Certification and Standardization and Market Access of Medical Devices

A special issue of Standards (ISSN 2305-6703). This special issue belongs to the section "Drugs Standards".

Deadline for manuscript submissions: closed (31 December 2023) | Viewed by 2038

Special Issue Editors

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Guest Editor
1. Department Global Health Economics & Policy, University of Kragujevac, 34000 Kragujevac, Serbia
2. Institute of Comparative Economic Studies, Hosei University, Tokyo 102-8160, Japan
Interests: global health; global burden of disease project; big data; health care financing & expenditures; evaluation of policy; programs and health system performance; organisation of health care markets; health economics; emerging markets
Special Issues, Collections and Topics in MDPI journals

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R&D Department, Portuguese Institute of Blood and Transplantation, Avenida Miguel Bombarda, 6, 1000-208 Lisbon, Portugal
Interests: ISO 9001, ISO 15189, ISO/IEC 17025, and ISO 13485 standards; risk-based thinking; CAPA and Pareto-based thinking; biostatistics; quality control techniques in the medical laboratory include selection, verification, validation, internal quality control, external quality assessment/proficiency testing, measurement uncertainty, and reference intervals of results; metrology principles including "Error Approach" (total analytical error and allowable total error) and "Uncertainty Approach" (measurement uncertainty and target uncertainty); sampling techniques; statistical process control; capability indexes and sigma-metrics; CLSI protocols appliance including EP15, EP5, EP21, EP6, EP7, EP12, EP2, EP18, EP23, and EP28
National Human Genome Research Institute, National Institutes of Health, Bethesda, MD 20894, USA
Interests: medical device; epidemiology; pediatrics; immunology; medical informatics
Division of Biology, Chemistry, and Materials Science, Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, MD 20993, USA
Interests: molecular biology, skin; medical devices; cosmetics

Special Issue Information

Dear Colleagues,

MDPI Standards Journal invites you to submit to our new thematic series on ‘Certification and Standardization and Market Access of Medical Devices’.

Health Econometric, Certification, and Standardization research for medical devices continues to lag behind pharmaceuticals across the Globe. Regulatory and reimbursement demands for medical devices are triggering demand for high-quality data, and evidence-based policies that are likely to deliver better quality standards in medical devices. FDA published a few guidance documents pointing out the use of Real-World Evidence (RWE) to support regulatory decision-making referring to pharmaceuticals and medical devices alike. RWE is increasingly disseminated and applied for both synthetic medicines and biologicals. Yet, there are peculiarities in how to generate RWE, tailored for medical devices. Vice versa this process gives impetus to potential barriers toward the broader adoption and exploitation of RWE for medical devices. Furthermore, there are heterogeneous methodological issues associated with the conduct of outcomes research under the umbrella of medical devices, with products ranging from diagnostics to implantable devices, making it difficult to develop a unifying set of standards for the industry. We believe that rapidly growing need to explore the opportunities and challenges of a wide range of health outcomes research in medical devices. These unmet needs in medical care may positively influence accessibility, affordability, and quality of medical devices for ordinary citizens and patients.

Within the current Special Issue of Standards, we invite you to submit high-quality original research articles or reviews presenting novel findings and filling contemporary knowledge gaps. Preference will be given to contributions using longitudinal data such as electronic health records, insurance claims, and health econometric methods. All manuscripts will undergo the journal’s normal peer review process and be subject to an article-processing charge. Manuscripts should be formatted according to our submission guidelines and submitted via the MDPI online submission system. In the submission system please make sure that the correct collection title is chosen from the drop-down list on the 'details' tab. Please also indicate clearly in the covering letter that the manuscript is to be considered for this collection. This series is currently open to new submissions. Manuscripts should be submitted by 31 December 2023.

Prof. Dr. Mihajlo (Michael) Jakovljevic
Dr. Paulo Pereira
Dr. Asiyah Lin
Dr. Diego Rua
Guest Editors

Manuscript Submission Information

Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All submissions that pass pre-check are peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 100 words) can be sent to the Editorial Office for announcement on this website.

Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Standards is an international peer-reviewed open access quarterly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 1000 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

Published Papers (1 paper)

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25 pages, 375 KiB  
Improving the Quality and Utility of Electronic Health Record Data through Ontologies
by Asiyah Yu Lin, Sivaram Arabandi, Thomas Beale, William D. Duncan, Amanda Hicks, William R. Hogan, Mark Jensen, Ross Koppel, Catalina Martínez-Costa, Øystein Nytrø, Jihad S. Obeid, Jose Parente de Oliveira, Alan Ruttenberg, Selja Seppälä, Barry Smith, Dagobert Soergel, Jie Zheng and Stefan Schulz
Standards 2023, 3(3), 316-340; https://doi.org/10.3390/standards3030023 - 15 Sep 2023
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The translational research community, in general, and the Clinical and Translational Science Awards (CTSA) community, in particular, share the vision of repurposing EHRs for research that will improve the quality of clinical practice. Many members of these communities are also aware that electronic [...] Read more.
The translational research community, in general, and the Clinical and Translational Science Awards (CTSA) community, in particular, share the vision of repurposing EHRs for research that will improve the quality of clinical practice. Many members of these communities are also aware that electronic health records (EHRs) suffer limitations of data becoming poorly structured, biased, and unusable out of original context. This creates obstacles to the continuity of care, utility, quality improvement, and translational research. Analogous limitations to sharing objective data in other areas of the natural sciences have been successfully overcome by developing and using common ontologies. This White Paper presents the authors’ rationale for the use of ontologies with computable semantics for the improvement of clinical data quality and EHR usability formulated for researchers with a stake in clinical and translational science and who are advocates for the use of information technology in medicine but at the same time are concerned by current major shortfalls. This White Paper outlines pitfalls, opportunities, and solutions and recommends increased investment in research and development of ontologies with computable semantics for a new generation of EHRs. Full article
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