Simulation of Radiation Sterilization: Choosing the Best Packing Configuration
For cost reduction, it is beneficial to choose a packing configuration that allows for the highest throughput. Typically, the ideal arrangement is found through experimental trial-and-error. In addition to being expensive and time-consuming, such an approach might miss the packing configuration that finds the

Simulation of Radiation Sterilization: Guiding Product Design
In a typical product design process, testing to ensure that the sterilization regulations are met is only performed after the product has been fully designed, built, tested, and readied for mass production. There is an inherent risk to this approach: a great deal of effort and resources have been invested in

Simulation of Radiation Sterilization: Selection and Optimization of the Right Source
When using radiation sterilization, medical device and pharmaceutical companies are faced with the choiceof gamma, electron-beam, or x-ray sources. But which one to choose? While it may be tempting to go withthe familiar option, each of these techniques has its own benefits that might make it the ideal choice

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)

Why Lean Manufacturing is Essential to Superior Product Quality
Contract manufacturing is a form of controlled chaos because most facilities have at least 30 different customers with differences in product technologies, preferred vendors, process specifications and demand patterns being manufactured in the same production area. SigmaTron International incorporates Lean ma

Continuous Microbial Air Monitoring in Clean Room Environments
Environmental monitoring is an important part of quality assurance for the production environments of medical devices and sterile pharmaceutical products. Especially for aseptic filling lines where products are filled without a terminal sterilization step it is of utmost importance for product safety and thus

The Benefits of Outsourcing with A Full Service Contract Manufacturer
Contract manufacturers serving the medical device market typically divide into two distinct segments: electronics contract manufacturing and precision engineering contract manufacturers. Electronics contract manufacturers build both printed circuit board assemblies (PCBAs) and electromechanical systems. Pr

Motor Type Selection
Parameters that define a motor type are the mechanical output power, the shaft bearing system, the commutation systemused, and the possible combinations with gearheads and sensors. The most important criteria include the speed andtorque requirements, and the commutation system.

High Efficiency Motors
To understand the concept of high efficiency motors, you must first know how to calculate efficiency and the losses associated with the motor components themselves.

Surgical Robotics: The Market Landscape Today and Tomorrow
Robotic surgery has been a reality since Intuitive Surgical came to market in 2000, but recent innovations are transforming the landscape significantly. Both startups and traditional medical device companies have introduced robotic approaches for a range of surgical procedures, while Intuitive has already

Using Polyisoprene to Differentiate Your Medical Device
3 Key Takeaways for Engineers

Piezo Technology in Pneumatic Valves
Piezo valves are often a better alternative to conventional solenoid valves, especially in the areas of flow and pressure control and as directly controlled proportional valves. They are small, lightweight, extremely precise, very durable, incredibly fast and above all they save energy. For example, piezo v

Meeting the Emerging Challenges in Manufacturing: The Practical Applications of Lightweight Robotics
Today’s global marketplace has changed and continues to change the dynamics of manufacturing. The speed of business is accelerating, competition has increased dramatically, and competitors are as likely to emerge from across the globe as around the corner.This white paper examines the advances in me

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

Automated Pill Dispenser
An automated pill dispensing system manufacturer required a unique seal coupler design to enhance pill counting and dispensing functions. Minnesota Rubber and Plastics provided a new lip seal design solving the initial problem of seal alignment with a more precise fitting lip configuration at the seal end for

Needless Injector
Provide the complete assembly of 39 components for improved quality while streamlining the projects oversight responsibility. Eliminate the customer's management of multiple vendors supplying individual components. 

Check Valve Assembly
Topical oxygen therapy is used to treat patients with nonhealing wounds. A new topical oxygen system utilizes a unique check valve that stops the fl ow of oxygen out of the oxygen-enriched container if the patient disconnects it from the oxygen source. The relief valve maintains the infl ation pressure inside

Agile in an FDA Regulated Environment

Breakthrough Inline Measurement Technology for Silicone Tubing
In an industry first, Freudenberg Medical has developed a ground-breaking new technology to continuously measure the inner geometry of silicone tubes. This new measurement technology, called Helix iMC™, uses sensors to continuously measure the inner geometry of extruded products such as single- or multi-lumen

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

Compression Spring Basic Features
Lee Spring (celebrating 100 years in manufacturing) provides a basic overview of compression springs used in a wide variety of Applications, including medical devices. A compression spring is an open-coil helical spring that offers resistance to a compressive force applied axially. Compression Springs are th

Compression Spring Design and General Considerations
There are a number of design considerations when working with compression springs. Let us first consider stress, set and weight as important considerations in establishing a custom spring design which need to be understood at the outset. Download the Lee Spring (celebrating 100 years in manufacturing) white

The Tooling Equation: Are You Maximizing Value?
Tooling for molded parts is often an area that many medical device manufacturing sourcing teams see simply as a line item in non-recurring engineering costs. However, anticipated project volumes, complexity of tool, tooling vendor selection and tool maintenance strategy are all issues that can impact prod

Resorbable Polymer Implants: Attention to WIP Exposure
This white paper is meant to identify critical considerations related to WIP Exposure vulnerabilities of resorbable polymers. A structured and disciplined assessment of the different contributors to the Overall Exposure Risk will enable a fact based decision pathway that will result in the establishment of a

Metrics That Matter for Quality Manufacturing
How MasterControl Customers Measure the Impact of Manufacturing Excellence™.

The Clock Is Ticking: Will Notified Body Capacity for the EU MDR Affect You?
In July, we published a white paper on the progress of the new European Union Medical Device Regulation (MDR) and In Vitro Device Regulation (IVDR) and how the lack of Notified Bodies (NB) could affect timely implementation. The deadline is looming larger and some small progress has been made, along with some

In a World of Shifting Trade Policies, Which Region is Best for Your Project?
Any outsourcing evaluation should recognize that every region has advantages and disadvantages. This whitepaper looks at regional advantages/disadvantages in Asia, the U.S. and Mexico, from the perspective of SigmaTron International, an electronics manufacturing services (EMS) provider with facilities in

The Essential Laser for Orthopedics
Ask any orthopedic surgeon to show you the tools of the trade, and the evidence of laser processing is not difficult to spot. Most devices and tools, even single-use items, bear the telltale traces of marking lasers used to indicate depth, part number, and lot or serial number. The growth of laser usage is

Crash Course: Heat Sealers and Sealer Validation
A collaboration between Packworld USA and Packaging Compliance Labs

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.