Newsletter | August 20, 2019

08.20.19 -- Drug Delivery Device Development Considerations | Standard Of Care And The IoT

 
Featured Editorial
4 Important Things To Consider Before Developing A Drug Delivery Device
 
By Michael Song, Ph.D.

This is Part 1 of a two-part article discussing important areas to consider when developing devices for combination products — and why they need to be addressed early in development. In this installment, we will look at the areas of primary container, device development, device selection, and design control.

Standard Of Care And The Internet Of Medical Things
 
By Joseph Honcz, Precision for Value

During the American College of Cardiology annual meeting in March, researchers from Stanford University, Apple Inc., and other academic centers unveiled the Apple Heart Study, a first-of-its-kind large-scale study involving more than 400,000 members of the general population (iPhone and Apple Watch owners). The goal of the study was to identify users with a potentially lethal irregular heart rhythm called atrial fibrillation (AF).

Industry Insights
Strategic Prototyping For Human-Factors Engineering
Article | By Andrew DiMeo, Trig

Human factors engineering (HFE) is gaining increasing attention, especially in the context of medical device product development. As technologies evolve, therapies advance, and devices become more complex, so does the role of HFE increase in priority.

Understanding Drawn Fiber: Polymers, Process, And Properties
White Paper | By Kevin J. Bigham, Ph.D., Zeus

Drawn fiber is an improved performance monofilament based on extrusion technology and found in a wide array of applications such as over-braiding for hoses, weaves as mist eliminators, medical braiding, instrument and racquet string, and strengthening for industrial belting applications. 

New Tool Measures 4 Surface Appearance Quality Conditions Simultaneously
Application Note | By Naomi Shisaike, Canon USA, Inc. Optoelectronic Components

If surface appearance quality is critical to your product, learn about a new manufacturing-friendly tool that allows you to establish numerical standards for and measure four conditions of surface quality: gloss, haze, image clarity, and BRDF including Canon’s new parameter “Scattering C20, C60.” 

A Balanced Distribution Of Risk: Is Your CDMO Relationship Set Up For Success?
Article | KMC Systems

Beware of any scenario where the word “partnership” is used only to obtain a better price and/or more aggressive terms, as this is the origin of failed relationships. A true partnership should define terms that balance the risk and reward for each party.

Is It True That Cooled Cameras Are More Sensitive Than Non-Cooled Cameras?
Article | PCO-TECH Inc.

The reduction of temperature through “cooling” of image sensor components or electronic circuits can improve image quality and performance. This paper will examine the underlying effects of cooling in cameras and their sensitivities.

Advancing Heart Simulation To Save Lives
Case Study | Dassault Systemes Americas

The project’s first output is the Living Heart Model (LHM), a realistic 3D computational model of the human heart. This case study discusses the Living Heart Project and the plans for further developments and clinical applications rising from its efforts.

Providing A Labeling Backbone For Medical Device Manufacturer: Boston Scientific
Case Study | PRISYM ID

Boston Scientific was looking to standardize on a single labeling system. The project arose when a worldwide branding exercise highlighted variances in label formats and styles on secondary packaging; standardizing on a single labeling system would offer consistency, increase efficiency, and compliance.

Resources
Medical Micromolding
Accumold
Parylene Coatings For Neurostimulation Devices
Specialty Coating Systems
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