LEAD STORIES

First Blood Test Developed To Diagnose Depression

Clinical depression, a disease that affects millions, has always been subjectively diagnosed. A new blood test from Northwestern University researchers, however, may provide a way to objectively identify measurable indicators of depression.

  • 3D Printing Transforms Cellphone Into A Microscope
    3D Printing Transforms Cellphone Into A Microscope

    A 3D printable clip has been developed to turn cellphone cameras into powerful microscopes, and its low-cost components are ideal for applications where contamination can occur.

  • Medtronic, J&J, Abbott Overcharging And Bribing Doctors, India Media Says
    Medtronic, J&J, Abbott Overcharging And Bribing Doctors, India Media Says

    Recent media reports in India claim that major medical device companies are engaged in unethical business practices in the country. Specifically, the reports allege that the companies overcharge hospitals and patients for their products and then using the profits to bribe doctors to drive sales.

  • 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.

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. 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.

More Guest Columns

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

More Articles

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

Connectors And Cable Assemblies For Medical Devices

Connectors And Cable Assemblies For Medical Devices

Fischer Connectors® offers a line of connectors and cable assemblies that feature unparalleled signal integrity, fully secured connections, medical standard compliance, durability, 360° EMC shielding, and advanced ergonomics.

Alcotabs: Critical-Cleaning Detergent Tablets

Alcotabs: Critical-Cleaning Detergent Tablets

Special slow release tablet formulation for maximum cleaning performance from your syphon pipette washers. Concentrated to save you money. Biodegradable and readily disposable. Free rinsing to give you reliable results and no interfering residues. Use to pass your cleaning validation tests for lab accreditation and plant inspection approval.
Cavity Filters

Cavity Filters

Corry Micronics offers a line of cavity filters. We have several stock cavity filters that are designed for specific industries. Some of the more popular stock units are for filtering CDMA repeaters with a Bandpass range of 825 to 835 MHz and other units designed to Bandpass a range of frequencies from 870 MHz to 880 MHz...
Micro Optics

Micro Optics

Ross Optical’s line of micro optics includes achromats, plano convex lenses, and bi-convex lenses. These optical components allow for shorter focal lengths in compact systems and feature diameters from sub-millimeter to 6 mm.

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.

Compact High Resolution NIR InGaAs Camera: FLIR A2600sc NIR

Compact High Resolution NIR InGaAs Camera: FLIR A2600sc NIR

With its low noise and high sensitivity 640 × 512 InGaAs sensor, the A2600sc NIR camera complements FLIR's range of imaging products for automation, research, and science applications. Economically priced, the FLIR A2600sc NIR Camera Series offers unique features and options for applications including imaging spectroscopy, astronomy, water or ice detection, laser profiling, medical testing, solar cell inspection, silicon wafer processing, high temperature furnace evaluation, and more.

More Featured Products
Newsletter Signup
Newsletter Signup
Get the latest medical device industry news, insights, and analysis delivered to your inbox.
By clicking Sign Me Up, you agree to our Terms and that you have read our Privacy Policy.

LATEST HEADLINES

  • First Blood Test Developed To Diagnose Depression
    First Blood Test Developed To Diagnose Depression

    Clinical depression, a disease that affects millions, has always been subjectively diagnosed. A new blood test from Northwestern University researchers, however, may provide a way to objectively identify measurable indicators of depression.

  • Medtronic Sells Instrument Lines To Integra LifeSciences For $60M
    Medtronic Sells Instrument Lines To Integra LifeSciences For $60M

    Medtronic is selling its MicroFrance and Xomed manual ENT (ear, nose, and throat) and laparoscopy instrumentation lines to Integra LifeSciences for $60 million in cash in a deal that is expected to close by the final quarter of this year.

  • FDA Proposes Reclassification of EPPG, PSA Devices To Class II
    FDA Proposes Reclassification of EPPG, PSA Devices To Class II

    The FDA is proposing to reclassify both external pacemaker pulse generator (EPPG) devices and pacing system analyzers (PSAs) as class II devices with special controls.

  • Neuroimaging Detects Concussion-Related Brain Disease In Living Brain
    Neuroimaging Detects Concussion-Related Brain Disease In Living Brain

    Historically, it was only possible to identify concussion-related brain diseases during autopsy. With a new neuroimaging technique developed by researchers at the Mt. Sinai School of Medicine, however, it is now possible to detect those diseases while a patient is still alive — an advance that may allow treatment before it’s too late.

  • 3D Printing Transforms Cellphone Into A Microscope
    3D Printing Transforms Cellphone Into A Microscope

    A 3D printable clip has been developed to turn cellphone cameras into powerful microscopes, and its low-cost components are ideal for applications where contamination can occur.

  • Medtronic, J&J, Abbott Overcharging And Bribing Doctors, India Media Says
    Medtronic, J&J, Abbott Overcharging And Bribing Doctors, India Media Says

    Recent media reports in India claim that major medical device companies are engaged in unethical business practices in the country. Specifically, the reports allege that the companies overcharge hospitals and patients for their products and then using the profits to bribe doctors to drive sales.

  • 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.

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

Corry Micronics, Inc.

Corry Micronics, Inc.

Corry Micronics, located in northwestern Pennsylvania, has been producing Feedthru Capacitors and Radio-Frequency Interference (RFI) Filters since 1970...