Guest Columns

1. 4 Steps To Kick Off Your Mold Production Project For Success 1/18/2021

   Zachi Fizik of ZF Consulting has been involved with injection molds production since the early 1990s. In the first article in this two-part article series, he'll detail the four milestones that are relevant and necessary for all mold production projects, no matter how tight your budget is or how quickly your deadline looms.

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. An Introduction to Polymeric Materials for Medical Devices 1/11/2021

   What's the best utility of polymeric materials employed in healthcare and medical devices? Eric George, Ph.D., of ERG Polymers LLC discusses terminology and nomenclature, polymer structure and chemistry, and a process for material selection for specific applications, focusing on thermoplastics. And stay tuned for future follow-up articles that do a deep dive on polymers for coronary angioplasty, point-of-care testing and wearables, ophthalmic applications, and drug delivery!

4. Introduction To ASTM E3263-20 On Qualification Of Visual Inspection For Residues 1/8/2021

   The new E3263 standard provides the science-, risk-, and statistical-based guidance and the tools needed for companies to implement the use of visual inspection within a quality risk management program that meets the criteria promulgated in the EMA's new Q&A 7 and Q&A 8.

5. 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.

6. 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.

7. The 3 Compliance Aspects For Passive Predictive Monitoring Device Success 12/28/2020

   The healthcare and life science industry has been undergoing a digital transformation, and the global COVID-19 public health emergency has accelerated the development of at-home monitoring products. Understanding the regulatory compliance landscape is critical for getting these products on the market and in patients’ hands quickly.

8. 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.

9. 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.

10. 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.