LEAD STORIES

Zapping Vocal-Cord Cancer With Lasers Proven Effective In Long-Term Study

A pioneering laser treatment for early vocal-cord cancer has shown promise as a long-term cure for the disease. In addition to being as effective as traditional approaches at curing tumors, the treatment developed at Massachusetts General Hospital is also able to spare the patient’s vocal cords and ability to speak.

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 quarterly 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

  • Hearing Health In Latin America Needs Awareness, Investment To Become More Than A Potential Market
    Hearing Health In Latin America Needs Awareness, Investment To Become More Than A Potential Market

    Accounting for nearly twice the population of the United States and experiencing an increase in over-65 population, Latin America has significant market potential for hearing devices. In Latin America, 4% to 6% of the population is affected by a disabling hearing loss, whereas the rates among North American and European countries are between 2% and 4%, according to World Health Organization estimates. There are approximately 32 million people in Latin America who suffer from mild to severe hearing loss, making up about 9% of the world’s total hearing impaired population.

  • What To Expect From The Upcoming ISO 13485 Revisions, Part 3
    What To Expect From The Upcoming ISO 13485 Revisions, Part 3

    The International Organization for Standardization (ISO) is currently in the process of revising ISO 13485, the international quality standard for medical devices. When the final version is released — potentially in 2015 — it will be the first revision to the standard in over a decade. In this three-part article series, we are looking at the proposed changes to ISO 13485, to help you prepare for its eventual publication and enforcement.

  • A Guide To Device, Label, And Package Requirements Of The UDI Rule
    A Guide To Device, Label, And Package Requirements Of The UDI Rule

    On the surface, unique device identification (UDI) is a simple concept. Put the device identifier (DI) on the device label in machine‑readable form. Include the production identifiers (PI) that you have selected, and make sure they are both machine‑readable and human‑readable.

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ARTICLES

  • Liquid Silicone Rubber Takes The Heat
    Liquid Silicone Rubber Takes The Heat

    Unlike thermoplastics, which soften when heated, liquid silicone rubber (LSR) is created in high heat and can easily withstand high-heat applications. As such, LSR is ideal for medical devices because it is capable of withstanding the high temperatures associated with sterilization. In this article, Proto Labs discusses the many merits of LSR, including an overview of LSR, a comparison between thermoplastics and thermosets, and design considerations for LSR parts.

Medtech Outsourcing: Is The Past Any Indication Of The Future?

As outsourcing in the medical device space becomes more prevalent, there are many variables to consider when making the decision to involve a third party. This paper will explore why companies should consider outsourcing, the keys to successful implementation, the potential problems associated with outsourcing, and when it may not be the best model for your company.

Could Ultraviolet Light Technologies Help Prevent The Spread Of Ebola?

The Ebola virus continues to spread through West Africa, with new outbreaks surging in Monrovia, Liberia. Healthcare workers are struggling to contain the spread of the virus, and unfortunately they risk contracting the virus in their efforts to care for those infected. While experimental vaccines are being developed, worldwide health organizations are searching for ways to protect healthcare workers on the frontline. This article discusses the use of ultraviolet germicidal irradiant (UVGI) devices, which use ultraviolet light to alter the DNA structure of viruses and prevent them from replicating.

Connector Selection: Ten Considerations For Getting It Right

This white paper provides a step-by-step guide for engineers to help them determine the proper connector for their device. Topics include contacts, sealing, materials, functionality, and cable assembly requirements, with short discussions on miniaturization and working with supplier engineering teams.

Six Trends In Robotics In The Life Sciences

Life science is one industry that is currently undergoing a turbulent development environment. Changes in government regulations and market conditions are forcing life science OEMs to build their products using faster, smaller, and more modular technologies. This article outlines the six major industry trends that have arisen from this dynamic environment.

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FROM THE EDITOR

  • How Dexcom Plans To Eliminate The Finger-Stick (And Bring CGM To The Masses), Part 2
    How Dexcom Plans To Eliminate The Finger-Stick (And Bring CGM To The Masses), Part 2

    In Part 2 of this Q&A, we continue our conversation with Dexcom CEO Terry Gregg, getting his insights on artificial pancreas technology, how Dexcom competes (and partners) with the major players in the diabetes device space, what startups should do to procure funding, and other topics.

  • How Dexcom Plans To Eliminate The Finger-Stick (And Bring CGM To The Masses), Part 1
    How Dexcom Plans To Eliminate The Finger-Stick (And Bring CGM To The Masses), Part 1

    Continuous glucose monitoring (CGM) has completely transformed the way diabetes is managed. However, the technology is currently approved only as a complement to the good, old-fashioned finger-stick, not a replacement for it. I recently spoke with a man whose company intends to change that — Terry Gregg, CEO of Dexcom, Inc. During our conversation, we discussed Dexcom's current and future plans for CGM, the company's regulatory strategy, how it competes with much larger device makers, artificial pancreas research, and much more.

  • 5 Big Trends Affecting Polymer Material And Process Selection For Medical Devices
    5 Big Trends Affecting Polymer Material And Process Selection For Medical Devices

    I recently joined a group of medical device makers, material suppliers, contract manufacturers, and other members of the medical plastics community at a one-day conference called Technology Advances in Plastic Materials and Processing for Medical Devices. The event crammed a whopping 14 technical presentations into eight hours, covering everything from emerging polymer formulations to injection molding challenges to new surface finishing technologies. Throughout the course of the event, several recurring themes emerged during presentations and conversations with attendees. Here are 5 major trends medical device OEMs should take into consideration when selecting plastic materials and manufacturing processes for their designs.

More From The Editor

PRODUCT SHOWCASE

Miniature Linear Positioner/Stage: MX80M

Miniature Linear Positioner/Stage: MX80M

The MX80M miniature linear stage is a manually driven positioner with precision cross roller bearings, optional clean room preparation, an optional low ESD coating, dowel holes in the top and base, and positive position lock.

Ultra Violet Light-Emitting Diodes (UV LEDs) – Center Wavelengths 300nm – 400nm

Ultra Violet Light-Emitting Diodes (UV LEDs) – Center Wavelengths 300nm – 400nm

First Sensor offers optimized Ultra Violet Light-Emitting Diodes with center wavelengths ranging from 300 nm to 400nm that are ideal for industrial applications. These UV LEDs feature high reliability and high output power and are available in a variety of packages. First Sensor has the capability to customize any of their emitters to meet your individual application.

DesiMax Desiccant Labels

DesiMax Desiccant Labels

The DesiMax® sorbent offers the solution to low level humidity-related problems in a wide range of packaging applications, and is ideal for use in the packaging of pharmaceuticals, diagnostic test kits, medical products and electronics.

Design and Development of Advanced Optical Applications

Design and Development of Advanced Optical Applications

Precision Optics Corporation, or POC, was formed over 30 years ago with the purpose of designing, developing, and realizing advanced optical applications and for volume production of specialized medical optical systems.

Custom Manufactured Achromats

Custom Manufactured Achromats

Achromats are a specialty at LaCroix Optical Co. Our manufacturing engineers will work with production specialists to optimize the manufacturing process utilizing a combination of CNC and conventional manufacturing methods. Special proprietary alignment devices are used to ensure the optical axis of the elements can be maintained to within seconds.

Production Prototyping: P3

Production Prototyping: P3

PTI’s P3 prototyping service differentiates itself from other prototyping services in that the same tool used for the prototyping and testing phase can also be used in the initial product run. The result is a reduced time-to-market window, lower overall costs, and functional injection-molded products.

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LATEST HEADLINES

  • Zapping Vocal-Cord Cancer With Lasers Proven Effective In Long-Term Study
    Zapping Vocal-Cord Cancer With Lasers Proven Effective In Long-Term Study

    A pioneering laser treatment for early vocal-cord cancer has shown promise as a long-term cure for the disease. In addition to being as effective as traditional approaches at curing tumors, the treatment developed at Massachusetts General Hospital is also able to spare the patient’s vocal cords and ability to speak.

  • 3D Printed Implant Promotes Meniscus Regeneration
    3D Printed Implant Promotes Meniscus Regeneration

    Replacing the knee’s meniscus, the protective layer that the joint slides on, has been approached in a novel way by Columbia University researchers. The team printed a personalized 3D scaffold, and loaded it with growth factors that helped turn it into a collagen-like tissue when implanted. Tested successfully in sheep, it could provide a long-lasting repair option to millions of patients.

  • Researchers 3D Print LED Into Contact Lens
    Researchers 3D Print LED Into Contact Lens

    As a proof-of-concept for new 3D printing techniques, a Princeton team has developed a contact lens that projects beams of light. The researchers embedded a light-emitting diode (LED) into a contact lens, which demonstrated the flexibility and power of their new 3D printing approach.

  • New DARPA Program Seeks Novel Neuromodulation Treatments
    New DARPA Program Seeks Novel Neuromodulation Treatments

    A new research program from DARPA is focused on developing groundbreaking methods of maximizing immunological, physical, and mental health through neuromodulation. Currently, the agency is seeking proposals to help restore and maintain the health of military service members and veterans without surgery or drugs.

  • Medtronic Launches New Biofragmentable Nasal Packing Stent
    Medtronic Launches New Biofragmentable Nasal Packing Stent

    Medtronic Inc. recently launched the NovaShield injectable and biofragmentable nasal packing stent. The gel-based nasal packing is designed to decrease post-operative bleeding and prevent adhesions in nasal structures in patients who undergo functional endoscopic sinus surgery (FESS).

  • BD Chairman, President And CEO Vincent Forlenza Named Chairman Of AdvaMed’s Board Of Directors

    The Advanced Medical Technology Association (AdvaMed) recently announced that BD Chairman, President and CEO Vincent A. Forlenza has been named chairman of the AdvaMed Board of Directors for a two-year term.

  • C.R. Bard Could Lose Billions In Damages, According To District Judge
    C.R. Bard Could Lose Billions In Damages, According To District Judge

    A federal court judge overseeing the consolidated multi-district litigation over defective transvaginal mesh products recently warned manufacturer C.R. Bard that the company could lose billions of dollars in damages if it refuses to settle.

  • FDA Releases New Guidance On Establishing Safety, Compatibility Of Passive Implants In MR Environments
    FDA Releases New Guidance On Establishing Safety, Compatibility Of Passive Implants In MR Environments

    A new guidance document on establishing the safety and compatibility of passive implants in the magnetic resonance (MR) environment has been released by the FDA. The updated document supersedes the previous release from August 21, 2008 and is focused on passive implants that function without electronic power.

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UPCOMING TRAINING COURSES

Pediatric Clinical Trials: Special Considerations and Requirements

January 12, 2015
1pm-2:30pm EST, Online Training

Root Cause Analysis for GCP – A Risk Action Plan Guide

January 16, 2015
1pm-3pm EST, Online Training

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
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