Guest Columns

  1. 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.

  2. 7 Rules For Properly Interpreting Control Charts 2/15/2021

    It is time to consider augmenting your validated production processes, including processing, packaging, and labeling, with continuous process monitoring using control charts to ensure continued compliance with established specifications and requirements. 

  3. Germany’s Digital Medical Device Regulations: A Framework For The World To Follow, Part II 2/12/2021

    Germany's BfArM, or the Federal Institute for Drugs and Medical Devices, released a new guide in August 2020 detailing the requirements for digital health application manufacturers in order to make your DiGAs available to the more than 73 million participants in the German statutory health insurance, and other countries will likely follow in its footsteps. In Part II of this three-part series, John Giantsidis of CyberActa, Inc. examines the data security requirements.

  4. ISO 14971:2019 — Clarifying Benefit, Risk, & Benefit-Risk 2/8/2021

    This is the third in a series of articles on the changes in the medical device risk management standard ISO 14971 that were released in Dec. 2019 and supported by guidance in the ISO TR 24971:2020 technical report or guidance. This article by Edwin L. Bills, member of ISO TC 210 JWG1, covers the change in the process for benefit-risk covered in Clause 8 of the standard.

  5. Top 3 Trends Affecting The Dental Implants Market In 2021 And Beyond 2/3/2021

    Dental implants have increasingly become the preferred treatment for edentulous individuals as practitioner expertise and supporting technology around dental implants continue to advance. William Guo and Kamran Zamanian, Ph.D., of iData Research Inc. delve into the three trends driving the growth of this market.

  6. An ISO 14155:2020 Primer — Good Clinical Practice For Medical Device Trials 2/2/2021

    An analysis of the recently released ISO 14155:2020, "Clinical investigation of medical devices for human subjects — Good clinical practice," a standard developed to guide clinical research professionals during the design, conduct, recording, and reporting of clinical trials related to the safety and effectiveness of medical devices.

  7. 3 Tips For Designing At-Home Monitoring Devices That Deliver Actionable Information 2/1/2021

    We’re all seeing it in real time: Healthcare is increasingly shifting from clinical settings to our homes. The COVID-19 pandemic has accelerated the development of at-home monitoring products and many are collecting data in the background without requiring specific user action. This acceleration is not likely to slow down post-pandemic. In this article, Anna (Ronning) Cohen and Hilde Viroux of PA Consulting discuss how to design such devices that deliver actionable information.

  8. Germany’s Digital Medical Device Regulations: A Framework For The World To Follow, Part I 1/29/2021

    Germany's BfArM (the Federal Institute for Drugs and Medical Devices) released a new guide in August 2020 detailing the requirements for digital health applications, and other countries will likely follow in its footsteps. John Giantsidis, president of CyberActa, Inc., gives an overview of the situation and will cover the many privacy requirements noted in the new guide in Part 1 of this three-part article series.

  9. Avoiding ISO 14971 Mistakes — What Does “Harm” Really Mean? 1/27/2021

    In the first two parts of this three-part series on ISO 14971 terminology, we discussed the terms “hazard” and “hazardous situation” in detail. In this third and final part, we will review the term “harm,” provide examples to illustrate how you can define potential harms applicable to your medical device, and explain how you can link them to relevant hazards and hazardous situations. 

  10. With Release Of New Guidance Document, FDA Launches Safer Technologies Program for Medical Devices 1/25/2021

    The FDA’s Center for Devices and Radiological Health (CDRH) released the Safer Technologies Program for Medical Devices (STeP) Guidance for Industry and Food and Drug Administration Staff on January 6, 2021, with plans to begin accepting applications for STeP beginning March 8, 2021. Is this a good fit for your medical device or device-led combination product?