Articles

A Strip You Can Rely On: Tips for Designing Blood Glucose Test Strips

When it comes to diabetes management, accurate blood glucose readings are paramount. And when it comes to generating accurate readings, the quality of the test strip is...

Automation: The Future of Medical Manufacturing

Manufacturers in the medical industry face unique challenges in terms of product mix, throughput requirements, quality standards, and regulatory guidelines. Whether a company is developing imaging...

Metal Stamping: Converting Parts for Cost Savings

In today’s world of medical device manufacturing, cost pressures are very real. At the same time, cost savings can be just as real, especially when companies examine their manufacturing...

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 of...

3 Areas of Innovation for Combination Medical Products

The combination of drugs with medical devices has the potential to take patient care in an entirely new direction. The power of these products is that they can deliver a precise amount of a...

Guide to Package Integrity & Validation Testing under ISO 11607 and MDR

Updates to ISO 11607, Parts 1 and 2, have left many medical device manufacturers wondering about the future of their packaging designs. These changes come at a stressful...

Capturing Unique Device Identifier Data on Non-Sterile Orthopedic Implants

Now that medical devices are being labeled and uniquely identified to meet the requirements of the U.S. Food and Drug Administration (FDA) Unique Device Identifier (UDI)...

Effects of Tube Processing on the Fatigue Life of Nitinol: Part 1

With medical devices approved for more demanding cardiovascular applications such as transcatheter aortic and mitral valve repair (TAVR/TMVR), the long-term structural integrity...

Industrial CT is Hip: Quality of Life Enhanced with Additive Manufacturing

Orthopedic devices play a crucial role in providing pain relief, improving mobility, and enhancing the quality of life for patients suffering from musculoskeletal...

Using Data-Centric Connectivity to Drive Innovation in Medical Imaging

Today's imaging systems save lives by making the unseen visible to a degree never before possible. Medical professionals can now view systems within the human body in high...

Why Cloud QMS Better Supports Regulatory Compliance

Companies regulated by the U.S. Food and Drug administration (FDA) need to establish current good manufacturing practices (CGMPs) as part of Title 21 CFR part 820 requirements. This includes...

Materials Matter for Connected Health

Technology has always played a central role in healthcare. From microscopes to medical imaging, and from pacemakers to prosthetics, technological breakthroughs throughout history have improved diagnosis,...

The ‘Relativity’ of High Q Capacitors

For many high-power RF applications, the “Q factor” of embedded capacitors is one of the most important characteristics in the design of circuits. This includes products such as cellular/telecom...

Force-Sensitive Innovations: Addressing Cerebral Palsy Challenges with Electronic Medical Training Devices

Nine years ago, Julian Gunderson was born three months prematurely and weighed just 1 kg (2.2 lb). After a year's worth of injections,...

Strategies for Low-Risk Sourcing of Components in a Constrained Market

The medical device industry often looks to independent distributors to address chronic shortages in the availability of electronic components. Direct sourcing of electronic...

Reimagining Innovation: Additive Manufacturing

In the injectable drug-delivery industry, expectations for improved patient experiences with administration and at-home delivery of therapeutic regimens are evolving. Products that combine the...

Style Meets Technology in the World of Wearables

People often talk about thinking “outside the box” but one of the things most exciting in modern technology is being able to design “off the glass” — meaning a piece of technology that...

Ultraminiature MEMS Sensors for Improved Patient Outcomes

Ultraminiature sensors (<1 mm in size) enable instrumentation of medical devices in order to advance monitoring capabilities, deliver new insight into complex cardiovascular cases,...

Design for Manufacturability Improves Articulating Instrument Development

Precision in surgery is paramount. Surgeons rely on a variety of handheld instruments, and they increasingly want tools that can aid in accessing hard-to-reach areas in...

How Reliable Is Your Diagnosis — Really?

Imagine learning the news that you have cancer. Stage Four, metastasized to multiple areas, roughly six to eight months to live — if you’re lucky. Then, imagine finding out your diagnosis was...

Advancing the Evolution of Skin-Contact Adhesion Technology

Whether used in wound care products, ostomy applications, or for adhering wearable devices to skin, advanced pressure-sensitive adhesives are being created to improve breathability,...

Luer Connectors: Testing to the New International Standard

The Luer connector is arguably one of the most important developments in the biomedical industry. Because it is reliable, simple to use, and economical to produce, the Luer connector...

Electrical Connectors: Design Considerations for Medical Devices

The myriad of devices used in surgical, interventional, imaging, diagnostic and therapeutic, sensors, and single-use medical applications use some form of transmission medium to...

The Ergonomics of Robotics: Part 2

In this two-part series on robotics and wearable devices, part 1 highlighted the wearable device product category. Part 2 moves the discussion from wearable devices to how robotic surgery is changing the...

Proactive Cybersecurity Saves Healthcare Organizations from Data Breaches

Over the past few years, healthcare organizations have increasingly become one of the leading targets for cyber criminals with data breaches exposing personal patient...

Demystifying Technology Transfer in Medical Device Contract Manufacturing

For medical device developers and original equipment manufacturers (OEMs), the transition from prototype to commercial-scale production with a contract manufacturing...

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...

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...

Investigating Cardiac Device Performance with Computer Modeling and Simulation

Why do some people develop malfunction of their mitral valve (MV) after a heart attack? The answers are complex, and treatments are not yet perfected. But biomedical...