LEAD STORIES

Can Webcams Detect Heart Conditions?

Electrocardiograms (ECGs) are currently the gold standard when detecting atrial fibrillation (AF), a heart condition that, if left untreated, can have serious consequences. ECGs are physician-supervised, but with a new technology, the condition may be identifiable with webcam and some software.

  • Antler-Inspired Prosthesis Breaches Skin Barrier
    Antler-Inspired Prosthesis Breaches Skin Barrier

    Typically, people who wear prosthetic legs can only be active for a limited amount of time. Stumps often get sore where they interface with the prosthetic cup, requiring the patient to rest. A new method of implanting the prosthetic anchor, however, may make prosthetic use essentially unlimited.

  • Medicinal Marijuana Inhaler Enables Controlled, Smokeless Doses
    Medicinal Marijuana Inhaler Enables Controlled, Smokeless Doses

    Though the evidence for medical marijuana’s effectiveness continues to mount, many physicians hesitate to prescribe it because dosage is uncontrolled and variable. These fears may soon be put to rest, however, due to a new device from Israeli researchers that delivers the drug in a highly controlled way.

  • How Will The Apple Watch Impact Healthcare?
    How Will The Apple Watch Impact Healthcare?

    Similar to what the company did with digital music more than a decade ago, Apple will have to create and nurture partnerships with players in the healthcare industry in order make its Apple Watch — and wearables in general — go mainstream.

INDUSTRY PERSPECTIVES

  • 510(k) Substantial Equivalence In Plain English — Part 1
    510(k) Substantial Equivalence In Plain English — Part 1

    The two most important components of a successful 510(k) submission are the substantial equivalence argument and the risk mitigation strategy. This two-part article will focus specifically on the substantial equivalence component, explaining what it is and how to establish it. It will also explore two recently issued FDA guidances related to substantial equivalence, and how they should influence your regulatory strategy.

  • Technology Advances, Consumer Preferences Transform European Dental Materials Markets
    Technology Advances, Consumer Preferences Transform European Dental Materials Markets

    The demand to eliminate waste, enhance patient comfort, and ensure quality continues to drive technological advancements in the dental materials market.

  • Out With The Old, In With The New: Considering Legacy Systems Early In The Design Process
    Out With The Old, In With The New: Considering Legacy Systems Early In The Design Process

    As a medical device innovator, you may be positioning your product to replace a legacy system. If you ignore how your device will affect an established workflow, you could negatively impact user experience and safety with your new design. This article will discuss these negative consequences and show the importance of understanding the legacy system workflow early in your design process — to help reduce use errors and achieve higher acceptance/retention rates.

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ARTICLES

  • Certification: Is It Worth The Hassle?
    Certification: Is It Worth The Hassle?

    In the life sciences and other regulated industries, obtaining certification in a range of international standards has become a necessity for companies hoping to access and compete in today’s global marketplace. Whether your organization is a laboratory, medical device manufacturer, or automobile maker, becoming certified by an impartial third-party accreditation body assures potential customers that you value quality and your products conform to the highest regulatory standards. This assurance can lead to tremendous marketing and business advantages. But certification can be a long and trying process. By Lisa Weeks, Marketing Communications, MasterControl

Medical Device Cleaning Validation Method References For Alconox

Identifying residue—in a medical device environment involves: the process fluids, polishing compounds, mold releases, bioburden, endotoxins, cleaning agents and any degredation or interaction products. This document is intended to help with the cleaner residue identification...

Electromagnetics In The Healthcare Industry

Electromagnetic (EM) fields are present in many of the medical applications today. The technology is becoming more complex, and it is therefore vitally important that the tools and procedures perform at their maximum capacity and always yield precise and accurate data. This article examines the design challenges of electromagnetic systems in healthcare applications by leveraging EM simulation software. By Peter Futter, Application Specialist, Business Development – EM Solutions at Altair South Africa

An Introduction To Ultrasonic Welds For Medical Devices

Ultrasonic welding is particularly well-suited for bonding medical devices because it does not introduce glues or adhesives into the device. A fast, clean, efficient, and repeatable process, ultrasonic welding is ideal for joining just about any set of plastic parts for many applications. This article focuses on advanced techniques in ultrasonic welding, including designing the joint, developing the fixtures, and optimizing the welding process.

Simplifying Selection And Improving Reliability Of Medical Device Passive Components

Passive components are produced on automated equipment in large-scale manufacturing facilities with good process controls to reduce lot to lot variability. Passive components used in medical devices require higher levels of reliability and performance in small sizes than the industry average. The purpose of this article is to provide fundamental concepts that can be used to select passive components for medical device applications with proven reliability based on established military (MIL) and Electronic Industries Alliance (EIA) test requirements and specifications.

More Articles

FROM THE EDITOR

  • Window Through The Skin: The Development Of A Pocket-Sized Imaging Device
    Window Through The Skin: The Development Of A Pocket-Sized Imaging Device

    I have a confession to make: I am more than a little afraid of needles. When it comes to getting blood drawn, an IV inserted, or pretty much any other procedure that involves shoving one of those pointy little devils through my skin and into my blood vessels, I am an abject coward. So you can imagine my enthusiasm when the folks at Analogic introduced me to their new Sonic Window ultrasound device, which was recently cleared by FDA for use in peripheral IV access procedures. Read on to learn how this novel approach to handheld ultrasound imaging made its way from the university to the clinic.

  • Could Your Next Device Be Exempt From FDA Premarket Requirements?
    Could Your Next Device Be Exempt From FDA Premarket Requirements?

    CDRH has been busy in August, issuing more than 10 new guidances and draft guidances — with a week left to go. The first new guidance of the month basically amounted to a list of some 170 medical devices that the FDA proposes exempting from 510(k) premarket notification requirements. If your device doesn't appear on the list, it would be tempting to simply disregard it. But by doing so, you could be missing out on an important opportunity.

  • 7 Unconventional Ways To Fund A Medtech Startup
    7 Unconventional Ways To Fund A Medtech Startup

    Bringing innovative new medical technology to market today is as challenging, complex, and competitive an endeavor as it’s ever been for entrepreneurs. Making matters worse, venture capital — the fuel that fledgling companies once depended on to drive product development — has dwindled in recent years. Hear what industry experts from Cleveland Clinic, UnitedHealthcare, and other organizations have to say about nontraditional sources of funding that just might fit the bill for your medtech startup.

More From The Editor

PRODUCT SHOWCASE

Custom Manufactured Mirrors

Custom Manufactured Mirrors

LaCroix Optical Company produces mirror substrates in a wide variety of shapes and sizes using optical or filter glass, fused silica or other glass-like materials. All of our mirrors are produced and coated at our facility in Batesville, Arkansas.

 

Fischer Plastic Series

This brochure is an overview of plastic connectors and cable assemblies ideal for medical, instrumentation, defense, broadcast, energy, and transport applications.

Optical Components Group

Optical Components Group

Zygo’s Optical Components Group uses innovative and proprietary manufacturing technologies to create high-precision optical components through CNC glass machining and light-weighting, weighting, rotational/double-sided/MRF polishing, and thin film coating. This page provides an overview of the different optical components Zygo offers.

High Purity Synthetic Fused Silica: Suprasil® CG

High Purity Synthetic Fused Silica: Suprasil® CG

Suprasil ® CG is a high purity synthetic fused silica manufactured by flame hydrolysis, ideal for DUV to UV/VIS commercial grade optics. This silica features a low bubble and inclusion content, typical UV transmission of k200: 3,5 x 10-3/ cm, stress induced birefringence, a well-established production process, and much more.

Prototype Tooling Services

Prototype Tooling Services

PTI’s tooling division has the ability to produce high quality prototypes in 2-5 week windows (in some cases, even faster). This type of turnaround is possible for both single-component to multi-part programs.

Endoscopes

Endoscopes

Precision Optics’ LensLock endoscopes are compatible with all commonly used sterilization methods and are approved for CE marking. They can actively stabilize lenses inside a device, resulting in a robust instrument that allows for quick and cost-effective repair.

More Featured Products
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LATEST HEADLINES

  • Can Webcams Detect Heart Conditions?
    Can Webcams Detect Heart Conditions?

    Electrocardiograms (ECGs) are currently the gold standard when detecting atrial fibrillation (AF), a heart condition that, if left untreated, can have serious consequences. ECGs are physician-supervised, but with a new technology, the condition may be identifiable with webcam and some software.

  • Congressional Leaders Question FDA Decision To Regulate LDTs
    Congressional Leaders Question FDA Decision To Regulate LDTs

    Congressional leaders this week grilled FDA officials on the agency’s legal authority to regulate lab-developed tests (LDTs), asking if new requirements would trigger additional costs to laboratories, and whether the FDA itself had the necessary resources to take on the task.

  • GE Files Charges Against Chinese Engineer For Stealing Trade Secrets
    GE Files Charges Against Chinese Engineer For Stealing Trade Secrets

    GE Healthcare (GEHC) recently charged a former engineer in federal court with criminal theft of trade secrets for allegedly copying millions of proprietary files and sending them to relatives in China.

  • Antler-Inspired Prosthesis Breaches Skin Barrier
    Antler-Inspired Prosthesis Breaches Skin Barrier

    Typically, people who wear prosthetic legs can only be active for a limited amount of time. Stumps often get sore where they interface with the prosthetic cup, requiring the patient to rest. A new method of implanting the prosthetic anchor, however, may make prosthetic use essentially unlimited.

  • Medicinal Marijuana Inhaler Enables Controlled, Smokeless Doses
    Medicinal Marijuana Inhaler Enables Controlled, Smokeless Doses

    Though the evidence for medical marijuana’s effectiveness continues to mount, many physicians hesitate to prescribe it because dosage is uncontrolled and variable. These fears may soon be put to rest, however, due to a new device from Israeli researchers that delivers the drug in a highly controlled way.

  • How Will The Apple Watch Impact Healthcare?
    How Will The Apple Watch Impact Healthcare?

    Similar to what the company did with digital music more than a decade ago, Apple will have to create and nurture partnerships with players in the healthcare industry in order make its Apple Watch — and wearables in general — go mainstream.

  • Qosina Announces Availability Of Multi-Purpose Swabs
    Qosina Announces Availability Of Multi-Purpose Swabs

    Qosina offers a wide selection of high quality and economical single-use swabs, in addition to its extensive line of single-use components.

  • Manufacturing A More Accurate Bioimaging Protein
    Manufacturing A More Accurate Bioimaging Protein

    Using certain cells lines, scientists at the Helmholtz Zentrum München research center in Germany have found a way to manufacture the bioimaging protein Amrose. The novel approach provided the cells with the right materials and then let them formulate into the complex molecule independently.

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UPCOMING TRAINING COURSES

Medical Device Supplier Management Programs: Building Compliant Systems

October 7, 2014
1pm-2:30pm EDT, Online Training

Got a Date with the FDA? Conducting Successful Meetings

October 20, 2014
1pm-2:30pm EDT, Online Training
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FEATURED SUPPLIERS

AR

AR

Since 1969, AR has played a major role in the success of the automotive, medical, military, aerospace and telecom industries. The company’s products are used for a variety of critical applications including RF Test & measurement in a multitude of industries throughout the world. At AR, there’s no substitute for quality. It’s the foundation of our business and the AR value that’s recognized around the globe...