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 ...

Quality Compounds Come From Quality Inputs
High quality, superior medical devices start with the highest quality materials and components.

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

BLE = Bluetooth Low Energy…
Bluetooth Low Energy is slowly migrating into every aspect of our lives. The protocol is being designed into sensors, home health care products, home automation products, consumer electronics, and so on. So why doesn’t my new BLE

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.

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

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 ...

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

UV-Curing Silicone Elastomers Enable New Medical Concepts
Momentive Performance Materials' new family of silicone elastomers cures with UV light alone, enabling innovative applications that support recent industry trends.

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 co...

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.

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

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

Need an IDE?
Clinical studies are usually expensive undertakings and can have significant regulatory hurdles to overcome. Many clinical studies require a FDA-approved IDE before they can begin. A link to the FDA regulations for IDEs can be found here and FDA has plenty of guidance here and especially here. But before you

Structure and Properties of Large Diameter Hot Rolled NiTi Bars for Seismic Applications

The Effect of Alloy Formulation, Inclusion Content and Cold Work on Void Formation in NiTi Alloys

Parallel Prototyping and the Engineer's Dilemma
Develop innovative products quickly, with superior quality, while controlling cost.

eBook: Tubing and Extrusion in Medical Manufacturing
Tubing is a vital component in medical devices ranging from catheters to IV sets to insulin pumps, but choosing the right type for a given application can be challenging. There are numerous factors to weigh, including diameter, lubricity, and rigidity, to name a few.This eBook offers advice on extru

Grinding Hypotubes to an Extremely Thin Wall
Processing of SST hypotubing to extremely thin wall thickness - achieving a diameter to wall ratio of 100:1 is possible on certain sizes of tubing by a specialized hybrid grinding process. Very consistent wall thickness deviation can be achieved and thus a very high diameter to wall ratio potentially attained

Case Study – High Stakes
Tall order, high stakes

Case Study – Critical Launch
Accelerated time-to-market keeps critical launch on track