LEAD STORIES

New Implantable Eye Devices Could Replace Reading Glasses

Presbyopia, the age-related condition that reduces near vision, can now be treated using implantable technology and a ten-minute procedure.

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. 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. 

  • 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

  • Miniature Camera Modules For Visualizing Micro Invasive Surgery
    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. 

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.

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FROM THE EDITOR

  • 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.

  • 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.

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PRODUCT SHOWCASE

Custom Prisms

Custom Prisms

Precision Optics Corporation can custom manufacture prisms with tolerances to .01mm, <10/5 scratch/dig, λ/20 flatness, <5 arc second parallelism, +/- 0.1mm; 0.2mm to 150 mm diameter, and +/- 0.02mm (and as thin as 0.2mm) thickness.

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.

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.  

Attenuators

Attenuators

Corry Micronics offers a line of 4 bit through 6 bit RF digital attenuators. The digital attenuators are designed using switched bit pin diodes. The attenuators require +/-5volt power supply and feature TTL compatible control logic. Corry Micronics also offers a high REL option that includes screen to the MIL-STD-883...
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.

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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

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.