Developing a Digital Solution for Remote Assessment in Multiple Sclerosis : From Concept to Software as a Medical Device
van der Walt, Anneke (The Alfred, Melbourne)
Butzkueven, Helmut (Monash University)
Shin, Robert K. (MedStar Georgetown University Hospital)
Midaglia, Luciana (Hospital Universitari Vall d'Hebron)
Capezzuto, Luca (F. Hoffmann-La Roche Ltd)
Lindemann, Michael (F. Hoffmann-La Roche Ltd)
Davies, Geraint (F. Hoffmann-La Roche Ltd)
Butler, Lesley M. (F. Hoffmann-La Roche Ltd)
Costantino, Cristina (F. Hoffmann-La Roche Ltd)
Montalban, Xavier (Hospital Universitari Vall d'Hebron)
Universitat Autònoma de Barcelona

Data:	2021
Resum:	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.
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	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
Publicat a:	Brain sciences, Vol. 11 (september 2021) , ISSN 2076-3425

DOI: 10.3390/brainsci11091247
PMID: 34573267

13 p, 1.1 MB

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