2020
DOI: 10.1017/dsd.2020.95
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Investigation on Methods and Characteristics in Medical Device Development

Abstract: 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… Show more

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Cited by 9 publications
(11 citation statements)
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“…The superior perception of the environment and precise robot controlling methods provided by advances in artificial intelligence have enabled the development of robotic solutions with the intelligence and maneuverability necessary to accurately perform challenging medical tasks under supervised autonomy (Beasley, 2012; Chen et al, 2020; Coelho et al, 2010). Nevertheless, a major problem with their integration into clinical practice is related to the increased demand for international standards for patient safety and security (Gualtieri et al, 2022; Haidegger, 2019; Kuhl et al, 2020). A strategy may rely on incorporating a commercially available robotic arm that already fulfills specific safety and security standards, reducing the effort to bring these solutions to the market.…”
Section: Introductionmentioning
confidence: 99%
“…The superior perception of the environment and precise robot controlling methods provided by advances in artificial intelligence have enabled the development of robotic solutions with the intelligence and maneuverability necessary to accurately perform challenging medical tasks under supervised autonomy (Beasley, 2012; Chen et al, 2020; Coelho et al, 2010). Nevertheless, a major problem with their integration into clinical practice is related to the increased demand for international standards for patient safety and security (Gualtieri et al, 2022; Haidegger, 2019; Kuhl et al, 2020). A strategy may rely on incorporating a commercially available robotic arm that already fulfills specific safety and security standards, reducing the effort to bring these solutions to the market.…”
Section: Introductionmentioning
confidence: 99%
“…The progress in artificial intelligence, with improved robot controlling strategies and environment perception, enabled the development of image-guided robotic solutions to execute challenging medical tasks with supervised autonomy and performance, comparable to experts [ 9 , 10 , 11 , 12 ]. To introduce the advantages of medical robotics for laser therapy, the development of personalized solutions to account for the task-specific requirements is fundamental [ 13 , 14 , 15 , 16 ]. However, the development of a robot-based system to execute a specific task is challenging and dependent on the designer’s subjectivity, specifically in medical robots.…”
Section: Introductionmentioning
confidence: 99%
“…As a result, sub-optimal solutions may be developed, limiting the overall performance of the system. Indeed, technology faults are usually connected to weak task requirement specifications rather than direct device failure [ 16 , 17 , 18 ].…”
Section: Introductionmentioning
confidence: 99%
“…Additionally, few facilities have worked with researchers in the development of new technology, as most are too busy [5,12,13]. As a result, many scholars have only involved users in the later phase of the system/service development process, i.e., test and evaluation [14]. In contrast, as safety issues are significant for assistive/medical devices, recent studies have emphasized the importance of intensive user involvement and risk management from the early phases of the design process [14].…”
Section: Introductionmentioning
confidence: 99%