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Communicate Early and Often

September 30, 2014 8:30 am | by Trisha Mowry, CEO, Metal Craft | Blogs | Comments

Engaging contract manufacturers as a partner allows each company to focus on core capabilities and best use of dollars and talent. Bringing on strategic partners to round out your supply chain with experts who are focused their specific...

A Comprehensive Cleaning Solution for ‘Critical’ Dental and Medical Products

September 30, 2014 8:30 am | by Doris Schulz, Journalist, SCHULZ. PRESSE. TEXT. | Articles | Comments

Products for use in dentistry and human medicine must meet the most exacting cleanliness standards – e.g., instruments classified as "critical" have to be sterile whenever they are used. In order to supply such items in an already sterilized...

Examining the Physician Office Lab Market: CLIA and Technology

September 29, 2014 9:21 am | by Richard Park, Contributing Editor | Blogs | Comments

Kalorama Information recently released a report entitled, “Physician Office Laboratory Markets, 3rd Edition,” which provides a complete review of this important segment of the IVD industry. The following presents some of the report’s analyses...

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FDA Finalized Guidance 510(k) and New Draft Guidance

September 29, 2014 8:30 am | by Jonathan S. Kahan, partner, John J. Smith, partner, Jennifer A. Henderson, counsel, Danielle C. Woodlee, associate; Hogan Lovells | Articles | Comments

On July 28, 2014, the U.S. Food and Drug Administration (FDA) finalized its guidance, The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] (Final Guidance), the draft version of which was released...

Intellectual Property for Competitive Advantage

September 29, 2014 8:30 am | by John Whynott, Technical Product Manager, Mikrotech | Mikrotech | Blogs | Comments

It is important and will always remain important. Most medical devices manufacturers have difficulty sustaining leadership in all areas of manufacturing (vertical integration). A more cost-effective approach is to outsource areas they have...

Photos of the Day: Helium Shortage Is No Laughing Matter

September 26, 2014 10:18 am | by GE Reports | News | Comments

The U.S. is running out of helium. The shortage is no laughing matter for makers of magnetic resonance machines, who use it to cool down powerful superconducting magnets. GE is investing $17 million in a new plant in Florence, SC, to recycle...

Important to Establish Trust

September 26, 2014 8:30 am | by Steve Heckman, Sr. R&D Engineer, Plastics One | Plastics One, Inc. | Blogs | Comments

To a degree it has always been important. The OEM expects the part their subcontractor builds meets the specifications they require. As a contract manufacturer, we generally take responsibility for sourcing all of the components required...

Photos of the Day: Color-Changing Heart and Skin Monitoring Patch

September 25, 2014 2:38 pm | by Megan Fellman, Northwestern University | News | Comments

The small device, approximately five centimeters square, can be placed directly on the skin and worn 24/7 for around-the-clock health monitoring. The wireless technology uses thousands of tiny liquid crystals on a flexible substrate to sense...

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'Aging in Place' and Staying Active

September 25, 2014 8:30 am | by Carly Dumas, Software Engineering Manager, Breck Petrillo, Director of Engineering, Andrew Leoncyzk, Sr. Electrical Engineer; Ximedica | Ximedica | Blogs | Comments

Ximedica is helping our customers leverage consumer electronics as adjuncts, or alternatives, to dedicated user interfaces and device controls. This is common in home based wellness devices, with connectivity to near field cell phones and...

September 2014 Digital Edition

September 24, 2014 4:57 pm | by MDT Staff | Digital Editions | Comments

Designers developing medical devices that are introduced into the body through a catheter or similar solution have very specific characteristics that need to be achieved for that transfer system. Streamlined Process for Wire-Reinforced Catheters and...

2014 Half-Year Review

September 24, 2014 11:33 am | by EP Vantage and Eileen Whitmore, Art Director | News | Comments

The editorial team at EP Vantage has released its 2014 Half-Year Review of the medtech sector. Highlighted in this infographic are several of the interesting findings that are featured in the report. Positives include faster FDA review times, venture...

Designing a Heart Rate Monitor for Wearable Devices

September 24, 2014 8:30 am | by Anand Udupa, Praveen Aroul, Texas Instruments | Articles | Comments

Within a few years about 170 million wireless devices are expected to be able to track personal health. Optical heart rate monitoring (OHRM) on an intelligent platform like a smartwatch or a smartphone provides the capability to continuously...

Biosensors in Smartphones and Tablets

September 24, 2014 8:30 am | by Karthik Soundar, Segment Manager, Texas Instruments | Blogs | Comments

Assembly technologies that were developed to enable miniaturization of smart phones and to support high-volume production over the last 5-10 years are finding their way into health/fitness and medical devices. Examples include wafer chip scale...

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Lego-Like Modular Components Make Building 3-D 'Labs-on-a-Chip' a Snap

September 23, 2014 10:29 am | by University of Southern California | News | Comments

Thanks to new LEGO-like components developed by researchers at the USC Viterbi School of Engineering, it is now possible to build a 3-D microfluidic system quickly and cheaply by simply snapping together small modules by hand. Microfluidic...

Photos of the Day: Dialysis Belt

September 23, 2014 10:06 am | by Leila Gray, HSNewsBeat | News | Comments

The Wearable Artificial Kidney, also known as the WAK, is a miniaturized dialysis machine that can be worn on the body. The carrier resembles a tool belt; the device connects to a patient via a catheter. The Wearable Artificial Kidney features...

Flexibility, Porosity Design Leads to Regeneration of Soft Tissue

September 23, 2014 8:30 am | by Dr. Torbjorn Mathiesen, Chief Technology Officer, Novus Scientific | Articles | Comments

The design of surgical biosynthetic mesh for breast surgery, whether reconstructive or cosmetic, and for hernia or abdominal surgery involves creating material and design that promotes faster healing with natural human tissue regeneration...

From the Hospital to the Home

September 23, 2014 8:30 am | by John DiCristina, Medical Equipment Director, Strategic Marketing Group | Blogs | Comments

The main efficiency driver is the elimination of the package and moving to wafer level packages (WLP). This allows for better cost efficiencies and for dense pin outs reducing the PCB board area. We also have the ability to package multiple...

The Clutter of Wires, a Thing of the Past

September 22, 2014 8:30 am | by Tony Zarola, Vital Signs Monitoring Marketing Manager, ADI | Analog Devices, Inc. | Blogs | Comments

No, not at all, apps alone cannot replace medical devices. Sensors/connectivity interfaces to the patient along with signal processing elements are still required to measure the patient’s vital signs accurately. The apps can complement the...

Congress Tackles LDT Regulation: IVD Innovation and the Device Tax

September 19, 2014 2:20 pm | by Richard Park, Contributing Editor | Blogs | Comments

A couple of weeks ago, the House of Representatives Energy and Commerce Committee’s Subcommittee on Health held a hearing on FDA’s notification to Congress at the end of July that it intends to issue draft guidance on a framework for oversight...

Innovative X-ray Technology – An Option for Improved Breast Cancer Diagnosis

September 19, 2014 8:30 am | by Dr. Thomas Kron, Technical Writer | Articles | Comments

The benefits of mammography for breast cancer screening have been discussed for years. By screening, some say that tumors are discovered earlier, save lives and eliminate the need of having to go through strenuous therapies. Others say that...

Making Light of a Serious Situation

September 19, 2014 8:30 am | by Sam Brusco, Editorial Intern | Blogs | Comments

The last item on a hospitalized patient’s agenda is to contract more illnesses during their stay. Unfortunately, The CDC estimates that five percent of all hospital admissions result in infections that patients acquire during their stay while...

Test with a Prototype

September 19, 2014 8:30 am | by Anthony Appling, Senior Director of Research & Development, MedVenture Technology, A Helix Medical Company | Blogs | Comments

There are a few crucial steps that should be taken before significant investment is made or development efforts are put forth. First of all, one should develop a problem statement. You need to determine what specific problem is being addressed...

The Pulse: Yawning at the Apple Watch and Diagnosing on the Go

September 18, 2014 10:23 am | by Jonathan Dipierro, Multimedia Production Specialist | Videos | Comments

On this episode of the Pulse, we’re yawning at the Apple Watch, testing blood, urine or saliva in minutes, determining cancer treatment with a 3D printed heart, and tracking fitness with our feet. Apple Watch: Last week came the much...

Photos of the Day: 4D Ultrasound Enables a Prenatal View

September 18, 2014 9:34 am | by GE Healthcare | News | Comments

There were people who thought that Italian priest and scientist Lazzaro Spallanzani had bats in the belfry. But he had bats on his mind. Working in the late 1700s, Spallanzani showed that blindfolded bats could still catch flies...

Don't Go It Alone

September 18, 2014 8:30 am | by David Perry, Engineer, Boston Device Department | Blogs | Comments

Focus your efforts on identifying the key assumptions or biggest lingering questions around your new medical device, then build something small and focused to test them. Intuition and math can tell you something should work, but you don't...

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