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Market Launch and Regulative Assessment of ICT-Based Medical Devices: Case Study and Problem Definition
Institute of Computer Science, University of Rostock, Rostock, Germany; Fraunhofer FOKUS, Berlin, Germany.
Jönköping University, School of Engineering, JTH, Department of Computer Science and Informatics. Institute of Computer Science, University of Rostock, Rostock, Germany.ORCID iD: 0000-0002-7431-8412
2022 (English)In: Business Information Systems Workshops: BIS 2021 International Workshops, Virtual Event, June 14–17, 2021, Revised Selected Papers / [ed] W. Abramowicz, S. Auer & M. Stróżyna, Springer, 2022, p. 304-315Conference paper, Published paper (Refereed)
Abstract [en]

The market launch and regulative assessment of ICT-based medical devices in Europe is very complex due to a multitude of regulations to be considered during requirements engineering and product management. Additionally, there are no established standards, best practices or support tools how to launch medical devices on the market. The paper is part of a project aiming for methodical support for medical device launch and assessment, and is dedicated to investigating problem relevance. To understand the processes and requirements three case studies were analysed and the necessary processes and requirements were matched towards enterprise architectures (EA). Based on this finding, we argue that EA could be a suitable way to visualize and recommend required processes and structures for medical device management. The main contributions of our work are (a) a literature analysis of EA use in health care and especially for telemedicine, (b) results from use case analysis investigating the business perspective from inside three health tech companies and (c) the analysis of problems of telemedicine integration into EA.

Place, publisher, year, edition, pages
Springer, 2022. p. 304-315
Series
Lecture Notes in Business Information Processing, ISSN 1865-1348, E-ISSN 1865-1356 ; 444
Keywords [en]
Assessment process, Enterprise architecture, Market launch, Medical device, Commerce, Systems engineering, Best practices, Case-studies, Engineering management, Medical Devices, Problem definition, Product management, Requirement engineering, Telemedicine
National Category
Production Engineering, Human Work Science and Ergonomics Information Systems
Identifiers
URN: urn:nbn:se:hj:diva-59486DOI: 10.1007/978-3-031-04216-4_27Scopus ID: 2-s2.0-85128776497ISBN: 9783031042157 (print)ISBN: 9783031042164 (electronic)OAI: oai:DiVA.org:hj-59486DiVA, id: diva2:1740358
Conference
BIS 2021 International Workshops, Virtual Event, June 14–17, 2021
Available from: 2023-03-01 Created: 2023-03-01 Last updated: 2023-03-01Bibliographically approved

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Sandkuhl, Kurt

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