Design & Testing

Packaging/​Sterilization

Have questions about medical device packaging and sterilization? Get the advice you need regarding options, regulatory compliance, and product development.

Latest Briefs & News

News : Packaging & Sterilization
Medbio Expands Manufacturing Capacity

Medbio, Grand Rapids, MI, has opened a second manufacturing facility. The company is an outsource manufacturer offering design and engineering, manufacturing, assembly, and packaging solutions for the...

Features : Medical
MIM and 3D Printing: Precision Cleaning and Product Finishing of Medical Devices

As the miniaturization trend continues to take the medical device world by storm, manufacturing with metal injection molding (MIM) and additive processes such...

News : Medical
Mindray North America Selects Eastman Medical Polymers to Enhance Patient Monitors

In an effort to improve patient safety and device durability, Mindray has incorporated Eastman’s medical polymers into its current generation of patient monitors. Used in healthcare facilities throughout North America, the Passport Series of bedside monitors,...

Features : Medical
Improving Cancer Screening by Design

Every year, 50,000 Americans die from colorectal cancer, a common cancer that is easy to detect and can be effectively treated if caught in its earliest stages. Unfortunately, 38 percent of Americans...

Features : Medical
Four-Step Plastic Testing Protocol: Making Informed Design and Material Decisions

Medical devices across the United States must not only keep pace with advances in technology but also with the increased use of harsh solvents and...

Features : RF & Microwave Electronics
RFID for Medical Device and Surgical Instrument Tracking

Ensuring patient safety and quality of care has become an increasingly technology-reliant process for most healthcare providers. With 4,000 reported “retained surgery items” cases...

Features : FDA/Regulatory
Reusable Medical Devices: BI Selection, Overkill Validation Approaches, and First-Time Validation Pass Rates in Common Healthcare Steam Sterilization Cycles

When validating the steam sterilization instructions for a reusable medical device,...

Features : Medical
Orthopedics: Springs Provide Precision, Cleanability

When engineers develop orthopedic surgical devices, they must often think beyond the design of the device, and find a way to make its installation easier, safer, and more accurate....

Features : Imaging
CMOS Imaging Sensors: Direct, Real-Time Color Imaging in Cardiovascular Devices

Advances in CMOS (complementary metal oxide semiconductor) imaging sensor (CIS) module technology are shrinking pixel size, allowing more pixels to fit into a...

News : Packaging & Sterilization
Sterigenics International Changes Name to Sotera Health

Sterigenics International has changed its parent company name to Sotera Health. Its three operating companies — Nelson Labs™, Nordion®, and Sterigenics® — will continue to maintain their current names. The new parent company name signals a more integrated and...

News : Medical
Sterigenics and Noxilizer Partner to Provide NO2 Sterilization

Noxilizer, Inc. (Baltimore, MD) and Sterigenics International LLC (Broadview Heights, OH) have signed a global agreement that will make Sterigenics the exclusive worldwide provider of nitrogen dioxide (NO2) contract sterilization services, as well as feasibility and...

Features : Packaging & Sterilization
Addressing Cleaning Challenges for Medical Electronics

The market for medical electronics is huge and growing. The astounding capabilities of digital technology and broadband connectivity are “a perfect storm,” enabling doctors to...

Features : Medical
New HAI-Prevention Cleaning Protocols Reinforce Need for Material Consideration for Medical Device Housings

As in any industry, new technologies and material choices present new opportunities and challenges for OEMs looking to build brand equity, bring products to market faster, and meet consumer demand. Medical device manufacturers are faced...

Features : Electronics & Computers
Understanding Proper Cleaning Procedures for Medical Device PCBs

Printed circuit boards (PCBs) are critical components in many medical devices. Prior to shipment to the OEM, PCBs must undergo a thorough cleaning process to remove excess solder, rosins, and other contaminants at the end of the manufacturing cycle. If not cleaned properly, PCBs...

Features : Materials
Disposables

The potential for environmental stress cracking is a common concern when plastics are used in medical devices. According to materials expert Jeffrey Jansen of The Madison Group, environmental stress cracking (ESC) is considered a leading cause of plastic part failure. “It is the premature embrittlement and subsequent cracking of a...

News : Electronics & Computers
Interactive screens on your packages

Instead of reading a label, consumers could be interacting with an electronic screen on packaging in the future, thanks to a development by scientists at the University of Sheffield. The scientists collaborated with technology company Novalia to create a new way of displaying information on packaging, a move...

Features : Materials
Silicone Adhesives for Medical Device Assemblies

Medical device assemblies present unique challenges beyond those associated with manufacturing and assembly of products for consumer and industrial applications. While sharing the need for ensuring reliable, robust seals or bonds with these industrial applications, medical applications are subject...

Features : Test & Measurement
Validating IFUs for Reprocessed Medical Devices

Incidents of nosocomial or healthcare acquired infections (HAIs) and bacteria that have become resistant to antibiotics (“superbugs”) are a concern for U.S. FDA. These ongoing incidents have heightened FDA’s attention to manufacturers of reprocessed medical devices. Manufacturers need to...

Products : Packaging & Sterilization
Thermoforming Packaging Machine

Multivac, Wolfertschwenden, Germany, has released the R 081 thermoforming packaging machine, an entry-level model for automatically packing small or medium-sized batches. The compact system is ideal for use in environments with limited space and is suitable for packaging sterile medical products in small batch...

Features : Medical
Current Trends in Sterile Medical Packaging and How They’re Impacting OEMs

The medical device industry often gets attention for its innovation and constant evolution. However, even the most innovative medical device technology is of no use if its integrity and functionality aren’t protected. The expanding medical packaging industry is in...

Briefs : Packaging & Sterilization
Ensuring Your Medical Device Meets Sterilization Standards Throughout the Supply Chain

Ensuring that device packaging meets specifications.

Considering the complex science and research that goes into developing medical devices, it is important to take time to consider the detailed process and requirements in place for safely delivering...

Features : Medical
How High-Performance Polymers Help Medical Device Designers Work Smarter and Sleep Better

Hospital acquired infections (HAIs) represent one of the key challenges facing today’s healthcare industry. According to a recent study published by the Journal of the American Medical Association (JAMA) Network, total costs associated with HAIs reached...

Features : Medical
A “Particle” of Prevention Is Worth a Pound of Cure: The Significant Benefits of Premarket and Postmarket Particulate Testing of Cardiovascular Devices

Particulate testing of cardiovascular medical devices is an important and valuable step on the road to regulatory clearance, market success, and patient safety. Device manufacturers that...

Briefs : Packaging & Sterilization
Engineering and Construction Process for Custom Device Cases

Design and development considerations can protect portable devices.

When bringing new medical equipment or portable mobile medical devices to market, manufacturers turn to packaging engineers to develop custom case solutions that can enhance and protect their...

Features : Electronics & Computers
DOEs Rescue Questionable Medical Electronics PCBs

Board cleaning is perhaps one of the most overlooked aspects of printed circuit board (PCB) assembly. But savvy medical electronics original equipment manufacturers (OEMs) have a keen sense of the importance it plays to ensure their products are free of miniscule flaws, defects, debris, and dust....

TECH SPOTLIGHT

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Bump or Tapered Tubing

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