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Prosthesis
Special Issues
Regulatory Data Science for Medical Devices
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Regulatory Data Science for Medical Devices

A special issue of Prosthesis (ISSN 2673-1592).

Deadline for manuscript submissions: closed (30 August 2021) | Viewed by 24546

Printed Edition Available!
A printed edition of this Special Issue is available here.

Special Issue Editor

Prof. Dr. Jeroen Bergmann

E-Mail Website
Guest Editor
Department of Engineering Science, University of Oxford, Oxford OX1 3PJ, UK
Interests: prosthesis; regulatory data science; medical devices

Special Issue Information

Dear Colleagues,

This Special Issue covers works that will be presented during the Oxford Regulatory Science Conference 2021 (ORSC21). Please visit www.in-li.org for more information on the conference.

Quantitative science for medical device regulations is an emerging field. The research focuses on applying quantitative methods to create new evidence, tools, methods/algorithms, guidance, quality management, and standards, with the purpose to progress the evaluation of medical technologies. The aim is to improve the safety, quality, efficacy, and performance of medical devices by providing cutting-edge quantitative science that can inform policies and processes. The impact of regulatory science is shown in the critical function that regulations play in bringing new technologies to market. The ability to place and keep relevant technologies on the market is essential for patient impact. Quantitative regulatory science can also assist regulatory bodies, by informing them about new evidence on process, guidance, or standards for technologies. Research can facilitate more transparent regulatory decision making for novel medical technologies and highlight problems that should be addressed. This journal will also cover regulatory research related to software as medical devices, including studies related to machine learning and artificial intelligence for medical use. The science in this area can be leveraged to aid harmonisation of global medical device regulations. Interdisciplinary research in this domain will create large-scale economic, social, and clinical impact. In the digital era, we believe that data-driven insights will be imperative to furthering the work currently being conducted within regulations for medical technology, and this journal will provide great value to all the regulatory stakeholders.

Prof. Dr. Jeroen Bergmann
Guest Editor

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. Prosthesis is an international peer-reviewed open access semimonthly 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 1600 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.

Keywords

  • medical device regulation
  • medical technology
  • data science
  • patient safety
  • medical software

Published Papers (6 papers)

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3 pages, 176 KiB  
Editorial
The Emerging Field of Medical Regulatory Technology and Data Science
by Jeroen H. M. Bergmann
Prosthesis 2022, 4(2), 169-171; https://0-doi-org.brum.beds.ac.uk/10.3390/prosthesis4020017 - 09 Apr 2022
Cited by 3 | Viewed by 1629
Abstract
Regulations contain rules setup by (governmental) authorities to control specific aspects of certain industries, which often influences the way companies operate [...] Full article
(This article belongs to the Special Issue Regulatory Data Science for Medical Devices)
17 pages, 1375 KiB  
Article
The Complexity of Medical Device Regulations Has Increased, as Assessed through Data-Driven Techniques
by Arthur Arnould, Rita Hendricusdottir and Jeroen Bergmann
Prosthesis 2021, 3(4), 314-330; https://0-doi-org.brum.beds.ac.uk/10.3390/prosthesis3040029 - 28 Sep 2021
Cited by 9 | Viewed by 3177
Abstract
Medical device regulations are dynamic, as they need to cover an ever changing landscape. In Europe this has led to a new set of regulations (both for Medical Devices and In Vitro Diagnostics), which replaced the old rules. This study is interested in [...] Read more.
Medical device regulations are dynamic, as they need to cover an ever changing landscape. In Europe this has led to a new set of regulations (both for Medical Devices and In Vitro Diagnostics), which replaced the old rules. This study is interested in how the complexity of these medical regulations changed over time and if additional time-based metrics can be associated with any of the complexity metrics. Complexity is defined in terms of readability of the text and it is computed using established linguistic measures, as well as Halstead complexity scores. It was shown that the regulatory complexity of new EU medical device regulations was higher than their predecessors, especially when Halstead complexity measures were considered. The complexity metrics obtained for the new regulations were subsequently associated with the time it took to consider these regulations. Only very weak Pearson’s correlation coefficients were found between the complexity scores and the obtained response times for the new regulations. This could indicate that there are issues with how complexity is perceived by those that need to apply these regulations. Taking the complexity of regulations into account can greatly help with the development of more user friendly regulations. The results from the data-driven methods that are applied in this research indicate that governments could benefit from focusing on making regulations more accessible and utilitarian. This would improve the stakeholder adherence and facilitate effective implementation. This work also highlighted the need to develop more suitable methods to analyse regulatory text to further inform the wider research community. Full article
(This article belongs to the Special Issue Regulatory Data Science for Medical Devices)
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12 pages, 1204 KiB  
Article
Using Rule-Based Decision Trees to Digitize Legislation
by Henry R. F. Mingay, Rita Hendricusdottir, Aaron Ceross and Jeroen H. M. Bergmann
Prosthesis 2022, 4(1), 113-124; https://0-doi-org.brum.beds.ac.uk/10.3390/prosthesis4010012 - 10 Mar 2022
Cited by 2 | Viewed by 3646
Abstract
This article introduces a novel approach to digitize legislation using rule based-decision trees (RBDTs). As regulation is one of the major barriers to innovation, novel methods for helping stakeholders better understand, and conform to, legislation are becoming increasingly important. Newly introduced medical device [...] Read more.
This article introduces a novel approach to digitize legislation using rule based-decision trees (RBDTs). As regulation is one of the major barriers to innovation, novel methods for helping stakeholders better understand, and conform to, legislation are becoming increasingly important. Newly introduced medical device regulation has resulted in an increased complexity of regulatory strategy for manufacturers, and the pressure on notified body resources to support this process is making this an increasing concern in industry. This paper explores a real-world classification problem that arises for medical device manufacturers when they want to be certified according to the In Vitro Diagnostic Regulation (IVDR). A modification to an existing RBDT algorithm is introduced (RBDT-1C) and a case study demonstrates how this method can be applied. The RBDT-1C algorithm is used to design a decision tree to classify IVD devices according to their risk-based classes: Class A, Class B, Class C and Class D. The applied RBDT-1C algorithm demonstrated accurate classification in-line with published ground-truth data. This approach should enable users to better understand the legislation, has informed policy makers about potential areas for future guidance, and allowed for the identification of errors in the regulations that have already been recognized and amended by the European Commission. Full article
(This article belongs to the Special Issue Regulatory Data Science for Medical Devices)
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7 pages, 492 KiB  
Communication
Medical Device Regulation from a Health Service Provider’s Perspective
by Man Ting Kwong, David Stell and Emmanuel Akinluyi
Prosthesis 2021, 3(3), 261-266; https://0-doi-org.brum.beds.ac.uk/10.3390/prosthesis3030025 - 14 Sep 2021
Cited by 4 | Viewed by 3518
Abstract
Unfamiliarity with medical device regulations can sometimes be a barrier to deploying technology in a clinical setting for researchers and innovators. Health service providers recognise that innovation can happen within smaller organisations, where regulatory support may be limited. This article sets out to [...] Read more.
Unfamiliarity with medical device regulations can sometimes be a barrier to deploying technology in a clinical setting for researchers and innovators. Health service providers recognise that innovation can happen within smaller organisations, where regulatory support may be limited. This article sets out to increase transparency and outline key considerations on medical device regulations from a UK healthcare provider’s perspective. The framework used by Guy’s and St Thomas’ NHS Foundation Trust (GSTFT) for assessing research devices is presented to give an overview of the routes that R&D medical devices take to enter a clinical setting. Furthermore, current trends on research studies involving medical devices were extracted from the GSTFT internal R&D database and presented as the following categories (i) commercial vs. non-commercial, (ii) assessment type and (iii) software vs. non-software. New medical devices legislation will be introduced within the UK in July 2023. It is anticipated regulating software as a medical device may become more challenging for healthcare providers and device manufacturers alike. It is therefore important for different stakeholders involved to work together to ensure this does not become a barrier to innovation. Full article
(This article belongs to the Special Issue Regulatory Data Science for Medical Devices)
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8 pages, 254 KiB  
Review
Evaluating the Presence of Software-as-a-Medical-Device in the Australian Therapeutic Goods Register
by Aaron Ceross and Jeroen Bergmann
Prosthesis 2021, 3(3), 221-228; https://0-doi-org.brum.beds.ac.uk/10.3390/prosthesis3030022 - 24 Aug 2021
Cited by 9 | Viewed by 3266
Abstract
In recent years, medical device regulatory bodies have recognised software-as-a-medical-device (SaMD) as a distinct subgroup of devices. The field of SaMD has been rapidly evolving and encompasses a range of different digital solutions. Many organisations have now started to look into digital healthcare, [...] Read more.
In recent years, medical device regulatory bodies have recognised software-as-a-medical-device (SaMD) as a distinct subgroup of devices. The field of SaMD has been rapidly evolving and encompasses a range of different digital solutions. Many organisations have now started to look into digital healthcare, as a way to solve key global challenges. However, there remains uncertainty regarding how many of these SaMD products are entering the market and to what extent these systems achieve a desired level of general safety once they are in the market. In this study, we utilise data collected from publicly available databases. The data are evaluated for trends and a descriptive analysis is performed of the recall and adverse events associated specifically with SaMD. We find that there is a significant positive trend (p < 0.05) of SaMD registrations, although the number of SaMD registrations remains relative low compared to non-SaMD. This rise in SaMD registrations coincides with increasing levels of recalls and adverse events. More importantly, it becomes apparent that adverse events notification is not yet fit for purpose with regards to SaMD. Full article
(This article belongs to the Special Issue Regulatory Data Science for Medical Devices)
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18 pages, 293 KiB  
Review
Regulating Environmental Impact of Medical Devices in the United Kingdom—A Scoping Review
by Pranay Arun Kumar
Prosthesis 2021, 3(4), 370-387; https://0-doi-org.brum.beds.ac.uk/10.3390/prosthesis3040033 - 08 Nov 2021
Cited by 4 | Viewed by 7862
Abstract
Medical devices are highly regulated to ensure safety and efficacy of the products and minimize the risk of harm to users and patients. However, the broader impacts of these devices on the environment have scarcely been questioned until recently. The United Kingdom National [...] Read more.
Medical devices are highly regulated to ensure safety and efficacy of the products and minimize the risk of harm to users and patients. However, the broader impacts of these devices on the environment have scarcely been questioned until recently. The United Kingdom National Health Service intends to achieve a “net zero” emissions service by 2040 and has identified specific targets to achieve through this process. However, medical device manufacturers do not see sufficient incentives to invest in reducing greenhouse gas emissions unless enforced by legislation. Furthermore, there is little evidence on the legislation required to reduce emissions from medical devices. This study addresses the relationship of medical device regulations and the environmental impact of the devices throughout their lifecycle. A scoping review was conducted on academic literature on the topic, followed by a critical review of the current medical device regulations and associated guidelines in the United Kingdom. The challenges to regulating environmental impact of medical devices were identified under seven themes. These challenges were contextualized with the National Health Service target of achieving zero emissions by 2040. The review indicates that current guidelines support single-use disposal of devices and equipment as the best approach to prevent pathogen transmission and landfilling and incineration are the most used waste management strategies. Manufacturers need to be guided and educated on reducing their emissions while ensuring the development of safe and effective devices. Full article
(This article belongs to the Special Issue Regulatory Data Science for Medical Devices)
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