Guide for Authors

Before submitting a manuscript, authors should ensure that the following items are complete:

•  the manuscript fits the journal's Aims and Scope;

•  the correct article type has been selected;

•  the manuscript follows the relevant structure and formatting requirements;

•  the title page includes complete author, affiliation and corresponding author information;

•  all authors have approved the submitted version;

•  authorship, author order and corresponding author details have been confirmed;

•  the abstract and keywords are included;

•  all tables and figures are cited in the text and uploaded in the required format;

•  figure legends and table titles are complete;

•  supplementary materials are cited and uploaded where applicable;

•  references are accurate and complete;

•  device name, manufacturer or developer, model, version, intended use and regulatory status are reported where applicable;

•  safety, performance, usability, device deficiency and malfunction information is reported where applicable;

•  ethics approval, informed consent, regulatory approval or exemption and trial registration information are provided where applicable;

•  author contributions, competing interests, funding and data availability statements are included;

•  manufacturer, sponsor, funder or technology provider involvement is disclosed where applicable;

•  AI-use disclosure is included where applicable;

•  reporting checklists and flow diagrams are uploaded for relevant study types;

•  permission has been obtained for third-party material;

•  the cover letter has been prepared;

•  all required files have been uploaded to the submission system.

This guide provides essential information for authors preparing manuscripts for submission to the journal. Authors are encouraged to read this guide carefully before submission and to consult the journal's Aims and Scope, Article Types, Open Access and Fees, and Journal Policies pages where applicable.

The journal publishes scholarly work on medical devices, diagnostics, monitoring systems, surgical and interventional technologies, digital health technologies, software-based tools, rehabilitation devices, imaging systems, wearable technologies, medical robotics, device safety, device regulation, translational engineering and related clinical or preclinical research.

Manuscripts that do not meet the journal's requirements may be returned for correction before editorial assessment or peer review. Submission of a manuscript does not guarantee external peer review or acceptance.

Before submitting a manuscript, authors should ensure that the work is suitable for the journal and that all required materials are prepared.

Authors should:

•  read the journal's Aims and Scope to confirm that the manuscript fits the journal's academic focus and target readership;

•  select the appropriate article type and follow the relevant requirements for structure, word limits, references, tables, figures and supplementary materials;

•  ensure that the manuscript is original, has not been formally published previously and is not under consideration by another journal;

•  obtain approval from all authors for the submitted version;

•  ensure that authorship, author order and corresponding author details have been agreed by all authors before submission;

•  prepare all required statements, including ethics approval, informed consent, author contributions, competing interests, funding, data availability, clinical trial     or clinical investigation registration and AI-use statements where applicable;

•  clearly identify the device, system, software, diagnostic tool or technology studied, including manufacturer or developer, model, version, intended use and   regulatory status where applicable;

•  disclose manufacturer, sponsor, funder or technology provider involvement in study design, device development, data access, analysis, interpretation,   manuscript preparation and publication decisions;

•  follow appropriate reporting guidelines according to the study design;

•  obtain permission for any third-party material, including figures, tables, images, videos, screenshots, software interfaces, device diagrams, technical drawings   or substantial text reproduced or adapted from other sources;

•  review the journal's policies on peer review, publication ethics, authorship, research ethics, data availability, use of AI, copyright, licensing and post-publication   updates.

Authors who are unsure whether their manuscript is suitable for the journal may contact the Editorial Office with a pre-submission inquiry. A pre-submission inquiry should include the manuscript title, author list, abstract and a brief explanation of the manuscript's relevance to the journal. A positive response to a pre-submission inquiry does not guarantee peer review or acceptance.

Preprints

The journal considers manuscripts that have been posted on recognized preprint servers, provided that the work has not been formally published and is not under consideration by another journal at the same time.

Authors must disclose any preprint at submission and provide the preprint server name, DOI or link where applicable. If the manuscript is accepted, authors are encouraged to update the preprint record with a citation and link to the final published article.

Online Submission

Manuscripts must be submitted through the journal's online submission system. Authors should create a user account, log in and submit the manuscript following the instructions in the system. Submissions sent by email are generally not considered unless specifically requested by the Editorial Office.

The maximum file size for individual uploaded files is 50 MB, unless otherwise specified by the submission system.

The journal considers several types of manuscripts. Authors should select the article type that best matches the purpose, design and scope of their work.

Detailed requirements for each article type, including word limits, abstract format, reference limits, figure and table limits and required sections, are provided on the Article Types page.

Common article types may include:

Original Research Article

Reports original research findings based on clinical, translational, engineering, preclinical, experimental, usability, diagnostic, methodological or other scholarly research. Original Research Articles should generally include Introduction, Methods, Results and Discussion sections.

Clinical Investigation / Clinical Trial

Reports prospective or retrospective clinical studies involving medical devices, diagnostic tools, surgical or interventional technologies, monitoring systems, software-based tools, digital health technologies, rehabilitation devices or other device-based interventions. Authors should provide ethics approval, registration information, regulatory status and safety reporting where applicable.

Device Evaluation / Validation Study

Reports evaluation, verification, validation or performance testing of a medical device, diagnostic system, software tool, monitoring system, digital health technology or related technology. Authors should describe the test setting, comparator, acceptance criteria, endpoints, validation methods, statistical analysis and limitations.

Bench, Engineering or Preclinical Study

Reports bench testing, engineering validation, simulated-use testing, biomechanical testing, electrical or mechanical testing, phantom studies, cadaveric studies, animal studies, in vitro studies or other preclinical work. Sufficient technical and methodological detail should be provided to support reproducibility.

Software, AI or Digital Health Study

Reports studies of software as a medical device, AI-enabled systems, diagnostic algorithms, prediction models, clinical decision support, mobile health applications, wearable technologies, digital therapeutics or remote monitoring tools. Authors should describe system version, data sources, development and validation methods, performance metrics, human oversight, limitations and safeguards.

Review Article

Provides a comprehensive, balanced and critical overview of a defined topic. Review Articles should synthesize current evidence, identify knowledge gaps and discuss future directions.

Systematic Review and Meta-analysis

Presents a systematic search, selection, appraisal and synthesis of existing evidence. Authors should follow appropriate reporting guidelines and provide protocol registration information where applicable.

Brief Report / Short Communication

Reports concise but significant findings that may not require a full-length article. These submissions should present clear methods, focused results and a well-supported conclusion.

Case Report / Case Series

Describes clinically or scientifically important cases involving medical devices, diagnostics, digital health technologies, adverse events, device performance, device malfunction or device-related clinical decision-making. Written informed consent for publication must be obtained when identifiable patient information, clinical images, videos or case details are included.

Technical Note / Method Article

Describes a novel method, technical improvement, device-related procedure, protocol, workflow, engineering approach, software tool or analytical method relevant to medical device research.

Guideline / Consensus

Provides evidence-based or expert consensus recommendations on a specific topic. The methodology for evidence review, panel composition, conflict-of-interest management, consensus development and recommendation grading should be clearly described.

Editorial / Commentary / Perspective

Presents expert opinion, critical discussion or interpretation of current issues in medical device research, regulation, safety, innovation or clinical translation. These article types are usually commissioned, but unsolicited submissions may be considered at the editors' discretion.

Letter to the Editor

Provides brief comments on articles published in the journal or concise observations of interest to readers.

Manuscripts should be prepared clearly, concisely and consistently. Authors should write for an international scholarly audience and avoid unnecessary jargon, unsupported claims or excessive technical detail that is not essential to understanding the work.

File Format

Manuscripts should be submitted in an editable format, such as Microsoft Word. LaTeX files may be accepted where appropriate. Figures, tables and supplementary materials should be prepared according to the journal's file and formatting requirements.

Title Page

The title page should include:

•  manuscript title;

•  full names of all authors;

•  author affiliations;

•  corresponding author name, email address and full contact details;

•  ORCID iDs, where available;

•  equal contribution or co-corresponding author notes, where applicable;

•  short running title, if required;

•  word count, number of figures, number of tables and number of supplementary files, if requested.

Abstract and Keywords

The abstract should accurately summarize the purpose, methods, main findings and conclusions of the manuscript. Original Research Articles, clinical investigations and device evaluation studies should generally use a structured abstract where required by the article type.

Authors should provide keywords that are specific, searchable and relevant to the manuscript. Standardized terms should be used where appropriate.

Main Text

Original Research Articles should generally include:

•  Introduction;

•  Methods;

•  Results;

•  Discussion;

•  Conclusions, where appropriate.

The Methods section should provide sufficient detail to allow the work to be evaluated and, where applicable, reproduced. Authors should describe study design, setting, participants or specimens, device or system details, comparator, testing conditions, endpoints, statistical methods, software, sample size considerations and analysis plans where relevant.

The Results section should present findings in a logical order, supported by appropriate tables, figures and statistical information. The Discussion should interpret the findings in the context of existing evidence, acknowledge limitations and avoid overstating conclusions.

Device, Software and Technical Details

Where applicable, manuscripts should clearly identify the device, software, system, platform, diagnostic tool or technology studied. Authors should provide the device name, manufacturer or developer, model, version, software or firmware version, intended use, regulatory status and any modifications made for the study.

Authors should avoid promotional language and should not present investigational, prototype, early-stage or limited-validation technology as established clinical practice.

Tables and Figures

Tables and figures should be numbered consecutively in the order in which they are cited in the text. Each table and figure should have a clear title and legend.

Figures should be of sufficient resolution for peer review and publication. Authors should avoid image manipulation that could misrepresent the data. Adjustments to brightness, contrast or color balance must not obscure, eliminate or misrepresent information.

Where figures or tables are reproduced or adapted from another source, authors must obtain appropriate permission and provide proper attribution.

Clinical Images, Device Images and Videos

Clinical images, videos, device-use images, imaging data, monitoring outputs, software screenshots, device diagrams, user-interface screenshots or procedural videos should be anonymized before submission where applicable.

Written consent for publication is required when any patient, participant or case detail may be identifiable. Authors are responsible for obtaining permissions for third-party device images, product images, software interfaces or technical drawings where permission is required.

Supplementary Materials

Supplementary materials should be directly relevant to the manuscript and should support, but not replace, the main text. Supplementary files may include extended methods, additional tables, figures, datasets, checklists, protocols, statistical analysis plans, technical specifications, validation materials, videos, code or other supporting information.

References

References should be accurate, complete and relevant. Authors are responsible for checking all references before submission. References may be formatted according to the journal's reference style, or in any clear and consistent style at initial submission if the journal permits format-free submission. Final accepted manuscripts may be required to conform to the journal's reference style.

Authors should avoid inappropriate citation practices, including excessive self-citation, citation manipulation or citation of unreliable sources.

Language and Style

Manuscripts should be written in clear English. Authors who are not fluent in English may consider professional language editing before submission. Language editing does not guarantee editorial review or acceptance.

Authors should follow appropriate reporting guidelines according to study design and should submit completed checklists where required.

Relevant guidelines may include:

•  CONSORT for randomized trials;

•  SPIRIT for clinical trial protocols;

•  PRISMA for systematic reviews and meta-analyses;

•  STROBE for observational studies;

•  STARD for diagnostic accuracy studies;

•  TRIPOD or TRIPOD+AI for prediction model studies;

•  CARE for case reports;

•  ARRIVE for animal studies;

•  TIDieR for intervention description;

•  SQUIRE for quality improvement studies;

•  CONSORT-AI or SPIRIT-AI for clinical studies involving AI components, where applicable.

Authors should consult the EQUATOR Network to identify the most appropriate reporting guideline for their study design.

Device Identification and Regulatory Status

Manuscripts reporting medical device research should provide clear information about the device, technology or system under study.

Where applicable, authors should report:

•  device, system, software or technology name;

•  manufacturer, developer or provider;

•  model, version, generation, configuration, software or firmware version;

•  intended use and target users;

•  device classification or risk category, where applicable;

• regulatory status, such as approved, cleared, CE-marked, investigational, prototype, research use only or not yet approved for clinical use;

•  whether the device was used within or outside its approved or intended use;

•  whether the device was modified for the study;

•  relevant regulatory approval, notification, exemption or oversight, where required.

Safety and Performance Reporting

Authors should report device safety and performance outcomes transparently. This may include device-related adverse events, device deficiencies, malfunctions, usability issues, operator-related factors, failure modes, software errors, cybersecurity concerns, technical limitations, learning curve effects and any unexpected risks identified during the study.

For clinical studies, authors should clearly distinguish between clinical effectiveness, technical performance, usability, workflow impact and safety outcomes.

For bench, engineering, preclinical, usability or performance validation studies, authors should describe the test conditions, comparator, acceptance criteria, performance endpoints, validation methods and limitations.

Clinical Investigations and Trial Registration

Clinical trials and clinical investigations involving medical devices should be registered in a publicly accessible registry before participant recruitment begins, where applicable. The registry name and registration number should be provided in the manuscript.

Authors should describe applicable ethics approval, regulatory approval, investigational device status, risk classification or exemption where relevant. Studies involving investigational or high-risk devices must comply with applicable institutional, national and regional regulatory requirements.

Manuscripts reporting clinical trials should include a data sharing statement where required by applicable standards or journal policy. The statement should indicate whether de-identified individual participant data will be shared, what data will be shared, whether related documents such as the study protocol or statistical analysis plan will be available, when and for how long data will be available, and the conditions for access.

Software, AI and Digital Health Technologies

For manuscripts involving software as a medical device, AI-enabled devices, diagnostic algorithms, prediction models, clinical decision support systems, digital therapeutics, mobile health applications, wearable devices or remote monitoring systems, authors should describe:

•  intended use and clinical context;

•  system version and update status;

•  development and validation datasets;

•  data sources and data governance;

• performance metrics and statistical uncertainty;

•  external validation, where available;

•  human oversight and workflow integration;

•  cybersecurity, privacy and safety considerations;

•  limitations, failure modes and potential risks.

Authors must include all statements required by the journal and applicable policies. These statements should usually appear in the manuscript file, title page, acknowledgements section or submission system, according to the journal's instructions.

Required statements may include:

Ethics Approval

Studies involving human participants, human data, human tissue, animals, cadaveric specimens or identifiable clinical information must include the name of the ethics committee, institutional review board or relevant authority, approval number or reference, and any relevant exemption information.

Regulatory Approval or Exemption

For studies involving investigational devices, modified devices, device-based interventions, software medical devices or other regulated technologies, authors should state the applicable regulatory approval, notification, exemption, risk classification or oversight where required by relevant laws and institutional policies.

Informed Consent

For studies involving human participants, authors should state whether informed consent was obtained. For identifiable patient information, case details, clinical images, device-use images, videos, monitoring data or any other identifiable material, written consent for publication must be obtained.

Clinical Trial or Clinical Investigation Registration

Clinical trials and clinical investigations should provide the registry name and registration number where applicable. Registration should occur before participant recruitment begins.

Author Contributions

Authors should describe each author's contribution to the work. The journal encourages use of the CRediT taxonomy where appropriate.

Competing Interests

All authors must disclose any financial or non-financial competing interests. For medical device research, relevant disclosures may include employment, consultancy, advisory roles, stock ownership, patents, patent applications, royalties, licensing agreements, device donation or loan, sponsored testing, technical support, statistical support, writing assistance, data access arrangements or relationships with device manufacturers, software developers, distributors or sponsors.

Funding

Authors should disclose all funding sources and grant numbers. The role of funders, sponsors or manufacturers in study design, device development, data collection, data access, analysis, interpretation, manuscript preparation and the decision to submit should be stated. If the work received no specific funding, this should also be declared.

Data Availability

Authors should include a Data Availability Statement describing where the data supporting the findings can be accessed or explaining why data cannot be shared. For clinical studies, authors should ensure that shared data are appropriately de-identified and consistent with ethics approval, informed consent and applicable data protection requirements.

Use of AI and AI-assisted Technologies

AI tools and large language models cannot be listed as authors. Authors remain responsible for the accuracy, originality and integrity of all submitted content.

Use of generative AI or AI-assisted technologies beyond basic language editing should be disclosed according to the journal's AI policy. Authors should identify the tool used, describe how it was used and verify all AI-assisted content, including references, factual claims and generated text.

Acknowledgements

Individuals or organizations that contributed to the work but do not meet authorship criteria should be acknowledged with their permission.

Manuscripts should be submitted through the journal's online submission system. Submissions sent by email are generally not considered unless specifically requested by the Editorial Office.

During submission, authors may be asked to provide:

•  manuscript title and abstract;

•  author names, affiliations and email addresses;

•  corresponding author details;

•  article type;

•  keywords;

•  cover letter;

•  manuscript file;

•  figures, tables and supplementary files;

•  required statements and declarations;

•  reporting checklists;

•  suggested or opposed reviewers, where permitted;

•  funding and competing interest information.

The cover letter should briefly explain the importance of the work, its relevance to the journal and why it may be of interest to the journal's readership. Authors should also disclose any related manuscripts, previous submissions, preprints, trial or clinical investigation registry records, regulatory reports or overlapping work.

Authors may suggest potential reviewers where permitted by the submission system. Reviewer selection remains at the editors' discretion. Suggested reviewers must be independent and free from conflicts of interest.

After submission, the corresponding author will receive confirmation from the submission system. The Editorial Office may contact the corresponding author if required information is missing or if files need correction before editorial assessment.

If revision is invited, authors should submit the revised manuscript within the deadline stated in the decision letter. Extensions may be requested from the Editorial Office where necessary.

A revised submission should usually include:

•  a clean version of the revised manuscript;

•  a marked-up or tracked-changes version showing revisions;

•  a detailed point-by-point response to all editor and reviewer comments;

•  revised figures, tables or supplementary materials, where applicable;

•  updated declarations or statements, if any changes have been made.

Authors should respond to each comment respectfully and clearly. Where authors disagree with a reviewer or editor comment, they should provide a reasoned explanation supported by evidence where appropriate.

Submission of a revised manuscript does not guarantee acceptance. Revised manuscripts may be returned to reviewers, assessed by the editors or declined if concerns have not been adequately addressed.

After acceptance, authors may be required to complete a publishing agreement, confirm copyright and licensing arrangements, select open access options where applicable and pay any applicable publication charges.

The corresponding author will receive proofs for review before publication. Proof corrections should be limited to typographical errors, formatting issues and factual corrections. Substantial changes to the content, authorship, data, analysis or conclusions after acceptance may require editorial approval.

Accepted articles may be published online before assignment to an issue, where applicable. The final published article will be assigned a DOI.

After publication, authors may share their article according to the journal's article sharing and self-archiving policies. Requests for corrections, retractions, expressions of concern or other post-publication updates will be handled according to the journal's relevant policies.