Electronic Medical Devices Research Articles

From Code to Care: The Impact of Software Engineering and QA on Healthcare Delivery Systems

The rapid digitalization of healthcare has led to an unprecedented reliance on software systems to improve patient care, streamline operations, and ensure regulatory compliance. This article presents a comprehensive analysis of the critical role that software engineering and quality assurance (QA) play in three key areas of modern healthcare: Electronic Health Records (EHRs), telemedicine platforms, and medical device software. Through an examination of current practices, challenges, and case studies, we demonstrate how robust software engineering methodologies and rigorous QA processes contribute to the development of reliable, secure, and efficient healthcare applications. Our findings highlight the importance of data integrity, interoperability, user experience, and regulatory compliance in healthcare software development. Furthermore, we explore emerging trends such as artificial intelligence, blockchain, and the Internet of Medical Things (IoMT), discussing their implications for future software engineering and QA practices in healthcare. This article provides valuable insights for healthcare organizations, software developers, and policymakers, offering recommendations to enhance the quality and safety of software-driven healthcare solutions.

On-demand detachable and reuseable adhesives assembled by organic-silicon nanogels with wide applicability and excellent harsh-environment resistance

Detachable adhesives are extensively utilized in many fields such as electronic assembly and medical devices, yet achieving a balance between adhesive strength and removability still remains a significant challenge. In this study, we designed a kind of novel adhesive of organic-silicon nanogels (P(TPHA-Si)) based on the self-polymerizing of an organic siloxane monomer (TPHA-Si) in ethanol/water mixture under mild conditions. P(TPHA-Si) self-assembled adhesive possessed not only detachable and reuseable advantages, but also wide applicability and excellent harsh-environment resistance. Remarkably, the adhesive strength to glass reached up to 14.6 MPa, heretofore one of the highest strengths of detachable adhesives. The P(TPHA-Si) adhesive could be easily dissociated by ethanol infiltration, allowing for an environmentally friendly detachability and user-friendly reusability. On the other hand, P(TPHA-Si) adhesive could withstand harsh environmental conditions including different acid, alkali and salt solutions, various organic solvents, and −20–120 °C temperatures. Through empirical and theoretical computations, the molecular mechanism underlying the high-strength, detachable adhesion had been validated and elucidated. Considering the ease of processing, cost-effectiveness, Eco-friendly ethanol-assisted detachability and reusability, as well as strong adhesion under harsh conditions, the design of transparent P(TPHA-Si) adhesive offers a commendable pathway for the development of multifunctional detachable adhesives, which are expected to be able to exhibit great potential for applications in electronics and medical fields.

Medical device management reform, United Republic of Tanzania.

Health-care technology is central to boosting the productivity and quality of health-care systems. In many sub-Saharan African countries, however, medical device management systems are weak or absent. The aim of this article is to illustrate, using a case study, how policy reforms can help ensure policy on health-care technology is translated into everyday practice and how an integrated systems approach can enhance the operation of medical device management. Between 2011 and 2023, a plan to improve medical device management systems in the United Republic of Tanzania was developed and implemented through Swiss-Tanzanian cooperation within the Health Promotion and System Strengthening Project. The availability of biomedical engineers was increased through new training courses and the creation of permanent positions in government. Moreover, additional district and regional maintenance and repair workshops were built, and a National Centre for Calibration and Training was established to ensure the correct functioning of medical devices. The introduction of an electronic medical device management system provided health facilities and the health ministry with data on the operational status of medical devices and the need for repairs and spare parts. Every level of government was encouraged to allocate more human and financial resources to medical device management. Following this decade-long effort, the percentage of functioning equipment increased substantially, and costs were reduced by repairing rather than replacing equipment. The project also demonstrated the value of an integrated, system-strengthening approach that considered personnel, maintenance and repair facilities, documentation and management, and government policy and budgeting.

Management of Continuous Glucose Monitors in Radiation Oncology Patients

AbstractContinuous glucose monitors (CGMs) are an increasingly prevalent electronic medical device used by patients with diabetes, offering several advantages over “finger sticks.” There is a resulting rise in patients with CGMs seen in radiation oncology clinics. Manufacturers specify that CGMs should not be exposed to radiation (both diagnostic and therapeutic) due to the risk of device damage, creating challenges for patients and providers. We present a workflow for the management of CGMs in radiation oncology patients, beginning with systematic screening by providers and staff. We propose options for CGM management together with the device prescriber, including removal of the CGM or keeping it in place with periodic finger sticks to confirm the accuracy and offer guidance to radiation oncology providers and staff.

Implantable Zinc Ion Battery and Osteogenesis-Immunoregulation Bifunction of Its Catabolite.

Biocompatible batteries can power implantable electronic devices and have broad applications in medicine. However, the controlled degradation of implantable batteries, the impact of battery catabolites on surrounding tissues, and wireless charging designs are often overlooked. Here, we designed an implantable zinc ion battery (ZIB) using a gelatin/polycaprolactone-based composite gel electrolyte. The prepared ZIBs deliver a high specific capacity of 244.0 mA h g-1 (0.5C) and long cycling stability of 300 cycles (4C). ZIBs were completely degraded within 8 weeks in rats and 30 days in a phosphate-buffered saline lipase solution, demonstrating good biocompatibility and degradability. ZIBs catabolites induced macrophage M2 polarization and exhibited anti-inflammatory properties, with mRNA levels of the M2 markers Arg-1 and CD206 up-regulated 15.8-fold and 13.4-fold, respectively, compared to the blank control group. Meanwhile, the expressions of two typical osteogenic markers, osteopontin and osteocalcin, were up-regulated by 3.6-fold and 5.6-fold, respectively, demonstrating that designed ZIBs promoted osteogenic differentiation of bone marrow mesenchymal stem cells. Additionally, a wireless energy transmission module was designed using 3D printing technology to realize real-time charging of the ZIB in rats. The designed ZIB is a promising power source for implantable medical electronic devices and also serves as a functional material to accelerate bone repair.

Revolutionizing Implantable Technology: Biocompatible Supercapacitors as the Future of Power Sources

AbstractAlmost all implantable electronic medical devices (IEMDs) are powered by bulky Li‐ion batteries (LIBs), limiting their miniaturization and lifespan advancements. In addition, LIBs contain toxic materials and flammable electrolytes that are dangerous if they leak into human organs. In this context, there is an urgent need to explore new approaches and concepts that can address the critical challenges of designing novel electrochemical energy storage systems and gain a mechanistic understanding of the phenomena taking place in diverse scenarios. This review summarizes recent advancements in biocompatible supercapacitors (B‐SCs) as a power source for various IEMDs, offering a potential solution to these challenges. Different types of IEMDs and their power requirements are briefly discussed, along with challenges arising from energy storage systems and their applications in IEMDs. Given the importance of electrode materials in determining the electrochemical performance of B‐SCs in terms of energy and power densities, different electrode materials and their developments are systematically reviewed. Finally, new insights are offered into potential opportunities and future prospects for the rational design of next‐generation B‐SCs.

Highly Sensitive Flexible Capacitive Pressure Sensor Based on a Multicross-Linked Dual-Network Ionic Hydrogel for Blood Pressure Monitoring Applications.

Flexible capacitive pressure sensors based on ionic hydrogels (IHs) have garnered significant attention in the field of wearable technology. However, the vulnerability of traditional single-network hydrogels to mechanical damage and the complexity associated with preparing double-network hydrogels present challenges in developing a highly sensitive, easily prepared, and durable IH-based flexible capacitive pressure sensor. This study introduces a novel multicross-linked dual-network IH achieved through the physical and chemical cross-linking of polymers polyvinyl alcohol (PVA) and chitosan (CS), ionic solution H3PO4, and cross-linking agent gum arabic. Flexible capacitive pressure sensors, characterized by high sensitivity and a broad pressure range, are fabricated by employing mesh as templates to design cut-corner cube microstructures with high uniformity and controllability on the IHs. The sensor exhibits high sensitivity across a wide pressure range (0-290 kPa) and with excellent features such as high resolution (∼1.3 Pa), fast response-recovery time (∼11 ms), and repeatable compression stability at 25 kPa (>2000 cycles). The IHs as a dielectric layer demonstrate long-term water retention properties, enabling exposure to air for up to 100 days. Additionally, the developed sensor shows the ability to accurately measure the pulse wave within the small pressure range. By combining the pulse wave acquired by the sensor with a trained neural network model, we achieve successful blood pressure (BP) prediction, meeting the standards set by the Association for the Advancement of Medical Instrumentation and the British Hypertension Society. Ultimately, the sensor proposed in this study holds promising prospects for broad applications in high-precision wearable medical electronic devices.

Circular economy for medical devices: Barriers, opportunities and best practices from a design perspective

In an era of electronics-driven healthcare, the disposability of many medical devices raises environmental concerns. Transitioning these devices towards a circular economy, involving practices like reuse, remanufacturing, and recycling, holds promise. Our paper explores this transition through desk research, literature review, and expert interviews, examining the current state of circular design in electronic medical devices. We unveil barriers, opportunities, and design recommendations for circularization. First, we highlight the circularity potential of medical devices currently on the market, implementing e.g. refuse, reuse, recycle, etc. Second, we present barriers for circular medical device design, (e.g. (perceived) safety and infection risks, (perceived) regulatory difficulties, financial constraints, and difficulties in collection and separation) and opportunities to overcome these barriers. Finally, we present 29 design-specific recommendations for creating circular medical devices. Our insights into circular healthcare practices urge design engineers to integrate sustainable principles into medical device development without compromising safety, quality, or functionality.

Enhancing cellular behavior in repaired tissue via silk fibroin-integrated triboelectric nanogenerators

Triboelectric nanogenerators (TENGs) have emerged as a promising approach for generating electricity and providing electrical stimuli in medical electronic devices. Despite their potential benefits, the clinical implementation of TENGs faces challenges such as skin compliance and a lack of comprehensive assessment regarding their biosafety and efficacy. Therefore, further research is imperative to overcome these limitations and unlock the full potential of TENGs in various biomedical applications. In this study, we present a flexible silk fibroin-based triboelectric nanogenerator (SFB-TENG) that features an on-skin substrate and is characterized by excellent skin compliance and air/water permeability. The range of electrical output generated by the SFB-TENG was shown to facilitate the migration and proliferation of Hy926, NIH-3T3 and RSC96 cells. However, apoptosis of fibroblast NIH-3T3 cells was observed when the output voltage increased to more than 20 V at a frequency of 2 Hz. In addition, the moderate electrical stimulation provided by the SFB-TENG promoted the cell proliferation cycle in Hy926 cells. This research highlights the efficacy of a TENG system featuring a flexible and skin-friendly design, as well as its safe operating conditions for use in biomedical applications. These findings position TENGs as highly promising candidates for practical applications in the field of tissue regeneration.

Degradable piezoelectric biomaterials for medical applications

The energy harvesting technology based on piezoelectricity promises to achieve a self-powered mode for portable medical electronic devices. Piezoelectric materials, as crucial components in electromechanical applications, have extensively been utilized in portable medical electronic devices. Especially, degradable piezoelectric biomaterials have received much attention in the medical field due to their excellent biocompatibility and biosafety. This mini-review mainly summarizes the types and structural characteristics of degradable piezoelectric biomaterials from degradable piezoelectric small-molecule crystals to piezoelectric polymers. Afterward, medical applications are briefly introduced, including energy harvester and sensor, actuator and transducer, and tissue engineering scaffold. Finally, from a material perspective, some challenges currently faced by degradable piezoelectric biomaterials are proposed.

Mechanically programmable substrate enable highly stretchable solar cell arrays for self-powered electronic skin

Development of stretchable solar cells to accommodate large strain without sacrificing the power conversion efficiency is challenging. This study presents a novel approach to manufacture highly stretchable solar cell arrays, which can be integrated into wearable medical devices to operate under challenging environments. Overcoming the limitations of rigid metal wires, liquid metal wires are employed to connect single crystal silicon solar cells, ensuring both high conversion efficiency and exceptional stretchability (up to 100%). The manufacturing process introduces embedding electrospinning films into elastic silicone substrates to create a tight bond between rigid solar cells and stretchable substrates with programmable strain capabilities. Notably, a stretchable interconnect wire is efficiently fabricated using the semi-liquid metal template printing technique and demonstrates remarkable conductivity (up to 6 × 106 S/m). Individual structural unit of solar cell presents an impressive tensile rate of 200%, and endures up to 5000 cycles of tensile testing. The overall solar cell array exhibits outstanding adaptability to extensive bending and twisting, with a mere 0.1% short-circuit current reduction in its maximum stretched state. The stretchable photovoltaic device is successfully employed in creating self-powered electronic skin for continuous real-time monitoring of parameters, showcasing its valuable potential in wearable medical electronic devices and comprehensive sports health monitoring.

MOSFET Characteristics and Related Biological Devices Analysis

With the development of modern electronic information technology, portable, fast, and high-performance electronic information products have brought great changes to people's life and health. People pay more and more attention to electronic information products. Not only in the civil aspect, high-end precision electronics industry, such as artificial intelligence, the new generation of electronic communication technology, medical devices, aerospace, and defense fields are based on various chips, to establish a complete national industrial system. This article describes MOSFET basic introduction, working principle and structure, etc., which plays an important role in the modern electronic information industry, including its application in implantable medical devices-current stimulator. The conclusion of this article is that with more and more capital and talent investment, the future of the chip industry with MOSEF as the basic component is very optimistic. The significance of this paper is to introduce the existing MOSFET technology and put forward views for future development.

A script-enabled interactive checklist document for efficient management of electronic devices in a busy multimodality radiotherapy clinic.

Develop an efficient, interactive, and instructive checklist document for the management of implanted electronic medical devices in a multimodality radiotherapy clinic. The built-in scripting and interactivity of a popular commercial word processor was used to develop an interactive document that changes the information presented to the user based on drop-down selections. The interactivity and scripting were compatible with the radiation oncology information system (ROIS) which allows the document to be accessible by all team members and serve as a permanent record in a patient's electronic chart. The final interactive document, which was clinically deployed after beta testing with a group consisting of nurses and medical physicists, presents information and action plans to the user based on multiple departmental medical device decision trees that are specific to the combination of device, treatment modality, rhythm-pacing dependence for cardiac devices, and distance from the device to the treatment volume. A script-enabled interactive document was developed for a busy multimodality clinic, condensing multiple comprehensive departmental guidelines spanning multiple device types and treatment modalities into a single interactive checklist accessible within the ROIS. Given the wide accessibility of the commercial word processor, this approach could be adopted by other clinics to streamline their own respective workflows.

Solvent-Resistant Adhesive Gel with Thermal Post-Tunability.

Adhesives have received extensive attention in flexible bioelectronics, wearable electronic medical devices, and biofuel cells. However, it is a challenge to achieve late regulation of performance once polymer-based gels are formed. Here, a double-network organogel composed of a hydrophilic and hydrophobic polymer network and a polyamide acid network was successfully prepared. In diverse liquid environments (including isopropyl alcohol, glycerol, epichlorohydrin, n-propanol, dichloromethane, triethanolamine, ethanol absolute, hydrogen peroxide, and ethyl acetate), the organogel adhesive demonstrated remarkable properties. It exhibits a strong tensile strength of 200 kPa, a high fracture strain reaching 560%, and an impressive adhesion strength of 38 kPa. In addition, the organogel demonstrates exceptional adhesive properties toward polytetrafluoroethylene, plastics, metals, rubber, and glass. Note that the organogel could also regulate adhesive and tough performance by thermally triggering a cyclization reaction even after the organogel has been formed. The strategy provides a new idea for designing soft materials with post-tunability.

A Cloud-Edge Collaboration Framework for Cancer Survival Prediction to Develop Medical Consumer Electronic Devices

A Cloud-Edge Collaboration Framework for Cancer Survival Prediction to Develop Medical Consumer Electronic Devices

A non-interventive monitoring system prototype for chronic patients with hypertension and asthma.

Monitoring the vital signs of chronic patients with hypertension, asthma, and chronic obstructive pulmonary disease (COPD) aids in disease prevention. This study enhances the patient quality of life while adding to the corpus of information about electronic medical devices. The requirements for both the functional and non-functional system architecture were determined and designs were made. Diagrams were used to describe the system's parts, behaviour, and connections before implementation. Although the project's development produced a remote monitoring system prototype with outcomes comparable to those of patented and regarded as reliable devices, CCFHAC is not yet prepared to be considered a fully finished good that can be used to define a person's health status with absolute certainty. This endeavour marks a step in investigating how the Internet of Things might improve the quality of life for Jordanian patients.

Polyampholyte saturated with simulated-body-fluid as a flexible, stretchable and self-healing gel electrolyte for biocompatible energy storages and capacitive circuit elements

As implantable electronic medical devices (IEMDs) develop, biocompatible polymer materials with body-friendly non-toxic nature are receiving great amount of attention. Polyampholyte hydrogels have mechanical flexibility and self-healing properties, as well as biocompatibility; thus, it can be applied in various implantable medical devices and wearable devices. In this study, the possibility of using a polyampholyte hydrogel saturated with simulated body fluid (PA-SBF) as the gel polymer electrolytes for energy storage devices and capacitive circuit elements of IEMDs is investigated. At the normal body temperature (35 °C), the PA-SBF exhibited high ionic conductivity of 17.6 mS cm−1 with negligible electron leakage. The supercapacitor fabricated with the PA-SBF gel electrolyte sandwiched between carbon-based electrodes showed an excellent areal capacitance of 219.6 mF cm−2 with a maximum potential window of 1.6 V. The self-healing properties and cytotoxicity of the PA-SBF gel electrolytes were examined as well. With high performance, flexibility, and self-healing property, the biocompatible PA-SBF gel electrolyte can be considered as a promising candidate for the electrolyte of electrochemical devices, energy sources and capacitive circuit elements of future IEMDs.

Modeling third-party reverse logistics for healthcare waste recycling in the post-pandemic era

The COVID-19 pandemic has increased the demand for life-saving devices known as ‘ventilators,’ which help critically ill patients breathe. Owing to the high global demand for ventilators and other medical equipment, many Indian nonmedical equipment companies have risen to meet this demand. This unexpected demand for ventilators during the COVID-19 pandemic, similar to that for other EOL electronic medical devices, has become a severe problem for the nation. Consequently, the healthcare industry must efficiently handle EOL ventilators, which can be outsourced to 3PRLPs. 3PRLPs play a vital role in a company’s reverse logistics activities. This study emphasises the 3PRLP selection process as a complex decision-making problem and the optimisation of order allocation to qualified 3PRLPs. As a result, this study proposes a two-phase hybrid decision-making problem. First phase combines the two multi-attribute decision-making methods to select 3PRLPs based on their assessed SPS and Second phase, the evaluated SPS was utilised as one of the objectives of a multi-objective linear programming model to allocate orders to the selected 3PRLPs. To solve the proposed model, both classical and modern approaches were used. The results show that the proposed framework can be successfully implemented in the current scenario of the healthcare industry.

Magnetoelectric Core–Shell Nanoparticle–Based Wearable Hybrid Energy Harvesters for Biomedical Applications

In this work, a novel barium titanate–coated cobalt ferrite core–shell magnetoelectric nanoparticle and poly(3,4‐ethylenedioxythiophene): polystyrene sulfonate–based wearable energy‐harvesting patch for wireless power‐transfer applications are proposed. The developed flexible patch has unique ease of fabrication and high‐efficiency energy conversion capability from the magnetic field and mechanical motion to the electric field as compared to bulk or thin‐film‐based devices. This unique power‐transfer capability of this device is achieved due to the crystalline nature of fabricated nanoparticles, which is confirmed using X‐ray diffraction and high‐resolution transmission electron microscopy. This wearable patch can generate a high voltage of 560 mV when exposed to a 40 μT alternating magnetic field at the resonance frequency of 48.6 kHz. The hybrid mode of electric power generation is achieved by coupling bodily motion with the remotely applied alternating magnetic field (40 μT), which results in the generation of a higher electric potential of 860 mV and maximum power density of 0.458 mW cm−3 across a 10 kΩ load. The maximum magnetoelectric coefficient is recorded as 1300 mV cm−1 Oe−1. The flexible nature and hybrid operation of the proposed device make it an efficient alternative for powering a wide range of wearable medical electronic devices.

Implantable polypyrrole bioelectrodes inducing anti-inflammatory macrophage polarization for long-term in vivo signal recording.

Bioelectrodes are critical components of implantable electronic devices that enable precise electrical signal transmission in close contact with living tissues. However, their in vivo performance is often compromised by inflammatory tissue reactions mainly induced by macrophages. Hence, we aimed to develop implantable bioelectrodes with high performance and high biocompatibility by actively modulating the inflammatory response of macrophages. Consequently, we fabricated heparin-doped polypyrrole electrodes (PPy/Hep) and immobilized anti-inflammatory cytokines (interleukin-4 [IL-4]) via non-covalent interactions. IL-4 immobilization did not alter the electrochemical performance of the original PPy/Hep electrodes. In vitro primary macrophage culture revealed that IL-4-immobilized PPy/Hep electrodes induced anti-inflammatory polarization of macrophages, similar to the soluble IL-4 control. In vivo subcutaneous implantation indicated that IL-4 immobilization on PPy/Hep promoted the anti-inflammatory polarization of host macrophages and significantly mitigated scarring around the implanted electrodes. In addition, high-sensitivity electrocardiogram signals were recorded from the implanted IL-4-immobilized PPy/Hep electrodes and compared to bare gold and PPy/Hep electrodes, which were maintained for up to 15 days post-implantation. This simple and effective surface modification strategy for developing immune-compatible bioelectrodes will facilitate the development of various electronic medical devices that require high sensitivities and long-term stabilities. STATEMENT OF SIGNIFICANCE: To fabricate highly immunocompatible conductive polymer-based implantable electrodes with high performance and stability in vivo, we introduced the anti-inflammatory activity to PPy/Hep electrodes by immobilizing IL-4 via non-covalent surface modification. IL-4-immobilized PPy/Hep could significantly mitigate inflammatory responses and scarring around implants by skewing macrophages to an anti-inflammatory phenotype. The IL-4-immobilized PPy/Hep electrodes could successfully record in vivo electrocardiogram signals for up to 15 days with no substantial sensitivity loss, retaining their superior sensitivity compared to bare gold and pristine PPy/Hep electrodes. Our simple and effective surface modification strategy for developing immune-compatible bioelectrodes will facilitate the development of various electronic medical devices that require high sensitivities and long-term stabilities, such as neural electrode arrays, biosensors, and cochlear electrodes.