LEAD STORIES

“Smart Catheter” Increases Ablation Success

Catheter ablation for atrial fibrillation may now be improved thanks to a device that delivers more uniform treatment. New studies show an increase in successful outcomes that is more than four times greater than older methods.

  • Safety Evidence Lacking For 510(k) Devices, Study Finds
    Safety Evidence Lacking For 510(k) Devices, Study Finds

    A study published in JAMA Internal Medicine claims that the U.S. Food and Drug Administration (FDA) has failed to adhere to a law requiring the public disclosure of safety information on new medical devices cleared by the agency.

  • 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.

  • “Lung Flute” Helps COPD Patients Breathe Easier
    “Lung Flute” Helps COPD Patients Breathe Easier

    A new device from University of Buffalo (UB) researchers provides long term chronic obstructive pulmonary disease (COPD) benefits when used over a 6 month period. The simple device promises to improve quality of life for those suffering from this prevalent disease. 

INDUSTRY PERSPECTIVES

  • Making Breast Cancer Screening Available Worldwide — Without Radiation Or Pain
    Making Breast Cancer Screening Available Worldwide — Without Radiation Or Pain

    In honor of Breast Cancer Awareness Month, this month’s CEO Corner profiles the founder of a breast cancer diagnostics company whose mission is to provide less-expensive, easy-to-use screening tools to the developing world — and radiation- and pain-free options to specific patient groups in the U.S. Mihir Shah, CEO of UE LifeSciences, recently told me the story about how his company began, the struggles it faced in bringing its products to market, and the strategies it used to overcome those challenges.

  • What To Expect From The Upcoming ISO 13485 Revisions, Part 1
    What To Expect From The Upcoming ISO 13485 Revisions, Part 1

    Earlier this month, 50 delegates from ISO Technical Committee 210 Working Group 1 met in Stockholm to review comments submitted by industry on the draft international standard of ISO 13485, the international quality standard for medical devices. In this three-part article series, we will look at the anticipated changes to ISO 13485, to help you prepare for its eventual publication and enforcement. This installment will explore the primary motivations behind the revisions and discuss what’s new in sections 4 through 6.

  • 510(k) Substantial Equivalence In Plain English — Part 2
    510(k) Substantial Equivalence In Plain English — Part 2

    Part 1 of this article sought to provide a better understanding of the concept of substantial equivalence in premarket notifications, more commonly known as 510(k)’s, using easy-to-understand metaphors. We also looked at recently issued CDRH draft guidance concerning different technological characteristics of a 510(k) submission. In Part 2, we move on to another piece of recent CDRH guidance, this one dealing with the controversial topic of split predicates.

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ARTICLES

  • Choosing The Right Linear Drive Train
    Choosing The Right Linear Drive Train

    Whether you are designing your own motion solution, selecting components from a supplier, or working with a system solutions provider, understanding drive train selection is a key to a successful and reliable machine. This paper will outline the key performance characteristics to take into account for your next motion application. The goal of the paper is to provide you with guidelines to make your decision easier, faster, and more accurate.

The Role Of 3D Scanning In Orthopedic Development And Manufacturing

To steal from old jokes, what do an orthopedist and a construction worker have in common? The answer is both use plaster. Fortunately, digital technology has helped orthopedics to make great strides and to move away from using plaster for casts and molds. In just a few years, plaster will be as rarely used by doctors as pencil and ruler designs by engineers. Plaster will be back to the construction sites, where it belongs.

Best Practices In Outsourcing Clinical Trials For Medical Device Companies

Today the U.S. is home to more than 6,000 medical device companies, and approximately 73 percent of those have fewer than 20 employees. The convergence of industry growth and development of medical devices by small companies necessitates the use of external resources to conduct product development functions, including clinical trials. 

The 10 Commandments Of Product Development

Product design and development is a journey with unexpected twists and turns. People often ask, “How can I make my design process more predictable?” In our firm’s 25 years of experience designing medical devices, we’ve found that you can’t always predict all the twists, but there are things that can be done to increase the certainty in a successful outcome. This article describes our top 10 list of important considerations.

FDA Regulation Of Mobile Medical Apps

The past decade has witnessed rapid advancement in telecommunication and computer technologies. The smartphone is one result of that technological development and has been adopted by hundreds of millions of people worldwide. Innovators in the medical device industry quickly recognized the potential to use smartphones to expand the capabilities of healthcare professionals via mobile medical applications (“apps”) resident on these devices. These apps raise unique challenges for regulation by the Food and Drug Administration (FDA). By Bruce A. MacFarlane, PhD

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FROM THE EDITOR

  • 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.

  • Graphene Biosensors — The Next Frontier In Medical Diagnostics?
    Graphene Biosensors — The Next Frontier In Medical Diagnostics?

    Graphene — the übermaterial that is 1 million times thinner than paper, 100 times stronger than steel, and the world’s best conductor of both electricity and heat — has become one of the hottest areas of materials science R&D over the past decade. Much of the graphene research has focused on two main objectives: 1) finding a way to better manufacture the substance, and 2) identifying the best applications for it. Recently, I was introduced to a company that claims to be close to achieving both goals, and its work could have considerable influence on how graphene is used in healthcare, particularly in the area of in vitro diagnostics.

More From The Editor

PRODUCT SHOWCASE

Single and Quadrant Photodiodes for 1064nm

Single and Quadrant Photodiodes for 1064nm

First Sensor’s line of Single and Quadrant Photodiodes (Series Q) optimized for 1064 nm feature fast rise times, highest quantum efficiency of any silicon photodiode at 1064nm (> 35%) as well as low dark current and low capacitance making these photodiodes well suited for laser range finding, laser based target designation or any application detecting YAG lasers or similar NIR radiation sources. The components are available as single detectors, quadrant detectors or surface arrays. Quadrant photodiodes are discrete components that usually feature four optically active areas separated by a small gap. These photodiodes are used in many applications for detecting the position of laser beams, collimators and other applications to facilitate adjustment.

Silicone Overmolds for High-Heat Applications

Silicone Overmolds for High-Heat Applications

Fischer Connectors has been providing custom silicone overmolds, custom geometries, and low friction coatings for silicone cable assemblies to medical device manufactures for over 10 years now. Silicone cable assemblies need to be able to withstand steam autoclaving, high heat, and resistance to disinfectants and sterliant solutions, and Fischer Connectors designs and manufactures overmolds for silicon cable assemblies that can withstand the same thing.

Miniature Linear Positioner/Stage: MX80M

Miniature Linear Positioner/Stage: MX80M

The MX80M miniature linear stage is a manually driven positioner with precision cross roller bearings, optional clean room preparation, an optional low ESD coating, dowel holes in the top and base, and positive position lock.

UV Curing Light Sources

UV Curing Light Sources

Hamamatsu offers UV-LEDs for curing adhesives in stents, catheters, needles, hearing aids, and other therapeutic medical devices. Their high output power makes them especially ideal for UV curing, and their low power consumption makes them an energy saving and environmentally friendly light source.

Laser Rotary Encoders For Highly Accurate Angle Sensing

Laser Rotary Encoders For Highly Accurate Angle Sensing

Canon USA has developed laser rotary encoders that can provide 81,000 pulses with a 36mm diameter. This is done through the use of the light-diffraction interference method in conjunction with a semiconductor laser acting as the light emitting element. The result is a family of laser rotary encoders that provide highly accurate angle sensing for applications involving robotic engineering, stage position control, direct motor control, measurement instruments, and more.

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.

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LATEST HEADLINES

  • “Smart Catheter” Increases Ablation Success
    “Smart Catheter” Increases Ablation Success

    Catheter ablation for atrial fibrillation may now be improved thanks to a device that delivers more uniform treatment. New studies show an increase in successful outcomes that is more than four times greater than older methods.

  • FDA Must Follow Congressional Procedures When Rescinding 501(k) Clearance
    FDA Must Follow Congressional Procedures When Rescinding 501(k) Clearance

    The FDA’s ability to reclassify devices was restricted by a federal appeals court, which issued a ruling that says the agency does not have the inherent authority to reclassify devices.

  • Supersensitive Nanodevice Could Detect Cancer Earlier
    Supersensitive Nanodevice Could Detect Cancer Earlier

    Researchers at the University of Alabama at Huntsville (UAH) have developed a nanodevice that senses extremely low levels of cancer biomarkers. The advance may allow earlier detection of disease and be broadly applicable to many different disease biomarkers.  

  • Safety Evidence Lacking For 510(k) Devices, Study Finds
    Safety Evidence Lacking For 510(k) Devices, Study Finds

    A study published in JAMA Internal Medicine claims that the U.S. Food and Drug Administration (FDA) has failed to adhere to a law requiring the public disclosure of safety information on new medical devices cleared by the agency.

  • “Lung Flute” Helps COPD Patients Breathe Easier
    “Lung Flute” Helps COPD Patients Breathe Easier

    A new device from University of Buffalo (UB) researchers provides long term chronic obstructive pulmonary disease (COPD) benefits when used over a 6 month period. The simple device promises to improve quality of life for those suffering from this prevalent disease. 

  • DARPA Seeks To Combine X-Ray And Neutron Radiography
    DARPA Seeks To Combine X-Ray And Neutron Radiography

    Portable neutron imaging is a target development by the Defense Advanced Research Projects Agency (DARPA), and the effort could extend and improve imaging in the field. While X-rays have their strengths, neutron imaging could provide a new level of visualization beyond current radiology methods.

  • AdvaMed Comments On Launch Of CMS Open Payments Website

    Christopher White, senior executive vice president and general counsel for the Advanced Medical Technology Association (AdvaMed), issued the following statement recently on the launch of the Open Payments website by the Centers for Medicare and Medicaid Services (CMS).

  • NIH Awards Initial $46M For BRAIN Initiative Research
    NIH Awards Initial $46M For BRAIN Initiative Research

    The National Institutes of Health announced recently its first wave of investments totaling $46M in fiscal year 14 funds to support the goals of the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative. More than 100 investigators in 15 states and several countries will work to develop new tools and technologies to understand neural circuit function and capture a dynamic view of the brain in action.

More News

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

Root Cause Analysis for GCP – A Risk Action Plan Guide

October 21, 2014
1pm-3pm EDT, Online Training

Process Validation: Ensuring Compliance With Multiple Standards

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

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.