LEAD STORIES

Stryker Considering Smith & Nephew Acquisition, Again

Stryker Corporation is reportedly planning a takeover bid for Smith & Nephew (S&N) now that a six-month prohibitive period under U.K. law is set to expire. S&N is currently valued at $16 billion.

  • X-Ray Laser Imaging Advances To Nanometer Scale
    X-Ray Laser Imaging Advances To Nanometer Scale

    Using an X-ray laser to create diffraction patterns, scientists were recently able to visualize individual carboxysomes without crystallizing them. At about 115 nanometers, carboxysomes are the smallest biological specimen studied by an X-ray laser to date.

  • New Metamaterial Enables Bone-Penetrating Ultrasound
    New Metamaterial Enables Bone-Penetrating Ultrasound

    Researchers recently developed a new acoustic metamaterial that improves ultrasonic penetration through bone and other challenging structures. The enhanced imaging capabilities could improve ultrasound for a variety of diagnostic and therapeutic applications.

  • New Medical Device Reduces Vascular Scarring
    New Medical Device Reduces Vascular Scarring

    Delivering retinoid antioxidants to an artery that has undergone surgery with a newly developed biodegradable membrane has been shown to significantly reduce vascular scarring. Enhanced healing like this may lead to better long-term outcomes by preventing restenosis of vessels.

INDUSTRY PERSPECTIVES

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ARTICLES

Cherenkov Emission Imaging And Spectroscopy Utilizing Isotopes And A Linear Accelerator

There are linear accelerators (LINACs) employed in radiation oncology that produce radiation in pulsed microseconds-long bursts, generated by the accelerator waveguide. By taking advantage of a LINAC’s inherent pulsed operation, time-gated detection of Cherenkov radiation is possible, significantly improving the ratio of signal to ambient light. Recently, a research group at Dartmouth College and Dartmouth-Hitchcock Medical Center in New Hampshire led by Dr. Brian Pogue has investigated fluorescence and absorption spectroscopy methods using pulsed LINAC-induced CES2, under ambient room lighting conditions. An overview of some of their work is provided in this application note.

Surface Engineering In Medical Technology

New materials and technological advances continue to rapidly proliferate in the medtech industry, and it is challenging to meet the demands of increasingly complex medical components and devices. This article outlines some of the surface engineering methodologies that can be leveraged to alter the surface properties of medical components, from traditional coating methods like wet chemicals to state-of-the-art methods like plasma treatment. 

The Future Of Biosensing

The emerging need for rapid pathogen detection, clinical diagnosis, and forensic science necessitates the development of lab-on-a-chip devices, which integrate laboratory functions and processes into a miniaturized chip format. Photonic sensors are under extensive development worldwide, combining multi-disciplinary research. Small, inexpensive, sensitive, selective, fast, robust, and remotely controllable sensors that are immune to electromagnetic interference are the ultimate goal. 

How To Address The Top 3 Supplier Management Issues

Choosing the right vendors and managing them effectively can increase a manufacturer’s efficiency — in terms of time, cost, and quality. Unfortunately, suppliers can also sometimes put their clients in hot water when their quality standards are below par. With over 12 years of experience in medical device development, I understand how hard it is to find and keep compliant suppliers. Based on my observations working with suppliers in the medtech industry, these are some of the major issues that impact a device manufacturer’s compliance efforts.

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FROM THE EDITOR

  • 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.

  • Bridging The FDA-CMS Divide: An Optimized Route To Market For Medical Devices, Part 2
    Bridging The FDA-CMS Divide: An Optimized Route To Market For Medical Devices, Part 2

    In the crucible that is today’s healthcare environment, medical device companies can no longer wait until they have regulatory approval or clearance to begin pursuing reimbursement for their products. Nor can they approach regulatory and reimbursement activities as completely independent initiatives. A more tactical, integrated methodology is required.

  • Bridging The FDA-CMS Divide: An Optimized Route To Market For Medical Devices, Part 1
    Bridging The FDA-CMS Divide: An Optimized Route To Market For Medical Devices, Part 1

    When Kevin Conroy joined Exact Sciences as president and CEO in April 2009, the company had a novel, highly accurate, and noninvasive diagnostic technology for the early detection of colorectal cancer — and a potentially huge market. It was also low on capital. Conroy and his team estimated that product development and separate clinical trials to satisfy FDA and CMS requirements would take the better part of a decade to complete, and there was no way to finance the company for that long. Yet here we are, less than six years later, and Exact Sciences’ Cologuard test has obtained both FDA approval and a CMS coverage. How did the company's prospects shift so dramatically? It all began with one fateful meeting.

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PRODUCT SHOWCASE

Position Sensitive Diodes (PSDs)

Position Sensitive Diodes (PSDs)

The lateral effect Position Sensitive Detector (PSD) is an optoelectronic device based on Silicon PIN diode technology. The PSD converts the energy from an incident light spot into a continuous, position relative, electrical output current. This position signal is relative to the total incident light pattern and indicates the “optical center” of the incident light.

Industrial Components and Subsystems

Industrial Components and Subsystems

Zygo’s Optical Systems Division designs and manufactures high precision optical components and electro-optical subsystems for industrial OEM applications in their certified ISO 9001:2000 and ISO 13485:2003 manufacturing and assembly facilities.

Filtered Military Circular Connectors

Filtered Military Circular Connectors

Corry Micronics offers a complete line of Filtered Military Circular Connectors, including MIL-C-38999 Series I, II, and III, MIL-C-26482 Series II, and MIL-C-83723 Series III. Various filtering options are available, including “C”, “C2”, “L”, “J”, and “Pi” circuits, and can include 0.1J or 0.3J Bi-Directional Transient protection
Ironless Linear Positioners for Medical and Life Science Applications: I-FORCE Series

Ironless Linear Positioners for Medical and Life Science Applications: I-FORCE Series

This series of linear positioners uses Parker Hannifin’s high performance I-Force ironless linear motors and has single or dual-bearing to match the performance and cost requirements of the application they’re being used in. Each positioner in the series has a magnetic encoder or an optical encoder with resolutions down to 0.1µm.

APA-1000 Sorbent Packet Dispenser

APA-1000 Sorbent Packet Dispenser

The Multisorb APA-1000 is the dispenser component of the StripPax® and StabilOx® Systems and is compatible with virtually all packaging lines.

Performance Level Infrared Cameras For Research And Science Applications

Performance Level Infrared Cameras For Research And Science Applications

Performance Level Infrared Cameras from FLIR feature coverage in the SWIR, MWIR, and LWIR spectrums, image spot size down to 3 µ, fast frame rates with variable integration times, thermal sensitivities better than 20 mK, built-in filter wheels, triggering and synchronization capabilities, and more. These infrared cameras are highly versatile and can be used in industrial R&D, auto manufacturing, and building diagnostics applications, as well as in aerospace and university research.

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LATEST HEADLINES

  • Stryker Considering Smith & Nephew Acquisition, Again
    Stryker Considering Smith & Nephew Acquisition, Again

    Stryker Corporation is reportedly planning a takeover bid for Smith & Nephew (S&N) now that a six-month prohibitive period under U.K. law is set to expire. S&N is currently valued at $16 billion.

  • How Do Prosthetic Miscues Impact Amputees?
    How Do Prosthetic Miscues Impact Amputees?

    Electrical signals from a patient’s muscles are sometimes coded into signals that drive robotic prostheses. At times, mixed signals can lead to errant prosthetic reactions, causing falls. Recently, a group of researchers from North Carolina State University studied those mixed signals to improve the design of prosthetic control systems and prevent falls.

  • High-Tech Analysis Of Genetic Data May Yield New Test For Endometriosis

    Using sophisticated computer-based technology to analyze genetic data obtained from uterine tissue, researchers have identified patterns of genetic activity that can be used to diagnose endometriosis, an often-painful condition that occurs when tissue that normally lines the inside of the uterus grows outside the uterus.

  • Boston Scientific Bombarded With Trial Losses Over Transvaginal Mesh
    Boston Scientific Bombarded With Trial Losses Over Transvaginal Mesh

    Boston Scientific recently absorbed consecutive defeats in federal court trials over transvaginal mesh devices, a trend that could make it more likely for the medical device company to settle thousands of other lawsuits over the implants.

  • AdvaMed Applauds Japan’s New Device Regulatory Framework

    Stephen J. Ubl, president and CEO of the Advanced Medical Technology Association (AdvaMed), recently released the following statement in conjunction with the Nov. 25 implementation date for Japan’s new Pharmaceutical and Medical Device Law (PMDL).

  • X-Ray Laser Imaging Advances To Nanometer Scale
    X-Ray Laser Imaging Advances To Nanometer Scale

    Using an X-ray laser to create diffraction patterns, scientists were recently able to visualize individual carboxysomes without crystallizing them. At about 115 nanometers, carboxysomes are the smallest biological specimen studied by an X-ray laser to date.

  • New Metamaterial Enables Bone-Penetrating Ultrasound
    New Metamaterial Enables Bone-Penetrating Ultrasound

    Researchers recently developed a new acoustic metamaterial that improves ultrasonic penetration through bone and other challenging structures. The enhanced imaging capabilities could improve ultrasound for a variety of diagnostic and therapeutic applications.

  • New Medical Device Reduces Vascular Scarring
    New Medical Device Reduces Vascular Scarring

    Delivering retinoid antioxidants to an artery that has undergone surgery with a newly developed biodegradable membrane has been shown to significantly reduce vascular scarring. Enhanced healing like this may lead to better long-term outcomes by preventing restenosis of vessels.

More News

UPCOMING TRAINING COURSES

Medical Device Supplier Management Programs: Building Compliant Systems

December 9, 2014
1pm-2:30pm EST, Online Training

Medical Devices: Managing Unannounced Visits from Notified Bodies

December 11, 2014
1pm-2:00pm EST, Online Training

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
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FEATURED SUPPLIERS

Fischer Connectors

Fischer Connectors

Fischer Connectors is a global leader in the manufacturing of high performance push-pull circular connectors and cable assemblies used in a variety of application areas like military, auto, instrumentation, industrial, energy, pharmaceutical, oil & gas, food, broadcast, transportation, medical devices and equipment, and many others.