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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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Enhancing Medical Devices and Personal Healthcare Products with Force Sensing Technology

March 6, 2014 3:18 pm | by Declan Flannery, Managing Director, Force-Sensing Resistor Business Unit, Interlink Electronics | Interlink Electronics | Comments

The medical field presents special challenges to equipment manufacturers. High reliability is an essential characteristic of equipment and instrumentation that may be used in life-or-death situations. This, in turn, places similar reliability...

Medical Device MVP: System Design

March 4, 2014 1:44 pm | by Renjith Ponnappan, Product Manager, eInfochips | Comments

What makes a medical device design stand out most? Electrical engineers and mechanical engineers will clamor that it is the hardware. In immediate retort, software engineers yell back that it is their software. We asked 35 medical device...

The Past, Present, and Future of M&A in the IVD Industry

March 3, 2014 2:01 pm | by Richard K. Park, Contributing Editor | Comments

PwC recently released its “Pharmaceutical and Life Sciences Deals Insights Quarterly” report. In this report, PwC stated that, “The diagnostics sector remained relatively quiet in the M&A market throughout 2013. However, this sector...

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Biggest Challenges in Medical Device Design: Highway to the Danger Zone

March 3, 2014 1:49 pm | by Renjith Ponnappan, Product Manager, eInfochips | Comments

Changes in the world of medical devices technology are accelerating. What was science fiction 15 years ago is in FDA trials today. Mechanical engineers are dealing with new materials, electrical engineers are moving to new low-power chips...

Medical Device Designers Hunting for Success

February 28, 2014 2:01 pm | by Renjith Ponnappan, Product Manager, eInfochips | Comments

The Jungle, the savanna, the plains…medical devices. Every ecosystem has a delicate equilibrium that is thrown into disarray when a new predator is introduced – or in the case of the medical device ecosystem – when a new technology is...   

Medical Device Platforms: Times They Are a Changin’

February 27, 2014 11:54 am | by Renjith Ponnappan, Product Manager, eInfochips | Comments

What do a BMW, a fridge and a portable ultrasound have in common? Ten years ago the answer would have been “nothing”, but the answer now is “low-power GPµs” spawned from the world of mobile phones. Ten years ago the answer would have been...

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Three Questions to Ask Before Choosing an AK-225 Replacement

February 26, 2014 12:56 pm | by Jay Tourigny Senior Vice President, MicroCare Medical | Microcare Medical | Comments

“I have to find a new cleaning solvent before the end of the year?” We heard that question repeatedly at our booth at the MD&M West show, earlier this month in Anaheim. While the phase-out of HCFC-225 is old news for some, others have...

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