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Development of a 3D stress foot plate meeting the medical device regulation and affordability - Product development without a business case

Elst, Daniëlle van (2023) Development of a 3D stress foot plate meeting the medical device regulation and affordability - Product development without a business case.

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Abstract:Ankle laxity and hindfoot instability are diagnosed through a physical examination by a clinician. These manual stress tests have the disadvantage of not being able to distinguish between talocrural instability, subtalar instability, or combinations thereof. A previously developed 3D CT stress test using a 3D stress foot plate to mimic manual stress tests in the CT scanner allows for quantitative one-stage measurement of subtalar and talocrural joint range of motion. This facilitates diagnosis and follow up of complex clinical cases. This project was aimed at redesigning the 3D stress foot plate device such that it is easy to produce, with offering open source drawings, production techniques, off-the-shelf components and assembly manual; and offering all documentation and tests in order to comply with the medical device regulation legislation. The results of this project provide an open source method to produce the 3D stress foot plate in an affordable manner, while being a safe medical device. In line with the open-source starting point, the imaging processing of the acquired CT scans can also be processed with open-source software. This was shown for a complex case of determining the range of motion of after ankle prosthesis replacement.
Item Type:Essay (Master)
Faculty:ET: Engineering Technology
Subject:44 medicine, 52 mechanical engineering
Programme:Biomedical Engineering MSc (66226)
Link to this item:https://purl.utwente.nl/essays/96365
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