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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...

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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Premarket Approval Update for AEDs and Accessories

February 25, 2014 2:38 pm | by Jeff Lind, President, Compliance West, and Jamie Young, Operations Manager, CALM Technologies | Compliance West USA | Comments

Manufacturers of AEDs and accessories take notice: By docket number FDA-2013-N-0234, the FDA is considering requiring a premarket approval application or notice of completion of a product development protocol for AED systems and accessories...

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Controlling Costs in Medical Device Development

February 24, 2014 2:37 pm | by Joe St. Cyr, Director and Program Manager, Farm | Farm | Comments

There are dozens of factors that contribute to the cost of developing a medical device and every project is different. There’s no question that the rigor required to meet standards in the medical industry plays a huge part, but based on my...

Star Trek Healing Devices Are Coming to Your Local Hospital

February 21, 2014 2:24 pm | by Allegra Sparta, Contributor | Comments

Maybe we can transport patients with hover-stretchers and flying ambulances, too. Announcements like this are bound to raise a few eyebrows, but we live in a world where 3D-printed hearts and other highly advanced surgical procedures are...

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