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

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.

IMPLICATIONS FOR REHABILITATION

• The mapped neuromuscular electrical stimulation (NMES) development phases and processes can serve as a framework for new device development initiatives

• Opportunities for NMES development included its adaptability to neurological disorders, its growth prospects, academia-industry relationships and regulatory standardisation initiatives

• Financial, political, regulatory, and natural barriers were barriers for concern.

• From an anatomical and practical standpoint, it seems feasible to use NMES to treat several features of acquired dysarthria, however, clinicians’ limited education on the use of electrical stimulation for neurorehabilitation may pose several constraints.

Keywords:

• Neurorehabilitation
• medical devices
• electrical stimulation
• dysarthria
• development

Acknowledgments

We thank the research participants for their valuable time and expertise in the field of transcutaneous NMES.

Disclosure statement

The authors report there are no competing interests to declare.

Additional information

Funding

The author(s) reported there is no funding associated with the work featured in this article.

Notes on contributors

Pasquale Balzan

Pasquale Balzan is a PhD researcher at the Division of Human Communication Sciences of the University of Sheffield. His research focuses on the potential use of transcutaneous neuromuscular electrical stimulation for dysarthria treatment.

Catherine Tattersall

Catherine Tattersall is a senior university teacher at the School of Allied Health Professions, Nursing, and Midwifery of the University of Sheffield and leads the specialist motor speech disorders clinic at the university. She earned her PhD in object naming at the University of York and completed a research fellowship on aphasia in Philadelphia, USA.

Rebecca Palmer

Rebecca Palmer is a professor in communication and stroke rehabilitation at the University of Sheffield. She holds a PhD in dysarthria treatment using speech recognition technology, was the chief investigator of the Big CACT US trial investigating the clinical and cost-effectiveness of aphasia computer treatment, and currently leads the NIHR-funded Aphasia Partnership Training (AP T) project, focused on communication partner training for individuals with aphasia and their families.

Michael Murray

Michael Murray is an Entrepreneur in Residence at the University of Sheffield. He is a dealmaker and commercial intellectual property (IP) specialist working in technology transfer in the biopharmaceutical industry.