Industry Perspectives - Design & Development

  1. Closing The Loop On Risk Management With ISO 14971:2019 1/22/2021

    Edwin L. Bills, member of ISO TC 210 JWG1, discusses the evolution of risk management standards for medical devices and how ISO 14971:2019's revision (which is also identical to EN ISO 14971:2019) is meant to "close the loop." Based on the extensive changes in Clause 10, all manufacturers of medical devices and in vitro medical devices will need extensive review and possible changes to their production and post-production activities section of their quality systems in order to meet the new requirements.

  2. Using Production And Postmarket Data To Validate FMEA Assumptions 1/15/2021

    One common issue with regulatory agencies and certification bodies regarding failure mode and effects analysis (FMEA) is that organizations are not utilizing production and postmarket surveillance data to validate the probability of occurrence and probability of detection assumptions, which leads to inspectional observations and audit findings.

  3. 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.

  4. Continuity Is The Key To Success For Your Medical Device Company 1/4/2021

    When your company focuses on improving its bottom line, two common methods are to reduce the size of the workforce or to divest from direct manufacturing responsibility. Also, gone are the days when an employee stays with a company until they retire. As a result of these factors, many medical device companies are losing valuable experience. Eric Hinrichs, retired from Ethicon, Johnson & Johnson, discusses what a company can do to address this knowledge drain.

  5. 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.

  6. Tips For Building A Voluntary QA Culture In A 2021 COVID World 12/21/2020

    As we say goodbye to 2020, the end of which couldn’t come soon enough, it is fitting to look at how to build a voluntary quality culture in our “new normal” work environment.

  7. 3 Creative Ways To Develop A Better UI For Your Medical Device 12/17/2020

    If you're an engineer, you were told in school that either you can't or don't need to participate in artistic activities — but that has unfairly pigeonholed you. Rethink what you've been taught about creative problem-solving! Tom KraMer of Kablooe Design discusses his three tips that result in a better user interface for your device.

  8. Bioresorbable Copolymer Combines Mechanical Strength With Rapid Degradation For Wound Healing And Pediatric Devices 12/15/2020

    This interview with Isabel Wahl, Head of Evonik’s RESOMER® development laboratory, discusses the use of a new bioresorbable copolymer that combines mechanical strength with rapid degradation for wound healing and pediatric devices.

  9. 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.

  10. 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.