LEAD STORIES

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.

  • FDA Proposes New Study To Test Device Labeling Standardization
    FDA Proposes New Study To Test Device Labeling Standardization

    The FDA is taking steps to further study the feasibility of standardizing device labeling using new formats currently under development.

  • Danaher To Acquire Nobel Biocare For $2.2 Billion
    Danaher To Acquire Nobel Biocare For $2.2 Billion

    Danaher Corporation, an American conglomerate that makes products for industrial and consumer markets, is set to purchase Swiss dental implant manufacturer Nobel Biocare for $2.2 billion in an all-cash transaction.

  • Novel “Biospleen” Selectively Cleans Pathogens From Blood
    Novel “Biospleen” Selectively Cleans Pathogens From Blood

    Sepsis, or a severe systemic reaction to infection, has historically been extremely difficult to treat. Instead of using large doses of general types of antibiotics, healthcare providers may now have another option called a “biospleen.” This device selectively and efficiently cleanses bacteria and other pathogens from the blood, without damaging the blood itself.  

INDUSTRY PERSPECTIVES

  • Designing For Humans, From Start To Finish
    Designing For Humans, From Start To Finish

    Human-centric design (HCD) can help medical device manufacturers reduce risks and development costs and maximize market acceptance — if it is engaged at the right points in the development cycle. Many device manufacturers view human factors testing as a necessary part of the regulatory process before a product launch. But purposeful use of HCD principals early in the design process can make development more efficient and cost effective, and ensure that the end product is not only safe but also desirable for patients and providers. This article will explore best practices in HCD across the development cycle, from ideation to market launch.

  • 510(k) Substantial Equivalence In Plain English — Part 1
    510(k) Substantial Equivalence In Plain English — Part 1

    The two most important components of a successful 510(k) submission are the substantial equivalence argument and the risk mitigation strategy. This two-part article will focus specifically on the substantial equivalence component, explaining what it is and how to establish it. It will also explore two recently issued FDA guidances related to substantial equivalence, and how they should influence your regulatory strategy.

  • Technology Advances, Consumer Preferences Transform European Dental Materials Markets
    Technology Advances, Consumer Preferences Transform European Dental Materials Markets

    The demand to eliminate waste, enhance patient comfort, and ensure quality continues to drive technological advancements in the dental materials market.

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ARTICLES

  • The 10 Commandments Of Product Development
    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

Certification: Is It Worth The Hassle?

In the life sciences and other regulated industries, obtaining certification in a range of international standards has become a necessity for companies hoping to access and compete in today’s global marketplace. Whether your organization is a laboratory, medical device manufacturer, or automobile maker, becoming certified by an impartial third-party accreditation body assures potential customers that you value quality and your products conform to the highest regulatory standards. This assurance can lead to tremendous marketing and business advantages. But certification can be a long and trying process. By Lisa Weeks, Marketing Communications, MasterControl

Medical Device Cleaning Validation Method References For Alconox

Identifying residue—in a medical device environment involves: the process fluids, polishing compounds, mold releases, bioburden, endotoxins, cleaning agents and any degredation or interaction products. This document is intended to help with the cleaner residue identification...

Electromagnetics In The Healthcare Industry

Electromagnetic (EM) fields are present in many of the medical applications today. The technology is becoming more complex, and it is therefore vitally important that the tools and procedures perform at their maximum capacity and always yield precise and accurate data. This article examines the design challenges of electromagnetic systems in healthcare applications by leveraging EM simulation software. By Peter Futter, Application Specialist, Business Development – EM Solutions at Altair South Africa

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FROM THE EDITOR

  • 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.

  • Window Through The Skin: The Development Of A Pocket-Sized Imaging Device
    Window Through The Skin: The Development Of A Pocket-Sized Imaging Device

    I have a confession to make: I am more than a little afraid of needles. When it comes to getting blood drawn, an IV inserted, or pretty much any other procedure that involves shoving one of those pointy little devils through my skin and into my blood vessels, I am an abject coward. So you can imagine my enthusiasm when the folks at Analogic introduced me to their new Sonic Window ultrasound device, which was recently cleared by FDA for use in peripheral IV access procedures. Read on to learn how this novel approach to handheld ultrasound imaging made its way from the university to the clinic.

  • 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 more than 10 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.

More From The Editor

PRODUCT SHOWCASE

Miniature Diaphragm Liquid Pumps: LTC Series

Miniature Diaphragm Liquid Pumps: LTC Series

These liquid pumps offer up to 650 mLPM free flow and are ideal for clinical diagnostics devices for urinalysis, liquid chromatography, and clinical chemistry. Maximum suction, priming, and continuous dry operation is made possible through a monolithic diaphragm pump design.  

High Purity Synthetic Fused Silica: Suprasil® CG

High Purity Synthetic Fused Silica: Suprasil® CG

Suprasil ® CG is a high purity synthetic fused silica manufactured by flame hydrolysis, ideal for DUV to UV/VIS commercial grade optics. This silica features a low bubble and inclusion content, typical UV transmission of k200: 3,5 x 10-3/ cm, stress induced birefringence, a well-established production process, and much more.

Fischer Plastic Series

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

Custom Manufactured Mirrors

Custom Manufactured Mirrors

LaCroix Optical Company produces mirror substrates in a wide variety of shapes and sizes using optical or filter glass, fused silica or other glass-like materials. All of our mirrors are produced and coated at our facility in Batesville, Arkansas.

 

Optical Components Group

Optical Components Group

Zygo’s Optical Components Group uses innovative and proprietary manufacturing technologies to create high-precision optical components through CNC glass machining and light-weighting, weighting, rotational/double-sided/MRF polishing, and thin film coating. This page provides an overview of the different optical components Zygo offers.

Prototype Tooling Services

Prototype Tooling Services

PTI’s tooling division has the ability to produce high quality prototypes in 2-5 week windows (in some cases, even faster). This type of turnaround is possible for both single-component to multi-part programs.

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LATEST HEADLINES

  • 3D Printed Hydrogels With Cartilage-Like Toughness
    3D Printed Hydrogels With Cartilage-Like Toughness

    Replicating the robust performance characteristics of cartilage has proven elusive to tissue engineers. Researchers at the University of Wollongong in Australia may have come close, however, with the development of hydrogel materials that are both strong and easy-to-manufacture.

  • Detecting Single Proteins By Their Shadows
    Detecting Single Proteins By Their Shadows

    For some time the field of optical sensing has been dominated by fluorescent marker methods. By eliminating these markers, however, a new method from the Max Planck Institute for the Science of Light might significantly advance this field of research.

  • FDA Proposes New Study To Test Device Labeling Standardization
    FDA Proposes New Study To Test Device Labeling Standardization

    The FDA is taking steps to further study the feasibility of standardizing device labeling using new formats currently under development.

  • Danaher To Acquire Nobel Biocare For $2.2 Billion
    Danaher To Acquire Nobel Biocare For $2.2 Billion

    Danaher Corporation, an American conglomerate that makes products for industrial and consumer markets, is set to purchase Swiss dental implant manufacturer Nobel Biocare for $2.2 billion in an all-cash transaction.

  • Surgical Equipment Market To Reach $12.1B By 2020

    Big Market Research has released a new report titled "Global Surgical Equipment Market (Types, Applications and Geography) - Size, Share, Global Trends, Company Profiles, Demand, Insights, Analysis, Research, Report, Opportunities, Segmentation And Forecast, 2013 - 2020."

  • Novel “Biospleen” Selectively Cleans Pathogens From Blood
    Novel “Biospleen” Selectively Cleans Pathogens From Blood

    Sepsis, or a severe systemic reaction to infection, has historically been extremely difficult to treat. Instead of using large doses of general types of antibiotics, healthcare providers may now have another option called a “biospleen.” This device selectively and efficiently cleanses bacteria and other pathogens from the blood, without damaging the blood itself.  

  • Apple Starts HealthKit Trials With Stanford, Duke, Medical Device Partners
    Apple Starts HealthKit Trials With Stanford, Duke, Medical Device Partners

    Apple Inc. is reportedly about to commence two clinical trials using its new HealthKit health platform with patients from two prestigious hospitals in the United States.

  • Combining The Power Of Chemotherapy With The Precision Of Radiotherapy
    Combining The Power Of Chemotherapy With The Precision Of Radiotherapy

    Chemotherapy and radiation have been used to treat cancer for some time, but the systemic effects of toxic therapeutic drugs are a major risk in this sort of treatment. Currently, researchers from Boise State University are working to address the issue by developing contained liposome cancer therapy that would eliminate cancer cells more effectively and spare healthy tissue.

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
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AR

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