Development Of Medical Devices Research Articles

Design of a syringe extension device (Chloe SED®) for low-resource settings in sub-Saharan Africa: a circular economy approach.

Underfunded healthcare infrastructures in low-resource settings in sub-Saharan Africa have resulted in a lack of medical devices crucial to provide healthcare for all. A representative example of this scenario is medical devices to administer paracervical blocks during gynaecological procedures. Devices needed for this procedure are usually unavailable or expensive. Without these devices, providing paracervical blocks for women in need is impossible resulting in compromising the quality of care for women requiring gynaecological procedures such as loop electrosurgical excision, treatment of miscarriage, or incomplete abortion. In that perspective, interventions that can be integrated into the healthcare system in low-resource settings to provide women needing paracervical blocks remain urgent. Based on a context-specific approach while leveraging circular economy design principles, this research catalogues the development of a new medical device called Chloe SED® that can be used to support the provision of paracervical blocks. Chloe SED®, priced at US$ 1.5 per device when produced in polypropylene, US$ 10 in polyetheretherketone, and US$ 15 in aluminium, is attached to any 10-cc syringe in low-resource settings to provide paracervical blocks. The device is designed for durability, repairability, maintainability, upgradeability, and recyclability to address environmental sustainability issues in the healthcare domain. Achieving the design of Chloe SED® from a context-specific and circular economy approach revealed correlations between the material choice to manufacture the device, the device's initial cost, product durability and reuse cycle, reprocessing method and cost, and environmental impact. These correlations can be seen as interconnected conflicting or divergent trade-offs that need to be continually assessed to deliver a medical device that provides healthcare for all with limited environmental impact. The study findings are intended to be seen as efforts to make available medical devices to support women's access to reproductive health services.

Evolution of the Chronic Venous Leg Ulcer Microenvironment and Its Impact on Medical Devices and Wound Care Therapies.

Studies have reported that the constituents of the wound microenvironment are likely to have critical roles in the degradation and fate of the polymeric matrix and the compounds dissolved in the wound dressing matrix. Thus, chronic wound assessment and the design of effective medical devices and drug products for wound care partly rely on an in-depth understanding of the wound microenvironment. The main aim of this review is to identify and discuss the different stages of chronic wound progression, focusing on the changes in the biochemical composition of the wound microenvironment, with particular attention given to venous leg ulcers (VLUs), as they are one of the most prevalent chronic wound aetiologies. The pathophysiology of venous ulcers is detailed, followed by a thorough review of what is known about the VLU microenvironment and its changes as a function of the evolution of the VLU. Simulating conditions for VLU are then discussed with the view of highlighting potentially relevant simulating media as a function of VLU evolution for a better assessment of biological safety, in particular medical devices intended to be in contact with these wounds.

Only senior managers lead business model innovation, or do they? Levels of management and dynamic capability deployment

Previous research has provided valuable insights into the connection between market-driving strategies, business model innovation, and dynamic capabilities. However, several open questions remain. In this abductive study of a leading medical devices manufacturer, we investigate the roles various employees play in market-driving firms. We focus on how senior and middle managers as well as non-managers contribute to a firm's sensing, seizing, and reconfiguring to drive business model changes towards digital servitization and customer centricity. Our primary contributions lie in filling the knowledge gap in understanding the role employees at different levels of management play in market-driving strategies, as enacted through dynamic capability deployment, to support BMI. Second, we advance knowledge by stressing that a sole focus on senior managers provides an incomplete understanding of how firms engage in market-driving strategies.

Lifecycle extension of single-use medical device sensors: Case study of an engineering sustainability transition program

Medical devices and consumables are contributors to the known, highly negative ecological impacts of healthcare provision. Medical device manufacturing organizations are increasingly met with pressures to convert thousands of their existing, post-market products to be more sustainable, yet there is limited knowledge of how these transition projects are achieved. This case study examines the execution of a large medical device manufacturer's sustainability transition program of a post-market single-use sensor. We provide both a detailed synthesis of the design verification steps and a review of the key challenges which were identified during a customer-driven lifecycle extension program of a single-use medical device sensor; the case study sensor was released with a doubled shelf life, thus increasing the time of safe and effective use plus decreased scrapping needs. This paper contributes to the knowledge for the practical development of the required design verification efforts of released, highly regulated single-use medical device sensor products during sustainability transition programs. This paper increases knowledge related to the complexities and challenges technology ecosystem sustainability programs face in the post-market medical device consumable space during reverification of legacy products to meet sustainability challenges. Additionally, the paper identifies six phases of waste during a single-use medical device sensor's lifecycle.

Promising Materials in the Fight against Healthcare-Associated Infections: Antibacterial Properties of Chitosan-Polyhedral Oligomeric Silsesquioxanes Hybrid Hydrogels.

New technologies and materials could help in this fight against healthcare-associated infections. As the majority of these infections are caused by antibiotic-resistant bacteria, the development of materials with intrinsic antibacterial properties is a promising field of research. We combined chitosan (CS), with antibacterial properties, with polyhedral oligomeric silsesquioxanes (POSS), a biocompatible polymer with physico-chemical, mechanical, and rheological properties, creating a hydrogel using cross-linking agent genipin. The antibacterial properties of CS and CS-POSS hydrogels were investigated against nosocomial Gram-positive and Gram-negative bacteria both in terms of membrane damage and surface charge variations, and finally, the anti-biofilm property was studied through confocal microscopy. Both materials showed a good antibacterial capacity against all analyzed strains, both in suspension, with % decreases between 36.36 and 73.58 for CS and 29.86 and 66.04 for CS-POSS, and in plates with % decreases between 55.29 and 78.32 and 17.00 and 53.99 for CS and CS-POSS, respectively. The treated strains compared to the baseline condition showed an important membrane damage, which also determined a variation of surface charges, and finally, for both hydrogels, a remarkable anti-biofilm property was highlighted. Our findings showed a possible future use of these biocompatible materials in the manufacture of medical and surgical devices with intrinsic antibacterial and anti-biofilm properties.

Enhancement of protein immobilization on polydimethylsiloxane using a synergistic combination of polydopamine and micropattern surface modification

Understanding protein interactions at biointerfaces is critical for the improved design of biomaterials and medical devices. Polydimethylsiloxane (PDMS) is used for numerous device applications, and surface modifications can enhance protein immobilization and the response to cells. A multifunctional approach combining topographical and biochemical modifications was applied to PDMS by fabricating 10–20 µm scale patterns onto PDMS surfaces and by coating with polydopamine (PDA). The modifications were confirmed by surface characterization and bovine serum albumin (BSA), fibrinogen (Fg), and fetuin-A (Fet-A) were radiolabeled with 125I. The amounts of protein attached to the surface before and after elution with sodium dodecyl sulfate (SDS) were quantified from single and complex multi-protein solutions to determine protein stability and competitive binding. The PDA coatings were the most stable and capable of immobilizing the highest levels of all proteins. Furthermore, combinations of PDA coatings with the smallest micropatterns provided an additional improvement, enhancing the amount immobilized and the stability. The adsorption of BSA and Fg from plasma demonstrated competitive binding and possible orientation changes, respectively. It was determined that Fet-A, a less studied protein, adsorbed from plasma at low levels, but the adsorption from fetal bovine serum (FBS) was significantly greater, providing important quantification data from radiolabeling that is relevant to many cell culture studies. Overall, combining topography and PDA modification has a synergistic effect on improving protein immobilization. These findings provide new insight on the quantities of proteins bound to PDMS and PDA coatings with implications for cell interactions in various biotechnology and medical applications.

Dielectric Spectroscopy Shows a Permittivity Contrast between Meningioma Tissue and Brain White and Gray Matter-A Potential Physical Biomarker for Meningioma Discrimination.

The effectiveness of surgical resection of meningioma, the most common primary CNS tumor, depends on the capability to intraoperatively discriminate between the meningioma tissue and the surrounding brain white and gray matter tissues. Aiming to find a potential biomarker based on tissue permittivity, dielectric spectroscopy of meningioma, white matter, and gray matter ex vivo tissues was performed using the open-ended coaxial probe method in the microwave frequency range from 0.5 to 18 GHz. The averages and the 95% confidence intervals of the measured permittivity for each tissue were compared. The results showed the absence of overlap between the 95% confidence intervals for meningioma tissue and for brain white and gray matter, indicating a significant difference in average permittivity (p ≤ 0.05) throughout almost the entire measured frequency range, with the most pronounced contrast found between 2 GHz and 5 GHz. The discovered contrast is relevant as a potential physical biomarker to discriminate meningioma tissue from the surrounding brain tissues by means of permittivity measurement, e.g., for intraoperative meningioma margin assessment. The permittivity models for each tissue, developed in this study as its byproducts, will allow more accurate electromagnetic modeling of brain tumor and healthy tissues, facilitating the development of new microwave-based medical devices and tools.

4D printing of biodegradable elastomers with tailorable thermal response at physiological temperature

4D printing has a great potential for the manufacturing of soft robotics and medical devices. The alliance of digital light processing (DLP) 3D printing and novel shape-memory photopolymers allows for the fabrication of smart 4D-printed medical devices in high resolution and with tailorable functionalities. However, most of the reported 4D-printed materials are nondegradable, which limits their clinical applications. On the other hand, 4D printing of biodegradable shape-memory elastomers is highly challenging, especially when transition points close to physiological temperature and shape fixation under ambient conditions are required. Here, we report the 4D printing of biodegradable shape-memory elastomers with tailorable transition points covering physiological temperature, by using poly(D,L-lactide-co-trimethylene carbonate) methacrylates at various monomer feed ratios. After the programming step, the high-resolution DLP printed stents preserved their folded shape at room temperature, and showed efficient shape recovery at 37 °C. The materials were cytocompatible and readily degradable under physiological conditions. Furthermore, drug-loaded devices with tuneable release kinetics were realized by DLP-printing with resins containing polymers and levofloxacin or nintedanib. This study offers a new perspective for the development of next-generation 4D-printed medical devices.

Clinical implementation of 3D printed plesiotherapy moulds using free open source software

PurposeFrom May 2021 the European regulation EU2017/745 covers the manufacture of medical devices in healthcare facilities under certain conditions. In this context, the use of 3D printing and free software can be combined to provide a solution to some of the problems for which no commercial product can be found in brachytherapy.What we present here is a procedure for the design, using open source software, and manufacture, with Fused Deposition Modeling technology, of brachytherapy surface moulds. Material and methodsThe procedure starts with a CT scan of the patient treatment area with radiopaque markers. 3D slicer software is then used to delimit the applicator mould that follows the patient's surface. After this, we use the Freecad software to design the channels where we will insert the plastic tubes through which the radiation source will deliver the treatment. We also use the Meshmixer software to make the final delimitation of the applicator edges as well as to find and correct any inconsistency. ResultsMoulds created by means of 3D printing allow us to combine the precise fit to the patient's surface of homemade solutions with the geometric accuracy between catheters of commercial products. This is clearly seen when treating small and irregular surfaces such as the ear pinna. ConclusionManufacture of brachytherapy surface moulds with FDG technology is a good example of customized solutions in healthcare facilities supported by new European legistation. If we add to this the use of free open source software, we are facing an alternative to classics solutions used up to now in superficial brachytherapy.

Characteristics and Results of Pediatric Medical Device Studies: 2017-2022.

The development of medical devices for children faces unique challenges that have contributed to a paucity of devices specifically designed and tested for children. Increased knowledge on research activities for pediatric devices can guide optimal study design and ensure timely dissemination of clinical findings. We performed a cross-sectional analysis of interventional studies registered on ClinicalTrials.gov, initiated January 1, 2017, through December 12, 2022, evaluating a Food and Drug Administration-regulated class II or III device, and enrolling any pediatric patients (aged ≤17 years). Data were extracted from ClinicalTrials.gov on study characteristics and from Devices@FDA on device features. For completed studies, we determined whether results were reported in a peer-reviewed publication as of December 27, 2022. Among 482 studies, 406 (84.2%) examined a class II device and 76 (15.8%) a class III device. The most common device types were diabetes-related devices (N = 57, 11.8%) and monitors and measurement devices (N = 39, 8.1%). Most studies were single-center (N = 326, 67.6%), used a nonrandomized (N = 255, 52.9%), open label (N = 350, 72.6%) design, and were funded by academic institutions (N = 278, 57.7%) or industry (N = 142, 29.5%). A total of 291 (60.4%) studies included a primary outcome of only efficacy without safety endpoints. Among completed studies, more than half (N = 64, 51.6%) enrolled <50 participants and 71.0% (N = 88) <100. After median follow-up of 3.0 years, results were available in publications for 27 (21.8%) completed studies. Our findings serve to inform programs and initiatives seeking to increase pediatric-specific device development. In addition to considerations on ensuring rigorous trial design, greater focus is needed on timely dissemination of results generated in pediatric device studies.

The Use of Crystalline Carbon-Based Nanomaterials (CBNs) in Various Biomedical Applications

This review study aims to present, in a condensed manner, the significance of the use of crystalline carbon-based nanomaterials in biomedical applications. Crystalline carbon-based nanomaterials, encompassing graphene, graphene oxide, reduced graphene oxide, carbon nanotubes, and graphene quantum dots, have emerged as promising materials for the development of medical devices in various biomedical applications. These materials possess inorganic semiconducting attributes combined with organic π-π stacking features, allowing them to efficiently interact with biomolecules and present enhanced light responses. By harnessing these unique properties, carbon-based nanomaterials offer promising opportunities for future advancements in biomedicine. Recent studies have focused on the development of these nanomaterials for targeted drug delivery, cancer treatment, and biosensors. The conjugation and modification of carbon-based nanomaterials have led to significant advancements in a plethora of therapies and have addressed limitations in preclinical biomedical applications. Furthermore, the wide-ranging therapeutic advantages of carbon nanotubes have been thoroughly examined in the context of biomedical applications.

Effect of Sterilization on the Dimensional and Mechanical Behavior of Polylactic Acid Pieces Produced by Fused Deposition Modeling.

To successfully implement additive manufacturing (AM) techniques for custom medical device (MD) production with low-cost resources, it is imperative to understand the effect of common and affordable sterilization processes, such as formaldehyde or steam sterilization, on pieces manufactured by AM. In this way, the performance of low-risk MDs, such as biomodels and surgical guides, could be assessed for complying with safety, precision, and MD delivery requirements. In this context, the aim of the present work was to evaluate the effect of formaldehyde and steam sterilization on the dimensional and mechanical stability of standard polylactic acid (PLA) test pieces produced by fused deposition modeling (FDM). To achieve this, PLA samples were sterilized according to the sterilization protocol of a public hospital in the city of Bucaramanga, Colombia. Significant changes regarding mechanical and dimensional properties were found as a function of manufacturing parameters. This research attempts to contribute to the development of affordable approaches for the fabrication of functional and customized medical devices through AM technologies, an issue of particular interest for low- and middle-income countries.

Characterisation of microneedle replication and flow behaviour in ultrasonic micro-injection moulding through design of experiments

This research investigates the impact of process parameters on ultrasonic micro-injection moulding (u-μIM) by studying microneedle replication efficiency, temperature evolution during moulding, melt flow consistency and sonication behaviour. The experimentation comprises of a full-factorial design of experiments using three process variables: sonication time, mould temperature and injection force. The current study presents that; (i) mould temperature was found to be the most influential parameter to tune and optimise micro-feature replication, (ii) consistent ultrasonic micromoulding flows can be achieved using higher mould temperatures, (iii) injection force is a key parameter influencing sonication frequency, a critical aspect of the ultrasonic method to obtain a repeatable manufacturing process. These outcomes will be a datum during development of the manufacturing processes for specific products using the ultrasonic method. The research presented here takes a unique approach to characterise the ultrasonic method for the development of this novel technique, particularly for microneedle patch and medical device production. With this increased level of understanding of u-μIM process characteristics, the method can become an energy efficient and cost-effective alternative to conventional micro-injection moulding processes for delivering high-quality, miniature components.

Application and evolution of design in oral health: A systematic mapping study with an interactive evidence map.

There is increasing recognition of the value and capabilities of design in healthcare. Beyond the development of medical devices, design is increasingly being applied to intangible, complex and systemic healthcare problems. However, there is limited evidence on the use of design specifically in the field of oral health. This systematic mapping study aims to collate and catalogue evidence of design in oral health. A systematic search of academic databases and grey literature was performed. Duplicate results were removed, and publications relating to the same project were grouped. Reviewers from design and oral health independently screened a sample of the dataset. Projects of both relevance to oral health, and with input from a designer or clear implementation of a design methodology or approach were included. Projects were coded and plotted on a novel interactive evidence map. 119 design and oral health projects were included between 1973 and 2022. Interventional (n = 94, 79%), empirical (n = 46, 39%), methodological (n = 35, 29%) and theoretical (n = 7, 6%) design contributions were identified across the projects. The projects were categorized by four orders of design: first-graphics (n = 6, 5%), second-products (n = 41, 34%), third-interactions (n = 70, 59%), and fourth-systems (n = 2, 2%). Design was found in a diverse range of contexts in oral health; most commonly being relevant to general patients (n = 61, 51%), and for use in general dental practice (n = 56, 47%). Further design outcome categories (digital material; printed material; object; room or space; apparel; process; smart device; tangible interface; graphical interface; virtual reality; service; policy; system) and oral health themes (oral health literacy; oral care training; dental clinic design; dental instruments and equipment; personal oral care; dental appliance; clinician health and productivity; clinical information systems; informed consent; oral health promotion and prevention; oral care training; patient interactions and experience) were identified. The novel interactive evidence map of design in oral health created enables ongoing and open-ended multivariant documentation and analysis of the evidence, as well as identification of strategic opportunities. Future research and policy implications include; recognition and engagement with the full capabilities of design; integration of design experts; fostering inclusive engagement and collaboration; disentangling patient and public involvement; advancing human-centred systems approaches; adopting design-led approaches for policy-making.

Explored the Function of Electromagnetic Compatibility (EMC) of Medical Devices from the Perspective of Test

To improve the electromagnetic compatibility (EMC) quality of medical devices, improve the efficiency of EMC testing, and promote the speed of market approval. The unqualified cases of EMC test items of medical devices in recent years were statistically analyzed, and the reasons of low EMC quality of medical devices were analyzed from the perspective of test. Based on the analysis of the reasons, the suggestions were given from the perspectives of medical device manufacturers and testing organizations. In order to ensure the quality of EMC of medical devices, medical device manufacturers, regulatory authorities and inspection and testing institutions should strengthen the monitoring and evaluation of medical device electromagnetic compatibility, to ensure the safety of products work together to promote the development of the medical device industry healthily and orderly.

Identifying the patient harms to include in an in silico clinical trial

Background and ObjectiveClinical trials represent a crucial step in the development and approval of medical devices. These trials involve evaluating the safety and efficacy of the device in a controlled setting with human subjects. However, traditional clinical trials can be expensive, time-consuming, and ethically challenging. Augmenting clinical trials with data from computer simulations, so called in silico clinical trials (ISCT), has the potential to address these challenges while satisfying regulatory requirements. However, determination of the patient harms in scope of an ISCT is necessary to ensure all harms are sufficiently addressed while maximizing the utility of the ISCT. This topic is currently lacking guidance. The objective of this work is to propose a general method to determine which patient harms should be included in an ISCT for a regulatory submission. MethodsThe proposed method considers the risk associated with the harm, the impact of the device on the likelihood of occurrence of the harm and the technical feasibility of evaluating the harm via ISCT. Consideration of the risk associated with the harm provides maximum clinical impact of the ISCT, in terms of focusing on those failure modes which are most relevant to the patient population. Consideration of the impact of the device on a particular harm, and the technical feasibility of modeling a particular harm supports that the technical effort is devoted to a problem that (1) is relevant to the device in question, and (2) can be solved with contemporary modeling techniques. Results and ConclusionsAs a case study, the proposed method is applied to a total shoulder replacement humeral system. With this framework, it is hoped that a consistent approach to scoping an ISCT can be adopted, supporting investment in ISCT by the industry, enabling consistent review of the ISCT approach across device disciplines by regulators, and providing maximum impact of modeling technologies in support of devices to improve patient outcomes.

Laser texturing of additively manufactured implants: A tool to programme biological response

The advent of additive manufacturing (AM) is rapidly shaping healthcare technologies pushing forward personalisation and enhanced implant functionalisation to improve clinical outcomes. AM techniques such as powder bed fusion (PBF) have been adopted despite the need to modify the as-built surface post manufacture. Medical device manufacturers have focused their efforts on refining various physical and chemical surface finishing approaches, however there is little consensus and some methods risk geometry alteration or contamination. This has led to a growing interest in laser texturing technologies to engineer the device surface. Herein, several bioinspired micro and nano textures were applied to laser PBF Ti-6Al-V4 substrates to alter physicochemical properties and in-turn we sought to understand what influences these alterations had on a human osteosarcoma cell line (MG63). Significant variations in roughness and time dependent contact angles were revealed between different patterns provide a tool to elicit desired biological responses. All surface treatments effectively enhanced early cell behaviour and in particular coverage was increased for the micro-textures. Influence of the patterns on cell differentiation was less consistent with alkaline phosphatase content increased only for the channel, grid and dual textures. While long term (21 days) mineralisation was found to be significantly enhanced in grids, dual, triangles and shark skin textures. Further regression analysis of all physicochemical and biological variables indicated that several properties should be used to strongly correlate cell behaviour, resulting in 82 % of the 21 day mineralisation dataset explained through a combination of roughness kurtosis and glycerol contact angle. Overall, this manuscript demonstrates the ability of laser texturing to offer tailored cell-surface interactions, which can be tuned to offer a tool to drive functional customisation of anatomically customised medical devices.

Recent Advances in the Production of Pharmaceuticals Using Selective Laser Sintering.

Selective laser sintering (SLS) is an additive manufacturing process that has shown promise in the production of medical devices, including hip cups, knee trays, dental crowns, and hearing aids. SLS-based 3D-printed dosage forms have the potential to revolutionise the production of personalised drugs. The ability to manipulate the porosity of printed materials is a particularly exciting aspect of SLS. Porous tablet formulations produced by SLS can disintegrate orally within seconds, which is challenging to achieve with traditional methods. SLS also enables the creation of amorphous solid dispersions in a single step, rather than the multi-step process required with conventional methods. This review provides an overview of 3D printing, describes the operating mechanism and necessary materials for SLS, and highlights recent advances in SLS for biomedical and pharmaceutical applications. Furthermore, an in-depth comparison and contrast of various 3D printing technologies for their effectiveness in tissue engineering applications is also presented in this review.

The role of Artificial Intelligence and the Internet of Things in health monitoring and disease detection for the elderly [ Diabetes and Covid-19] as a model:

AbstractRecent challenges in the medical field have emphasized the need to exploit new technology, starting with the production of medicines and medical devices, to electronic medical service technologies, electronic archiving of medical records, and even the use of intelligent devices to communicate with patients and tracking their health status in real-time. the most significant impact is attributed to technological fields of all kinds and forms, including cloud computing technologies, robots, sensors, Artificial Intelligence, and the Internet of Things. these two fields have contributed to serving the health care field from a variety of, most notably the elderly. This paper presents two diseases which are [Diabetes and Covid 19] by reviewing the latest research published in recent years in this field of healthcare, analyzing and categorizing through comparison tables to discover their strengths and weaknesses and judge them fairly.

Pelatihan pembuatan sensor medis berbasi IoT sebagai pengenalan smart medical devices

Cardiovascular disease (CVD) is a leading cause of death globally, resulting in approximately 17.9 million deaths each year (WHO, 2017), with estimates projecting a rise to 23.3 million deaths by 2030 (Pusdatin Kemenkes RI, 2014). Early detection of heart disease plays a crucial role in CVD prevention, with heart rate (bpm) being a key indicator to assess heart function, ranging from 60 to 100 beats per minute. To address the need for early detection, a practical heart rate monitoring device utilizing the Internet of Things (IoT) and Smart Medical Devices (SMDs) was developed. This research aimed to provide training on IoT-based heart rate detection to high school students in Trenggalek. The training encompassed lectures and hands-on practice, successfully enhancing participants' knowledge of IoT, as demonstrated by improved test scores. Moreover, the training resulted in a prototype of an IoT-based heart rate monitoring system that utilizes Arduino and a heart rate sensor. Post-training evaluations showed the majority of participants were satisfied with the quality of materials and organization, indicating the positive impact of this engagement on the partners. The results support the potential of this IoT training to equip high school students with essential skills, fostering self-reliance in medical device production and reducing dependence on imports in the face of ASEAN Economic Community challenges. Ultimately, this initiative contributes to building a competent healthcare workforce in Indonesia