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

References

• European Commission. Questions and Answers: commission proposes an extension of the transitional periods for the application of the Medical Devices Regulation. [Internet]. European Commission. Available from: https://ec.europa.eu/commission/presscorner/detail/en/qanda_23_24
   Google Scholar
• Ramakrishna S, Tian L, Wang C, et al. Medical devices: regulations, standards and practices. Cambridge: Woodhead Publishing, an imprint of Elsevier; 2015.
   Google Scholar
• McCulloch P. The EU’s system for regulating medical devices. BMJ. 2012;345(1):e7126–6–e7126. doi: 10.1136/bmj.e7126.
   Google Scholar
• MedTech Europe. The European medical technology industry in figures 2020 [Internet]. MedTech Europe; 2020. Available from: https://www.medtecheurope.org/wp-content/uploads/2020/05/The-European-Medical-Technology-Industry-in-figures-2020.pdf
   Google Scholar
• Takeda K, Tanino G, Miyasaka H. Review of devices used in neuromuscular electrical stimulation for stroke rehabilitation. Med Devices (Auckl). 2017;10:207–213. doi: 10.2147/MDER.S123464.
   PubMedGoogle Scholar
• Liberson WT. Functional electrotherapy. Trans Am Soc Artif Intern Organs. 1962;8(1):373–377. doi: 10.1097/00002480-196204000-00075.
   PubMedGoogle Scholar
• Duffy JR. Motor speech disorders: substrates, differential diagnosis, and management. St. Louis (MO): Elsevier Mosby; 2013.
   Google Scholar
• Emerson J, Enderby P. Does speech and language therapy work. London: Whurr; 1995.
   Google Scholar
• Yorkston KM. Treatment efficacy. J Speech Lang Hear Res. 1996;39(5):S46–S57. doi: 10.1044/jshr.3905.s46.
   Google Scholar
• Chiaramonte R, Pavone P, Vecchio M. Speech rehabilitation in dysarthria after stroke: a systematic review of the studies. Eur J Phys Rehabil Med. 2020;56(5):547–562. doi: 10.23736/S1973-9087.20.06185-7.
   PubMed Web of Science ®Google Scholar
• Mitchell C, Bowen A, Tyson S, et al. Interventions for dysarthria due to stroke and other adult-acquired, non-progressive brain injury. Cochrane Database Syst Rev. 2017;1(1):CD002088. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6464736/ doi: 10.1002/14651858.CD002088.pub3.
   PubMedGoogle Scholar
• Balzan P, Tattersall C, Palmer R. Non-invasive brain stimulation for treating neurogenic dysarthria: a systematic review. Ann Phys Rehabil Med. 2022;65(5):101580. doi: 10.1016/j.rehab.2021.101580.
   PubMed Web of Science ®Google Scholar
• Smith A. The control of orofacial movements in speech. Crit Rev Oral Biol Med. 1992;3(3):233–267. doi: 10.1177/10454411920030030401.
   PubMedGoogle Scholar
• Manske RC, Reiman MP. Muscle weakness. In: Cameron MH, Monroe LG, editors. Physical rehabilitation: evidence-Based examination, evaluation, and intervention. St. Louis, (MI): saunders, Elsevier; 2007. p. 64–86.
   Google Scholar
• Auchstaetter N, Luc J, Lukye S, et al. Physical therapists’ use of functional electrical stimulation for clients with stroke: frequency, barriers, and facilitators. Phys Ther. 2016;96(7):995–1005. doi: 10.2522/ptj.20150464.
   PubMed Web of Science ®Google Scholar
• Abouzakhm N, Choy S, Feld R, et al. Evaluating the validity of a functional electrical stimulation clinical decision making tool: a qualitative study. Front Neurol. 2022;13:1001123. doi: 10.3389/fneur.2022.1001123.
   PubMed Web of Science ®Google Scholar
• O'Connor D, Lennon O, Minogue C, et al. Design considerations for the development of neuromuscular electrical stimulation (NMES) exercise in cancer rehabilitation. Disabil Rehabil. 2021;43(21):3117–3126. doi: 10.1080/09638288.2020.1726510.
   PubMed Web of Science ®Google Scholar
• O'Connor D, Lennon O, Wright S, et al. Self-directed home-based neuromuscular electrical stimulation (NMES) in patients with advanced cancer and poor performance status: a feasibility study. Support Care Cancer. 2020;28(11):5529–5536. doi: 10.1007/s00520-020-05394-0.
   PubMed Web of Science ®Google Scholar
• Walker DM, Fletcher-Smith J, Sprigg N, et al. Designing a trial of early electrical stimulation to the stroke-affected arm: qualitative findings on the barriers and facilitators. Br J Occup Therapy. 2022;85(3):181–186. doi: 10.1177/03080226211008706.
   Google Scholar
• Santos IC, Gazelle GS, Rocha LA, et al. Medical device specificities: opportunities for a dedicated product development methodology. Expert Rev Med Devices. 2012;9(3):299–311. doi: 10.1586/erd.12.3.
   PubMed Web of Science ®Google Scholar
• Medina LA, Kremer GEO, Wysk RA. Supporting medical device development: a standard product design process model. J Eng Des. 2013;24(2):83–119. doi: 10.1080/09544828.2012.676635.
   Web of Science ®Google Scholar
• Descript. [Internet]. 2021. Available from: https://www.descript.com/tour
   Google Scholar
• QSR International Pty Ltd. NVivo (Version 12). [Internet]. 2018. Available from: https://www.qsrinternational.com/nvivo-qualitative-data-analysis-software/home
   Google Scholar
• Bengtsson M. How to plan and perform a qualitative study using content analysis. NursingPlus Open [Internet]. 2016;2(2):8–14. doi: 10.1016/j.npls.2016.01.001.
   Google Scholar
• European Union. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance.) [Internet]. 2017. Available from: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0745
   Google Scholar
• Ogot MM, Okudan-Kremer G. Engineering design. Bloomington, IN: Trafford Publishing; 2004.
   Google Scholar
• Pietzsch JB, Shluzas LA, Paté-Cornell ME, et al. Stage-Gate process for the development of medical devices. J Med Dev. 2009;3(2):021004-1–021004-15. doi: 10.1115/1.3148836.
   Google Scholar
• Moses H, Dorsey ER, Matheson DHM, et al. Financial anatomy of biomedical research. JAMA. 2005;294(11):1333–1342. doi: 10.1001/jama.294.11.1333.
   PubMed Web of Science ®Google Scholar
• Marešová P, Klímová B, Honegr J, et al. Medical device development process, and associated risks and legislative Aspects-Systematic review. Front Public Health. 2020;8:308. doi: 10.3389/fpubh.2020.00308.
   PubMed Web of Science ®Google Scholar
• Kaplan AV, Baim DS, Smith JJ, et al. Medical device development. Circulation. 2004;109(25):3068–3072. doi: 10.1161/01.CIR.0000134695.65733.64.
   PubMed Web of Science ®Google Scholar
• Everhart AO, Sen S, Stern AD, et al. Association between regulatory submission characteristics and recalls of medical devices receiving 510(k) clearance. JAMA. 2023;[329(2):144–156.
   PubMed Web of Science ®Google Scholar
• Kadakia KT, Beckman AL, Ross JS, et al. Renewing the call for reforms to medical device safety—the case of penumbra. JAMA Intern Med. 2022;182(1):59–65.
   PubMed Web of Science ®Google Scholar
• Feldman MD, Petersen AJ, Karliner LS, et al. Who is responsible for evaluating the safety and effectiveness of medical devices? The role of independent technology assessment. J Gen Intern Med. 2008;23 Suppl 1(Suppl 1):57–63. doi: 10.1007/s11606-007-0275-4.
   PubMedGoogle Scholar
• National Institute for Health and Care Excellence. Transcutaneous neuromuscular electrical stimulation for oropharyngeal dysphagia in adults Interventional procedures guidance Your responsibility Your responsibility [Internet]. 2018. Available from: https://www.nice.org.uk/guidance/ipg634/resources/transcutaneous-neuromuscular-electrical-stimulation-for-oropharyngeal-dysphagia-in-adults-pdf-1899874043109061
   Google Scholar
• Hwang TJ, Sokolov E, Franklin JM, et al. Comparison of rates of safety issues and reporting of trial outcomes for medical devices approved in the European union and United States: cohort study. BMJ. 2016;353:i3323. doi: 10.1136/bmj.i3323.
   PubMed Web of Science ®Google Scholar
• Grandjean PA, Mortimer JT. Recruitment properties of monopolar and bipolar epimysial electrodes. Ann Biomed Eng. 1986;14(1):53–66. doi: 10.1007/BF02364648.
   PubMed Web of Science ®Google Scholar
• Loeb GE. Galvani’s delayed legacy: neuromuscular electrical stimulation. Expert Rev Med Devices. 2005;2(4):379–381. doi: 10.1586/17434440.2.4.379.
   PubMed Web of Science ®Google Scholar
• Rasmussen K, Bero L, Redberg R, et al. Collaboration between academics and industry in clinical trials: cross sectional study of publications and survey of lead academic authors. BMJ. 2018;363:k3654. doi: 10.1136/bmj.k3654.
   PubMedGoogle Scholar
• Euromonitor International. Global Overview of the Pharmaceuticals and Medical Equipment Industry. 2022.
   Google Scholar
• Niemiec E. Will the EU medical device regulation help to improve the safety and performance of medical AI devices? Digit Health. 2022;8:20552076221089079. doi: 10.1177/20552076221089079.
   Web of Science ®Google Scholar
• Garzotto F, Comoretto RI, Dorigo L, et al. Preparing healthcare, academic institutions, and notified bodies for their involvement in the innovation of medical devices under the new european regulation. Expert Rev Med Devices. 2022;19(8):613–621. doi: 10.1080/17434440.2022.2118046.
   PubMed Web of Science ®Google Scholar
• Han JED, Ibrahim H, Aiyegbusi OL, et al. Opportunities and risks of UK medical device reform. Ther Innov Regul Sci. 2022;56(4):596–606. doi: 10.1007/s43441-022-00394-0.
   PubMed Web of Science ®Google Scholar
• Yan D, Vassar R. Neuromuscular electrical stimulation for motor recovery in pediatric neurological conditions: a scoping review. Dev Med Child Neurol. 2021;63(12):1394–1401. doi: 10.1111/dmcn.14974.
   PubMed Web of Science ®Google Scholar
• Centers for Medicare & Medicaid Services. NCD - Neuromuscular Electrical Stimulation (NMES) (160.12) [Internet]. 2006 [cited 2023 Feb 18]. Available from: https://www.cms.gov/medicare-coverage-database/view/ncd.aspx?ncdid=175&ncdver=2
   Google Scholar
• Kirisits A, Redekop WK. The economic evaluation of medical devices. Appl Health Econ Health Policy. 2013;11(1):15–26. doi: 10.1007/s40258-012-0006-9.
   PubMedGoogle Scholar
• Ramsey SD, Luce BR, Deyo R, et al. The limited state of technology assessment for medical devices: facing the issues. Am J Manag Care. 1998;4: SP188–99.
   PubMed Web of Science ®Google Scholar
• Bown CP, Bollyky TJ. How COVID‐19 vaccine supply chains emerged in the midst of a pandemic. World Econ. 2022;45(2):468–522. doi: 10.1111/twec.13183.
   PubMed Web of Science ®Google Scholar
• World Health Organization. Shortage of personal protective equipment endangering health workers worldwide [Internet]. 2020. Available from: https://www.who.int/news/item/03-03-2020-shortage-of-personal-protective-equipment-endangering-health-workers-worldwide
   Google Scholar
• Rubin JP, Neligan P. Plastic surgery. In Aesthetic surgery. Vol. 2. Amsterdam: Elsevier; 2018.
   Google Scholar
• Alamer A, Melese H, Nigussie F. Effectiveness of neuromuscular electrical stimulation on Post-Stroke dysphagia: a systematic review of randomized controlled trials. Clin Interv Aging. 2020;15:1521–1531. doi: 10.2147/CIA.S262596.
   PubMed Web of Science ®Google Scholar
• Kristensen MGH, Busk H, Wienecke T. Neuromuscular electrical stimulation improves activities of daily living Post-Stroke: a systematic review and meta-analysis. Arch Rehabil Res Clin Transl. 2022;4(1):100167. doi: 10.1016/j.arrct.2021.100167.
   PubMedGoogle Scholar
• Mäkelä E, Venesvirta H, Ilves M, et al. Facial muscle reanimation by transcutaneous electrical stimulation for peripheral facial nerve palsy. J Med Eng Technol. 2019;43(3):155–164. doi: 10.1080/03091902.2019.1637470.
   PubMedGoogle Scholar
• Marotta N, Demeco A, Inzitari MT, et al. Neuromuscular electrical stimulation and shortwave diathermy in unrecovered bell palsy. Medicine (Baltimore). 2020;99(8):e19152. doi: 10.1097/MD.0000000000019152.
   PubMed Web of Science ®Google Scholar
• McGettigan P, Golden J, Fryer J, et al. Prescribers prefer people: the sources of information used by doctors for prescribing suggest that the medium is more important than the message. Br J Clin Pharmacol. 2001;51(2):184–189. doi: 10.1111/j.1365-2125.2001.01332.x.
   PubMed Web of Science ®Google Scholar
• Lublóy Á. Factors affecting the uptake of new medicines: a systematic literature review. BMC Health Serv Res. 2014;14:469. doi: 10.1186/1472-6963-14-469.
   PubMed Web of Science ®Google Scholar