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This is the third in a series of articles on the changes in the medical device risk management standard ISO 14971 that were released in Dec. 2019 and supported by guidance in the ISO TR 24971:2020 technical report or guidance. This article by Edwin L. Bills, member of ISO TC 210 JWG1, covers the change in the process for benefit-risk covered in Clause 8 of the standard.
By Alexandra Piotrowicz,Evonik Corporation
Devices such as introducer sheaths, delivery catheters, endoscopes, and neurovascular microcatheters aim to minimize trauma during insertion and removal, reduce tissue inflammation, enable maneuverability through tortuous blood vessels, and improve patient comfort. Surface properties should promote smooth movement between certain device components.
In this paper, Lindsay Mann, director of marketing for MTD Micro Molding, tells MD+DI that about 25% of the micro medical device components they produce are for miniaturized devices. This article also gives an update on miniaturization, including recent advancements in materials and manufacturing.
The digitalization bottleneck poses a real threat to patient outcomes. A solution is the implementation of an IoT platform powered by RFID to enable clinicians to effectively use medical equipment and reduce human error in healthcare processes, which can ensure higher quality of care.