LEAD STORIES

Will The Medtronic-Covidien Merger Create U.S. Jobs?

Medtronic Inc. chairman and CEO Omar Ishrak recently defended his company’s contentious decision to merge with Irish medical device maker Covidien by saying that the deal will create more jobs for Americans in the long run.

  • 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.

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

  • Robotic Biopsy System Drives The Point Home
    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.

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.

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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.

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.

New, Very Small PIN Module for Radiation Detection

New, Very Small PIN Module for Radiation Detection

First Sensor is expanding its product range in the area of ionizing radiation detection with a radiation detection module that combines a 100 mm² photodiode with an 8 mm CsI:Tl scintillator. The module measures only 17x16x19 mm, detects gamma radiation in the energy range of 150 to 1,500 keV and is optimized for detection of 137Cs. The pulse output allows for very simple integration in instruments used to measure gamma radiation.

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.

Engineering for Plastic Products

Engineering for Plastic Products

PTI offers plastic design and engineering services for the conversion of concepts into efficiently manufactured plastic medical products. The result is an optimum design with reduced parts, ease of assembly, and a reduced overall cost.  PTI’s plastics engineering services encompass the processing, design, development, and manufacture of complex geometrical plastic products.

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LATEST HEADLINES

  • Will The Medtronic-Covidien Merger Create U.S. Jobs?
    Will The Medtronic-Covidien Merger Create U.S. Jobs?

    Medtronic Inc. chairman and CEO Omar Ishrak recently defended his company’s contentious decision to merge with Irish medical device maker Covidien by saying that the deal will create more jobs for Americans in the long run.

  • Carbon Nanotubes For Cheap, Accurate Cell Manipulation
    Carbon Nanotubes For Cheap, Accurate Cell Manipulation

    Perforating cell membranes is a key part of effective gene transfection or drug delivery, and a Japanese research team has found a way to do it accurately and inexpensively.

  • China Looks To Boost Homegrown Medical Device Sector
    China Looks To Boost Homegrown Medical Device Sector

    Chinese authorities want to increase the use of medical devices manufactured by local companies — potentially making it more difficult for foreign device makers to do business in the country’s medtech sector in which they have traditionally dominated.

  • Microsoft And TracFone Collaborate To Offer Innovative Mobile Health Management Solution To The Healthcare Market

    Microsoft Corp. and TracFone Wireless on Thursday announced a collaboration that will bring the benefits of smartphone technology and services to underserved and high-risk populations through a new mobile health management solution offered through providers and insurers.

  • 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.

More News

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
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.