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Framework for creating a qualified medical device development tool of autoinjectors. 创建自动注射器合格医疗器械开发工具的框架。
Pub Date : 2023-11-24 eCollection Date: 2023-01-01 DOI: 10.3389/fmedt.2023.1281403
Marlon Luca Machal

Objectives: Autoinjectors are pivotal for precise self-administration of medications across a wide range of medical conditions. Nevertheless, the absence of a dedicated Medical Device Development Tool (MDDT) for autoinjectors represents a gap that may result in variations in the quality and regulatory compliance of autoinjectors as components of combination products. This research aim is to utilize the recently introduced Primary Functions outlined in ISO 11608-1:2022 with the title "Needle-based injection systems for medical use. Requirements and test methods. Part 1: Needle-based injection systems" to create a comprehensive MDDT framework tailored specifically for autoinjectors.

Methods: To support the creation of the framework, the analysis of the FDA MDDTs that were already approved, FDA's design controls regulations, FDA's guidance related to autoinjectors, and the Primary functions outlined in ISO 11608-1:2022 were utilized.

Results: The research identifies the Primary Functions in autoinjector to be Holding Force, Cap Removal Force, Activation Force, Extended Needle Length, Injection Time, Dose Accuracy and Needle Guard Lockout. Leveraging these Primary Functions and the FDA's MDDT approach, the research aims to bridge the gap by proposing a structured framework for the development of a specific MDDT tailored to autoinjectors.

Conclusion: This study presents a MDDT framework tailored to the development of autoinjectors for drug delivery. This framework provides a structured methodology to support predictability and effectiveness of the autoinjector development and support regulatory review process, thereby expediting FDA approval for autoinjectors as part of combination product.

目标:自动注射器对于在各种医疗条件下精确地自行给药至关重要。然而,自动注射器专用医疗器械开发工具(MDDT)的缺乏是一个空白,可能会导致作为组合产品组成部分的自动注射器在质量和合规性方面出现差异。本研究旨在利用 ISO 11608-1:2022(标题为 "医用针式注射系统")中最近推出的主要功能。要求和测试方法。方法:为了支持该框架的创建,我们分析了已获批准的 FDA MDDT、FDA 的设计控制法规、FDA 与自动注射器相关的指南以及 ISO 11608-1:2022 中概述的主要功能:研究发现,自动注射器的主要功能包括保持力、瓶盖移除力、激活力、延长针头长度、注射时间、剂量准确性和针头保护锁定。本研究利用这些主要功能和 FDA 的 MDDT 方法,提出了一个结构化框架,用于开发专门针对自动注射器的 MDDT,从而弥补了这一差距:本研究提出了一个 MDDT 框架,专门用于开发用于给药的自动注射器。该框架提供了一种结构化方法,可支持自动注射器开发的可预测性和有效性,并支持监管审查流程,从而加快美国食品及药物管理局对作为组合产品一部分的自动注射器的审批。
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引用次数: 0
Designing for flexibility in hybrid care services: lessons learned from a pilot in an internal medicine unit. 混合护理服务的灵活性设计:从内科试点中汲取的经验教训。
Pub Date : 2023-11-20 eCollection Date: 2023-01-01 DOI: 10.3389/fmedt.2023.1223002
Nirit Putievsky Pilosof, Michael Barrett, Eivor Oborn, Galia Barkai, Eyal Zimlichman, Gad Segal

Digital transformation in healthcare during the COVID-19 pandemic led to the development of new hybrid models integrating physical and virtual care. The ability to provide remote care by telemedicine technologies and the need to better manage and control hospitals' occupancy accelerated growth in hospital-at-home programs. The Sheba Medical Center restructured to create Sheba Beyond as the first virtual hospital in Israel. These transformations enabled them to deliver hybrid services in their internal medicine unit by managing inpatient hospital-care with remote home-care based on the patients' medical condition. The hybrid services evolved to integrate care pathways multiplied by the mode of delivery-physical (in person) or virtual (technology enabled)-and the location of care-at the hospital or the patient home. The study examines this home hospitalization program pilot for internal medicine at Sheba Medical Center (MC). The research is based on qualitative semi-structured interviews with Sheba Beyond management, medical staff from the hospital and the Health Maintenance Organization (HMO), Architects, Information Technology (IT), Telemedicine and Medtech organizations. We investigated the implications of the development of hybrid services for the future design of the physical built-environment and the virtual technological platform. Our findings highlight the importance of designing for flexibility in the development of hybrid care services, while leveraging synergies across the built environment and digital platforms to support future models of care. In addition to exploring the potential for scalability in accelerating the flexibility of the healthcare system, we also highlight current barriers in professional, management, logistic and economic healthcare models.

在 COVID-19 大流行期间,医疗保健领域的数字化转型促进了新的混合模式的发展,将实体医疗和虚拟医疗融为一体。通过远程医疗技术提供远程护理的能力,以及更好地管理和控制医院占用空间的需求,加速了医院上门服务项目的发展。示巴医疗中心进行了重组,创建了以色列首家虚拟医院 Sheba Beyond。这些转型使他们能够根据病人的病情,在内科病房提供混合服务,通过远程家庭护理管理住院病人的护理。混合服务的发展整合了护理路径,并根据提供方式--实体(亲自)或虚拟(技术)--以及护理地点--医院或患者家中--进行了倍增。本研究探讨了沙巴医疗中心(MC)内科的家庭住院计划试点。研究以半结构化定性访谈为基础,访谈对象包括舍巴 Beyond 管理层、医院和健康维护组织 (HMO) 的医务人员、建筑师、信息技术 (IT)、远程医疗和医疗技术组织。我们调查了混合服务的发展对未来实体建筑环境和虚拟技术平台设计的影响。我们的研究结果强调了在开发混合医疗服务时进行灵活设计的重要性,同时利用建筑环境和数字平台的协同作用来支持未来的医疗模式。除了探索加速医疗保健系统灵活性的可扩展性潜力,我们还强调了目前在专业、管理、物流和经济医疗保健模式方面存在的障碍。
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引用次数: 0
Eye tracking technology in medical practice: a perspective on its diverse applications. 眼动追踪技术在医疗实践中的应用
Pub Date : 2023-11-17 eCollection Date: 2023-01-01 DOI: 10.3389/fmedt.2023.1253001
Mohammed Tahri Sqalli, Begali Aslonov, Mukhammadjon Gafurov, Nurmukhammad Mukhammadiev, Yahya Sqalli Houssaini

Eye tracking technology has emerged as a valuable tool in the field of medicine, offering a wide range of applications across various disciplines. This perspective article aims to provide a comprehensive overview of the diverse applications of eye tracking technology in medical practice. By summarizing the latest research findings, this article explores the potential of eye tracking technology in enhancing diagnostic accuracy, assessing and improving medical performance, as well as improving rehabilitation outcomes. Additionally, it highlights the role of eye tracking in neurology, cardiology, pathology, surgery, as well as rehabilitation, offering objective measures for various medical conditions. Furthermore, the article discusses the utility of eye tracking in autism spectrum disorders, attention-deficit/hyperactivity disorder (ADHD), and human-computer interaction in medical simulations and training. Ultimately, this perspective article underscores the transformative impact of eye tracking technology on medical practice and suggests future directions for its continued development and integration.

眼动追踪技术已经成为医学领域的一种有价值的工具,在各个学科中提供了广泛的应用。这篇观点文章旨在全面概述眼动追踪技术在医疗实践中的各种应用。通过总结最新的研究成果,本文探讨了眼动追踪技术在提高诊断准确性、评估和改善医疗绩效以及改善康复效果方面的潜力。此外,它还强调了眼动追踪在神经病学、心脏病学、病理学、外科以及康复中的作用,为各种医疗条件提供了客观的衡量标准。此外,本文还讨论了眼动追踪在自闭症谱系障碍、注意缺陷/多动障碍(ADHD)以及医学模拟和训练中的人机交互中的应用。最后,这篇观点文章强调了眼动追踪技术对医疗实践的变革性影响,并提出了其持续发展和整合的未来方向。
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引用次数: 0
Feasibility of Parylene C for encapsulating piezoelectric actuators in active medical implants. 聚对二甲苯在主动医疗植入物中封装压电驱动器的可行性。
Pub Date : 2023-11-17 eCollection Date: 2023-01-01 DOI: 10.3389/fmedt.2023.1211423
Alina Kohler, Felix Blendinger, Sonja Müller, Ulrich Mescheder, Volker Bucher

Parylene C is well-known as an encapsulation material for medical implants. Within the approach of miniaturization and automatization of a bone distractor, piezoelectric actuators were encapsulated with Parylene C. The stretchability of the polymer was investigated with respect to the encapsulation functionality of piezoelectric chips. We determined a linear yield strain of 1% of approximately 12-µm-thick Parylene C foil. Parylene C encapsulation withstands the mechanical stress of a minimum of 5×105 duty cycles by continuous actuation. The experiments demonstrate that elongation of the encapsulation on piezoelectric actuators and thus the elongation of Parylene C up to 0.8 mm are feasible.

聚对二甲苯是一种众所周知的医用植入物的封装材料。为了实现骨牵张器的小型化和自动化,将压电驱动器封装在聚对二甲苯c中,研究了聚合物的可拉伸性,并对压电芯片的封装功能进行了研究。我们确定了约12微米厚的聚对二甲苯C箔的线性屈服应变为1%。通过连续驱动,聚对二甲苯封装承受最小5×105占空比的机械应力。实验表明,在压电致动器上延长包封率,从而使聚对二甲苯的延伸率达到0.8 mm是可行的。
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引用次数: 0
Cardiovascular medtech: the grand challenge of computer simulations 心血管医疗技术:计算机模拟的巨大挑战
Pub Date : 2023-11-13 DOI: 10.3389/fmedt.2023.1304223
Stéphane Avril
SPECIALTY GRAND CHALLENGE article Front. Med. Technol., 13 November 2023Sec. Cardiovascular Medtech Volume 5 - 2023 | https://doi.org/10.3389/fmedt.2023.1304223
专业大挑战文章前沿。地中海,抛光工艺。2023年11月13日心血管医疗技术卷5 - 2023 | https://doi.org/10.3389/fmedt.2023.1304223
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引用次数: 0
Editorial: Innovative medical technology based on artificial cells, including its different configurations. 社论:基于人造细胞的创新医疗技术,包括其不同的结构。
Pub Date : 2023-11-10 eCollection Date: 2023-01-01 DOI: 10.3389/fmedt.2023.1306419
Thomas Ming Swi Chang
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引用次数: 0
Harnessing artificial intelligence in radiology to augment population health 利用放射学中的人工智能来增强人口健康
Pub Date : 2023-11-08 DOI: 10.3389/fmedt.2023.1281500
Jordan Z. T. Sim, K. N. Bhanu Prakash, Wei Min Huang, Cher Heng Tan
This review article serves to highlight radiological services as a major cost driver for the healthcare sector, and the potential improvements in productivity and cost savings that can be generated by incorporating artificial intelligence (AI) into the radiology workflow, referencing Singapore healthcare as an example. More specifically, we will discuss the opportunities for AI in lowering healthcare costs and supporting transformational shifts in our care model in the following domains: predictive analytics for optimising throughput and appropriate referrals, computer vision for image enhancement (to increase scanner efficiency and decrease radiation exposure) and pattern recognition (to aid human interpretation and worklist prioritisation), natural language processing and large language models for optimising reports and text data-mining. In the context of preventive health, we will discuss how AI can support population level screening for major disease burdens through opportunistic screening and democratise expertise to increase access to radiological services in primary and community care.
这篇综述文章旨在强调放射服务是医疗保健部门的主要成本驱动因素,以及通过将人工智能(AI)纳入放射工作流程可以提高生产力和节省成本的潜在改进,并以新加坡医疗保健为例。更具体地说,我们将讨论人工智能在降低医疗成本和支持我们在以下领域的护理模式转型方面的机会:用于优化吞吐量和适当转诊的预测分析,用于图像增强的计算机视觉(以提高扫描仪效率并减少辐射暴露)和模式识别(以帮助人类解释和工作列表优先级),用于优化报告和文本数据挖掘的自然语言处理和大型语言模型。在预防性卫生方面,我们将讨论人工智能如何通过机会性筛查支持人口层面的重大疾病负担筛查,并使专业知识民主化,以增加初级和社区保健中获得放射服务的机会。
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引用次数: 0
Editorial: Advances in cardiovascular medical technology. 社论:心血管医学技术的进步。
Pub Date : 2023-10-30 eCollection Date: 2023-01-01 DOI: 10.3389/fmedt.2023.1309784
Kevin Willy, Philipp Maximilian Doldi
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引用次数: 0
Accessible art in healthcare facilities: exploring perspectives of healthcare art for visually impaired people. 医疗机构中的无障碍艺术:探索视障人士医疗艺术的视角。
Pub Date : 2023-10-23 eCollection Date: 2023-01-01 DOI: 10.3389/fmedt.2023.1205361
Daryia Palityka, Evangelia Chrysikou, Niamh Murtagh

Introduction: Art in healthcare facilities shows promising results in improving patients' health and well-being and, as such, meets the WHO's definition of health technology. Yet, it remains unclear if healthcare art equally benefits all users. Given the growing number of visually impaired people (VIP), it is valuable to determine whether healthcare art is accessible to VIP and to explore strategies for improving it.

Methods: This study employed a mixed methodology, which included (1) secondary research of 25 cases of healthcare art programmes to identify the presence of accessible art in healthcare facilities and the practices that influence it; (2) review of thirty-one Health Building Notes and four supplementary British guidelines on healthcare art to discover if the accessibility of art is required and identify which recommendations influence it; and (3) interview surveys of healthcare art practitioners from three London NHS Trusts to identify opportunities to increase arts accessibility.

Results and discussion: The evidence showed that healthcare art programmes were mostly inaccessible to VIP. Most healthcare art programmes did not involve VIP in the commissioning process and, thus, lacked procedures that could facilitate accessibility. There were not enough recommendations in the healthcare facility guidelines to support the accessibility of arts for VIP. The recommendations on artwork in healthcare facility guidelines could increase accessibility if particular conditions were met. Interviews with NHS trusts in London revealed numerous opportunities to improve arts accessibility for healthcare art programmes.

简介:医疗设施中的艺术在改善患者健康和福祉方面显示出有希望的结果,因此符合世界卫生组织对卫生技术的定义。然而,目前尚不清楚医疗保健艺术是否同样惠及所有用户。鉴于视障人士(VIP)的数量不断增加,确定VIP是否可以获得医疗保健艺术并探索改善策略是有价值的。方法:本研究采用了混合方法,其中包括(1)对25个医疗保健艺术项目案例进行二次研究,以确定医疗保健设施中存在无障碍艺术以及影响无障碍艺术的实践;(2) 审查三十一份《健康建筑笔记》和四份关于医疗艺术的英国补充指南,以确定是否需要艺术的可及性,并确定哪些建议会对其产生影响;以及(3)对三家伦敦NHS信托基金的医疗保健艺术从业者进行访谈调查,以确定增加艺术可及性的机会。结果和讨论:有证据表明,VIP大多无法参加医疗艺术节目。大多数医疗保健艺术项目在委托过程中没有VIP参与,因此缺乏便于访问的程序。医疗机构指南中没有足够的建议来支持VIP获得艺术。如果满足特定条件,医疗机构指南中关于艺术品的建议可以提高可及性。对伦敦NHS信托机构的采访揭示了许多改善医疗艺术项目艺术可及性的机会。
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引用次数: 0
A di-electrophoretic simulation procedure of iron-oxide micro-particle drug attachment system for leukemia treatment using COMSOL software: a potential treatment reference for LMICs. 使用COMSOL软件的氧化铁微粒药物附着系统用于白血病治疗的双电泳模拟程序:LMIC的潜在治疗参考。
IF 2.7 Q3 ENGINEERING, BIOMEDICAL Pub Date : 2023-10-12 eCollection Date: 2023-01-01 DOI: 10.3389/fmedt.2023.1250964
Henry Fenekansi Kiwumulo, Haruna Muwonge, Charles Ibingira, Michael Lubwama, John Baptist Kirabira, Robert Tamale Ssekitoleko

Background: Leukemia encompasses various subtypes, each with unique characteristics and treatment approaches. The challenge lies in developing targeted therapies that can effectively address the specific genetic mutations or abnormalities associated with each subtype. Some leukemia cases may become resistant to existing treatments over time making them less susceptible to chemotherapy or other standard therapies.

Objective: Developing new treatment strategies to overcome resistance is an ongoing challenge particularly in Low and Middle Income Countries (LMICs). Computational studies using COMSOL software could provide an economical, fast and resourceful approach to the treatment of complicated cancers like leukemia.

Methods: Using COMSOL Multiphysics software, a continuous flow microfluidic device capable of delivering anti-leukemia drugs to early-stage leukemia cells has been computationally modeled using dielectrophoresis (DEP).

Results: The cell size difference enabled the micro-particle drug attachment to the leukemia cells using hydrodynamic focusing from the dielectrophoretic force. This point of care application produced a low voltage from numerically calculated electrical field and flow speed simulations.

Conclusion: Therefore, such a dielectrophoretic low voltage application model can be used as a computational treatment reference for early-stage leukemia cells with an approximate size of 5 μm.

背景:白血病包括各种亚型,每种亚型都有其独特的特征和治疗方法。挑战在于开发能够有效解决与每种亚型相关的特定基因突变或异常的靶向疗法。随着时间的推移,一些白血病患者可能会对现有的治疗方法产生耐药性,从而降低他们对化疗或其他标准治疗的敏感性。目标:制定新的治疗策略以克服耐药性是一项持续的挑战,尤其是在中低收入国家。使用COMSOL软件进行的计算研究可以为治疗白血病等复杂癌症提供一种经济、快速、足智多谋的方法。方法:利用COMSOL Multiphysics软件,利用介电泳(DEP)对一种能够向早期白血病细胞输送抗白血病药物的连续流微流体装置进行了计算建模。这种护理点应用通过数值计算的电场和流速模拟产生了低电压。结论:因此,这种介电泳低电压应用模型可以作为大小约为5的早期白血病细胞的计算治疗参考 μm。
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