LEAD STORIES

J&J Slapped With Injunction In Covidien Patent Case

A federal district court granted a preliminary injunction sought by Covidien against a subsidiary of Johnson & Johnson related to the alleged infringement of three surgical device patents held by Covidien.

  • Stryker Reduces Tax Rate, Repatriates $2B For Acquisitions
    Stryker Reduces Tax Rate, Repatriates $2B For Acquisitions

    Stryker Corporation reported that third quarter net sales grew across all business units despite incurring a one-time tax hit for moving some IP assets to the company’s new European regional headquarters in Amsterdam. The company also announced that it will repatriate $2 billion in cash for acquisitions in 2015.

  • FDA Invites Participation In Pilot 510(k) eSubmission Program
    FDA Invites Participation In Pilot 510(k) eSubmission Program

    A pilot program for the electronic submission of 510(k) documents is being expanded after a successful initial test period. The online process has been likened to commercial tax software and promises to increase ease of use for companies that are submitting a 510(k) application.

  • St. Jude’s CardioMEMS Improves Another Patient Outcome
    St. Jude’s CardioMEMS Improves Another Patient Outcome

    The newly released CardioMEMS device for real-time monitoring of congestive heart failure (CHF) is now being used at the University of California San Francisco (UCSF).

INDUSTRY PERSPECTIVES

  • Understanding The UDI Rule – A Guide For Medical Device Manufacturers
    Understanding The UDI Rule – A Guide For Medical Device Manufacturers

    The FDA’s UDI (unique device identification) final rule has arrived, and medical device manufacturers are working on their implementation strategies

  • 10 Steps To Overcome Your Fear Of Using Open Source Software
    10 Steps To Overcome Your Fear Of Using Open Source Software

    The entire Internet runs on open source software (OSS) and, if we used it more in medical devices, it would lead to reduced costs and increase the quality of devices. If you ask some regulatory affairs folks in medical device companies, they think OSS is too “dangerous” for use in safety critical systems.

  • Biologic Grafts Driving Growth In U.S. Soft Tissue Reinforcement And Regeneration Market
    Biologic Grafts Driving Growth In U.S. Soft Tissue Reinforcement And Regeneration Market

    Soft tissue is a crucial component of the human body that serves to connect, support, or surround other structures. Seeing as the main component of soft tissue, collagen, is the most abundant protein in mammals, it is of utmost importance that this tissue remains healthy. Complications with soft tissue can result in a myriad of medical conditions that often can only be treated successfully via surgical intervention.

More Guest Columns

ARTICLES

Intelligent Fluid Couplings Communicate Critical Device And Process Data

Like many other devices these days, a select group of fluid connectors can now be found in the growing ranks of “intelligent” products. In addition to moving fluids, these high-tech connectors move data, thanks to the innovative use of wireless communication technology. This article outlines the benefits of implementing RFID-enabled couplings into a fluid handling system. By Dennis Downs, Colder Products Company

Proto Labs Helps Develop a Wearable Hand Sanitizer

This case study explains how the SwipeSense, a portable hand sanitizer that attaches to clothing and tracks usage, went from a design on a Post-It note to a tangible product. It also discusses how ProtoLabs’ plastic injection molding services and their design software were used to help. 

Improved Production Yields While Reducing Processing Costs For Blood Sampling Device

Axis-Shield created the Afinion blood analyzer for doctors located mainly in Europe and the United States for quantitative testing of certain complaints at a patient’s point of care.

Managing Risk in Medical Connectors

This paper will help to educate designers and manufacturers of medical devices who integrate electrical connectors into their design on some recent changes made by the FDA, and the implications of the new regulations.

More Articles

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

Custom Prisms

Custom Prisms

Precision Optics Corporation can custom manufacture prisms with tolerances to .01mm, <10/5 scratch/dig, λ/20 flatness, <5 arc second parallelism, +/- 0.1mm; 0.2mm to 150 mm diameter, and +/- 0.02mm (and as thin as 0.2mm) thickness.

Miniature Optical Encoders For Medical Positioning Devices

Miniature Optical Encoders For Medical Positioning Devices

The SR series of miniature optical encoders has been designed to fit into motion control devices with limited space, such as robotic arms for surgery, nanopositioning stages, microscopes, and other medical devices.

Entry-Level Infrared Cameras For Research And Science Applications

Entry-Level Infrared Cameras For Research And Science Applications

These infrared cameras for research and science applications offer image quality, ease of use, and accurate temperature measurement, all with a low cost. They’re available in handheld and fixed mount configurations, and feature thermal sensitivity up to 50 mK, temperature measurement up to 2,000° C, flexible optics for close-up and distance imaging, and more. Engineers that work in general medical and bioresearch applications, as well as researches involved with universities, power conversion, the electronics industry, and solar cell development can benefit from the use of FLIR’s entry-level Infrared Cameras. This line starts at under $10,000.

R10699 Photomultiplier Tube

R10699 Photomultiplier Tube

Hamamatsu’s R10699 is a new 28 mm (1-1/8 inch) side-on photomultiplier tube (PMT) with high sensitivity from UV to NIR (185 nm to 900 nm). It also features a high gain value and high quantum efficiency (QE), giving this new PMT very high sensitivity and good signal-to-noise ratio.

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.

Ceramic Core Alumina Heater for Medical and Life Science Applications

Ceramic Core Alumina Heater for Medical and Life Science Applications

Heatron’s ceramic core alumina heater is ideal for dialysis, CPAP, DNA analysis/testing, blood diagnostics, surgical devices, blood/fluid warming, MRI equipment, instrument sterilization, temperature therapy, and vessel sealers.  

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

More News

UPCOMING TRAINING COURSES

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

How To Take Advantage Of The Companion Diagnostics Opportunity

November 13, 2014
1pm-2:30pm EST, Online Training

Reducing Human Error in Life Sciences Manufacturing

November 18, 2014
1pm-2:30pm EST, Online Training
More Upcoming Courses

FEATURED SUPPLIERS

ATL (Ad Tape & Label)

ATL (Ad Tape & Label)

ATL has more than 50 years of flexographic label printing experience, two decades of disposable medical device converting, and ten years of complex multi-panel booklet label manufacturing. As an FDA-registered medical device manufacturer and cGMP compliant supplier, we understand the criticalities of providing you with a fail-safe product.