LEAD STORIES

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.

  • 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.

  • NASA-Inspired Robotics For Pediatric Surgery
    NASA-Inspired Robotics For Pediatric Surgery

    Space robots have been a part of science fiction for several decades, providing entertainment to children for generations. For a newly developed surgical device, however, inspiration from NASA and the International Space Station promises to help children in another way.

  • Endo’s Medical Device Unit Up For Sale
    Endo’s Medical Device Unit Up For Sale

    Pharmacological firm Endo International PLC is reportedly looking to sell its medical device subsidiary American Medical Systems (AMS), three years after acquiring the business.

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.

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PRODUCT SHOWCASE

Miniature Single and Multi-Axis Linear Positioners: MX45S Series

Miniature Single and Multi-Axis Linear Positioners: MX45S Series

This series of linear positioners/stages can be used to provide reliable linear positioning during the development and/or design of medical devices. They’re very small (45mm wide x 25mm high) and have 5mm, 15mm, and 25mm selectable travels.

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.

Medical Device Prototyping & Design Services

Medical Device Prototyping & Design Services

Carclo's product engineers have multiple years of experience with medical device prototyping and design. They address your medical device design needs by getting involved as early in the product prototype and design cycle as possible.

Custom Manufactured Lenses

Custom Manufactured Lenses

Our customers design lenses to meet their system requirements. Our expertise is determining the most efficient way to manufacture them. Depending on attributes and quantity, our manufacturing engineers will determine whether to use a conventional, CNC or hybrid method to make the lenses.

High Speed Low Light Imaging CCD Camera: SPOT Pursuit USB

High Speed Low Light Imaging CCD Camera: SPOT Pursuit USB

These high speed, low light imaging CCD cameras come in monochrome, color mosaic, and slider configurations. Each model features high sensitivity and fast frame rates, which helps greatly in preserving live cells and fading specimens for imaging and fluorescence applications.

Optical Thickness Gauge: 157 Series

Optical Thickness Gauge: 157 Series

The Model 157 optical thickness gauge uses proven optical interferometer technology to measure the absolute thickness of specialty plastic films, medical membranes, and ophthalmic products.

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LATEST HEADLINES

  • 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.

  • NASA-Inspired Robotics For Pediatric Surgery
    NASA-Inspired Robotics For Pediatric Surgery

    Space robots have been a part of science fiction for several decades, providing entertainment to children for generations. For a newly developed surgical device, however, inspiration from NASA and the International Space Station promises to help children in another way.

  • Endo’s Medical Device Unit Up For Sale
    Endo’s Medical Device Unit Up For Sale

    Pharmacological firm Endo International PLC is reportedly looking to sell its medical device subsidiary American Medical Systems (AMS), three years after acquiring the business.

  • Remcom Announces Enhanced Biological Thermal Sensor And Other Biomedical Features In XFdtd EM Simulation Software Update

    Remcom announces an update to XFdtd 3D Electromagnetic Simulation Software with new features for the biomedical industry. The central biomedical addition in the release is an enhanced Biological Thermal Sensor, exclusive to the Bio-Pro version of the software.

  • Regenerative Medicine Makes Old Immune Organ Young Again
    Regenerative Medicine Makes Old Immune Organ Young Again

    The desire to culture replacement organs for damaged or diseased ones has been a significant driving force since regenerative medicine’s infancy. Now, for the first time, University of Edinburgh researchers have regrown a thymus in a living host by transplanting laboratory-grown cells — fully restoring the function of the organ.

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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
More Upcoming Courses

FEATURED SUPPLIERS

Skyworks Solutions, Inc.

Skyworks Solutions, Inc.

Skyworks is the industry’s leading wireless semiconductor company focused on RF and complete semiconductor systems for mobile communications applications...