Medical device manufacturers: What capabilities should the ideal medical polymer compounder have?
If you are a medical device OEM or a supplier subcontractor who has been entrusted with developing components for your client’s new product, you may be uncertain as to how to evaluate a compounder with whom to partner. This white paper has been structured to provide you with a multi-discipline consideration t

Styrenic TPE Compounds: Growth Drivers & Challenges in Medical Applications
Over the past three decades, regulatory and market drivers, as well as cost pressures, have continued to generate a material choice discussion between polyvinyl chloride (PVC), thermoplastic elastomer (TPE) and rubber materials.

Case Study: Tekni-Plex Solves Material Supply Problem for Contract Packager; Helps Expand Applications
Sourcing blister packaging materials from Asia was resulting in long lead times, high air freight costs and inability to solve a broad range of packaging challenges

Case Study: Tekni-Plex Medical IV Tubing Solution Helps Protect Healthcare Professionals, While Providing Needed Therapy to COVID-19 Patients
Tekni-Plex harnesses global manufacturing footprint to provide tubing ASAP

Elcam Medical’s New & Innovative Minimal Residual Volume Luer Activated Stopcock
Catheter Related Blood Stream Infections (CRBSI) are a well-known and increasingly disturbing problem in hospitals, especially in Intensive Care Units (ICUs) and other units utilizing catheters and their accessories for patient care. Reducing the risk of microbial colonization and proliferation on stopcock

Clinical Study using Marvelous Stopcock
Elcam creates products to minimize infection as noted in the paper by Randy Loftus, MD, et. al, published in the November 2012 issue of Anesthesia and Analgesia using the Ultraport

SafeT™ Stopcocks Lipid Compatibility
The need for a more reliable stopcock increases in an ever-advancing industry objective towards a safer and efficient care-giving environment. Addressing lipid-induced cracking is one way to reach this objective. Lipid induced cracks and leakages are considered under-reported adverse events or mistakenly attr

Corona vs. Plasma Technical Bulletin
What is the difference between corona and plasma? The context of this question is important as some industries have adopted unique definitions of each term. In this article, Enercon explains the similarities and differences of corona & plasma and types of in-line plasma technologies offered.

What Plasma Does to a Surface to Improve Adhesion
Plasma surface treatment is used to improve a surface’s receptiveness to adhesives, inks, paints & coatings. Three distinct surface modification processes occur simultaneously when exposing a surface to plasma treatment: Cleaning, Etching & Functionalizing.

Surface Treating Comparison Chart & Tech Paper
Ultimately your application’s requirements will define which technology is best for you. Enercon can compare various plasma & flame surface treating technologies for your application in our lab, and we can run trials in your facility to prove which is best for you. In this document we’ll share in

Material Selection & Thin-Wall Micromolding Study
This study tackles one of the most widely asked questions of Accumold, resin selection assistance. This study shows how, in terms of micro-molding, picking resins based on data sheets can be misleading or confusing. It’s important to consult with your molder when designing parts that may be considered ou

Finding the Optimal Metal Tubing for Medical and Critical Applications
Selecting the best alloy for a tubing application can be a daunting task considering the wide variety of stainless steel and metal alloys available. The chromium in stainless steel forms a coherent passive oxide film and oxygen barrier, which imparts corrosion resistance. All stainless steels contain at least

Identification of Adhesive Formulations Minimally Effected by E-Beam Sterilization
A selection of medical/skin adhesives were coated onto substrates and physical properties (Shear, Adhesion to Release, 180° Peel and MVTR) tested before and after exposure to e-beam sterilization of 27 and 40 kGy. Of the four adhesives tested, two displayed a much lower effect from e-beam exposure than the ot

Evaluation of the Wear Duration of Acrylic Wearable Device Adhesives on Healthy Human Volunteers
Healthy Human wear studies were performed using different formulations of acrylic adhesives on substrates (non-woven polyester, LDPE film, PU film and PU foam) to evaluate the wear durations of the different combinations. Differences in wear durations were seen depending on the identity of the adhesive and th

Cox Manufacturing: Advancing A Legacy of Delivering Confidence
When William T. “Bill” Cox, Jr. talks about his business, the conversation turns easily and naturally to the Cox Manufacturing Company’s watchword – Cox delivers confidence – and the Tornos technologies that help him make good on that promise every day. (from deco magazine - March 2017)

Piezo Technology in Pneumatic Valves
Compared to traditional solenoid valves, piezo valves are lightweight, precise and energy efficient. These advantages make them ideal for many critical applications—from semiconductor manufacturing to laboratory automation. This white paper explores piezo valves in greater detail, including valve design princ

Biological Evaluation of Medical Devices as an Essential Part of Risk Management Process: Updates and Challenges of ISO 10993-1:2018
In August 2018, a new version of ISO 10993-1 was published, which highlighted the importance of gaining deeper knowledge of the device. In the new version of the standard, not all biological effects should be assessed by biological testing. Some tests can now be waived if there is a sound rationale to support

Sterility Testing of Medical Devices: An Overview
A sterile medical device is one that is free from viable microorganisms. Medical devices produced under standard manufacturing conditions in accordance with the requirements for Quality Management Systems (QMS) may have microorganisms present on and/or within them prior to sterilization (non-sterile products)

Endocrine Disruptors in Medical Devices: An Integrated Approach for Compliance with Regulatory Requirements
The goal of the present paper is to propose a systematic, standard workflow for the safety assessment of endocrine disruptors through the understanding of what EDCs are, where they are found and how to mitigate their exposure via the performance of the biological evaluation of MDs, followed by the evaluat

Insights into in-vitro Hemocompatibility testing according to ISO 10993-4
Hemocompatibility testing of blood-contacting medical devices is one of the most important criteria for successful clinical application.

Medical Device Extractables and Leachables Testing in 2020
The world of physics has a foundation built on beautiful universal constants which work they way steadfastly into the equations governing electrodynamics, and the further extend themselves into our very hands in the design of smart interconnected electrical devices that are commonplace to modern life.

Incorporating User Needs into Medtech Design
User-centered design is not a new concept for medical devices, but it can be a challenging one. Designers need to consider a wide range of end-user skills, a variety of use environments, and all the associated risks. In this ebook, MD+DI has gathered advice from design experts on building human factors and

Optimizing Usability in Augmented Reality Medical Devices
Augmented Reality (AR) is fast becoming the future in the medical and healthcare world as intraoperative patient data continues to flood physicians’ clinical decision making. It has been said that AR has the potential to revolutionize how physicians access, view, and analyze data while caring for patients, wh

Eliminating Adhesives in Medical Tubing Assemblies
EJ BioMed, an Eldon James Company, released information on the successful testing and application of PVC FREE tubing and fittings that do not require adhesives. Working alongside their supplier, Teknor Apex, the assemblies were tested for pull-off force, flow test, and leak test. The EJ BioMed fittings c

Eldon James shelf-life determination for products produced with Flint Hills Resources 13R9A polypropylene random copolymer and tubing produced with FX polymer.
DENVER, COLORADO  – August 12, 2016 – Eldon James Corporation – a leading, U.S. based manufacturer of plastic tubing and fittings – announced the successful results of accelerated aging test results for their polypropylene fittings and FX polymer tubing.

Rapid Sterility Testing: A New Solution for Short Shelf Life Products
All drug products undergo sterility testing to comply with Good Manufacturing Practices (GMP). Parenteral drug products go through especially rigorous testing to ensure sterility and safety, otherwise risking contamination, which can lead to expensive reputation-damaging recalls and illness. Until recently

Five Areas to Audit when Utilizing a Low Cost Medical Contract Manufacturer
Medical device manufacturers face a significant challenge in the market-driven need to reduce cost without sacrificing quality. This has driven sourcing teams to seek suppliers in lower cost labor regions. The lowest cost regions may lack suppliers with quality systems, procedures and production infrastruc

Production Inefficiency: Can A Specialized Medical Contract Manufacturer Be a Solution?
Most sourcing teams and many production managers have run into a common issue: manufacturing projects whose lower volumes, near end-of-life status or specialized manufacturing processes make them outliers in the overall sourcing or manufacturing strategy. When forced on contract manufacturers as part of ov

Developing Cost Effect Refurbishment/Remanufacturing Solutions to Extend the Life of Legacy Products
While the wealthier nations of the world want the latest technology in their medical products and have the budgets to pay for it, developing nations are often happier with the price points of older technology, provided it has been refurbished and meets appropriate quality standards. In a perfect world, thi

Is Made in Seychelles a Solution for Lowest Cost Entry into African Markets?
While medical technology can make a big difference in the overall health of developing nations, these nations have the smallest budgets for that technology. Medical device manufacturers often address this with lower cost, more basic product versions manufactured through contract manufacturers or joint ven