Balzan, P., Tattersall, C. orcid.org/0000-0001-9796-7733, Palmer, R. orcid.org/0000-0002-2335-7104 et al. (1 more author) (2024) Mapping the development process of transcutaneous neuromuscular electrical stimulation devices for neurorehabilitation, the associated barriers and facilitators, and its applicability to acquired dysarthria: a qualitative study of manufacturers’ perspectives. Disability and Rehabilitation: Assistive Technology, 19 (5). pp. 1923-1934. ISSN 1748-3107
Abstract
Purpose
The fragmented nature of the medical device market limits our understanding of how particular sub-markets navigate the device development process. Despite the widespread use of transcutaneous neuromuscular electrical stimulation (NMES), its use for acquired dysarthria treatment has not been sufficiently explored. This study aims to provide a preliminary understanding of the stages involved in the development of NMES devices designed for neurorehabilitation. It also aims to investigate manufacturers’ perceptions concerning factors that facilitate or impede its development and determine its applicability for acquired dysarthria.
Materials and methods
In-depth semi-structured online interviews were conducted with eight NMES device manufacturers located across Europe, North America and Oceania. The interviews were video-recorded, automatically transcribed, manually reviewed, and analysed using a qualitative content analysis.
Results
NMES device development for neurorehabilitation involves six complex phases with sequential and overlapping activities. Some emerging concepts were comparable to established medical device models, while others were specific to NMES. Its adaptability to different neurological disorders, the positive academia-industry collaborations, the industry’s growth prospects and the promising global efforts for standardised regulations are all key facilitators for its development. However, financial, political, regulatory, and natural constraints emerged as barriers. Indications and challenges for the applicability of NMES for acquired dysarthria treatment were also discussed.
Conclusion
The findings provide a foundation for further investigations on the NMES market sub-sector, particularly in the context of neurorehabilitation. The study also provides insights into the potential adoption of NMES for acquired dysarthria, which can serve as a reference for future research.
Metadata
Item Type: | Article |
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Authors/Creators: |
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Copyright, Publisher and Additional Information: | © 2023 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. The terms on which this article has been published allow the posting of the Accepted Manuscript in a repository by the author(s) or with their consent. |
Keywords: | Neurorehabilitation; development; dysarthria; electrical stimulation; medical devices; Humans; Dysarthria; Qualitative Research; Neurological Rehabilitation; Transcutaneous Electric Nerve Stimulation; Interviews as Topic |
Dates: |
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Institution: | The University of Sheffield |
Academic Units: | The University of Sheffield > Faculty of Medicine, Dentistry and Health (Sheffield) > Health Sciences School (Sheffield) The University of Sheffield > Faculty of Medicine, Dentistry and Health (Sheffield) > School of Medicine and Population Health |
Depositing User: | Symplectic Sheffield |
Date Deposited: | 08 Aug 2024 16:01 |
Last Modified: | 08 Aug 2024 16:01 |
Status: | Published |
Publisher: | Informa UK Limited |
Refereed: | Yes |
Identification Number: | 10.1080/17483107.2023.2269976 |
Related URLs: | |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:215462 |