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Understanding The UDI Rule – A Guide For Medical Device Manufacturers

The FDA’s UDI (unique device identification) final rule has arrived, and medical device manufacturers are working on their implementation strategies

INDUSTRY PERSPECTIVES

  • Understanding The UDI Rule – A Guide For Medical Device Manufacturers
    Understanding The UDI Rule – A Guide For Medical Device Manufacturers

    The FDA’s UDI (unique device identification) final rule has arrived, and medical device manufacturers are working on their implementation strategies

  • 10 Steps To Overcome Your Fear Of Using Open Source Software
    10 Steps To Overcome Your Fear Of Using Open Source Software

    The entire Internet runs on open source software (OSS) and, if we used it more in medical devices, it would lead to reduced costs and increase the quality of devices. If you ask some regulatory affairs folks in medical device companies, they think OSS is too “dangerous” for use in safety critical systems.

  • Biologic Grafts Driving Growth In U.S. Soft Tissue Reinforcement And Regeneration Market
    Biologic Grafts Driving Growth In U.S. Soft Tissue Reinforcement And Regeneration Market

    Soft tissue is a crucial component of the human body that serves to connect, support, or surround other structures. Seeing as the main component of soft tissue, collagen, is the most abundant protein in mammals, it is of utmost importance that this tissue remains healthy. Complications with soft tissue can result in a myriad of medical conditions that often can only be treated successfully via surgical intervention.

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ARTICLES

  • Intelligent Fluid Couplings Communicate Critical Device And Process Data
    Intelligent Fluid Couplings Communicate Critical Device And Process Data

    Like many other devices these days, a select group of fluid connectors can now be found in the growing ranks of “intelligent” products. In addition to moving fluids, these high-tech connectors move data, thanks to the innovative use of wireless communication technology. This article outlines the benefits of implementing RFID-enabled couplings into a fluid handling system. By Dennis Downs, Colder Products Company

Proto Labs Helps Develop a Wearable Hand Sanitizer

This case study explains how the SwipeSense, a portable hand sanitizer that attaches to clothing and tracks usage, went from a design on a Post-It note to a tangible product. It also discusses how ProtoLabs’ plastic injection molding services and their design software were used to help. 

Improved Production Yields While Reducing Processing Costs For Blood Sampling Device

Axis-Shield created the Afinion blood analyzer for doctors located mainly in Europe and the United States for quantitative testing of certain complaints at a patient’s point of care.

Managing Risk in Medical Connectors

This paper will help to educate designers and manufacturers of medical devices who integrate electrical connectors into their design on some recent changes made by the FDA, and the implications of the new regulations.

Choosing The Right Linear Drive Train

Whether you are designing your own motion solution, selecting components from a supplier, or working with a system solutions provider, understanding drive train selection is a key to a successful and reliable machine. This paper will outline the key performance characteristics to take into account for your next motion application. The goal of the paper is to provide you with guidelines to make your decision easier, faster, and more accurate.

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FROM THE EDITOR

  • 5 Keys To Protecting Your Medical Device From Cybersecurity Threats
    5 Keys To Protecting Your Medical Device From Cybersecurity Threats

    In this nascent era of connected healthcare, medical devices must be evaluated in a much broader context than simply a series of discrete patient engagements. They should be viewed as the basic building blocks of a massive national biomedical device network, one that undergirds our nation’s entire healthcare infrastructure. Unfortunately, they are also the most vulnerable components of that system. Learn how to protect your devices, the national network, and patients from malware and hackers.

  • The DOJ & cGMP Enforcement: What The Medtech Industry Can Learn From Pharma’s Folly
    The DOJ & cGMP Enforcement: What The Medtech Industry Can Learn From Pharma’s Folly

    What would you say if I told you that failure to comply with FDA Current Good Manufacturing Practices (cGMPs) could soon cost your company millions — as much as $505 million, or even $750 million? Those are the amounts paid by pharmaceutical manufacturers in recent years to settle allegations of manufacturing adulterated product that eventually ended up in Medicaid and other government healthcare programs. If you think these examples don’t apply to you because you’re a medical device manufacturer, then think again.

  • Graphene Biosensors — The Next Frontier In Medical Diagnostics?
    Graphene Biosensors — The Next Frontier In Medical Diagnostics?

    Graphene — the übermaterial that is 1 million times thinner than paper, 100 times stronger than steel, and the world’s best conductor of both electricity and heat — has become one of the hottest areas of materials science R&D over the past decade. Much of the graphene research has focused on two main objectives: 1) finding a way to better manufacture the substance, and 2) identifying the best applications for it. Recently, I was introduced to a company that claims to be close to achieving both goals, and its work could have considerable influence on how graphene is used in healthcare, particularly in the area of in vitro diagnostics.

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PRODUCT SHOWCASE

Ceramic Core Alumina Heater for Medical and Life Science Applications

Ceramic Core Alumina Heater for Medical and Life Science Applications

Heatron’s ceramic core alumina heater is ideal for dialysis, CPAP, DNA analysis/testing, blood diagnostics, surgical devices, blood/fluid warming, MRI equipment, instrument sterilization, temperature therapy, and vessel sealers.  

Entry-Level Infrared Cameras For Research And Science Applications

Entry-Level Infrared Cameras For Research And Science Applications

These infrared cameras for research and science applications offer image quality, ease of use, and accurate temperature measurement, all with a low cost. They’re available in handheld and fixed mount configurations, and feature thermal sensitivity up to 50 mK, temperature measurement up to 2,000° C, flexible optics for close-up and distance imaging, and more. Engineers that work in general medical and bioresearch applications, as well as researches involved with universities, power conversion, the electronics industry, and solar cell development can benefit from the use of FLIR’s entry-level Infrared Cameras. This line starts at under $10,000.

Micro-Patterned Filters

Micro-Patterned Filters

PIXELTEQ has the ability to pattern single and multiple precision optical filters and coatings with complex features due to their patented micro-patterning technology. This technology is particularly ideal for optical device and OEM applications.

Detergent 8: Low-Foaming Ion-Free Detergent

Detergent 8: Low-Foaming Ion-Free Detergent

Detergent 8 is concentrated to save you money, biodegradable, and readily disposable. Its penetrating wetting power saves you time. It’s free rinsing to give you reliable results and no interfering residues.

R10699 Photomultiplier Tube

R10699 Photomultiplier Tube

Hamamatsu’s R10699 is a new 28 mm (1-1/8 inch) side-on photomultiplier tube (PMT) with high sensitivity from UV to NIR (185 nm to 900 nm). It also features a high gain value and high quantum efficiency (QE), giving this new PMT very high sensitivity and good signal-to-noise ratio.

Miniature Optical Encoders For Medical Positioning Devices

Miniature Optical Encoders For Medical Positioning Devices

The SR series of miniature optical encoders has been designed to fit into motion control devices with limited space, such as robotic arms for surgery, nanopositioning stages, microscopes, and other medical devices.

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ATL (Ad Tape & Label)

ATL (Ad Tape & Label)

ATL has more than 50 years of flexographic label printing experience, two decades of disposable medical device converting, and ten years of complex multi-panel booklet label manufacturing. As an FDA-registered medical device manufacturer and cGMP compliant supplier, we understand the criticalities of providing you with a fail-safe product.