Industry Perspectives
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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.
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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.
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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.
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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.
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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.
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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.
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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!
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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.
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4 Emerging Approaches to Medtech Contracting Agreements
11/25/2020
In recent years, a range of factors, including increasing budget pressures, requirements for real-world data, the availability of more innovative medical devices and technologies, and the shift toward value-based care are driving the development of new pricing and reimbursement models in the medical device sector. What are the four medtech contracting agreements that have emerged?
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How To Utilize Extrusion To Optimize Processing And Supply Of High-Quality Tubes For Use With Stents, Scaffolds, And Other Medical Devices
10/16/2020
This interview with Dr. Thiago Borges covers how to utilize extrusion to optimize the processing and supply of high-quality tubes for use in stents, scaffolds, and other medical devices.