New Requirements for Medical Device Cleaning Validations: An Overview of ST98

As medical devices become more advanced and innovative, so do the regulations that surround them.

A Fast, Simple Sampling Method for Characterizing Volatile Organic Compounds Emitted from Medical Devices

In 2018, an update on regulations for respiratory medical devices meant that volatile organic compounds (VOCs) emitted from the devices...

Pen and Autoinjectors: Testing for the Future

The injectable drug-delivery device market is growing at a staggering rate, with an anticipated global market value of $37.5 billion by 2025 compared to $16.7 billion in 2016. The driving factors...

Four Best Practices for Software Testing

Great quality assurance is what turns great software into great product. Testing is a crucial part of any software development process, whether to ensure safety in a medical device, to minimize risk...

Integrating Vision and Force Measurement into Medical Quality Control

Vital for ensuring compliance to federal regulations, dimensional metrology systems facilitate critical measurement of medical parts, and force testing systems are used to...

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...

Tests Prove Immersion Method of Production of Implantable Devices is Effective

Healthcare-associated infections (HAI) are a major, yet often preventable threat to patient safety, and they can have a significant impact on the survival rate of...

Researchers Develop At-Home Pap Smear Test

An at-home Pap smear test is designed to reduce anxiety associated with the procedure and give women more control over their health without interfering with their work or social life. The Domi Care,...

Diagnostics Manufacturing: Strategies for Outsourcing

When new assays or diagnostic tests are ready for commercialization, there can be tremendous hurdles to overcome, including significant investment in the infrastructure for automated...

Package Engineering for Sterilization

After years of research and development, surveys and polls, functional device testing, and countless other preparatory actions, your medical device is almost ready to go to market. You have determined...

New Rapid Test Helps Diagnose Malaria

The WHO reports an estimated 429,000 malaria deaths each year. The disease mostly affects tropical and sub-tropical regions and in particular the African continent. The Fraunhofer Institute for Silicate...

Implementing IEC 62304 for Safe and Effective Medical Device Software, PART 2

The reliability of the embedded software used in medical devices and the risk associated with it has become a vital concern. IEC 62304, “Medical device...

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...

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...

Improving the Design of Medical Device Components with Rolled Threads

Fasteners and threaded parts are among the many small, precision-machined components found in medical devices. Because threaded parts can play a critical role in the...

Testing & Quality Control for Nanomanufacturing

Researchers at the National Institute of Standards and Technology (NIST) say that manufacturers may soon have a speedy and nondestructive way to test a wide array of materials under real-world...

2015 Create the Future Design Contest: Honorable Mentions

Method for Treating Cartilage Defects Michael Lytinas
Ideas Foundation, Boston, MA

This invention is a method to treat cartilage defects in osteoarthritis and...

Applying Metallic Thermal Interface Materials for Medical Electronics

A well-performing thermal interface material (TIM) fulfills a variety of application requirements within the broad range of electronic modules and systems incorporated in...

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...

ISO 80369 Standards for Small Bore Connectors Move Closer to Implementation

After a 20-year effort to establish standards which would minimize the risk of medical misconnections, the pending release of the ISO 80369 series of standards has...

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...

Using Surge Testers for Design Verification and Production Testing

Not only are medical devices expected to function as intended, they must meet ergonomic, safety, FDA and functional requirements. They must be designed to function in adverse...

Customized Imaging for Manufacturing Surface Inspection

Fraunhofer Institute for Industrial Mathematics ITWM, Munich, Germany www.fraunhofer.de/en

Quality control of component surfaces can be very complex. Researchers at the Fraunhofer...

Design Considerations for Selection of Skin-Contacting Adhesives

Medical device designers frequently face the need to adhere products to the skin, whether it is for a few minutes or in perpetuity. The huge array of pressure-sensitive...

Managing Post-Traumatic Pain with Ultrasound Neuromodulation

The objective of this effort was to demonstrate the feasibility of using ultrasound induced neuromodulation (UNMOD) to manage pain. Pain management for acute trauma is generally...

Coloring Polymers for Today’s Medical Devices

Competition amongst device companies in the institutional market has energized the use of colors for brand recognition amongst physicians, nurses, and other healthcare providers. With the rise...

Development of a Low-Cost, Portable Biosensor for Blood Protein Detection

Current blood testing procedures are expensive and time consuming, and the equipment required is often bulky and difficult to transport. A new low-cost, portable...

Controlling Heat Curing Adhesive Processes Using Infrared Spot Curing

Adhesives are often used as the joining compound between substrates in the medical device industry. Typical applications for adhesives include tube-to-connector bonding,...