LEAD STORIES

Bacterial ‘Biosurgery’ Shrinks Tumor In Human Patient

Bacteria generally get a bad rap, especially in the field of medicine, but the same properties that make them harmful may also improve outcomes in certain tumors.

  • Common Medical Device Quality System Pitfalls — And How To Avoid Them, Part 2
    Common Medical Device Quality System Pitfalls — And How To Avoid Them, Part 2

    In Part 1 of this article, we looked at five mistakes medical device companies make during the quality management review process. In this installment, we turn our attention to measurement, analysis, and improvement activities — where several problems can occur and what you can do to prevent them. By Marcelo Trevino, Senior Regulatory Compliance Manager, Medtronic

  • Ebola Virus Tracked With CDC App
    Ebola Virus Tracked With CDC App

    Centers for Disease Control and Prevention (CDC) officials have turned to technology in an effort to more effectively manage the recent West African Ebola outbreak. By using a new computer application, the CDC is focusing on an area of disease detection that has historically been one of the most difficult — finding potentially infected people who were exposed to the disease.

  • FDA Issues UDI Guidance Tailored For Small Device Makers
    FDA Issues UDI Guidance Tailored For Small Device Makers

    The FDA recently issued guidance advising small medtech companies on how to comply with the agency’s unique device identification (UDI) system, which requires device makers to label their products with codes aimed at improving product recalls, organizing electronic health records, and deterring counterfeiting efforts.
     

INDUSTRY PERSPECTIVES

  • Common Medical Device Quality System Pitfalls — And How To Avoid Them, Part 2
    Common Medical Device Quality System Pitfalls — And How To Avoid Them, Part 2

    In Part 1 of this article, we looked at five mistakes medical device companies make during the quality management review process. In this installment, we turn our attention to measurement, analysis, and improvement activities — where several problems can occur and what you can do to prevent them. By Marcelo Trevino, Senior Regulatory Compliance Manager, Medtronic

  • Is Your Boring Regulatory Strategy Costing You Business?
    Is Your Boring Regulatory Strategy Costing You Business?

    When people in the medical device world use the phrase “regulatory strategy,” they usually mean the path they will take to get their product onto the market. And when they say “competitive regulatory strategy,” they are usually referring to the way their competitor(s) got their products onto the market.

  • Common Medical Device Quality System Pitfalls — And How To Avoid Them, Part 1
    Common Medical Device Quality System Pitfalls — And How To Avoid Them, Part 1

    Establishing and maintaining an airtight quality system is a prerequisite for survival in the medical device and diagnostics industry. Problems can arise in many areas of a quality system, but one area where manufacturers struggle is in management reviews. This article identifies some of the common snares manufacturers fall prey to when conducting these reviews, and shares strategies to help you avoid those mistakes in your organization.

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ARTICLES

  • Biocompatibility of Anesthesia/Respiratory Products
    Biocompatibility of Anesthesia/Respiratory Products

    This biocompatibility technical whitepaper is a reference guide for navigating aspects of the various biocompatibility standards for respiratory devices. It is intended to aid design engineers in understanding the complexity of biocompatibility standards as applied to anesthesia workstations, ventilators, and oxygen concentrators.

Considering Human Factors And Training In Medical Device Design

The patient has become the end user when it comes to many types of medical technology, and that trend is likely to continue with the rise of mobile health (mHealth), remote patient monitoring, and other healthcare industry drivers. As a result, the human factor is becoming increasingly important in the design of next-generation medical devices and diagnostics. 

Introduction To Injection Molding Part Design For Dummies

This article provides insight into the injection molding process that makes it possible for you to get plastic parts made in as little as one day. It provides tips on how to design your parts to make them better and easier to manufacture. It also discusses design options that allow even complex parts to be made quickly. Finally, the article provides an overview of the materials available and demonstrates how you can make your parts look great without spending too much or waiting too long.

Safety In Medical Electrical Equipment Starts With The Power Input

Electrical equipment used in medical technology must not place patients or medical staff in danger. This, in turn, requires that designing safe equipment starts at the point where the power is supplied. Power connectors and power entry modules with or without a power-line filter must fulfill the requirements of the base standard for medical electrical equipment, IEC/UL 60601-1.

Clinical Data Interchange Standards For Medical Devices — Lessons Learned From Pharma/Biotech

It is only a matter of time before medical device companies must begin submitting clinical data in CDISC (Clinical Data Interchange Standards Consortium) standards to the FDA. Which best practices can pharmaceutical companies share when implementing CDISC standards? What are the vast differences between pharma/biotech and medical device companies when it comes to adopting and converting clinical data to CDISC standards? These are some of the questions addressed in this roundtable Q&A involving both medical device and pharmaceutical experts.

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FROM THE EDITOR

  • 7 Unconventional Ways To Fund A Medtech Startup
    7 Unconventional Ways To Fund A Medtech Startup

    Bringing innovative new medical technology to market today is as challenging, complex, and competitive an endeavor as it’s ever been for entrepreneurs. Making matters worse, venture capital — the fuel that fledgling companies once depended on to drive product development — has dwindled in recent years. Hear what industry experts from Cleveland Clinic, UnitedHealthcare, and other organizations have to say about nontraditional sources of funding that just might fit the bill for your medtech startup.

  • Cutting Through The Remote Patient Monitoring Hype
    Cutting Through The Remote Patient Monitoring Hype

    There is so much hype surrounding remote patient monitoring (RPM) — and related buzzterms like wearables, mobile apps, big data, the Internet of Things (IoT), and mHealth — that sometimes it is difficult to separate hyperbole from reality. What opportunities does RPM really afford medical device makers? What should they do to take advantage? How do wearables fit into the equation? Should the medtech industry fear or embrace the involvement of tech titans like Google and Apple? Read on for answers to these and other important RPM-related questions.

  • Reverse Engineering A Human Heart Valve
    Reverse Engineering A Human Heart Valve

    The man who literally wrote the book (two books, in fact) on the aortic valve has devised a new artificial valve design that that he says will revolutionize transcatheter aortic valve implementation (TAVI). And if everything goes according to plan, his heart valve could reach European patients in 2015 and U.S. patients soon after. Find out how he and his startup company developed this technology — by using the natural aortic valve for their design output.

More From The Editor

PRODUCT SHOWCASE

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.

Fused Silica Materials & Components

Fused Silica Materials & Components

Heraeus has been providing breakthrough solutions for the world's most challenging optical applications for over 100 years — where high performance fused silica is an absolute necessity. Heraeus offers material for several optic segments, which have been optimized for performance in each application.

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.

RF Radiated Immunity System: MT06000

RF Radiated Immunity System: MT06000

AR’s Multistar is a multi-tone RF radiated immunity system covering the 80 MHz to 6 GHz frequency range. It’s a complete testing solution for the following standards: EN/IEC62000-4-3, EN/IEC60601-1-2, EN50130-4, EN61000-6-1/2, EN55024.

Medical RF & Microwave Semiconductors

Medical RF & Microwave Semiconductors

Skyworks offers a large variety of RF and microwave semiconductor products for use in medical devices. Common applications include glucose monitoring, defibrillators, hearing aids, heart monitors/pacemakers, MRI scanners, patient monitors, and others.

8Mp Cooled High Resolution CCD Camera: SPOT Xplorer USB

8Mp Cooled High Resolution CCD Camera: SPOT Xplorer USB

SPOT Imaging’s 8MP XplorerTM USB camera features low read noise for lower detection threshold, reduced height for easier installation into existing enclosures, and a -25oC cooled CCD detector to minimize hot pixels. The 8 Mp images it provides resolves fine image detail and the camera’s USB interface simplifies computer connection.

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LATEST HEADLINES

  • Bacterial ‘Biosurgery’ Shrinks Tumor In Human Patient
    Bacterial ‘Biosurgery’ Shrinks Tumor In Human Patient

    Bacteria generally get a bad rap, especially in the field of medicine, but the same properties that make them harmful may also improve outcomes in certain tumors.

  • Drones Give New Meaning To Drug Delivery
    Drones Give New Meaning To Drug Delivery

    A Palo Alto- and London-based startup company is developing unmanned aerial vehicle (UAV) technology with a new twist. Instead of performing remote surveillance or delivering explosives with surgical accuracy, they distribute payloads of medical supplies.

  • Smart Hydrogel Prevents Graft Rejection
    Smart Hydrogel Prevents Graft Rejection

    For many patients receiving a tissue transplant leads to an immeasurably greater quality of life. This benefit, however, comes with a price, as most patients must take immunosuppressive drugs to keep their body from rejecting their transplant. This may soon be over, however, thanks to a newly developed hydrogel that acts locally at the transplant site — only when it is needed.

  • U.S. DoD Awards Several Multi-Million Dollar Contracts To Medtech Companies
    U.S. DoD Awards Several Multi-Million Dollar Contracts To Medtech Companies

    The United States Department of Defense (DoD) recently awarded separate, multi-million dollar contracts to medical device companies Abbott Laboratories Inc., Philips Healthcare, and Dentsply Caulk.

  • Ebola Virus Tracked With CDC App
    Ebola Virus Tracked With CDC App

    Centers for Disease Control and Prevention (CDC) officials have turned to technology in an effort to more effectively manage the recent West African Ebola outbreak. By using a new computer application, the CDC is focusing on an area of disease detection that has historically been one of the most difficult — finding potentially infected people who were exposed to the disease.

  • Molex Dongguan China Achieves FDA Registration For Class I Medical Devices

    Molex Incorporated, a global manufacturer of electronic solutions, announced recently that the Molex Dongguan, China facility is now registered with the U.S. Food and Drug Administration (FDA) as a compliant manufacturer of Class I medical devices.

  • FDA Issues UDI Guidance Tailored For Small Device Makers
    FDA Issues UDI Guidance Tailored For Small Device Makers

    The FDA recently issued guidance advising small medtech companies on how to comply with the agency’s unique device identification (UDI) system, which requires device makers to label their products with codes aimed at improving product recalls, organizing electronic health records, and deterring counterfeiting efforts.
     

  • Intel, Michael J. Fox Foundation Partner To Fight Parkinson’s
    Intel, Michael J. Fox Foundation Partner To Fight Parkinson’s

    Tech giant Intel Corp. and the Michael J. Fox Foundation (MJFF) recently announced a research collaboration that will involve thousands of Parkinson’s disease (PD) patients using smartwatches and other wearable devices. Using big data analytics, the partnership will seek to develop new treatments for the insidious nervous system disorder.

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UPCOMING TRAINING COURSES

Medical Device Complaint Handling and MDR Reporting

September 3, 2014
1pm-2:30pm EDT, Online Training

Pediatric Clinical Trials: Special Considerations and Requirements

September 8, 2014
1pm-2:30pm EDT, Online Training
More Upcoming Courses

FEATURED SUPPLIERS

Precision Optics Corporation

Precision Optics Corporation

For over 30 years, Precision Optics Corporation has provided state-of-the-art optical designs, components and complete optical systems for medical, biomedical, military (ITAR complainant) and industrial applications. As next generation techniques in these areas have advanced to use smaller and less invasive tools and equipment, Precision Optics responded with microprecision™ optical technology to provide components, assemblies, and products with sizes on the order of one millimeter and smaller.