ARTICLES BY JAYET MOON
The Role Of Failure Mode In ISO 14971:2019’s Hazard-Based Approach5/10/2023
In the context of ISO 14971:2019 and risk management for medical devices, manufacturers and designers are often confused about the implementation of hazard analyses and FMEAs, especially since this standard takes a hazard-based approach. In this article, Jayet Moon demystifies the topic.
EU MDR’s Benefit-Risk Ratio: Making Your Clinical Evaluations Safety-Focused5/13/2022
The EU's MDR refers to a benefit-risk ratio multiple times, especially with respect to clinical evaluation and in Sections 1 and 8 of Annex I. However, no universally accepted method exists for calculation of such a ratio. This article proposes a method for calculating it in the spirit of focusing on patient safety and the ability to track changes in products' safety profiles.
FMECA: Relevance In Context Of ISO 14971 & EU MDR Compliance2/9/2022
This article focuses on failure modes and effects and criticality analysis (FMECA) and the hazard-based approach in ISO 14971. It uses these definitions and discussions to illustrate EU MDR compliance, and how a top-down approach of FMEA can help.
COVID-19 Vaccine Benefit-Risk Analysis/Ratio Using Real World Data10/6/2021
For National Immunization Awareness Month, we're highlighting timely vaccine manufacturing-centric articles such as this one, covering a method by which benefit-risk analysis can be objectively carried out to arrive at a benefit-risk ratio. The article provides a relevant, contemporary example of how it can be used to calculate COVID-19 vaccine benefit-risk.
A Quantitative Benefit-Risk Analysis & Benefit-Risk Ratio Using Real World Data: Part I10/4/2021
This article introduces a novel model of benefit-risk by taking a bottom-up approach using the _risk of the therapy_ and comparing it to _risk of no therapy_ to quantify risk and benefit with the same scale. This overview is relevant not only to the pharmaceutical and biotech industries, but also the medical device industry.
5 Foundations Of Lean Leadership For Pharmaceutical & Medical Device Professionals7/2/2021
Every life sciences company, now more than ever before, is on a journey to provide greater returns to stakeholders by manufacturing products at better quality and lower cost, which is the aim of lean manufacturing. However, many people forget about the cultural and leadership aspects of lean, which at its foundation are responsible for the success or failure of a lean transformation.
Risk Intelligence And Risk-Based Decision-Making: Combining Strategic Risk Management With Safety Risk Management2/17/2021
You’re familiar with ISO 14971, the “Application of Risk Management to Medical Devices” standard. Upon closer inspection, you’ll learn that this standard is in fact a standard for medical device safety risk management. However, risk management goes beyond the product safety aspects and includes strategic and operational elements. This article discusses how risk managed at one level allows for opportunities for value creation at other levels.
Risk-Based Postmarket Surveillance In The Age Of EU MDR2/2/2021
As the central focus of the EU’s Medical Device Regulations (MDR), postmarket surveillance (PMS) and its related processes and subsystems have been in the limelight since 2017. Jayet Moon, author of the book Foundations of Quality Risk Management, takes a bottom-up approach to PMS with this e-book.
Risk-Based Postmarket Surveillance (PMS) In The Age Of EU MDR: Risk-Based Trending1/6/2021
Risk-based incident trending for postmarket signal detection is quickly becoming an expectation from most regulatory agencies and EU MDR is one of the first regulations to expressly document this requirement. Jayet Moon concludes his four-part article series on risk-based postmarket surveillance in the age of EU MDR by examining the salient features of a sound risk-based trending process and methodology and discussing what to look for in a trend analysis.
Risk-Based Postmarket Surveillance (PMS) In The Age Of EU MDR: The Binding Thread Of Risk Management12/22/2020
The thread of risk management connects every piece in the quality management system and guides the manufacturer in quality related decision-making throughout the lifecycle of the device. In Part 3 of his article series on risk-based postmarket surveillance (PMS) in the age of EU MDR, Jayet Moon discusses how quality risk management and PMS are natural partners. He also examines the five elements for which the PMS system should be on the lookout.