82f8ab34d3012c15047225fb47295e00 275821.pdf 614c747d01fad8095798b653ef67fe60186ff52e 275821.pdf 5d1641708fe843fd0cd88b107f6b7184bbf5d24db16d812dbb8e074b80651c41 275821.pdf Title: Developing a Digital Solution for Remote Assessment in Multiple Sclerosis: From Concept to Software as a Medical Device Subject: 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 Author: Anneke van der Walt, Helmut Butzkueven, Robert K. Shin, Luciana Midaglia, Luca Capezzuto, Michael Lindemann, Geraint Davies, Lesley M. Butler, Cristina Costantino and Xavier Montalban Creator: LaTeX with hyperref Producer: pdfTeX-1.40.21 CreationDate: Tue Sep 21 10:38:59 2021 CEST ModDate: Tue Sep 21 10:46:51 2021 CEST Tagged: no UserProperties: no Suspects: no Form: none JavaScript: no Pages: 13 Encrypted: no Page size: 595.276 x 841.89 pts (A4) Page rot: 0 File size: 1127059 bytes Optimized: no PDF version: 1.7 name type encoding emb sub uni object ID ------------------------------------ ----------------- ---------------- --- --- --- --------- RAFMMA+VnURWPalladioL Type 1 Custom yes yes no 10 0 CMXSSQ+URWPalladioL-Ital Type 1 Custom yes yes no 15 0 FJLJXF+URWPalladioL-Bold Type 1 Custom yes yes no 20 0 YECKEM+URWPalladioL-Roma Type 1 Custom yes yes no 24 0 SLUQMQ+TimesNewRomanPS-BoldItalicMT Type 1C WinAnsi yes yes no 32 0 MCBCCI+SourceSansRoman-Regular Type 1C Custom yes yes no 54 0 MCBCCM+SourceSansRoman.613wght Type 1C Custom yes yes no 58 0 MCBCCO+SourceSansRoman-Bold Type 1C Custom yes yes no 62 0 FJAHEI+PalatinoLinotype,Bold TrueType WinAnsi yes yes no 80 0 FJAHEK+PalatinoLinotype TrueType WinAnsi yes yes no 83 0 FJAHEM+PalatinoLinotype,Italic TrueType WinAnsi yes yes no 86 0 FJAHEI+PalatinoLinotype,Bold TrueType WinAnsi yes yes no 96 0 FJAHEK+PalatinoLinotype TrueType WinAnsi yes yes no 99 0 FJAHEM+PalatinoLinotype,Italic TrueType WinAnsi yes yes no 102 0 DVCMRV+CMSY10 Type 1 Builtin yes yes no 109 0 FJAHEI+PalatinoLinotype,Bold TrueType WinAnsi yes yes no 119 0 FJAHEK+PalatinoLinotype TrueType WinAnsi yes yes no 122 0 FJAHEM+PalatinoLinotype,Italic TrueType WinAnsi yes yes no 125 0 Jhove (Rel. 1.22.1, 2019-04-17) Date: 2023-06-26 02:28:38 CEST RepresentationInformation: 275821.pdf ReportingModule: PDF-hul, Rel. 1.12.1 (2019-04-17) LastModified: 2023-06-23 13:02:36 CEST Size: 1127059 Format: PDF Version: 1.7 Status: Well-Formed and valid SignatureMatches: PDF-hul MIMEtype: application/pdf PDFMetadata: Objects: 331 FreeObjects: 1 IncrementalUpdates: 0 DocumentCatalog: PageLayout: SinglePage PageMode: UseNone Outlines: Item: Title: Introduction Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@44c8afef Item: Title: Concept, Proof of Concept, and Assessment of Unmet Needs Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@7b69c6ba Item: Title: Desirability: Challenges in Developing a Digital Solution That PLwMS and HCPs Need and Use Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@46daef40 Item: Title: Regulatory Standards: Data Security, Verification and Validation Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@12f41634 Item: Title: Taking an Adaptive Approach Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@13c27452 Item: Title: Future Horizons Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@262b2c86 Item: Title: References Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@371a67ec Info: Title: Developing a Digital Solution for Remote Assessment in Multiple Sclerosis: From Concept to Software as a Medical Device Author: Anneke van der Walt, Helmut Butzkueven, Robert K. Shin, Luciana Midaglia, Luca Capezzuto, Michael Lindemann, Geraint Davies, Lesley M. Butler, Cristina Costantino and Xavier Montalban Subject: 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. 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