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Brain Sciences
Volume 11
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10.3390/brainsci11091247
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Review

Developing a Digital Solution for Remote Assessment in Multiple Sclerosis: From Concept to Software as a Medical Device

by
Anneke van der Walt
1,2,*,
Helmut Butzkueven
1,
Robert K. Shin
3,
Luciana Midaglia
4,
Luca Capezzuto
5,
Michael Lindemann
5,
Geraint Davies
5,
Lesley M. Butler
5,
Cristina Costantino
5 and
Xavier Montalban
6
1
Department of Neuroscience, Central Clinical School, Monash University, Melbourne, VIC 3004, Australia
2
The Alfred, Melbourne, VIC 3004, Australia
3
MedStar Georgetown University Hospital, Washington, DC 20007, USA
4
Servei de Neurologia-Neuroimmunologia, Centre d’Esclerosi Múltiple de Catalunya (Cemcat), Institut de Recerca Vall d’Hebron (VHIR), Hospital Universitari Vall d’Hebron, Universitat Autònoma de Barcelona, 08035 Barcelona, Spain
5
F. Hoffmann-La Roche Ltd., 4070 Basel, Switzerland
6
Multiple Sclerosis Centre of Catalonia (Cemcat), Department of Neurology/Neuroimmunology, Hospital Universitari Vall d’Hebron, Universitat Autònoma de Barcelona, 08035 Barcelona, Spain
*
Author to whom correspondence should be addressed.
Brain Sci. 2021, 11(9), 1247; https://doi.org/10.3390/brainsci11091247
Submission received: 13 August 2021 / Revised: 10 September 2021 / Accepted: 16 September 2021 / Published: 21 September 2021
(This article belongs to the Special Issue Digital Innovation in Multiple Sclerosis Management)
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Abstract

There is increasing interest in the development and deployment of digital solutions to improve patient care and facilitate monitoring in medical practice, e.g., by remote observation of disease symptoms in the patients’ home environment. Digital health solutions today range from non-regulated wellness applications and research-grade exploratory instruments to regulated software as a medical device (SaMD). This paper discusses the considerations and complexities in developing innovative, effective, and validated SaMD for multiple sclerosis (MS). The development of SaMD requires a formalised approach (design control), inclusive of technical verification and analytical validation to ensure reliability. SaMD must be clinically evaluated, characterised for benefit and risk, and must conform to regulatory requirements associated with device classification. Cybersecurity and data privacy are also critical. Careful consideration of patient and provider needs throughout the design and testing process help developers overcome challenges of adoption in medical practice. Here, we explore the development pathway for SaMD in MS, leveraging experiences from the development of Floodlight™ MS, a continually evolving bundled solution of SaMD for remote functional assessment of MS. The development process will be charted while reflecting on common challenges in the digital space, with a view to providing insights for future developers.
Keywords: multiple sclerosis; software as a medical device; digital health; participatory health; monitoring; smartphone-based assessments; clinical validation; technical validation; MS apps; digital health solution development multiple sclerosis; software as a medical device; digital health; participatory health; monitoring; smartphone-based assessments; clinical validation; technical validation; MS apps; digital health solution development

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MDPI and ACS Style

van der Walt, A.; Butzkueven, H.; Shin, R.K.; Midaglia, L.; Capezzuto, L.; Lindemann, M.; Davies, G.; Butler, L.M.; Costantino, C.; Montalban, X. Developing a Digital Solution for Remote Assessment in Multiple Sclerosis: From Concept to Software as a Medical Device. Brain Sci. 2021, 11, 1247. https://doi.org/10.3390/brainsci11091247

AMA Style

van der Walt A, Butzkueven H, Shin RK, Midaglia L, Capezzuto L, Lindemann M, Davies G, Butler LM, Costantino C, Montalban X. Developing a Digital Solution for Remote Assessment in Multiple Sclerosis: From Concept to Software as a Medical Device. Brain Sciences. 2021; 11(9):1247. https://doi.org/10.3390/brainsci11091247

Chicago/Turabian Style

van der Walt, Anneke, Helmut Butzkueven, Robert K. Shin, Luciana Midaglia, Luca Capezzuto, Michael Lindemann, Geraint Davies, Lesley M. Butler, Cristina Costantino, and Xavier Montalban. 2021. "Developing a Digital Solution for Remote Assessment in Multiple Sclerosis: From Concept to Software as a Medical Device" Brain Sciences 11, no. 9: 1247. https://doi.org/10.3390/brainsci11091247

APA Style

van der Walt, A., Butzkueven, H., Shin, R. K., Midaglia, L., Capezzuto, L., Lindemann, M., Davies, G., Butler, L. M., Costantino, C., & Montalban, X. (2021). Developing a Digital Solution for Remote Assessment in Multiple Sclerosis: From Concept to Software as a Medical Device. Brain Sciences, 11(9), 1247. https://doi.org/10.3390/brainsci11091247

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