Proactive Risk Mitigation in Orthopedic Device Manufacturing: An FMEA-Centric Approach

Authors: Premsanth Sadasivam

DOI: https://doi.org/10.5281/zenodo.14752507

Short DOI: https://doi.org/g827rw

Country: USA

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Abstract: Orthopedic devices, particularly knee implants, are critical in restoring patient mobility. Ensuring their reliability is paramount, as any failure may lead to serious complications. This paper focuses on proactive risk management in orthopedic device manufacturing using Failure Modes and Effects Analysis (FMEA). By systematically identifying, evaluating, and mitigating potential failure modes, manufacturers can significantly improve device quality and patient safety. In addition, we explore how emerging technologies such as Artificial Intelligence (AI), Machine Learning (ML), and Internet of Things (IoT) can augment traditional risk management methods. A case study on the manufacturing of knee implants demonstrates the practical application of FMEA, and the article concludes with a discussion of future directions and research opportunities to further improve the reliability of orthopedic devices.

Keywords: FMEA, Risk Management, Orthopedic Implants, Manufacturing, Medical Devices, Artificial Intelligence, Reliability

Paper Id: 232061

Published On: 2019-11-13

Published In: Volume 7, Issue 6, November-December 2019

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