Perfecting PFOA-FREE PTFE COATING ADHESION on Stainless Guidewires
New process provides PTFE adhesion after soaking in saline solutions But that is what struck the guidewire industry last year after a voluntary recall – that the FDA classified as Class 1† – for stainless steel guidewires going back to April 2013. The problem was poor adhesion of an aqueo

Lithium Metal Battery Shipping Regulations 2015
Shipping on the Right Side of the Law

The Hidden Costs of Multiple-Vendor Contract Manufacturing
Review any directory of medical device outsourcing resources and you’ll see an assortment of offerings and services: design and engineering, components, assembly, legal, regulatory, sterilization and many more. You can find virtually any company to handle any part of the medical device manufacturing process.

A Toolmaker's Perspective on the Challenges and Opportunities in PIM
Dynamic Group: A toolmakers perspective on the challenges and opportunities in Powder Injection Moulding

Generating Ultrasonically Welded Parts with Improved Strength and Reliability for Critical Applications in Medical Device Manufacturing by Utilizing Advanced Melt Flow Controls of Servo Driven Ultrasonic Welding Equipment
Ultrasonic welding of thermoplastics is widely used by many industries to fuse together two parts in a short time without additional consumables. The development of servo-driven ultrasonic welders introduces unique levels of control. This study pursues previous research and investigates the capabilities

Clinical Feasibility Trials
A clinical feasibility trial is a research study in which the product is used in a small number of human patients who are carefully monitored.

Low Friction Plastic Technology for Single-Use Drug Delivery Devices
Start-up coefficient of friction and stick-slip (or “stiction”) elimination are dominant performance drivers in single-use drug delivery devices that have moving parts. RTP Company has completed a rigorous investigation that establishes and defines a new friction test to measure and compare plastic-against-pl

Pressure Point 10: Media Capability
All Sensors Pressure Points are application tips to simplify designing with microelectromechanical systems (MEMS) pressure sensors and avoiding common pitfalls.

Nitinol Implant Design & Manufacturing
The nickel and titanium alloy known as Nitinol, is a superelastic shape-memory alloy responsible for major advances in medical technology over the last 15 years.

The Six Reasons We Specialize in Medical Devices
Sleek and shapely consumer products like cell phones, flat screen TVs, and some kitchen gadgets are celebrated and "sexy". Medical devices are not so exalted. Some are elegant in their own way, but outside of a hospital or doctor’s office, most people don’t recognize the products we design. But that's all rig

Top 10 EMS Providers in USA Northeast – 2015
Our inaugural list of the Top 10 EMS Providers in USA Northeast for 2015 in no particular order. We define USA Northeast as Connecticut, Delaware, Maine, Maryland, Massachusetts, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island, Vermont, West Virginia.

Implementation of Redundancy in Miniature Stepper Motors
Some of the recent research in the area of electric motor drives for critical applications (such as aerospace and nuclear power plants) are focused on various fault tolerant motor and drive topologies. This paper focuses on a miniature PM stepper motor design which falls in this fault-tolerant category by

How to Manage Field Inventory More Effectively
Field inventory is a crucial part of many medical device manufacturers' business. Manufacturers commonly struggle with overstocking, cost containment, sales rep productivity, and device traceability for compliance and financial audits. There are emerging field-inventory management products, such as mobile RFI

Close Tolerance Cutting Methods Get a Closer Look.
This guide looks at the five most common methods of 2-axis metal cutoff and provides a basic comparison to help you make the best decision for your specific application.

Simplify a Complex User Interface with a Virtual Instrument
Virtual instruments or virtual tools are computer simulations of physical devices. They are most useful for developing and testing complex systems that would be too costly to modify after they are constructed, and to simplify the operation of any device or instrument that has an intricate or potentially confu

IEC 60601-1-2 4th Edition EMC
The fourth edition of IEC 60601-1-2 has been approved, and this means dramatic changes for the medical device industry. This edition introduces new product categories, new test levels, and eliminates the “life-support” device category. Due to increases in test requirements, there’s strong possibility that leg

Medical Multi-Lumen Catheter Leak and Flow Testing - Case Study
A medical device manufacturer needed a test instrument to test single, dual, triple and quadruple lumen CVC & PICC Catheters with female Luer fittings. The distal ends of these Catheters are tipped and skive holes cut into each lumen. The manufacturer requested automated testing that would be initiated by the

What Is A Control Plan? What Is An FDA Performance Qualification (P.Q.)?
Control Plan/ Performance Qualification (P.Q.) methodology is to aid the manufacturing and quality assurance functions.

Composite Reinforced Coatings
The future of medical device coatings

Spring Types for Medical Applications
In some of the most demanding and stringent quality requirements, Vulcan Spring has a perfect record - not one reported failure in over 30 years!

Case Study: Executing a Seamless Manufacturing Transfer
Minnetronix’ manufacturing capabilities allowed the client to mitigate risk while doubling its build capacity.

Precision Manufacturing in the Medical Device Industry
The English (North America) dictionary definition of the word “precision” is accuracy (noun) or relating to accuracy (adjective). You will find the word “precision” takes on all the synonyms of the word “accuracy” in the manufacturing world. This rings especially true in the medical device industry.

Case Study – Development to Deployment
From development to deployment in six months flat

Meeting Unique Device Identification (UDI) Requirements with Laser Marking
In 2013 the FDA enacted a final rule requiring that most medical devices distributed in the U.S. carry a unique device identifier (UDI) to improve enhanced quality of information and tracking of medical devices. The

Container Closure Integrity Testing of IV Bags
As a means to ensuring the safety of sterile products, the Food and Drug Administration (FDA) and the United States Pharmacopeia (USP) have provided strict guidelines for the testing of container closure systems. Manufacturers of IV bags are one of the ma

Tool Re-shoring Success Guide
Re-shoring has become a popular topic in the news lately, with large corporations making a push to bring manufacturing projects back to the United States from overseas and Mexico. Major OEMs and manufacturers have always looked for the most cost effective ways to produce their products. Thirty years ago co

Reducing Risk: Validated Methods for Cleaning Orthopedic Devices that Use Complex Componts

Top 3 Packaging Hazards That Could Lead to a Recall
The best way to avoid a possible recall due to product damage during distribution is to subject your packaged product to a series of distribution tests. Here’s a primer on the topic and the Top 3 Failure Modes During Distribution Testing we’ve experienced at

FiberStar Micro WeldingArticle
LaserStar Technologies Corp., of Rhode Island, USA, a worldwide supplier of laser micro welding, cutting and marking workstations for industrial applications, premiered it’s first FiberStar

Engineering Metal Stampings and Springs for Manufacturability
Engineering expertise is taking on an ever-more important role in designing for manufacturability in the world of metal stamped parts and springs. Particularly in today’s new medical devices engineering expertise is invaluable in drivi