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Catheter Transfer Case Study Cardiac catheters are used for both diagnostic and interventional purposes. During diagnostic procedures, catheters monitor blood flow and pressure within the heart, as well as provide a conduit to deliver radiopaque media that enables visualization of vascular system.
Using “RFID-enabled” Fluid Couplings to Verify and Track Critical IVD Consumable Fluids There has been much discussion lately about the “internet of things” “iOT” and its role within the medical industry. Like many other IVD instruments, fluidic connectors have gotten “smart”. Equipped with a control unit and RFID technology, it is possible to communicate data that ensures the proper consumable
Get a Grip! An Introduction to Hose Barbs Fittings with hose barbs offer a simple, dependable and inexpensive means for terminating tubing or hoses. Hose barb fittings may have one barb or several barbs (see figures below). Barbs may be spaced evenly or with extra space behind, between or in front of each barb. The fitting itself may be constructed o
What you need to know before selecting high tech adhesives Discussion of the proper selection process to determine the most appropriate adhesive.
How to Select Illumination (Lighting) Systems for Stereo Microscopes Free whitepaper focusing on how to choose illumination systems that produce the best imaging results. The illumination used for microscopic observation has a very important effect on the final image quality. Choosing the illumination to achieve the best results depends upon the type of sample and i
The 6 Sciences of Medical Micro Molding: How to Achieve Better Long-Term Results and Faster Speed to Market The medical micromolding industry is still fairly young, but is rapidly growing and evolving. Being aware of shifts in trends and changes in technology helps to see where –and how– the next major innovations and breakthroughs will occur.
Micro Molding with Bioabsorbables Not Your Average Thermoplastics
Design for manufacturing breakthroughs: Producing Innovative Micro Medical Devices Everyone wants to be innovative, to find the next big idea in their field. Innovation doesn’t strike like a lightning bolt out of the blue. It takes collaboration and a deliberate search process.
Features, Benefits and Applications of ecoGenesis RF Welding Technology This Paper: Presents an overview of ecoGenesis, Genesis Plastics Welding’s proprietary RF technology, including capabilities and applications Offers third-party validation of the technology Offfers third-party identification and support for end-use applications across many
Why Your Medical Microelectronics Development Partner Needs Both Particulate - and Microbial-Controlled Clean Rooms Microelectronics technology is increasingly ubiquitous, even within the human body, as medical researchers develop new approaches to monitoring and treating a growing array of illnesses and injuries. A variety of implantable medical devices are now used routinely, ranging from
Large & Thin Dies New die sorting techniques target large, low-thickness die in microelectronics assembly
Case Study 569 Currier Plastics was asked to develop a new Injection Stretch Blow Molding (ISBM) Jar that could be used in the medical/healthcare market. The Jar could be subjected to 4,500 RPM of centrifugal forces. A study is necessary to determine proper material, wall thickness, geometry and base push up characteristics
Why you need an ISO certified design house and Contract Manufacturer Working with a development firm with a certified quality system saves time and reduces cost.
Fact or Fiction: Debunking the 1 lb. standard for seal strength testing… • Challenges in the early 90’s with 1.0 lb. minimum for pouches • “How do you validate to a 1.0 lb. minimum using 90° unsupported peel test method for uncoated pouches?” • The answers were that you can’t, unless you use the 180° supported test method. • Over 25 years, people are still asking the ...
Case Study: Full Product Line, Tight Timeline Developing a new medical device, especially a long-term implant, is never easy. But bringing an entire metal implant line of over a hundred parts to market raises the difficulty factor to a whole new level. That was the challenge a growing medical device company brought to Donatelle, along with the requiremen
Femtosecond Laser Machining of Nitinol – What you need to know! Memry Corporation’s Nitinol component manufacturing capabilities specifically Laser Manufacturing has been at the forefront of state-of-the-art medical device technologies. In this article, Memry will present femtosecond laser machining processes with a specific focus on Nitinol medical devices.
Urethane Rubber White Paper Urethane is an extremely versatile elastomer that is applied particularly where highly stressed parts are subject to wear. Engineers and manufacturers regularly rely on a variety of urethane parts, ranging from the smallest bushings, bearings, and O-Rings to the materials used in agriculture, hydraulics, cons
The Advantages of Silicone Elastomers in Healthcare Device Development and Manufacturing Benefits of Silicone Elastomers in Healthcare
Multiconductor Compatibility with Steam and Gas Plasma Sterilization New England Wire Technologies Corporation has defined the sterilization compatibility of its proprietary jacket compounds used on ultra-flexible medical electronics cables. Two specialty silicone rubber compounds, NF11 and NF04, were evaluated for compatibility in both autoclave and the increasingly common...
Materials Selection for Medical Electronics Insulating and jacketing material options for wire and cable are innumerable, even if the field is narrowed to those with some qualification for use in medical electronics. Factors that contribute to materials selection decisions include biocompatibility, disinfection and sterilization compatibility, revis...
Designing for Mechanical and Signal Integrity in Handheld Medical Treatment Applications Handheld medical devices must perform across a wide range of device specifications and end-user environmental conditions. Mechanical and signal integrity of cable components is especially important for high-level performance, accuracy, durability, longevity, and user satisfaction. Medical cables undergo ex...
Gamma Sterilization Validations VDmax 25 and Method 1: Frequently Asked Questions View a list of frequently asked questions regarding gamma irradiation validations, as well as applicable definitions
Overview of Ethylene Oxide Residuals Sterilizing medical devices with ethylene oxide (EO) is a common practice primarily due to its extensive material compatibility. This TechTip discusses the residues that may be found after EO processing and residual reduction methods.
Performance Qualification of Ethylene Oxide Sterilization Process Method C Overview and detailed steps of Process Method C, the most commonly used method for an ethylene oxide performance qualification.
Sterility Assurance Levels This TechTip provides information on the selection of an appropriate Sterility Assurance Level (SAL) for medical devices
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
Hydrophilic Coatings: Considerations for Product Development and Choice “Hydrophilic” coatings exhibit “water loving” characteristics. Chemically, this means they participate in dynamic hydrogen bonding with surrounding water. In most cases, hydrophilic coatings are also ionic, usually negatively charged, which further facilitates aqueous intera
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...
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