From The Editor
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How To Optimize And Accelerate The 3D Printing And Testing Of Bioresorbable Device Parts
11/23/2020
The convergence of modern 3D printing technologies such as selective laser sintering (SLS), fused filament fabrication (FFF), and bioplotters with a new generation of custom bioresorbable polymers in powder, filament, and granule is revolutionizing what’s possible in the development of bioresorbable medical device parts.
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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.
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Reducing Bacterial Adhesion And Biofouling On Medical Device Surfaces: An Interview With Jeannette Ho
10/13/2020
This interview with Jeannette Ho, the head of surface modification at Evonik, discusses opportunities for medical device companies to leverage a passive, stable, and durable technology platform to reduce bacterial adhesion and biofouling.
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What 3D Printing Technology And Material Is Right For Your Medical Device Application?
9/9/2020
In this interview with Balaji Prabhu, from Evonik’s Medical Device Competence Center in the U.S., we review how medical device companies can best evaluate current biomaterial options for the four leading 3D printing technologies.
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What Factors Impact Quality For Medical Device Manufacturers?
9/8/2020
This article asks Corporate Vice President of Quality at B. Braun Medical Inc. about how quality is impacted in medical device companies by FDA regulations, collected data, and more.
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Improve The Injection Experience In Chronic Care
7/23/2020
This series of frequently asked questions covers the research and design mindset applied to the development of the BD Neopak™ XtraFlow™ solution and the anticipated clinical benefits of 8 mm needles.
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Integrated Systems For Sophisticated Drug Device Combination Products
7/20/2020
Experts discuss the benefits of using integrated systems for sophisticated drug device combination products with multiple device subsystems, and the crucial role a partner can play as systems integrator.
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COVID-19 & The Virtual Trial Rush: Front-Line Insights
5/19/2020
The COVID-19 pandemic caught many sponsor companies and sites unprepared. Clinical trial participants were told to stay home for their own safety and to relieve the burden on site personnel. For companies that had millions invested in trials that required data from those patients, panic set in and the rush was on for new technology solutions.
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Teva Develops First FDA-Approved Digitally-Integrated Inhaler
1/8/2020
Two challenges have plagued asthma sufferers and researchers for year. The first is patients not adhering to their maintenance medication. The other is patients not using proper inhaler technique. A new digitally-integrated inhaler from Teva hopes to eliminate both problems.
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Challenges To FDA’s Modernization Of The 510(k) Pathway
12/12/2018
The FDA and CDRH need to take a hard look at their plan to revamp the 510(k) pathway -- as well as how that regulatory path has been handled to date.