Newsletter | May 16, 2019

05.16.19 -- Patent Strategy And The Internet Of Medical Things | Writing Better Clinical SOPs

Featured Editorial
Patent Strategy And The Internet Of Medical Things
By James R. Love, Oblon, McClelland, Maier & Neustadt, LLP

Not only must new IoMT patents make it through the typical granting process, the market’s size suggests that post-grant challenges may become increasingly common.

3 Powerful Writing Tips that Will Significantly Improve Your Clinical SOPs
By Penelope Przekop, MSQA, RQAP-GCP

The medical writing professionals in our industry develop excellent documents, and their ability to do so is highly supported across the industry. Yet I’m often surprised at the lack of priority that writing skills receive when it comes to SOPs.

Industry Insights
EU MDR: Are Your Labels Compliant?
Article | By Mark Cusworth, PRISYM ID

Mark Cusworth, VP of research and development at PRISYM ID, examines the EU Medical Device Regulation and its implications on labeling, and looks ahead to the future and the predicament companies will begin to face unless they start to make changes now.

Reducing The Life Cycle Cost Of Validation (Part 2): Mold Design, Construction, And Protocols
Article | By Kyle Kulwicki, PTI Engineered Plastics, Inc.

In Part Two of this series, we look at best practices for mold design, mold construction, and development of protocols, as these steps of the process also play a vital role in the long-term costs of validation.

Parameterization And Optimization Of Balloon Expandable Stent
White Paper | By Karthik Shankaran, and Senthil Karrupaswamy, Dassault Systemes Americas

This paper discusses the use of advanced techniques to solve stent design problems like recoil and foreshortening, and covers the essence of finite element analysis, FE model parameterization, and optimization.

Viscous Products No Match For New Container Closure Integrity Technology
White Paper | By Oliver Stauffer, PTI Packaging and Inspection Systems

New product types and packaging configurations, such as highly viscous formulations, pose a threat to traditional leak-testing methods, challenging current practices for container closure integrity testing. 

Transcutaneous Electrical Nerve Stimulation (TENS): An Overview Of Its Expanding Role In Pain Management
White Paper | Cardinal Health, Inc.

The gate theory of pain states that before reaching the brain, pain messages pass through a series of nerve “gates” in the spinal cord. This white paper discusses TENS technology, how it works, and the advantages this treatment has over alternative pain management techniques.

Getting The Most From Your IR Camera
Article | FLIR Systems, Inc - Research & Science

Understanding IR camera calibration and corrections help ensure accurate temperature measurements and thermographic mapping. This article is part 3 of a handbook by FLIR that discusses how to get the most out of using your IR camera.

Micro-MIM Succeeds At Making Precise Micro Metal Parts
Article | Donatelle

As component sizes for medical devices shrink to micron size, conventional machining may not be the most efficient or consistent method for manufacturing. Learn why Micro-MIM is preferred for components with tight tolerances at high volumes.

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