Keren Sookne

Could FDA's ASCA program save submission time and boost pre-market testing consistency in the medical device industry?

Demystifying FDA’s ASCA on Biocompatibility for Expedited Review

The SentiAR Wearable Command Center is an interprocedural augmented reality (AR) system—with the user interface built off the Microsoft HoloLens—that enables the electrophysiologist to model the heart.

Medical Product Changes Stemming from User Centered Design

Live from MD&M BIOMEDigital: a startup, a consultancy, and a large brand owner talk about how interacting with end users changed their medical device and machinery designs.

The system, which has not launched yet commercially, is courier agnostic so that any delivery service, grocery pharmacy, big box retailer, or friend or family member can leave deliveries in the secure, temperature controlled lock-box.

Last-Mile-Delivery System: IoT Lockbox with Temperature Control

Designed to preserve medications and food delivered to consumers and save retailers millions in contactless delivery, the product appeared on Shark Tank on April 2.

GOLD AWARD—Expanding the Use of Flexible Packaging—Chameleon for Tyve by Paxxus, Inc.

Colorful Seal Assurance Supports EU MDR for Device Packaging

The FPA awarded PAXXUS a Gold Award in Expanding the Use of Flexible Packaging for its Chameleon for Tyvek.

More from Keren Sookne

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5 Tips To Improve Your Remote/Hybrid Audits

Whether you’re a manufacturer or contract organization, audits are a key part of ensuring quality. Don’t overlook these tips from our 'Take Five with HCP' video when switching from in-person supplier audits to virtual or hybrid audits in the pandemic.

Communicating acceptance criteria with your lab is key in mechanical testing of passive shippers.

Mechanical Testing for Passive Thermal Coolers: Practical Q&A for Life Sciences

Live from ISTA’s TempPack: Experts discuss acceptance criteria guidance, payload selection, actual product versus placebo, testing multiple product configurations, and more.

Each 'bird type' has specific ways of communicating, receiving information, and responding to crises.

Use ‘Bird Styles’ to Improve Your Communication in Crisis

Tips for communicating in a crisis so that people listen. Says one consultant, 'If you find yourself carefully crafting an email because you're instinctively cautious about how it might be received, don't write it.'

GOLD AWARD—Technical Innovation—Amcor's Dual Chamber Pouch by Amcor Flexibles

Dual Chamber Pouch Keeps Medical Devices Safe

The FPA honored Amcor with a Gold Award in Technical Innovation for its Dual Chamber Pouch, a specialty multi-layer pouch consisting of a peelable medical device chamber and a non-peelable desiccant chamber.

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Blow-Fill-Seal Expands in Aseptic Filling, Vaccines

Live from #PDAannual: Recent developments in the technology have bolstered the use of BFS in aseptic processing, including temperature control and needle addition for pre-filled syringes.

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5 Tips on Remote Auditing Contract Organizations

Switching to hybrid or virtual audits? Check out these tips for a smoother transition. Additionally, PDA is holding a remote audit and inspection workshop Apr. 8.

Part 2: RFID Labels Open Doors for Continuous Supply Chain Improvement

In this Q&A, a manager of pharmacy operations explains why RFID-embedded vial labels just may change the world of inventory management and dispensing.

Easy-Application Tube for Veterinary Products Wins Gold

Antiparasitic Revolt™ Topical Solution from Aurora Pharmaceuticals is housed in a customized version of Neopac’s Twist’n’use™ tube.

With the CCL/Kit Check partnership, manufacturers receive labels with RFID inlay that appear identical to their existing label—and don’t require artwork changes and new FDA approval—and do not affect packaging lines.

Part 1: From Drug Supply to Staffing, the Benefits of RFID Integrated into Vial Labels

In this Q&A, a manager of pharmacy operations explains why RFID-embedded vial labels just may change the world of inventory management and dispensing.