Guest Columns

1. Statistics Abuse In QA/QC: 3 Lessons Learned 3/3/2021

   One of the best tools at our disposal in a quality assurance/quality control context (manufacturing, supplier quality, etc.) is statistics. However, you should use caution and be mindful that you use it correctly and effectively. Eric Hinrichs, retired from Ethicon, Johnson & Johnson, shares his 3 lessons learned.

2. Introduction to Injection Mold Verification 3/1/2021

   Throughout Zachi Fizik's article series, he has focused on plastic parts used in your medical device and the associated mold production process. In this article, he explains the difference between T0 and T1, which is the first trial. He also discusses sending T1 remarks to the mold maker. With a combination of experience and agility, you'll be able to approve final samples in a timely manner.

3. Germany’s Digital Medical Device Regulations: A Framework For The World To Follow, Part III 2/26/2021

   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. In this concluding article in the series, John Giantsidis of CyberActa, Inc. delves into the interoperability, robustness, consumer protection, and patient safety requirements. Other countries will likely soon follow Germany's example.

4. Answer These 3 Questions Before Developing Software As A Medical Device 2/22/2021

   Whether your organization is interested in software adoption to build in continuous data acquisition, offer remote care capabilities, improve patient engagement, or simplify routine clinical tasks, software as a medical device (SaMD) is at the center of it. Before getting started on your SaMD project, answer these three questions.

5. FDA’s COVID-19 PREPP Initiative Summary Report — Key Takeaways For Manufacturers 2/19/2021

   Published in January 2021, the FDA COVID-19 Pandemic Recovery and Preparedness Plan (PREPP) Initiative Summary Report is the culmination of work performed by the FDA’s PREPP Initiative, which launched in April 2020 to examine lessons learned from the agency’s response to the global COVID-19 pandemic. This article provides a brief overview of the report’s overarching themes and highlights key regulatory insights for manufacturers in light of two action areas in particular.

6. 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.

7. 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. 

8. 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.

9. 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.

10. 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.