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Thermal Management Solutions for MedTech

January 27, 2014 12:21 pm | by Matt Connors, Engineering Group Leader, Thermacore, Inc. | Thermacore, Inc. | Comments

Regardless of whether the 2.3% medical device tax is here to stay or not in 2014, regulatory and competitive pressures are forcing medical OEMs to consider new technologies to reduce costs. Active thermal management technologies, such as...

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Helping to Shape the Future of Medical Device Design

January 23, 2014 2:39 pm | by Renjith Ponnappon, Product Manager, eInfochips | Comments

I think mobile device technology is changing the world of medical device design, the components used, and the skills needed to succeed. If you want to help me shape the future of medical device design, or you want to know what other designers...

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Securing Patient Information Is the Top Priority

January 22, 2014 12:46 pm | by Steve Spatig, General Manager, Electronic Access Solutions, Southco | Southco | Comments

With HIPAA audits scheduled to begin in 2014, many healthcare providers are concentrating their efforts on their approach to how patient information is secured. With audits focusing on breach notification, it is essential that healthcare...

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Ventilator Improvements Through Motion Control Advancements

January 21, 2014 11:41 am | by Dave Beckstoffer, Product Manager, Portescap | Portescap | Comments

High end ventilation and BPAP equipment continually require high efficiency at high speeds for optimum flow generation. As the equipment strives to improve on performance without being noticed by the patient, advancements in motion technology...

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Looking Ahead at Imaging Technology

January 20, 2014 1:52 pm | by Adrian Wilson, Head of Technologies, Element Six | Comments

Today’s magnetic resonance imaging (MRI) technologies, aiding the measurement of illness diagnose and treatment, even when stretched to their limits, have not allowed for resolution beyond a few micrometers and traditionally require expensive...

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MedTech Strategic Convergence Set for 2014

January 17, 2014 12:28 pm | by Deb Kacera, Regulatory & Industry Strategist, Pilgrim Software Inc. | Pilgrim Software, Inc. | Comments

In 2014, we will see the next evolution of the most effective utilization of resources across the medical device industry, based on “smart” information that will touch almost every healthcare stakeholder, where key data will have a tighter...

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Direct Part Marking for UDI Needs

January 16, 2014 3:01 pm | by Gerry Gunderson, CPP, VP of Engineering, Quality Tech Services | Quality Tech Services, Inc. | Comments

The Final Rule for FDA’s Unique Device Identification (UDI) mandate is now released and will be in focus in 2014. Class III device manufacturers will need to comply by September 2014, unless granted an exception (and excluding grandfathered...

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Developing Medical Devices at a ‘Sprint’ Pace

January 15, 2014 2:04 pm | by Eric Sugalski, Founder and CEO, Boston Device Development | Boston Device Development | Comments

In 2014, the medical device industry will see increasing interest in “agile development,” a process of iteration that has become a mainstay in software development. Rather than following the standard waterfall process, teams will rely on...

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USP <1115>—Bioburden Control of Nonsterile Drug Substances and Products

January 14, 2014 1:40 pm | by Jonathan Swenson, Microbiology Department Manager, B.S., RM (NRCM), Nelson Labs | Nelson Laboratories, Inc. | Comments

The control of microorganisms when manufacturing products that are nonsterile is an ongoing challenge. Since the products are intended to be “nonsterile,” there is an inherent acceptance that organisms may be present in the product; however...

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Following Up from RSNA 2013

January 13, 2014 1:58 pm | by Pierre Lemire, President and CTO, Calgary Scientific | Comments

Heading into RSNA 2013, I wrote about advancements in technology over the past 25 years and how significant improvements in technology has allowed us to deliver on what we hoped would be possible. This seemed to resonate with many people...

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Setting the Bar for Blood Glucose Meter Performance

January 10, 2014 2:34 pm | by Courtney Lias, Director, Division of Chemistry and Toxicology Devices, CDRH | Comments

Many of the nearly 19 million Americans diagnosed with diabetes must monitor their blood glucose (sugar) frequently throughout the day using an at-home meter to make sure that their blood glucose is within a safe range. The ability to measure...

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EO Batch Release—Use for Specialized Medical Devices or Those that Need to Go to Trials

January 9, 2014 3:03 pm | by Derek Peterson, EO Sterilization Study Director, Nelson Labs | Nelson Laboratories, Inc. | Comments

Ethylene oxide (EO) is a widely accepted form of sterilization for medical devices that are sensitive to radiation or heat. Batch release sterilization is ideal for medical device manufactures whose devices are very specialized and expensive...

The Future of Wearable Computing in Healthcare

January 8, 2014 4:05 pm | by Jeremy Schroetter, Director - Program/Account Management, GlobalLogic | Comments

Wearable computing devices have the potential to provide a significant impact on workflow, quality of care, access and driving positive outcomes, which are key success factors for a growing patient population. This technologies will enable...

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Driving Innovation Is a Key Part of Our Mission

January 6, 2014 2:43 pm | by Margaret A. Hamburg, M.D., Commissioner, FDA | Comments

Ensuring the safety of the food supply and the safety and effectiveness of drugs, devices and biologics has always been at the core of FDA’s responsibility to protect the public health – and always will be. But what is often lost or neglected...

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The MDT Top 10 from 2013

January 3, 2014 4:05 pm | by Sean Fenske, Editor-in-Chief | Comments

The past year of 2013 was certainly full of news for the healthcare sector as a whole. Obviously Obamacare topped the headlines (seemingly daily) with the media reporting on the latest Congressional battle, digital blunder, cost analysis...

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