LEAD STORIES

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.

  • 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 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

  • 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

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...
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FROM THE EDITOR

  • 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.

  • 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.

More From The Editor

PRODUCT SHOWCASE

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.

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.

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.
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.

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®.

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LATEST HEADLINES

  • New Graphene Microfabrication Enhances Cancer Biomarker Detection
    New Graphene Microfabrication Enhances Cancer Biomarker Detection

    A new, ultrasensitive graphene biosensor was recently introduced by researchers from the University of Swansea that shows tremendous promise for the detection of cancer-indicating biomarkers.

  • Surgeons Still Using Morcellators Despite FDA Warning
    Surgeons Still Using Morcellators Despite FDA Warning

    A number of gynecologists in the U.S. continue to use power morcellators, even several months after the Food and Drug Administration (FDA) issued a warning about the tools’ potential to inadvertently spread cancer.

  • Mussel Protein Enables Powerful Medical Adhesive
    Mussel Protein Enables Powerful Medical Adhesive

    Mussels have inspired the biomimetic development of marine- and medical-grade glues for some time and with some success. New research from the Massachusetts Institute of Technology (MIT) has taken things further by developing a wet-dry adhesive that’s even stronger than those seen in nature.

  • 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.

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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...