LEAD STORIES

Regenerative Medicine Makes Old Immune Organ Young Again

The desire to culture replacement organs for damaged or diseased ones has been a significant driving force since regenerative medicine’s infancy. Now, for the first time, University of Edinburgh researchers have regrown a thymus in a living host by transplanting laboratory-grown cells — fully restoring the function of the organ.

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

  • Innovation In CMOS Bio-Optical Sensors Enables Portable Diagnostics
    Innovation In CMOS Bio-Optical Sensors Enables Portable Diagnostics

    In the past 10+ years we have seen great progress in molecular diagnostic technologies. Doctors can now take advantage of the emerging nucleic acid or protein analysis techniques to get very precise answers about the type of virus, bacteria, or cancerous cells that cause illnesses. This article provides an in-depth look at a new CMOS image sensor design that enabled the development of a low-cost, portable molecular diagnostic system. By Zhimin Ding, Anitoa Systems, LLC

Robotic Biopsy System Drives The Point Home

Why, with CT scanners routinely achieving submillimeter resolutions, are manual needle biopsies performed with only centimeters of accuracy? To solve that issue, a team from MIT built a robotic biopsy system with unprecendented efficiency and accuracy, powered by compact, high-torque DC servomotors from MICROMO.

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.

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FROM THE EDITOR

  • Could Your Next Device Be Exempt From FDA Premarket Requirements?
    Could Your Next Device Be Exempt From FDA Premarket Requirements?

    CDRH has been busy in August, issuing 14 new guidances and draft guidances — with a week left to go. The first new guidance of the month basically amounted to a list of some 170 medical devices that the FDA proposes exempting from 510(k) premarket notification requirements. If your device doesn't appear on the list, it would be tempting to simply disregard it. But by doing so, you could be missing out on an important opportunity.

  • 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.

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PRODUCT SHOWCASE

High Speed Low Light Imaging CCD Camera: SPOT Pursuit USB

High Speed Low Light Imaging CCD Camera: SPOT Pursuit USB

These high speed, low light imaging CCD cameras come in monochrome, color mosaic, and slider configurations. Each model features high sensitivity and fast frame rates, which helps greatly in preserving live cells and fading specimens for imaging and fluorescence applications.

Optical Thickness Gauge: 157 Series

Optical Thickness Gauge: 157 Series

The Model 157 optical thickness gauge uses proven optical interferometer technology to measure the absolute thickness of specialty plastic films, medical membranes, and ophthalmic products.

Custom Manufactured Lenses

Custom Manufactured Lenses

Our customers design lenses to meet their system requirements. Our expertise is determining the most efficient way to manufacture them. Depending on attributes and quantity, our manufacturing engineers will determine whether to use a conventional, CNC or hybrid method to make the lenses.

Miniature Single and Multi-Axis Linear Positioners: MX45S Series

Miniature Single and Multi-Axis Linear Positioners: MX45S Series

This series of linear positioners/stages can be used to provide reliable linear positioning during the development and/or design of medical devices. They’re very small (45mm wide x 25mm high) and have 5mm, 15mm, and 25mm selectable travels.

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.

Medical Device Prototyping & Design Services

Medical Device Prototyping & Design Services

Carclo’s product designers and engineers have multiple years of experience with medical device prototyping and design. We take a partner approach to your medical device design needs by getting involved as early in the product prototype and design cycle as possible.

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LATEST HEADLINES

  • Regenerative Medicine Makes Old Immune Organ Young Again
    Regenerative Medicine Makes Old Immune Organ Young Again

    The desire to culture replacement organs for damaged or diseased ones has been a significant driving force since regenerative medicine’s infancy. Now, for the first time, University of Edinburgh researchers have regrown a thymus in a living host by transplanting laboratory-grown cells — fully restoring the function of the organ.

  • Amazon’s FDA Meeting Signals Big Healthcare Plans
    Amazon’s FDA Meeting Signals Big Healthcare Plans

    Amazon recently met with officials from the U.S. Food and Drug Administration (FDA) to possibly talk about how the agency’s regulatory powers can affect both the company’s existing and potential healthcare products and services.

  • For Second Year in a Row, RIVA Named Top IV Robot in Study Ranking Pharmacy Automation

    For the second consecutive year, RIVA, the fully automated IV compounding system developed by Intelligent Hospital Systems (IH Systems), has been recognized as category leader in “Pharmacy automation: IV robots” by independent healthcare research firm KLAS. The top ranking was announced in its recent “2014 Best in KLAS: Medical Equipment & Infrastructure” report. RIVA’s overall score of 81.3 is the highest for IV robots (one component of the RIVA system is a robotic arm) used in pharmacy automation that were evaluated in the report.

  • 3D Printed, Resorbable Drug-Releasing Implants
    3D Printed, Resorbable Drug-Releasing Implants

    Combining the concepts of 3D printing and drug-releasing, degradable plastics is the focus of a Lousiana Technical University (LTU) research team, and they appear to be making great strides forward.

  • Laser-Based Diabetes Testing, No Blood Required
    Laser-Based Diabetes Testing, No Blood Required

    Every day, millions of diabetics measure their blood glucose levels by pricking themselves to get a blood sample, but thanks to a new advance from Princeton researchers, this may not be necessary for much longer.

  • Boston Scientific Denied Bid To Sever Pelvic Mesh Cases
    Boston Scientific Denied Bid To Sever Pelvic Mesh Cases

    A federal judge overseeing the trial over pelvic mesh device cases involving Boston Scientific has recently denied the motion by the company to sever four cases from ongoing multi-district litigation.

  • FDA Guidance Advises Industry To Monitor Gender Equality In Clinical Trials
    FDA Guidance Advises Industry To Monitor Gender Equality In Clinical Trials

    The FDA recently released final guidance advising device makers performing clinical trials to consider the gender distribution of study participants throughout various points of a study.

  • China Food And Drug Administration Updates Clinical And Registration Requirements
    China Food And Drug Administration Updates Clinical And Registration Requirements

    The China Food and Drug Administration (CFDA) last month released revisions (in Chinese) to administrative measures that, on Oct. 1, will affect the way medical devices are registered in the country.

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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

Got a Date with the FDA? Conducting Successful Meetings

October 3, 2014
1pm-2:30pm EDT, Online Training
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FEATURED SUPPLIERS

Skyworks Solutions, Inc.

Skyworks Solutions, Inc.

Skyworks is the industry’s leading wireless semiconductor company focused on RF and complete semiconductor systems for mobile communications applications...