Publisher URL:
Publisher DOI: 10.1017/dsd.2020.95
Title: Investigation on methods and characteristics in medical device development
Language: English
Authors: Kuhl, Juliane  
Sankowski, Olga 
Krause, Dieter 
Keywords: biomedical design;design methods;risk management;user-centred design;medical device development
Issue Date: 11-Jun-2020
Publisher: Cambridge University Press (CUP)
Source: Proceedings of the Design Society, DESIGN Conference ; (1), 1969-1978 (2020)
Journal or Series Name: Proceedings of the Design Society 
Abstract (english): A targeted development of safe medical products can be supported by design methods. This paper analyses which design methods are applied in the development of medical devices and whether they are adapted for considering medical devices’ special features (legal, human and technical issues). In particular, variety management, risk assessment and user-centered design for medical devices are examined. Typically, interdisciplinary risk assessment is methodically supported. Additionally, user-centered design methods for requirements assessment, design verification and design validation are applied.
Conference: Design Society: DESIGN Conference 2020 
ISSN: 2633-7762
Institute: Produktentwicklung und Konstruktionstechnik M-17 
Type: (wissenschaftlicher) Artikel
Funded by: Deutschland, Bundesministerium für Bildung und Forschung
Project: Individualisierte Flow Diversion Behandlung 
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