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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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Newly Insured Bring New Opportunities and Challenges

December 19, 2013 4:12 pm | by Michael Frank, Healthcare Industry Expert, PA Consulting Group | Comments

The medical device sector has emerged from the winter of the great recession into a much more price sensitive market. Pressure is mounting to reduce cost of devices where there are cheaper alternatives. While the 2.3% medical device excise...

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Wireless, Disposable Sensors for Patient Monitoring on the Way

December 18, 2013 4:11 pm | by Jonathan Sbert, Product Line Manager for Healthtech, Texas Instruments | Texas Instruments Inc. | Comments

Technology that enables wireless and disposable human diagnostic sensors for ECG, pulse oximetry, heart monitoring, temperature, and other measurements will be prevalent in 2014. Imagine the day when a patient lies in a hospital bed completely...

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Reducing Costs by Extending Product Life

December 17, 2013 2:25 pm | by Tim Taylor, Director of Sales, Medical, XP Power | XP Power | Comments

As a manufacturer of medical grade power supplies, we see many changes in the coming year. The U.S. healthcare industry is going through a transformation that will have a different landscape. The medical device manufacturers that are leading...

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A MedTech Accelerator Model

December 16, 2013 3:13 pm | by Laura Faulconer, Business Development Manager, STC | Comments

With the dramatic growth of the IT sector over the last decade, novel commercialization models like the start-up accelerator have emerged. A typical IT accelerator provides a small investment (usually $10,000 to $50,000) alongside rigorous...

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Through Emerald Lenses

December 13, 2013 2:43 pm | by Sean Fenske, Editor-in-Chief | Comments

Recently, I had the pleasure of a media tour to Ireland. While weather-wise, the Fall is not the ideal time of year to visit the island (although as I was informed, you don’t go to Ireland for the weather), it was fantastic timing in terms...

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Changing Medicine Through Technology

December 11, 2013 2:56 pm | by Michael Lewis, Writer, Money Crashers Personal Finance | Comments

Medical devices serve a number of purposes from the most mundane to the esoteric. Some are constantly being redesigned and updated to be more effective while others have remained little-changed for decades. Even bed pans—stainless steel...

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