ARTICLES BY JAYET MOON

• A Quantitative Benefit-Risk Analysis & Benefit-Risk Ratio Using Real World Data: Part 2 — COVID-19 Vaccine Benefit-Risk

  10/6/2021

  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 I

  10/4/2021

  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 Professionals

  7/2/2021

  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 Management

  2/17/2021

  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 (PMS) In The Age Of EU MDR: Risk-Based Trending

  1/6/2021

  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 Management

  12/22/2020

  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.

• Risk-Based Postmarket Surveillance (PMS) In The Age Of EU MDR: A Systems Approach

  12/15/2020

  Jayet Moon continues his four-part series on risk-based postmarket surveillance in the age of the EU Medical Device Regulations (MDR) with Part 2, which delves into the systems approach. Such an approach gives due consideration to process interfaces with other organizational functions and knowledge management. It would not only make compliance to EU MDR easy but also make the organizational processes much more effective and efficient.

• Risk-Based Postmarket Surveillance In The Age Of EU MDR: Incident Investigation

  12/11/2020

  Jayet Moon begins this four-part series on risk-based postmarket surveillance (PMS) in the age of EU MDR by delving into the incident investigation. Such investigations are the basic iota of the PMS system upon which all further analysis, synthesis, and decision-making is based. By looking into the Who? What? When? Where? Why? and How? of serious events related to your device, you'll be able to provide answers to regulatory bodies.