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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...

Powering the Next Generation of Medical Breakthroughs with In-Memory Computing

April 21, 2014 3:53 pm | by Nikita Ivanov, Co-founder and CTO, GridGain | Comments

The amount of data and number of sources that can be drawn to inform medical design is expanding exponentially. In addition to the explosion of web-based information, sensor-based wearable medical devices offer a treasure trove of health...

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Roche Ups Its Ante in Molecular POC Testing

April 21, 2014 9:59 am | by Richard Park, Contributing Editor | Comments

Last week, Roche Diagnostics (Indianapolis) announced its acquisition of IQuum Inc. (Marlborough, MA), a privately held company that develops point-of-care (POC) test systems for the molecular diagnostics market. Under the terms of the deal...

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FDA Works with China to Ensure Medical-Product Safety

April 18, 2014 8:02 am | by Christopher Hickey, Ph.D., Country Director for the People’s Republic of China, FDA | Comments

Americans benefit greatly from medical products produced by other countries. Approximately 40 percent of finished drugs in the United States come from overseas, as well as more than 50 percent of all medical devices. About 80 percent of the...

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Top Ten (+1) Disposables Outsourcing Vendor Tips that Save Money

April 17, 2014 3:40 pm | by Donald J. Dobert, President, ATL Medical-Pharmaceutical | ATL (Ad Tape & Label) | Comments

Follow these eleven tips. They will save you heartache, frustration, and money. 1. Clearly define your needs and the function of the product. Your vendor may be able to suggest cost efficient ways to improve product quality and lower unit...

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App-t Development for Next Generation Healthcare

April 16, 2014 2:38 pm | by Sean Fenske, Editor-in-Chief | Comments

I am a recent addition to the “smartphone revolution.” While I never doubted the usefulness of these devices, I was simply steadfast in holding out for a reduction in data rates. I figured that with more users adopting smartphones, eventually...

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