Medical Devices Evidence and Research

期刊简介：Medical Devices: Evidence & Research is an international, peer-reviewed journal dedicated to publishing high-quality research that advances the development, evaluation, implementation, and optimisation of medical devices across all clinical specialities. The journal serves as a platform bridging device innovation, clinical evidence, real-world performance, and health technology assessment. We aim to cross-fertilise translational research that moves from bench to bedside, comparative effectiveness studies, post-market surveillance data, patient-centred outcomes, and the integration of emerging technologies, including digital health, artificial intelligence, and precision healthcare. The journal aims to enhance the scientific understanding of medical device performance, safety, and efficacy across various clinical settings. The journal supports translating medical device innovation from laboratory research to clinical application through rigorous clinical evidence, while promoting best practices in medical device assessment, post-market surveillance, and real-world evidence collection. By encouraging interdisciplinary collaboration among engineers, clinicians, regulators, and health economists, the journal offers actionable insights for healthcare professionals, device manufacturers, and policymakers to improve patient care and optimise device-related clinical outcomes. Medical Devices: Evidence & Research publishes high-quality research across the entire medical device lifecycle, from concept and design through clinical implementation and post-market evaluation. The journal welcomes submissions on: Device Development & Innovation : Novel device designs, materials science, bioengineering approaches, and technological advancements Clinical Evaluation : Clinical trials, comparative effectiveness studies, safety and efficacy assessments, and patient-reported outcomes Regulatory Science : Regulatory pathways, approval processes, post-market surveillance, and compliance strategies Health Economics & Outcomes Research : Cost-effectiveness analyses, health technology assessment, and budget impact models Real-World Evidence : Registry data, observational studies, implementation science, and pragmatic trials Device-Related Complications : Adverse events, failure analysis, risk management, and mitigation strategies Digital Health & Connected Devices : Software as medical device (SaMD), artificial intelligence/machine learning applications, remote monitoring, and digital therapeutics Human Factors & Usability : User experience research, design optimisation, and safety considerations. We welcome original research, systematic reviews, meta-analyses, clinical trials, real-world evidence studies, health economics analyses, and innovative methodological papers that contribute to the evidence base for medical device safety, application, efficacy, and effectiveness. The journal particularly encourages submissions that address: Translational device research from early-stage development through clinical implementation Comparative efficacy of devices versus standard care or competing technologies Real-world evidence and post-market performance data Patient-reported outcomes and quality of life assessments related to device use Health technology assessment and cost-effectiveness analyses Regulatory science, including novel approval pathways, post-market surveillance and implementation of policy mandates for service providers Implementation science examining barriers and facilitators to device adoption Human factors and usability engineering in device design Digital health integration, including connected devices, remote monitoring, and device interoperability Artificial intelligence and machine learning applications in medical devices Sustainability and lifecycle assessment of medical device technologies Health equity and access considerations in device development and deployment. Focus Areas of the Journal: Medical Specialities & Device Categories: Cardiovascular devices (stents, pacemakers, heart valves, ventricular assist devices, cardiac monitors) Respiratory & ventilation devices (ventilators, CPAP/BiPAP devices, nebulisers, oxygen delivery systems) Orthopaedic & musculoskeletal devices (joint replacements, spinal implants, fracture fixation devices, back pain management devices) Neurological devices (neurostimulators, brain-computer interfaces, epilepsy devices, deep brain stimulation) Diabetes management devices (glucose monitors, insulin pumps, continuous glucose monitoring systems) Surgical instruments & robotic systems (minimally invasive surgical tools, robotic-assisted surgery, surgical navigation) Diagnostic & imaging devices (ultrasound, MRI/CT innovations, point-of-care diagnostics, wearable sensors) Wound care & tissue engineering devices (negative pressure wound therapy, skin substitutes, regenerative medicine products) Ophthalmic devices (intraocular lenses, glaucoma devices, retinal implants) Renal & dialysis devices (hemodialysis systems, peritoneal dialysis, kidney support technologies) Women's health devices (contraceptive devices, pelvic floor devices, obstetric monitoring) Rehabilitation & assistive devices (prosthetics, orthotics, mobility aids, hearing aids) Drug delivery systems (infusion pumps, transdermal systems, inhalation devices, implantable drug delivery) Infection control & sterilisation devices. Specific Conditions & Clinical Applications: Chronic pain management (back pain, neuropathic pain, chronic regional pain syndrome) Heart failure and arrhythmias Chronic obstructive pulmonary disease (COPD) and sleep apnea Diabetes and metabolic disorders Osteoarthritis and degenerative joint disease Spinal stenosis and disc herniation Stroke prevention and management Peripheral vascular disease and venous insufficiency Urinary incontinence and pelvic organ prolapse Chronic kidney disease and end-stage renal disease Age-related macular degeneration and cataracts Epilepsy and movement disorders Pressure ulcers and chronic wounds Cancer diagnostics and therapeutic devices Sepsis monitoring and management.

【译文】《医疗器械：证据与研究》是一本国际同行评审期刊，致力于发表高质量的研究成果，推动所有临床专业的医疗器械的开发、评估、实施和优化。该杂志是连接设备创新、临床证据、现实世界性能和健康技术评估的平台。我们的目标是交叉促进从实验室到临床的转化研究、比较有效性研究、上市后监测数据、以患者为中心的结果以及新兴技术的整合，包括数字健康、人工智能和精准医疗保健。该杂志旨在增强对各种临床环境中医疗器械性能、安全性和有效性的科学理解。该杂志支持通过严格的临床证据将医疗器械创新从实验室研究转化为临床应用，同时推广医疗器械评估、上市后监测和现实世界证据收集的最佳实践。通过鼓励工程师、临床医生、监管机构和健康经济学家之间的跨学科合作，该杂志为医疗保健专业人员、设备制造商和政策制定者提供了可行的见解，以改善患者护理并优化设备相关的临床结果。医疗器械：证据与研究发布了整个医疗器械生命周期的高质量研究，从概念和设计到临床实施和上市后评估。该杂志欢迎提交以下内容： 器械开发与创新：新型器械设计、材料科学、生物工程方法和技术进步 临床评估：临床试验、比较有效性研究、安全性和功效评估以及患者报告的结果 监管科学：监管途径、审批流程、上市后监督和合规策略 健康经济学和结果研究：成本效益分析、卫生技术评估和预算影响模型 真实世界证据：注册数据、观察研究、实施科学和实用试验 设备相关并发症：不良事件、故障分析、风险管理和缓解策略 数字健康和互联设备：软件即医疗设备 (SaMD)、人工智能/机器学习应用、远程监控和数字疗法 人为因素和可用性：用户体验研究、设计优化和安全考虑。我们欢迎原创研究、系统评价、荟萃分析、临床试验、现实世界证据研究、健康经济学分析和创新方法论论文，这些论文有助于为医疗器械的安全性、应用、功效和有效性提供证据基础。该杂志特别鼓励提交以下内容：从早期开发到临床实施的转化设备研究；设备与标准护理或竞争技术的功效比较；真实世界证据和上市后性能数据；患者报告的结果和与设备使用相关的生活质量评估；健康技术评估和成本效益分析；监管科学，包括新颖的审批途径、上市后监督和服务提供商政策要求的实施；实施科学检查设备采用的障碍和促进因素；设备设计中的人为因素和可用性工程；数字健康集成，包括连接设备、远程监控和设备互操作性 医疗设备中的人工智能和机器学习应用 医疗设备技术的可持续性和生命周期评估 设备开发和部署中的健康公平和访问注意事项。期刊重点领域： 医疗专业和设备类别： 心血管设备（支架、起搏器、心脏瓣膜、心室辅助设备、心脏监护仪） 呼吸和通气设备（呼吸机、CPAP/BiPAP 设备、雾化器、氧气输送系统） 骨科和肌肉骨骼设备（关节置换、脊柱植入物、骨折固定设备、背痛管理设备） 神经设备（神经刺激器、脑机接口、癫痫）设备、深部脑刺激）糖尿病管理设备（血糖监测仪、