LEAD STORIES

NIH Issues Final Genomic Data Sharing Policy

A new final policy from The National Institutes of Health (NIH) will give scientists of government-funded research six months to load any collected genomic data into a government-stablished database. The policy will apply to all researchers with NIH-funded grants who are conducting large-scale human and non-human projects that generate genomic data.

  • Handheld DNA Diagnostic Device Enables Rapid Virus Detection
    Handheld DNA Diagnostic Device Enables Rapid Virus Detection

    In the age of Ebola and other deadly viral diseases, the ability to rapidly diagnose an infection is critical. Now, a team at the University of Otago has developed a device to measure viral DNA levels — a breakthrough that may give healthcare personnel increased freedom and an improved ability to respond.

  • Multi-Tasking Nanoparticle Combines Imaging And Therapeutics
    Multi-Tasking Nanoparticle Combines Imaging And Therapeutics

    Using nanoparticles for diagnosis is a hot area of research, as is the use of nanoparticles for therapeutic delivery. Combining the two functions together in a single nanoparticle, however, is a new step forward from UC Davis researchers. 

  • World’s First 3D Printed Vertebrae Implanted
    World’s First 3D Printed Vertebrae Implanted

    Commercially available spine implants generally work well, but for special situations like those involving smaller pediatric patients, they can be inadequate. To address the issue, researchers at Peking University Third Hospital in China turned to 3D printing. 

INDUSTRY PERSPECTIVES

  • 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.

  • Common Medical Device Quality System Pitfalls — And How To Avoid Them, Part 2
    Common Medical Device Quality System Pitfalls — And How To Avoid Them, Part 2

    In Part 1 of this article, we looked at five mistakes medical device companies make during the quality management review process. In this installment, we turn our attention to measurement, analysis, and improvement activities — where several problems can occur and what you can do to prevent them. By Marcelo Trevino, Senior Regulatory Compliance Manager, Medtronic

  • Is Your Boring Regulatory Strategy Costing You Business?
    Is Your Boring Regulatory Strategy Costing You Business?

    When people in the medical device world use the phrase “regulatory strategy,” they usually mean the path they will take to get their product onto the market. And when they say “competitive regulatory strategy,” they are usually referring to the way their competitor(s) got their products onto the market.

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ARTICLES

  • Simplifying Selection And Improving Reliability Of  Medical Device Passive Components
    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.

Innovation In CMOS Bio-Optical Sensors Enables Portable Diagnostics

In the past 10+ years we have seen great progress in molecular diagnostic technologies. Doctors can now take advantage of the emerging nucleic acid or protein analysis techniques to get very precise answers about the type of virus, bacteria, or cancerous cells that cause illnesses. This article provides an in-depth look at a new CMOS image sensor design that enabled the development of a low-cost, portable molecular diagnostic system. By Zhimin Ding, Anitoa Systems, LLC

Robotic Biopsy System Drives The Point Home

Why, with CT scanners routinely achieving submillimeter resolutions, are manual needle biopsies performed with only centimeters of accuracy? To solve that issue, a team from MIT built a robotic biopsy system with unprecendented efficiency and accuracy, powered by compact, high-torque DC servomotors from MICROMO.

Biocompatibility of Anesthesia/Respiratory Products

This biocompatibility technical whitepaper is a reference guide for navigating aspects of the various biocompatibility standards for respiratory devices. It is intended to aid design engineers in understanding the complexity of biocompatibility standards as applied to anesthesia workstations, ventilators, and oxygen concentrators.

Considering Human Factors And Training In Medical Device Design

The patient has become the end user when it comes to many types of medical technology, and that trend is likely to continue with the rise of mobile health (mHealth), remote patient monitoring, and other healthcare industry drivers. As a result, the human factor is becoming increasingly important in the design of next-generation medical devices and diagnostics. 

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FROM THE EDITOR

  • 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 14 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.

  • Cutting Through The Remote Patient Monitoring Hype
    Cutting Through The Remote Patient Monitoring Hype

    There is so much hype surrounding remote patient monitoring (RPM) — and related buzzterms like wearables, mobile apps, big data, the Internet of Things (IoT), and mHealth — that sometimes it is difficult to separate hyperbole from reality. What opportunities does RPM really afford medical device makers? What should they do to take advantage? How do wearables fit into the equation? Should the medtech industry fear or embrace the involvement of tech titans like Google and Apple? Read on for answers to these and other important RPM-related questions.

More From The Editor

PRODUCT SHOWCASE

Custom Manufactured Aspheres

Custom Manufactured Aspheres

For more than 65 years we’ve been a trusted industry leader in manufacturing custom spherical and plano precision optics.  With this extensive experience we have now expanded our capabilities to include grinding and polishing Aspheric surfaces.

4 MP Deep Cooled CCD Camera with Wide Field of View: SPOT Xplorer

4 MP Deep Cooled CCD Camera with Wide Field of View: SPOT Xplorer

Spot Imaging’s XplorerTM deep cooled CCD cameras are available in a monochrome version and a slider version. The monochrome model is well suited for wide field fluorescence microscopy, gel documentation, bioluminescence, immunofluorescence, and 3D deconvolution. Its slider counterpart provides both monochrome and color images and is ideal for the same applications, but also for FISH and GFP imaging.

Digital Galvano Scanner

Digital Galvano Scanner

Canon is releasing an ultra-small digital Galvano scanner.

Pressure Sensors for Medical Analysis Instrumentation: HMI Series

Pressure Sensors for Medical Analysis Instrumentation: HMI Series

First Sensor’s HMI pressure sensors are ideal for medical analysis instrumentation that calls for increased media compatibility and the ability to work with pressure ranges from 1 to 150 psi (100 mbar to 10 bar).  They have a Total Error Band (TEB) better than ±1.5 %FSS from -20 to +85 °C (-4 to 185 °F), and very small SIL and DIP housings with a selection of pressure ports.

Power Dividers

Power Dividers

Corry Micronics offers three main types of power dividers. These power dividers are the Wilkinson style, N connector communications power dividers, Broadband and Ultra-Broadband, SMA connector style and the reactive type power dividers...
Medical RF & Microwave Semiconductors

Medical RF & Microwave Semiconductors

Skyworks offers a large variety of RF and microwave semiconductor products for use in medical devices. Common applications include glucose monitoring, defibrillators, hearing aids, heart monitors/pacemakers, MRI scanners, patient monitors, and others.

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LATEST HEADLINES

  • NIH Issues Final Genomic Data Sharing Policy
    NIH Issues Final Genomic Data Sharing Policy

    A new final policy from The National Institutes of Health (NIH) will give scientists of government-funded research six months to load any collected genomic data into a government-stablished database. The policy will apply to all researchers with NIH-funded grants who are conducting large-scale human and non-human projects that generate genomic data.

  • BiliCam: A Smarthone App For Diagnosing Jaundice In Newborns
    BiliCam: A Smarthone App For Diagnosing Jaundice In Newborns

    Blood testing is the current gold standard for diagnosing newborn jaundice, a condition that affects many children but can become severe and require treatment. Now, a new smartphone application developed by University of Washington (UW) engineers may help parents or healthcare workers determine if a blood test is necessary.  

  • 10 Finalists Selected In Qualcomm’s Tricorder XPRIZE Competition
    10 Finalists Selected In Qualcomm’s Tricorder XPRIZE Competition

    Scenes of Star Trek’s Dr. Leonard McCoy diagnosing a crew member on a distant alien planet are pervasive in modern culture. Using a small handheld device, he had more resources at his disposal than a modern day hospital to figure out what’s wrong and heal the ailing crew member, usually within a scene (or maybe two). Bringing this type of healthcare accessibility to reality is the goal of Qualcomm Tricorder XPRIZE competition, and now 10 teams have been chosen to move on to the final round.

  • Medtronic Pays $350M For NGC Medical In Second European Acquisition Of The Week
    Medtronic Pays $350M For NGC Medical In Second European Acquisition Of The Week

    Medtronic recently announced that it is buying the rest of hospital services firm NGC Medical for $350 million, after having held a 30 percent ownership stake in the Italian firm for the past year.

  • Handheld DNA Diagnostic Device Enables Rapid Virus Detection
    Handheld DNA Diagnostic Device Enables Rapid Virus Detection

    In the age of Ebola and other deadly viral diseases, the ability to rapidly diagnose an infection is critical. Now, a team at the University of Otago has developed a device to measure viral DNA levels — a breakthrough that may give healthcare personnel increased freedom and an improved ability to respond.

  • Multi-Tasking Nanoparticle Combines Imaging And Therapeutics
    Multi-Tasking Nanoparticle Combines Imaging And Therapeutics

    Using nanoparticles for diagnosis is a hot area of research, as is the use of nanoparticles for therapeutic delivery. Combining the two functions together in a single nanoparticle, however, is a new step forward from UC Davis researchers. 

  • World’s First 3D Printed Vertebrae Implanted
    World’s First 3D Printed Vertebrae Implanted

    Commercially available spine implants generally work well, but for special situations like those involving smaller pediatric patients, they can be inadequate. To address the issue, researchers at Peking University Third Hospital in China turned to 3D printing. 

  • Medtronic Acquires Sapiens For $200M, Bolsters Neuromodulation Business
    Medtronic Acquires Sapiens For $200M, Bolsters Neuromodulation Business

    Medtronic recently purchased the Dutch firm Sapiens Steering Brain Stimulation (Sapiens SBS) for $200 million in cash to bolster its neuromodulation business. With the acquisition, Medtronic will be able to offer Sapiens’ next-generation deep brain stimulation (DBS) device, which utilizes an advanced lead with 40 individual stimulation points that enables precise stimulation of the brain with less side effects.

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UPCOMING TRAINING COURSES

Medical Device Complaint Handling and MDR Reporting

September 3, 2014
1pm-2:30pm EDT, Online Training

Pediatric Clinical Trials: Special Considerations and Requirements

September 8, 2014
1pm-2:30pm EDT, Online Training

Got a Date with the FDA? Conducting Successful Meetings

October 3, 2014
1pm-2:30pm EDT, Online Training
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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...