LEAD STORIES

Enhanced Protein Fluorescence Yields Better Neuronal Observations

Studying neural activity is a delicate process that historically has been done using microelectrodes. While observing whole networks of neurons in a living organism has proven elusive, a new method developed by researchers from the California Institute of Technology (CalTech) may make this type of work possible.

  • 3D Printable Syringe Pump Design Lowers Lab Costs
    3D Printable Syringe Pump Design Lowers Lab Costs

    Lab equipment costs are a major consideration when planning experimental work. However, a recent open access contribution from Michigan Technological University (MTU) can help other researchers save a significant amount of time and money.

  • 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.

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

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.

DesiCap® Desiccant Caps/Vials

DesiCap® Desiccant Caps/Vials

Desiccants- DesiCap® custom-designed and standard caps and vials offer an innovative desiccant to keep bottle contents fresh and dry. If you package your product in a bottle and it requires protection from moisture damage or odors, you can speed up your packaging line and save space by using DesiCap®.

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.

Plastic Injection Molding

Plastic Injection Molding

PTI’s plastic injection molding services include short-run molding, scientific molding, and micro molding for a wide variety of applications. These services can be utilized for single prototype testing all the way through high volume production.

More Featured Products
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LATEST HEADLINES

  • Enhanced Protein Fluorescence Yields Better Neuronal Observations
    Enhanced Protein Fluorescence Yields Better Neuronal Observations

    Studying neural activity is a delicate process that historically has been done using microelectrodes. While observing whole networks of neurons in a living organism has proven elusive, a new method developed by researchers from the California Institute of Technology (CalTech) may make this type of work possible.

  • Apple’s HealthKit Delayed By Software Bug
    Apple’s HealthKit Delayed By Software Bug

    Apple delayed the release of its HealthKit health platform after an unspecified software bug was discovered. The platform — along with third-party apps that are to send it health data — will now be available in late September.

  • Shark Skin Inspires Antimicrobial Surfaces
    Shark Skin Inspires Antimicrobial Surfaces

    In order to combat superbugs, alternative methods of preventing infection have become paramount. A recent study from researchers at Sharklet Technologies shows significant promise and may provide a tool in the fight against hospital-based infections.

  • Industry Lauds Passing Of Bill To Repeal Device Tax
    Industry Lauds Passing Of Bill To Repeal Device Tax

    The House of Representatives recently voted to pass a bill that would repeal the hotly debated 2.3 percent medical device excise tax.

  • 3D Printable Syringe Pump Design Lowers Lab Costs
    3D Printable Syringe Pump Design Lowers Lab Costs

    Lab equipment costs are a major consideration when planning experimental work. However, a recent open access contribution from Michigan Technological University (MTU) can help other researchers save a significant amount of time and money.

  • 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.

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...