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

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

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

Yet Another Technical Gap Closed: Measuring Lowest Flow Rates in Medical Therapies
Medical procedures and therapies are often faced by the same challenge: accurately measuring and controlling lowest flow rates down to the microliter per hour range. In most of these cases the outcome of the therapy, as well as the well-being or even the survival of the patient strongly rely on the reliable a

Flow Measurement in Smart Inhalers for Connected Drug Delivery
Inhalers are among the most commonly used devices for treating respiratory diseases such as asthma and chronic obstructive pulmonary disease (COPD). With each inhalation through the inhaler, the device delivers a specific amount of medication to the lungs. However, when it comes to proper inhaler use, misuse

Whitepaper: Long-term Wear Adhesives II

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Flow Sensor Solutions in Modern Medical Ventilators
Continuous airflow measurements during anesthesia monitoring, intensive care treatment as well as in clinical and ambulatory environments provide important information for the assessment of cardiorespiratory and breathing circuit behavior and have become indispensable in modern medicine. The increase of intel

Case Study - UV15: For Fabrication of Polymer Optical Waveguides
With its outstanding light transmission properties and optical clarity, Master Bond UV15 is widely used for a variety of bonding, coating and sealing applications in the optical, electronic and optoelectronic industries. In fact, it has been effectively used by RMIT University, the University of Texas at Aust

Flame Retardant Epoxies and Silicones Meet Critical Safety Requirements
Designed to mitigate the worst effects of fires, fire retardant materials play a particularly important role in aircraft construction. Used in aircraft, epoxies and silicones must maintain their primary role as adhesives or coatings while exhibiting resistance to heat and flame in accordance with government a

Die Attach Adhesives Impact Product Quality Well Beyond Manufacturing
Die attach adhesives serve a vital role in semi-conductor assembly, manufacturing and throughout the product life cycle. In this white paper, learn how they facilitate assembly and about the application process. Find out why thin bond lines are so important for product life cycle. Bond strength is only one, a

Catalog: Adhesives for the Medical Industry
For an overview of Master Bond’s most popular medical grade epoxies, please browse this easy to read catalog organized by chemistry, key properties and curing schedules. From the prototype stage through the manufacturing process, each compound in this 20 page catalog is designed to meet specific applicatio

When To Use a Fast Cure Adhesive
To reduce assembly costs, why not consider a fast cure adhesive? But one caveat might be to question the need for speed when selecting the appropriate adhesive for an application. In this white paper, you’ll find an overview of the different types of fast cure adhesives, including one and two part epoxies,

Innovative Medical Adhesives Simplify and Improve Fastening in Medical Devices
Modern adhesives offer medical device engineers a leg up with new options to simplify fastening and improve performance as medical devices and materials continue to advance. When faced with often hostile environments of human bodies and hospitals, modern, well-designed structural medical adhesive compounds

Epoxies Safeguard Medical Electronic Devices
The combination of increasingly complex assemblies and exacting quality requirements is compelling design engineers to be extremely diligent when selecting materials for the assembly of medical electronic devices. In this white paper, we explore various polymer chemistries and what the different families of c

Porex Medical
A Study of Analytical & Clinical Interference in Porous Laboratory Components

The Hassle of Li-ion Batteries for Miniature Applications and Why Silver-Zinc is an Easy Solution
As a society, we rely on our electronic devices and therefore batteries more than ever before. Small electronic devices, depending on their function, can improve communication, enhance quality of life, contribute to physical well-being, and generally provide entertainment, safety and security. However, the li

Electrocutting and Mechanical Cutting for Endoscopic Applications
Even the simplest medical cable assembly projects contain numerous engineering considerations. And among the most complex applications, the quantity of requirements can skyrocket. Factors such as diameter, construction, material, coating, length, and tolerance are only a few of the often-mountainous specifica

10 Key Areas to Consider When Evaluating Suppliers
Understand the key areas that should be included in your vendor evaluation before you entrust your valuable project to a third party.

Coil Spring Design
A demanding application requires a custom spring solution engineered for consistent performance. From critical medical instruments, pharmaceutical delivery systems, robotic platforms, orthopedic implants or other system designs, reliability is the only option.

Designing Auto-Injectors for Multiple Drug Viscosities
Components—specifically springs used for device activation and needle retraction—play a key role in creating a flexible design. Pharma and biopharma OEMS need to engage spring suppliers at the very onset of new device planning.

Managing the 2020 Medical Device Windows Upgrade Cycle - Solutions for the Windows 7 End-of-Life in January 2020
On January 14, 2020, medical device manufacturers that use Windows® 7 in their devices face a critical, expensive deadline. Windows 7 support is set to expire on that day. Millions of devices in the field run on Windows, and without upgrades, they are security risks. System upgrades are needed to maintain