LEAD STORIES

Australian Government To Initiate Review Of Medical Device Regulations

A group of experts will review the Australian Therapeutic Goods Administration’s (TGA) framework for the regulation of medical devices and pharmaceuticals, according to a recent government announcement.

  • Covidien To Divest Assets Before Medtronic Merger
    Covidien To Divest Assets Before Medtronic Merger

    Covidien plans to sell some assets that are part of its Vascular Therapies line ahead of its planned merger with Medtronic, which is expected to close later this year or in early 2015.

  • Bridging The FDA-CMS Divide: An Optimized Route To Market For Medical Devices, Part 2
    Bridging The FDA-CMS Divide: An Optimized Route To Market For Medical Devices, Part 2

    In the crucible that is today’s healthcare environment, medical device companies can no longer wait until they have regulatory approval or clearance to begin pursuing reimbursement for their products. Nor can they approach regulatory and reimbursement activities as completely independent initiatives. A more tactical, integrated methodology is required.

  • FDA Issues Emergency Use Authorization For Ebola Diagnostic Device
    FDA Issues Emergency Use Authorization For Ebola Diagnostic Device

    FDA officials recently issued an emergency use authorization (EUA) for Utah-based BioFire Defence’s FilmArray Biothreat-E test for the detection of the Ebola Zaire virus. The test runs and can only be used with the device maker’s FilmArray systems. 

INDUSTRY PERSPECTIVES

  • What To Expect From The Upcoming ISO 13485 Revisions, Part 2
    What To Expect From The Upcoming ISO 13485 Revisions, Part 2

    The International Organization for Standardization (ISO) is currently in the process of revising ISO 13485, the international quality standard for medical devices. When the final version is released — potentially in 2015 — it will be the first revision to the standard in over a decade. In this three-part article series, we are looking at the proposed changes to ISO 13485, to help you prepare for its eventual publication and enforcement.

  • Responsible Disclosure: 8 Security Mistakes You Don’t Know You’re Making
    Responsible Disclosure: 8 Security Mistakes You Don’t Know You’re Making

    Imagine this scenario: Your company has received an unsolicited email from someone who claims to be a security researcher. This person has broken into one of your medical devices, and reverse engineered the code. In the process, she has discovered a potential security vulnerability that could put patient safety at risk if exploited — and now she wants to tell you about it.

  • 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. The first compliance date — for Class III devices produced after September 24, 2014 — passed last month, and additional deadlines are coming up quickly. This article provides an introduction to important UDI concepts and explains the steps manufacturers should be taking to get moving on on UDI compliance. 

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ARTICLES

  • Bringing Radiology And X-ray Imaging To The Wounded Warrior
    Bringing Radiology And X-ray Imaging To The Wounded Warrior

    The transformation from the traditional X-ray film to digital detectors has occurred within the last two decades, which led to the elimination of process chemicals, time delays for developing, and to the arrival of nearly instantaneous image viewing, transmission, and storage. Now a similar transformation is set to occur for the X-ray source.

Miniature Camera Modules For Visualizing Micro Invasive Surgery

The miniaturization of camera modules allows visualization inside the body with ever smaller incisions. These miniature digital camera modules — hardly bigger than a grain of salt — enable novel medical tools, where visualization is possible for the first time and where previous procedures had to be done completely blind. In this article, AWAIBA, a reputed leader in miniature camera modules as small as 500 mm side length, provides an overview of these miniaturized cameras and explores potential new applications for the technology.

The Evaluation Of Increase And Distribution Of Temperature During The Dental Drilling Using A Thermal Imaging Camera

This paper discusses the use of infrared technology to study the optimal method for post space preparation of teeth including how long to drill, the type and size of dental drill used, and the type of cooling used. By Joanna Lubieniecka, M. Sc. Eng., Jerzy Lukasiewicz, M. Sc. Eng., Joanna Bozyk, MDS, and Janusz Kleinrok, DMD

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. 

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FROM THE EDITOR

  • Bridging The FDA-CMS Divide: An Optimized Route To Market For Medical Devices, Part 2
    Bridging The FDA-CMS Divide: An Optimized Route To Market For Medical Devices, Part 2

    In the crucible that is today’s healthcare environment, medical device companies can no longer wait until they have regulatory approval or clearance to begin pursuing reimbursement for their products. Nor can they approach regulatory and reimbursement activities as completely independent initiatives. A more tactical, integrated methodology is required.

  • Bridging The FDA-CMS Divide: An Optimized Route To Market For Medical Devices, Part 1
    Bridging The FDA-CMS Divide: An Optimized Route To Market For Medical Devices, Part 1

    When Kevin Conroy joined Exact Sciences as president and CEO in April 2009, the company had a novel, highly accurate, and noninvasive diagnostic technology for the early detection of colorectal cancer — and a potentially huge market. It was also low on capital. Conroy and his team estimated that product development and separate clinical trials to satisfy FDA and CMS requirements would take the better part of a decade to complete, and there was no way to finance the company for that long. Yet here we are, less than six years later, and Exact Sciences’ Cologuard test has obtained both FDA approval and a CMS coverage. How did the company's prospects shift so dramatically? It all began with one fateful meeting.

  • 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.

More From The Editor

PRODUCT SHOWCASE

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.

Multispectral Photodiodes: PixelSensor

Multispectral Photodiodes: PixelSensor

Multispectral photodiodes by PIXELTEQ benefit from a micro-patterned optical filter technology that shrinks spectral sensors enough to pack up to eight into a 9mm square footprint. They’re ideal for applications in color meters and monitors, portable optical sensors, biomedical instrumentation, industrial sorting and sensing, and in OEM multispectral devices.

Micro Prisms

Micro Prisms

Micro prisms have a minimum of two plano surfaces that are separated by a wedge angle. Precision Optics Corporation manufactures prisms as small as 0.18 mm to rotate, deflect, and deviate beams of light and disperse their wavelengths.

PMC Series: Couplings

PMC Series: Couplings

The 1/8" flow PMC coupling covers a wide variety of general-purpose applications. Featuring the Colder thumb latch, the PMC is easier to use than ball-and-sleeve designs. One-hand connection and disconnection and integral terminations make the PMC the choice for ease of use and manufacture.

Fischer Plastic Series

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

Synthetic Fused Silica: Spectrosil® 2000

Synthetic Fused Silica: Spectrosil® 2000

Spectrosil is a chlorine and bubble free synthetic fused silica ideal for deep UV optical applications. It features exceptional optical transmission in the deep ultraviolet and visible spectrums with a range from below 180 nm through 2000 nm.

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UPCOMING TRAINING COURSES

Process Validation: Ensuring Compliance With Multiple Standards

November 4, 2014
1pm-2:30pm EST, Online Training

How To Take Advantage Of The Companion Diagnostics Opportunity

November 13, 2014
1pm-2:30pm EST, Online Training

Reducing Human Error in Life Sciences Manufacturing

November 18, 2014
1pm-2:30pm EST, Online Training

Medical Device Supplier Management Programs: Building Compliant Systems

December 9, 2014
1pm-2:30pm EST, Online Training
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FEATURED SUPPLIERS

Carclo Technical Plastics

Carclo Technical Plastics

Carclo Technical Plastics is an international engineering based company led by engineers coupling industry standards with a Six Sigma culture.  We specialize in injection molding and contract manufacturing services for medical devices, medical equipment, optics, and electronics applications.