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Updated: Dec 18, 2025

Rapid and Low-cost Prototyping of Medical Devices Using 3D Printed Molds for Liquid Injection Molding
Published on: June 27, 2014
Impact of Design on Medical Device Safety
Teodora Miclăuş1, Vasiliki Valla1, Angeliki Koukoura1
1Evnia Group, Copenhagen Business Center, Hellerup Strandvejen 60, 2900, Copenhagen, Denmark.
Abstract:
The growing number of emerging medical technologies and sophistication of modern medical devices (MDs) that improve both survival and quality of life indexes are often challenged by alarming cases of vigilance data cover-up and lack of sufficient pre- and post-authorization controls. Combining Quality with Risk Management processes and implementing them as early as possible in the design of MDs has proven to be an effective strategy to minimize residual risk. This article aims to discuss how the design of MDs interacts with their safety profile and how this dipole of intended performance and safety may be supported by Human Factors Engineering (HFE) throughout the Total Product Life-Cycle (TPLC) of an MD in order to capitalize on medical technologies without exposing users and patients to unnecessary risks.
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