Integrating stakeholder perspectives in the co-design of medical device software to monitor Parkinson's disease symptoms- A case-study.

Rituja A Raut, Barbara Polus, Quoc Cuong Ngo, Nemuel D Pah, Robyn Clay-Williams, Dinesh K Kumar

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Article in MethodsX, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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1 · What the graph read from it

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5 · Who and what money

Authors and funding

6 authors.

Rituja A RautRMIT University, School of Engineering, Melbourne, 3000, Victoria, Australia.

Barbara PolusRMIT University, School of Engineering, Melbourne, 3000, Victoria, Australia.

Quoc Cuong NgoRMIT University, School of Engineering, Melbourne, 3000, Victoria, Australia.

Nemuel D PahRMIT University, School of Engineering, Melbourne, 3000, Victoria, Australia.

Robyn Clay-WilliamsMacquarie University, Faculty of Medicine, Health and Human Sciences, Sydney, 2109, New South Wales, Australia.

Dinesh K KumarRMIT University, School of Engineering, Melbourne, 3000, Victoria, Australia.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

There has been a rapid proliferation of AI-based medical devices and Software as a Medical Device (SaMD), largely due to their ease of deployment and scalability. Despite these advantages, many such technologies face limited clinical acceptance and reduced effectiveness in real-world healthcare settings. This gap is frequently attributed to technology-driven development approaches that insufficiently involve end users and other key stakeholders. This paper describes a structured co-design approach applied to the development of NCare, a smartphone-based SaMD designed to monitor motor symptoms associated with Parkinson's disease. Co-design engaged people living with Parkinson's Disease, clinicians, developers, and commercial stakeholders in iterative system refinement. Workshops, surveys, observational methods, and a trial phase were used to capture experiential, clinical, and contextual insights across different stages of development. This approach enabled the identification of usability challenges, workflow integration requirements, and reporting requirements absent from developer-led approaches. The paper presents a case study of co-design protocol intended to support the development of needs-driven, clinically relevant, and adoptable digital health technologies.

Indexed as

Co-designDigital healthParkinson’s diseaseSoftware as a medical device (SaMD)Stakeholder engagement

Identifiers

PMID42181080

DOI10.1016/j.mex.2026.103935

PMCPMC13191614

What OpenQuestion holds

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LicenceCC BY

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.