Medical Devices: Evidence and Research

Aims and Scope

Editor-in-Chief: Professor Mohamad Bashir

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:
1. Device Development & Innovation: Novel device designs, materials science, bioengineering approaches, and technological advancements
2. Clinical Evaluation: Clinical trials, comparative effectiveness studies, safety and efficacy assessments, and patient-reported outcomes
3. Regulatory Science: Regulatory pathways, approval processes, post-market surveillance, and compliance strategies
4. Health Economics & Outcomes Research: Cost-effectiveness analyses, health technology assessment, and budget impact models
5. Real-World Evidence: Registry data, observational studies, implementation science, and pragmatic trials
6. Device-Related Complications: Adverse events, failure analysis, risk management, and mitigation strategies
7. Digital Health & Connected Devices: Software as medical device (SaMD), artificial intelligence/machine learning applications, remote monitoring, and digital therapeutics
8. 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:
The journal's key focus areas include device trials and outcome studies, human-factors and usability engineering, regulatory science and quality assurance, and the use of real-world data for safety monitoring and performance benchmarking. It also welcomes research into value-based evaluation frameworks, post-market surveillance methodologies, and the integration of digital endpoints into clinical studies. Collectively, these themes position Medical Devices as a platform where innovation meets evidence, improving both device quality and patient outcomes. Specific applications include cardiovascular, respiratory, orthopaedic, neurostimulation, surgical, ophthalmic, dental, and diagnostic devices.

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

Article Types:
The journal publishes:
• Original research articles
• Systematic reviews and meta-analyses
• Clinical trial reports
• Case series and case reports (when demonstrating significant clinical insights)
• Technical notes and device evaluations
• Regulatory perspectives and policy analyses
• Editorials and commentaries
• Letters to the editor

Updated 26 November 2025