Newsletter | April 27, 2019

04.27.19 -- April's Most Popular Articles & Solutions

Top Featured Editorial
Calculating Sample Sizes For Human Factors Studies: What’s The Magic Number?
By Seda Japp, Core Human Factors Inc.

Although sample sizes for medical device usability testing are mostly defined by regulatory standards, it is important for manufacturers to understand the underlying principles, and to make sound decisions accordingly.

What Is The Current State Of BREXIT, And What Happens Next?
By Zaid Al-Nassir, Decision Resources Group (DRG)

The United Kingdom’s plan to leave the European Union has devolved into a mess of shifting deadlines and what-ifs. Here, Zaid Al-Nassir breakdown for medtech leaders has been updated to include events taking place through April 11, 2019.

Understanding Prototype Development Phases For Medical Products
By Tommy Cooper, Cooper Consulting Service

Medical device prototypes at each development stage have a utility that needs to be understood to justify the cost and time invested to develop them.

Top Industry Insights
New Guidelines Offer Menu Of Standard Sterile Package Tests
White Paper | By John Kalkowski, PTI Packaging and Inspection Systems

High-risk packaging applications, such as pharmaceutical and class III medical devices, are coming under increasing scrutiny. A package protects the product throughout the product life cycle, and package integrity is a significant pocket of risk that can be mitigated. 

Molding Process Validation For Medical Devices: Five Things To Know
Article | By Gregory E. Dziomba, Caplugs

Understanding what is involved in injection-molding process validation and why it is important will help you choose a molding partner who can provide you with the confidence that your plastic parts will work well every time.

Advances In Adhesion Solutions For Medical Applications
White Paper | By Rakesh Kumar, Specialty Coating Systems

Without adequate adhesion, moisture molecules can pass through the coating and deposit on the substrate, causing a variety of potential problems. This white paper describes the effectiveness of a new adhesion solution on various difficult substrates.

Top Resources
Contract Manufacturing For Single Use Finished Medical Devices
SMC Ltd.
Cleanroom Molding
PTI Engineered Plastics, Inc.
Custom Kits And Trays
B. Braun OEM Division
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