LEAD STORIES

Will The EPA’s Sterilizer Assessment Disrupt The Medical Device Industry?

The Chemical Assessment Advisory Committee (CAAC) of the Environmental Protection Agency’s Science Advisory Board (SAB) met recently to evaluate the agency’s Integrated Risk Information System (IRIS) draft assessment of the carcinogenic effects of ethylene oxide (EO). The final draft conclusion on the risks of EO could have major implications for medical device makers.

INDUSTRY PERSPECTIVES

  • Top 9 Benefits Of Open Sourcing Your Proprietary Medtech Source Code
    Top 9 Benefits Of Open Sourcing Your Proprietary Medtech Source Code

    Last month, I described techniques to help regulatory teams overcome their fear of using open source software (OSS) in medical devices and digital health applications.

  • Orthopedic Biomaterial Bone Graft Market To Increase With Stem Cell Therapy Market Growth
    Orthopedic Biomaterial Bone Graft Market To Increase With Stem Cell Therapy Market Growth

    Stem cells derived from embryonic sources have a high degree of therapeutic potential because such immature cells have not yet undergone differentiation: the process of maturation. There are many ethical issues involved with human embryonic stem cell research, despite the regenerative benefits of this form of therapy.

  • Companion Diagnostics: Why Medical Device Manufacturers Should Care
    Companion Diagnostics: Why Medical Device Manufacturers Should Care

    Why should we have to wait until a patient swallows a pill to find out if it works on them? This is something that’s always bothered me about the way we practice medicine. If you think about it, it really makes no sense. I would like to be able to know, to a very high degree of certainty, whether or not that pill will work in that patient before they put it in their body. Herein lies the promise of companion diagnostics.

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ARTICLES

  • Cherenkov Emission Imaging And Spectroscopy Utilizing Isotopes And A Linear Accelerator
    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.

Measuring Battery Life On Battery-Powered Medical Devices

Battery-powered devices are everywhere in medicine, from pacemakers to operating room tools. For all of these devices, battery run-time is a key requirement and an important aspect to improving your medical device design. This article discusses the many variables of battery run-down testing and proposes considerations and solutions to those challenges.

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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.

More From The Editor

PRODUCT SHOWCASE

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.

Liquid Silicone Rubber Injection Molding

Liquid Silicone Rubber Injection Molding

Liquid silicone rubber (LSR) molding is a thermoset process that mixes a two-component compound together, which is then heat cured in the mold with a platinum catalyst to produce a final part. Liquid Silicon Rubber parts are formed through an injection-molding process similar to that of conventional plastic injection molding with one major difference — the material delivery system is cooled and the mold is heated. Liquid silicone rubber possesses thermal, chemical and electrical resistance, plus biocompatibility. Also, Liquid Silicone Rubber parts can withstand sterilization while maintaining physical properties at extreme temperatures.

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
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.

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

  • Will The EPA’s Sterilizer Assessment Disrupt The Medical Device Industry?
    Will The EPA’s Sterilizer Assessment Disrupt The Medical Device Industry?

    The Chemical Assessment Advisory Committee (CAAC) of the Environmental Protection Agency’s Science Advisory Board (SAB) met recently to evaluate the agency’s Integrated Risk Information System (IRIS) draft assessment of the carcinogenic effects of ethylene oxide (EO). The final draft conclusion on the risks of EO could have major implications for medical device makers.

  • Smith & Nephew Sells U.K. Facility, Closes Another, Cuts 108 Jobs
    Smith & Nephew Sells U.K. Facility, Closes Another, Cuts 108 Jobs

    Smith & Nephew (S&N) recently announced the sale of its Gilberdyke facility in the U.K., along with its nets and foams product portfolio and manufacturing assets, to DelStar Inc., a unit of SWM. The agreement is expected to close by the end of the year and to be accretive starting in 2015. Other terms of the deal were not disclosed.

  • “NanoFlares” Illuminate Individual Cancer Cells
    “NanoFlares” Illuminate Individual Cancer Cells

    Recently, a team from Northwestern University developed nanoparticles with a built-in fluorescent tag that are capable of identifying genetic biomarkers specific to cancer. Deemed “NanoFlares,” these particles operate inside the cell and can identify cancer cells in the bloodstream, potentially providing an early warning of metastasis.

  • Enhancing Ebola Surveillance With Faster, More Accurate Genome Sequencing
    Enhancing Ebola Surveillance With Faster, More Accurate Genome Sequencing

    A new method of genomic sequencing has been developed that could provide efficient and affordable Ebola surveillance for West African nations. The process enables shorter test times and allows viruses to be tracked in populations where it may be spreading. 

  • Brazil’s ANVISA Seeking Industry Feedback Following Manufacturing Inspections
    Brazil’s ANVISA Seeking Industry Feedback Following Manufacturing Inspections

    Brazil’s medical device regulatory body, the Agência Nacional de Vigilância Sanitária (ANVISA), recently announced that it will now be accepting industry feedback following Brazilian Good Manufacturing Practice (BGMP) inspections.

  • Dual-Action Nanoparticle Allows Fluorescence Imaging And MRI
    Dual-Action Nanoparticle Allows Fluorescence Imaging And MRI

    A hybrid nanoparticle has been developed that is compatible with both fluorescence imaging and magnetic resonance imaging (MRI). The new agent may allow a better real-time understanding of tumor biochemistry and drug delivery.

  • Novartis, QIAGEN Sign Deal To Develop Companion Diagnostics
    Novartis, QIAGEN Sign Deal To Develop Companion Diagnostics

    QIAGEN, a provider of sample and assay technologies, recently signed an agreement with Swiss pharmaceutical firm Novartis to develop and commercialize companion diagnostics for Novartis’ existing and future portfolio of drugs. Financial terms of the deal were not made available.

  • Qosina Swabbable Pre-Slit Transfer Valve
    Qosina Swabbable Pre-Slit Transfer Valve

    Qosina is pleased to announce the addition of a new Swabbable Pre-Slit Transfer Valve (80191).

More News

UPCOMING TRAINING COURSES

Medical Device Supplier Management Programs: Building Compliant Systems

December 9, 2014
1pm-2:30pm 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

Reducing Human Error in Life Sciences Manufacturing

February 26, 2015
1pm-2:30pm EST, Online Training
More Upcoming Courses

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.