Robot-assisted fracture surgery: surgical requirements and system design
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Published version
Author(s)
Georgilas, Ioannis
Dagnino, Giulio
Tarassoli, Payam
Atkins, Roger
Dogramadzi, Sanja
Type
Journal Article
Abstract
The design of medical devices is a complex and crucial process to ensure patient safety. It has been shown that improperly designed devices lead to errors and associated accidents and costs. A key element for a successful design is incorporating the views of the primary and secondary stakeholders early in the development process. They provide insights into current practice and point out specific issues with the current processes and equipment in use. This work presents how information from a user-study conducted in the early stages of the RAFS (Robot Assisted Fracture Surgery) project informed the subsequent development and testing of the system. The user needs were captured using qualitative methods and converted to operational, functional, and non-functional requirements based on the methods derived from product design and development. This work presents how the requirements inform a new workflow for intra-articular joint fracture reduction using a robotic system. It is also shown how the various elements of the system are developed to explicitly address one or more of the requirements identified, and how intermediate verification tests are conducted to ensure conformity. Finally, a validation test in the form of a cadaveric trial confirms the ability of the designed system to satisfy the aims set by the original research question and the needs of the users.
Date Issued
2018-10-01
Date Acceptance
2018-03-02
Citation
Annals of Biomedical Engineering, 2018, 46 (10), pp.1637-1649
ISSN
0090-6964
Publisher
Springer Verlag
Start Page
1637
End Page
1649
Journal / Book Title
Annals of Biomedical Engineering
Volume
46
Issue
10
Copyright Statement
© The Author(s) 2018. This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.
Identifier
https://www.ncbi.nlm.nih.gov/pubmed/29524041
PII: 10.1007/s10439-018-2005-y
Subjects
Computer-assisted surgery
Medical robotics
Percutaneous fracture surgery
System design and development
Publication Status
Published
Coverage Spatial
United States
Date Publish Online
2018-03-09