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The Time and Place for RTLS Standardization

April 1, 2014 12:34 pm | by Andrew J. Mazotas, MS, PMP, Clinical Engineer, RTLS PMO, Veterans Health Administration | Comments

The far-reaching potential benefits of Real-Time Location Systems (RTLS) in healthcare are increasingly well understood and documented. Still, adoption of the technology among hospitals is not growing substantially. Might standardization...

FDA Wants Your Perspective on Clinical Trial Demographic Data

March 31, 2014 10:38 am | by Jonca Bull, M.D., Director of Office of Minority Health, FDA | Comments

When designing clinical trials, it is essential to test the safety and effectiveness of medical products in the people they are meant to treat. Although FDA’s policies, guidances, and regulations reflect decades of agency efforts to foster...

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Barriers to Companion Diagnostics: Market Sales and Clinical Utility

March 31, 2014 10:27 am | by Richard Park, Contributing Editor | Comments

The term companion diagnostic may be defined differently based on the perspective of the user. The term is sometimes used to refer to any IVD employed to select or modify use of a therapeutic agent. The definition for this blog reflects the...

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A Brief History Lesson on Obama and Companion Diagnostics

March 21, 2014 4:12 pm | by Richard Park, Contributing Editor | Comments

About eight years ago, a little known junior U.S. senator from a midwestern state introduced a bill called the Genomics and Personalized Medicine Act of 2006. In this bill, the senator proposed to increase funding for research on genomics...

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This App Could Prevent 1,600 Deaths Every Day

March 21, 2014 2:16 pm | by Kasey Panetta, Managing Editor, ECN | Comments

The move towards mobile medicine is pretty incredible in a few different ways. For one, it offers an aging population — in the U.S. it’s the baby boomers — an option for treatment that doesn’t involve more doctor’s offices or hospitals than...

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Human Factors in Medical Device Design

March 20, 2014 2:25 pm | by David Foshee, Design Engineer, Gilero | Comments

Human factors have been around a long time, but recently there has been movement towards a more consistent application of these principles in the design of medical devices. If you are a design engineer you may be thinking, “Hey, I’m a Human...

Self-Powered Medical Monitoring Devices: Harnessing Free Ambient Energy

March 19, 2014 3:58 pm | by Niranjan Pathare, Sr. Market Development Manager — Battery Management Solutions, Texas Instruments Inc. | Texas Instruments Inc. | Comments

Advances in semiconductor design have opened up the possibility of self-powered medical devices in the near future. Typical use cases would be for personal fitness or medical heath monitoring. A self-powered device would be able to energize...

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Sentinel: Harnessing the Power of Databases to Evaluate Medical Products

March 18, 2014 2:24 pm | by Michael D. Nguyen, MD, Acting Director of the Division of Epidemiology, FDA’s Center for Biologics Evaluation and Research | Comments

Clinical trials are designed to evaluate the safety and effectiveness of medications. But the number of participants in clinical trials represents only a fraction of the number of people who will ultimately use the product after FDA approves...

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The Continuing Problem of Regulating Home Brew Tests

March 17, 2014 4:36 pm | by Richard Park, Contributing Editor | Comments

Xconomy.com recently published an article, “Molecular Diagnostics Are in a Rut. The Industry Needs the FDA.” The article argues that IVD manufacturers, clinical laboratories, and payers would all benefit from heightened and predictable FDA...

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Design Inspiration from The Home Depot

March 14, 2014 1:36 pm | by Sean Fenske, Editor-in-Chief | Comments

Developing medical devices is not something I do. I write about it, but I’m not “in the trenches” getting dirty with medical device designers. That is, until recently. Allow me to explain. Typically, when my 8th grade daughter comes home...

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China in Your Hands: Grasping the Potential of Emerging Markets

March 13, 2014 3:23 pm | by Vince Postill, SVP of Global Business Development, PrisymID | Comments

In 2011, China officially became the third biggest pharmaceutical market in the world – almost 50% bigger than fourth-placed Germany. Brazil, meanwhile, overtook mature European markets such as the UK, Italy and Spain, to climb to sixth place...

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Reassessing Risk in the Design Process

March 11, 2014 3:09 pm | by Brian Gough, Projects Director, IDC | Comments

The recent change in ISO 14971:2012 Application of risk management to medical devices, requires a change to the way risk is assessed during the design process. Where user risk was once mitigated by the Instructions for Use (IFU), the IFU...

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Are IVDs Being Overused or Underused?

March 10, 2014 4:26 pm | by Richard K. Park, Contributing Editor | Comments

PLOS One published an article, “The Landscape of Inappropriate Laboratory Testing: A 15-Year Meta-Analysis,” that examined 15 years’ worth of published research on this topic and revealed some surprising findings about IVDs in the clinical...

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What’s New in the FDA’s 2015 Budget?

March 10, 2014 3:41 pm | by William Tootle, Director – Office of Budget, FDA | Comments

A few days ago, President Obama released his Fiscal Year 2015 Budget Message to Congress, which included a high-level summary of his proposed funding for the FDA. Today the White House is out with the full budget, complete with all of the...

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Microbial Quality: Acceptance Criteria for Non-Sterile Products

March 7, 2014 1:56 pm | by Jonathan Swenson, Microbiology Department Manager, B.S., RM(NRCM), Nelson Laboratories | Nelson Laboratories, Inc. | Comments

Managing the potential microbial risks when manufacturing non-sterile products can be a complex task. Risk-based assessments are used to help determine the manufacturing areas that may contribute to product contamination by objectionable...

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