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Involving End Users in Risk-Based Co-design

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mHealth and Human-Centered Design Towards Enhanced Health, Care, and Well-being

Part of the book series: Studies in Big Data ((SBD,volume 120))

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Abstract

The increasing availability of digital technologies in healthcare provides the means for increased participation of patients in their care path. This increased empowerment is becoming more widespread day by day. Nevertheless, still little or no inclusion in the design process is part of the common practice during the mHealth medical device design. This chapter proposes an approach based on the indications of international standards for medical device design and manufacturing to foster the adoption of co-design techniques and the inclusion of end-users in the decisional process. The adoption of the proposed method, in particular, is suitable with processes based on international standards for medical device management as per a compliant quality management system (ISO 13485), usability evaluation (IEC 62366) and risk management (ISO 14971), which are the methods used by manufacturers to prove compliance with the requirements of the European Regulations. Such a method ensures a high level of protection for all stakeholders while fostering innovation and participation.

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Authors and Affiliations

  1. USE-ME-D srl, I3P Politecnico di Torino, Torino, Italy

    Federico Sternini & Alice Ravizza

  2. PolitoBIOMed Lab, Politecnico di Torino, Torino, Italy

    Federico Sternini

  3. Rehab Technologies Lab, Istituto Italiano di Tecnologia (IIT), Genoa, Italy

    Giacinto Barresi

Authors
  1. Federico Sternini
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  2. Giacinto Barresi
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  3. Alice Ravizza
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Corresponding author

Correspondence to Federico Sternini .

Editor information

Editors and Affiliations

  1. Faculty of Medicine and Health Sciences, Department of Rehabilitation Sciences and Physiotherapy, Center for Health and Technology (CHaT), 4D4ALL Lab, University of Antwerp, Antwerpen, Belgium

    Sofia Scataglini

  2. Dipartimento di Architettura, Università degli Studi di Ferrara, Ferrara, Italy

    Silvia Imbesi

  3. Department of Science and Technology, Polytechnic Institute of Coimbra, Technology and Management School of Oliveira do Hospital, Oliveira do Hospital, Portugal

    Gonçalo Marques

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Sternini, F., Barresi, G., Ravizza, A. (2023). Involving End Users in Risk-Based Co-design. In: Scataglini, S., Imbesi, S., Marques, G. (eds) mHealth and Human-Centered Design Towards Enhanced Health, Care, and Well-being. Studies in Big Data, vol 120. Springer, Singapore. https://doi.org/10.1007/978-981-99-3989-3_1

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  • DOI: https://doi.org/10.1007/978-981-99-3989-3_1

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  • Print ISBN: 978-981-99-3988-6

  • Online ISBN: 978-981-99-3989-3

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