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.
Highlights
Multiple sclerosis (MS) is an inflammatory demyelinating and degenerative disease [1] characterised by a wide clinical variability in disease trajectory between individuals [2]
The diagnosis of progression in MS is typically retrospective with a heavy reliance on clinical history, requiring progressive worsening for more than 6 months based on Expanded Disability Status Scale (EDSS) score, without evidence of relapses [3,4]
The findings indicated that assessments within the solution must be convenient, with a reasonable duration and frequency
Summary
Multiple sclerosis (MS) is an inflammatory demyelinating and degenerative disease [1] characterised by a wide clinical variability in disease trajectory between individuals [2]. New clinical and research tools are needed to address the unmet need of early detection and ongoing assessment of progressive worsening, rendering this an inviting area for innovation in the digital health space Remote digital solutions such as smartphone-based apps, wearables, and decision support algorithms are increasingly utilised in research and clinical trial settings [9] and are beginning to emerge in routine medical care. Data and digital biomarkers collected by patient-facing apps may provide clinical value by generating new insights into the MS disease course, improving the understanding of individual disease trajectories and response to intervention Despite their promise, smartphone-based solutions have not yet been fully integrated into routine medical practice. Figure 2F. iIgllusrtera2ti.onIloluf scturrarteinotnveorfsiocnurorfeFnltoovdelrigshiotTMn MofSFvl1o.2odaplipghantTMd asMseSssmv1e.n2tsa. pHpCPa,nhdealathssceasresmpreonfetss. ioHnCalP; P, RO, patient-rheepaolrtthedcaoruetpcormofee.ssional; PRO, patient-reported outcome
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