LEAD STORIES

Better Math Could Make MRIs 6x Faster

A mathematical theory called compressed sensing (CS) could reduce the number of measuring points necessary to perform magnetic resonance imaging (MRI) to one sixth of its present level. This discovery could conceivably reduce radiation exposure and allow clinicians to perform more tests per day, thus reducing healthcare costs.

  • New Proposal Seeks To Redefine FDA’s Regulation Of Off-Label Medical Device Use
    New Proposal Seeks To Redefine FDA’s Regulation Of Off-Label Medical Device Use

    Researchers at UCLA and Yale have collaborated to propose changes to the FDA’s role in the novel use of pre-approved drugs and medical devices.

  • J&J Agrees To Settle First Cases Over Transvaginal Mesh Implants
    J&J Agrees To Settle First Cases Over Transvaginal Mesh Implants

    Johnson and Johnson (J&J) recently agreed to settle four lawsuits over defective transvaginal mesh implants made by its Ethicon unit. The terms of the settlements were not disclosed. The four cases were the first settlements made by J&J over claims by women alleging that the devices caused injuries.

  • Development Of A Pathogen Inactivation System To Stop Ebola And Other Deadly Outbreaks
    Development Of A Pathogen Inactivation System To Stop Ebola And Other Deadly Outbreaks

    It wasn’t so long ago that the world was in an absolute panic over Ebola. One company that found itself smack in the middle of the global healthcare industry's response to Ebola was Cerus Corporation, maker of a technology that inactivates pathogens in transfused blood components. I recently had the pleasure of speaking with William “Obi” Greenman, the company's president and CEO. We discussed the Intercept system, the factors behind Cerus’ recent public stock offering, the modular premarket approval (PMA) pathway it used for Intercept, the story behind its Ebola involvement, and why it is uniquely positioned to help stop future infectious disease outbreaks.

INTRODUCING MED DEVICE INSIGHTS

Success in today’s medical device industry requires innovative ways of thinking about traditional and evolving problems. To this end, Med Device Online is pleased to bring you Med Device Insights, a new digital publication that imparts fresh perspectives and strategies from your peers and other thought leaders in the space. Our first issue includes original articles about:

  • A revolutionary new approach to rapid prototyping
  • The unintended consequences of new payment paradigms
  • Factors to consider when developing your India strategy
  • Using Internet-of-Things-style protocols for connected devices
  • Steps to identify the right clinical outsourcing partner
  • A company developing laser-based tumor ablation systems
  • And more...

Check out Med Device Insights today!

INDUSTRY PERSPECTIVES

  • Why You Need Cybersecurity (Even If You Think You Don’t)
    Why You Need Cybersecurity (Even If You Think You Don’t)

    Does your medical device present a threat to hospital network security? If you haven’t baked cybersecurity into your device design, the answer may be yes.

  • U.S. Minimally Invasive Spinal Implant Market To Outpace Growth In Traditional Spine Market
    U.S. Minimally Invasive Spinal Implant Market To Outpace Growth In Traditional Spine Market

    Growth in the spine market today is largely driven by the rapid rise in popularity of some motion preservation devices, most notably artificial discs, and vertebral compression fracture devices. Certain traditional fusion markets are expected to show strong rates of growth, but the overall market will eventually begin to stabilize in value as minimally invasive spine (MIS) procedures become increasingly popular among surgeons. Though the minimally invasive spine market will see the highest rates of growth, many traditional spine market segments are expected to continue to increase over the next few years.

  • Medical Device Design Controls: Following The Regulation Vs. Understanding Its Intent
    Medical Device Design Controls: Following The Regulation Vs. Understanding Its Intent

    When it comes to design controls, one of the most common problems I see medical device companies make is focusing on following the regulation rather than understanding its intent. In other words, they focus on what the words say, and not what the regulation is trying to accomplish.

More Guest Columns

ARTICLES

  • How To Develop A Quality Culture In Your Medical Device Manufacturing Operation
    How To Develop A Quality Culture In Your Medical Device Manufacturing Operation

    The lengths to which medical device companies go to deliver a quality product vary widely, but clearly there are some commonalities with regard to the development and maintenance of a quality management system that produces consistently excellent products. One of these has to do with the amount of attention given to manufacturing operator and technician training.

The 12 Questions To Ask When Outsourcing Medical Devices

The decision to outsource a medical device has serious consequences for your business and for your ultimate customer. This article will help you design a Q&A checklist for choosing the right outsourcing partner. In the article, you will learn the 12 questions that are most likely to elicit information critical to identifying a partner with the quality, experience, capacity (current and future), and financial stability to produce those products which are proudly labeled with your company name and logo.

Optimal Data Analysis In Medical Device Trials

The United States is the acknowledged world leader in medical devices and diagnostic products. As the largest medical device market in the world, representing around $110 billion, The U.S. market is expected to reach $133 billion by 2016. In 2012, the U.S held about 38 percent of the global medical device market.

3 Key Questions When Doing A "Product Refresh"

Today’s healthcare environment is pressuring medical device manufacturers more than ever to demonstrate value for low cost. As a result the focus in new product development has become less on brand new innovation and more on incremental improvements, or the “product refresh”.

Stimulating Development: Best Practices For Accelerating Neurotech Medical Device Commercialization

The time and cost of bringing neurostimulation devices to market are significant challenges. Here are some ways to overcome them.

More Articles

FROM THE EDITOR

  • Development Of A Pathogen Inactivation System To Stop Ebola And Other Deadly Outbreaks
    Development Of A Pathogen Inactivation System To Stop Ebola And Other Deadly Outbreaks

    It wasn’t so long ago that the world was in an absolute panic over Ebola. One company that found itself smack in the middle of the global healthcare industry's response to Ebola was Cerus Corporation, maker of a technology that inactivates pathogens in transfused blood components. I recently had the pleasure of speaking with William “Obi” Greenman, the company's president and CEO. We discussed the Intercept system, the factors behind Cerus’ recent public stock offering, the modular premarket approval (PMA) pathway it used for Intercept, the story behind its Ebola involvement, and why it is uniquely positioned to help stop future infectious disease outbreaks.

  • Nearshore Or Offshore? How To Decide Where You Should Manufacture Your Medical Device
    Nearshore Or Offshore? How To Decide Where You Should Manufacture Your Medical Device

    Nearshoring has become a major buzzword in recent years. But despite all the hoopla, nearshoring is not the right approach for everyone, warns medical device manufacturing consultant Mark Bonifacio, a 25-year veteran of the industry. During a recent conversation, Mark shared four questions medical device companies need to answer before making the decision to nearshore or offshore production of their products.

  • Google, Apple, & Other New Medtech Players: If You Can’t Beat Them, Join (Or Copy) Them
    Google, Apple, & Other New Medtech Players: If You Can’t Beat Them, Join (Or Copy) Them

    The U.S. healthcare sector is currently engaged in a bizarre game of musical chairs. Traditional participants are snatching up seats they haven’t historically occupied, while still clinging desperately to their own, and new players are constantly jumping into the fray. When the music finally stops, will medical device incumbents still have chairs to sit on?

More From The Editor

PRODUCT SHOWCASE

Custom Packaging And Pouching

Custom Packaging And Pouching

As demands in customer packaging and pouching grow in sophistication, ATL has kept pace by expanding our packaging capabilities. We have the engineering expertise to go beyond typical "cookie-cutter" type packaging modes in order to accommodate your one-stop supplier needs.

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 and multi-part programs.

Solutions For On-time, Deficient-Free Delivery Of Medical Supplies, Medicines And Other Products

For the person with diabetes in need of insulin, the heart patient awaiting a monitor or the individual expecting critical lab results, a delay of even one day isn't acceptable. Timely delivery of medical supplies or medication could mean the difference between recovery and relapse.

Selective Laser Sintering (SLS) for Additive Manufacturing

Selective Laser Sintering (SLS) for Additive Manufacturing

Selective laser sintering is an additive process that draws on a bed of thermoplastic powder to create a fully sintered, Nylon-based part. This technique is ideal for parts with highly complex geometries.

Ultra-Broadband Low Loss Power Divider

Ultra-Broadband Low Loss Power Divider

Corry Micronics has developed a 6-way ultra-wide band power divider that has a typical insertion loss of 2 dB with a frequency range from 800 MHz to 18 GHz. The 6 way power divider is rated at 30W CW or 5W CW per input channel. The design is compact and rugged.

Thermoplastic Molding

Thermoplastic Molding

ProMed works with and molds a variety of thermoplastics for medical devices. This includes EVA, PSU, PLA, PLGA, PEEK, filled PEEK, and Ultem. Their main area of expertise involves both long and short-term implantable components as small as .002g, and shot sizes of .05g up to 3g.

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LATEST HEADLINES

  • Better Math Could Make MRIs 6x Faster
    Better Math Could Make MRIs 6x Faster

    A mathematical theory called compressed sensing (CS) could reduce the number of measuring points necessary to perform magnetic resonance imaging (MRI) to one sixth of its present level. This discovery could conceivably reduce radiation exposure and allow clinicians to perform more tests per day, thus reducing healthcare costs.

  • Samsung Designs Wearable Stroke-Detecting Device
    Samsung Designs Wearable Stroke-Detecting Device

    Samsung has developed a prototype of a wearable device that can track brainwaves and alert the user of the very earliest signs of an impending stroke. The device is designed to be compatible with mobile devices and is capable of analyzing a number of neurological health markers.

  • High-Tech Hydrogel Helps Promote Blood Vessel Healing
    High-Tech Hydrogel Helps Promote Blood Vessel Healing

    Using a new high-tech hydrogel, Rice University researchers have developed a way to improve wound healing. The new hydrogel can be injected into a wound where it assists in healing and enhances vascular growth. The material slowly degrades and is eventually replaced by natural tissue.

  • Medtronic Closes Covidien Deal
    Medtronic Closes Covidien Deal

    Medtronic recently completed its $43 billion purchase of Covidien and officially became an Irish company. The transaction closed after the Irish High Court approved the deal, which effectively moved Medtronic's tax base to Ireland. The company will remain operationally headquartered in the United States.

  • New Proposal Seeks To Redefine FDA’s Regulation Of Off-Label Medical Device Use
    New Proposal Seeks To Redefine FDA’s Regulation Of Off-Label Medical Device Use

    Researchers at UCLA and Yale have collaborated to propose changes to the FDA’s role in the novel use of pre-approved drugs and medical devices.

  • J&J Agrees To Settle First Cases Over Transvaginal Mesh Implants
    J&J Agrees To Settle First Cases Over Transvaginal Mesh Implants

    Johnson and Johnson (J&J) recently agreed to settle four lawsuits over defective transvaginal mesh implants made by its Ethicon unit. The terms of the settlements were not disclosed. The four cases were the first settlements made by J&J over claims by women alleging that the devices caused injuries.

  • Dow Corning, Silcotech To Introduce Step-Change In Silicone Molding Technology For Medical Devices

    Silcotech, a leader in liquid injection molding (LIM) technologies, will be showcasing with Dow Corning at MD&M West 2015, a step-change in liquid silicone rubber (LSR) processing made possible, in part, by Dow Corning’s LSR technology.

  • FDA Approves Dexcom Continuous Glucose Monitoring System With Mobile Share Receiver

    DexCom, Inc., a leader in continuous glucose monitoring (CGM) for patients with diabetes, announced recently that it has received U.S. Food and Drug Administration (FDA) approval for its Dexcom G4 PLATINUM Continuous Glucose Monitoring System with Share.

More News

UPCOMING TRAINING COURSES

Design Controls 101: Beyond Regulatory Requirements

January 29, 2015
1pm-2:30pm EST, Online Training

Monitoring Informed Consent (IC): Frequently Asked Questions

February 2, 2015
1pm-2:30pm EST, Online Training

Design Change Analysis – Key Considerations and How to Implement Them

February 3, 2015
1pm-2:30pm EST, Online Training

Strategic Clinical Project Management: Principles and Practical Applications

February 11, 2015
1pm-2:30pm EDT, Online Training

FDA Pre-Sub Meetings for Medical Devices – Make The Most Of Your Opportunity

February 17, 2015
1pm-2:30pm EST, Online Training
More Upcoming Courses

FEATURED SUPPLIERS

MPI Research

MPI Research

MPI Research, with global headquarters in Mattawan, Michigan, provides discovery, safety evaluation, bioanalytical, and analytical services to the biopharmaceutical, medical device, animal health, and chemical industries.