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)

Four Key Dynamics Driving Effective Outsourcing Decision-Making for Lab Automation OEMs
Lab automation OEMs need to maintain flexible outsourcing strategies—enabling them to better accommodate and respond to new operating and market needs. This white paper explores the four factors that can impact and change outsourcing strategies: economic rationales, accelerating innovations, supply chain v

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.

Dark Marking with Picosecond Lasers
Ultrashort pulse lasers create high contrast dark or black marks that are resistant to passivation, corrosion, and autoclaving and that meet federally regulated UDI standards for medical devices. 

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

Cubis® II Balances - Pharma Compliant by Design
Sartorius’s Cubis® II is designed to follow US FDA data integrity principles that require data to be accurate, legible, contemporaneous, original, and attributable (ALCOA). The Cubis® II balance, with pharma package, contains all the technical controls to support compliance with common regulations. Full co

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

The Value of ISO 13485 in a Design Centric, Medical Product Development Firm
This article explores the value that ISO 13485 Certification brings to both the medical design and development firms that maintain certification and to the clients that benefit from them. Common misconceptions about a Certified QMS include that it adds expense to the project and that it is

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

Safety in medical electrical equipment starts with the power input
Electrical equipment used in medical technology must not place patients or medical staff in danger. This, in turn, requires that designing safe equipment starts at the point where the power is supplied. Power connectors and power entry modules with or without a power-line filter must fulfill the requiremen

Medtech Mergers & Acquisitions of 2019
Mergers and acquisitions (M&As) continued to change the landscape in the medical device and diagnostics industry in 2019. See which companies were bought, sold, or spun-off last year with our comprehensive list of 2019 medtech M&As. Information in the report includes the following: Buyers

Is Heatsealing Art or Science?
The evolution of heat sealing perfection from hot bars, to impulse to VRC TOSS Technology. Today's heat sealers provide much more than just sealing the pouches.  Advanced security, information downloading, recipe storage, easy validation.....  

The Real Story About Controlled Impulse Heat Sealing of Polymeric Materials
Toss VRC Technology is an improved method of impulse heat sealing that overcomes the limitations of simplistic convention methods. It brings advantages to the fabrication and packaging requirements of the Medical/Pharmaceutical/Healthcare and Biotech Industries. Advantages that are not available with oth

Avoid Pouch Sealing Disasters - The 9-Steps to Heat Sealing Perfection
Step 1 Heat Sealing Configuration. Determine what is expected from the seal. What does one expect from a heat seal? Wide, narrow, shaped, or just seal or seal and cut? Before a satisfactory sealing system can be designed it is necessary to decide what seal configuration is desired. Step 2 Heatseal Ban

What Causes Wrinkles in Heat-Sealed Pouches?
Wrinkles in the seal area can cause a package to be rejected. Let's look at somethings that can be done to avoid packaging failures.

Less is More: How Lean Processes can Bolster Profits and Sustainability
Medical device manufacturers are just like every other business regarding their desire to maximize profits and sustainability by reducing waste and losses. However, unlike most businesses, medical device manufacturers don’t use specific, proven methodologies to achieve these goals.