Unique Device Identification (UDI) Requirements, Deadlines, Secure Labeling
The implementation of the UDI Directive is mandated for medical device manufacturers. This is not only true for companies that sell their products on the American market, since UDI is also being implemented in the EU and other countries. Medical products must be clearly identified to ensure safe traceability

Effects of Testing Parameters on Pinch Test Results for Hydrophilic Coatings
For an array of medical procedures, it is often necessary to navigate an invasive device through a tortuous series of blood vessels or other tissues. With these procedures come risks of tissue damage due to abrasion which can lead to negative clinical outcomes, including death. Moreover, in cases where a devi

10 Things You Need to Know about Manufacturing FDA-Approved Medical Devices
There are many critical elements to quality manufacturing of FDA-Approved medical devices The purpose of the Food and Drug Administration (FDA) is to safeguard the health of the American public through the regulation of certain products, including medical devices and food-processing equipment. He

Hydrophobic vs. Hydrophilic Coatings
Understanding the advantages, characteristics, and functions of a hydrophobic coating vs. a hydrophilic coating allows design engineers to make the right choice for their applications. “Hydrophobic” and “hydrophilic” are easy to get confused with one another and it is important to learn the origins of thes

Design and Materials Considerations Affecting Reprocessing Durability of Reusable Medical Devices
Newer reprocessing technologies and higher rates of medical device use are resulting in significant changes to reprocessing practices. In light of these changes, manufacturers of reusable medical products that wish to remain competitive are advised to consider fresh approaches to design and the use of new

Lubricious Materials for Medical Devices
The need for lubricity in medical device technology is nothing new.  It has been a need since the early days of the industry in everything from simple guide catheters to complex articulating neural catheters, drug delivery systems and more.  The basic need for lubricity is a function of design based

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

Design Considerations for Multi-Material Molding of Thermoplastic Elastomers
Global market-leading original equipment manufacturers (OEM’s) are facing tremendous market pressure to create innovative designs in record time for the least possible cost. In addition to maintaining the highest possible quality throughout the product’s expected lifecycle, consumers are demanding that produc

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