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MedTech and the Wireless Power Challenge

May 19, 2014 2:50 pm | by Dianne Kibbey, Global Head of Community, element14 | Comments

One sector that stands to gain a great deal from wirelessly powered devices is the medical industry. As we enter the age of self-administrable treatments, wearable technology and advanced surgical robotics, the sophisticated use of wireless...

Assessing FDA’s Crackdown of 23andMe

May 19, 2014 9:14 am | by Richard Park, Contributing Editor | Comments

Last November, FDA ordered 23andMe (Mountain View, CA) to discontinue offering its direct-to-consumer DNA testing service, which provided individuals with assessments of their genetic risk for nearly 200 diseases. Many had praised 23andMe’s...

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Medical Device Molding Insights

May 16, 2014 2:40 pm | by Jeff Randall, VP – Engineering, MRPC | MRPC | Comments

Following is a Q&A with Jeff Randall, Vice President of Engineering at MRPC. Randall offers a number of insights on molding for the medical device space. He discusses topics such as micro molding, materials, consumer medtech, UDI, and...

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Build Your Avatar by Jogging

May 14, 2014 4:08 pm | by Jason Orszt, Editorial Intern | Comments

It all begins with what you know. When the Tamagatchi had rolled in, it was all the rage at elementary school. Everyone had some tiny animal; I had R2D2. You fed your pet or it died. Clean up after it or the pile grew higher. Run out...  

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Building Expertise and Crossing Boundaries to Improve Oversight

May 13, 2014 2:59 pm | by Howard Sklamberg, J.D., Deputy Commissioner for Global Regulatory Operations and Policy, FDA | Comments

To keep the food supply safe, have safe, effective, and high quality medical products, and decrease the harms of tobacco product use, we have to work with the rest of the world. As FDA’s Deputy Commissioner for Global Regulatory Operations...

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Five Hard-Learned Lessons from a Medical Device Start-Up

May 12, 2014 1:37 pm | by Emily Cross, Ph.D., Director of Media and Communication, TecMed Inc. | Comments

Just the idea of starting something from scratch can be overwhelming.  Ask the average shopper at your local grocer how they prepare a simple meal at home and you’ll find the majority who cook use prepared ingredients, making the whole...

Trends in the U.S. IVD Market: Diseases and Testing Venues

May 12, 2014 9:06 am | by Richard Park, Contributing Editor | Comments

My blog last week looked at a report released by Kalorama Information entitled, “The United States Market For In Vitro Diagnostic Tests.” This report examines the current state of the U.S. IVD market, analyzes the various emerging trends...

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Strong Review Performance Brings Innovative Medical Products to Patients

May 8, 2014 3:38 pm | by Margaret A. Hamburg, M.D., Commissioner, FDA | Comments

There are many ways FDA supports biomedical innovation as part of our mission to protect and promote public health. We are committed to finding ways to ensure that safe and effective products can get to the people who need them as swiftly...

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Trends in the U.S. IVD Market: Healthcare System Utilization and Aging Demographics

May 5, 2014 8:58 am | by Richard Park, Contributing Editor | Comments

Kalorama Information (New York) recently released a report entitled, “The United States Market For In Vitro Diagnostic Tests.” This report examines the current state of the U.S. IVD market, analyzes the various emerging trends in the market...

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Overcoming Regulatory Challenges in Companion Diagnostics

April 28, 2014 10:07 am | by Richard Park, Contributing Editor | Comments

For my occasional series of blogs examining various facets of the companion diagnostics market, I asked some IVD regulatory experts to share their thoughts and opinions on the current regulations for companion diagnostics. The following...

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Regulatory Considerations and Revalidation Tests for Managing Change in Packaging Materials or Critical Supplies

April 25, 2014 11:35 am | by Stacey Drosner, Director of Regulatory Affairs, and Wendy S. Mach, Packaging Section Leader, BS, RM(NRCM), CQA(ASQ), Nelson Laboratories | Nelson Laboratories, Inc. | Comments

In light of recent material changes within the medical device packaging industry, it is imperative manufacturers respond to triggers built into their change management process so they can (1) assess the impact a change in materials or processes...

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Engineers Feel Underpaid & Overworked

April 25, 2014 10:32 am | by Chris Fox, Managing Editor, PD&D | Comments

PD&D recently asked engineers industry-plaguing questions centered on the OEM industry’s cogs, the engineers. As technology continues to move faster than Moore’s law predicted, and unlike the rest of the world who can sit and enjoy the...

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Collaboration and Medical Countermeasures: Furthering Regulatory Science

April 24, 2014 2:31 pm | by Stephen Ostroff, M.D., Acting Chief Scientist, FDA | Comments

“I hope no one ever needs these products,” isn’t something you hear too often, particularly from those developing drugs, biologics, or devices. That point of view—and a universal desire to protect the American public—is what sets biodefense....

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Step into Virtual Reality with a Scalpel

April 23, 2014 2:33 pm | by Jason Orszt, Editorial Intern | Comments

A matte black, cube-shaped room with the holographic projection of a cadaver at a surgeon’s disposal? That’s better than playing a turn at the classic board game “Operation.” Housed at the University of Michigan’s 3D Lab, the Michigan Immersive...

New Exposure Recommendations on nPB Will Mandate Change for Most Users

April 22, 2014 2:11 pm | by David Ferguson, Senior Market and Technical Manager, MicroCare Medical | Microcare Medical | Comments

Normal propyl bromide (nPB) has become a popular solvent in the last 15 years. It is commonly found in inks, coatings, as a dry cleaning fluid and as a metal cleaning solvent. Its popularity arose due to its high solvency and lack of regulatory...

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