipped to manage supply disruptions, achieve consistent quality, and sustain performance in highly regulated environments. Full article