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May the Force Be with You in Developing 6 Medical Devices from Star Wars

February 9, 2015 4:06 pm | by Sam Brusco, Associate Editor, @SamISureAm | Comments

Continuing on with my beloved theme of innovative medtech making its debut in classic sci-fi, this past weekend I sat down with a few friends and embarked on the seven-hour journey of watching the original Star Wars trilogy. (This is a tri-yearly...

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Adaptability and a Highly Skilled Engineering and Production Team are Crucial

February 9, 2015 8:30 am | by Perry Sainati, President, Belden Universal | Comments

As adaptive technologies enabling patient mobility and portable care are reaching new heights in sophistication and automation, OEMs rightfully expect similarly high levels of performance and quality from their suppliers. For Belden as a...

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FDA Considering How to Tailor its Oversight for Next Generation Sequencing

February 8, 2015 11:00 am | by Margaret A. Hamburg, M.D., Commissioner, Food and Drug Administration | Comments

FDA is weighing the appropriate regulatory approach to advances in technology that allow physicians to obtain information on large segments of a patient’s genetic makeup very quickly. This technology is known as next generation sequencing...

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Smaller, More Portable Home Medical Equipment

February 8, 2015 8:30 am | by Robert Kim, Strategic Marketing Director, Honeywell Sensing and Control | Honeywell Sensing And Control | Comments

There is a growing demand for smaller, lighter and more portable home healthcare equipment. For example, smaller respirators, infusion pumps, and vital sign monitors are being designed for home use to improve patient quality of life and reduce...

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Wearables Are Making Us Stupid

February 7, 2015 11:00 am | by Kaylie Duffy, Associate Editor, PD&D, @kaylieannduffy | Comments

I appreciate the innovation and thought that goes into the development of wearable devices, but I believe they are slowly derailing our ability to perform everyday tasks. I realize this statement may sound like a contradiction. Wearables are...

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Save Money by Avoiding Multiple Failures During Evaluation

February 7, 2015 8:30 am | by Ajay Sankhla, Senior Engineering Consultant, Intertek | Comments

The adoption of new and expanded payment and delivery models is spurring demand for home healthcare growth. But navigating the required patient and user safety standards that these technologies require is different than traditional clinical...

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Ensuring Data Security and Best Practices for Home Healthcare

February 6, 2015 9:30 am | by Delmar Howard, mHealth Program Manager, Intertek | Comments

Data security and patient privacy are top issues facing every medical device company operating in the mHealth landscape. Even with FDA’s recent Guidance on Management of Cybersecurity in Medical Devices, OEMS struggle with the necessary...  

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Maintaining a Laser Focus on the Medical Device Industry

February 6, 2015 8:30 am | by Sean Fenske, Editor-in-Chief, @SeanFenske | Comments

New processes for conceptualization, design, production, and even collaboration, will yield all new medical devices. It will continue to be that each progressing year, and certainly each half century, reveals new innovations. As our exposure in medical R&D...

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4 Important Security Concerns for Medical Devices

February 6, 2015 8:30 am | by Alan Grau, President, Icon Labs | Comments

To meet FDA Guidelines for cyber security, medical device manufacturers need to design security into the device itself. Leveraging ecosystem partners with security expertise allows medical device OEMs to focus on their strengths while building...

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The Next Wearable Fitness Monitor, Actual Clothing

February 5, 2015 3:08 pm | by Sam Brusco, Associate Editor, @SamISureAm | Comments

Wearable fitness trackers are proliferating like crazy – it seems like every big name tech company is jumping on the bandwagon to develop their own fitness tracking device. I’ve already offered my insight into the fitness tracking fad... 

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The Elusive Search for Funding Continues into 2015

February 5, 2015 10:24 am | by Emily L. Cross, Ph.D. Director of Media and Communications, TecMed, Inc | Comments

Leadership guru Peter Drucker is famously quoted as saying, “The best way to predict the future is to create it.” This is a powerful statement to the new, or experienced, entrepreneur who strives to change the face of the world, or at least a fragment...

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Drone Surgery and HoloLens: Hello 2015

February 5, 2015 8:30 am | by Zev Ginzburg, UX Research Copywriter, Codal Inc. | Comments

In 2001 the medical world got its first real taste of remote robotic surgery when operating surgeons in New York performed a gallbladder removal procedure on a patient in France. A three armed robot was at their disposal, and the surgery was a...

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Listening to Patients’ Views on New Treatments for Obesity

February 4, 2015 4:32 pm | by Jeffrey Shuren, M.D., J.D., Director, Kathryn O’Callaghan, Associate Director for Science and Strategic Partnerships; FDA’s Center for Devices and Radiological Health | Comments

The world was a very different place in 1976, when the Food and Drug Administration launched its medical device program. Since Steve Jobs and Steve Wozniak were just that year launching a computer company called Apple, doctors weren’t yet able to...

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Let's Not Make 'Precision Medicine' an IT Horror

February 4, 2015 3:49 pm | by Sam Brusco, Associate Editor | Comments

About two weeks ago, during his State of the Union address, President Obama unveiled the initiative (with a $215 million budget) to fund “Precision Medicine”. He didn’t go into a huge amount of detail explaining it, but put simply...   

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3 Likely Trends in MedTech in 2015

February 4, 2015 10:30 am | by John Smith, Partner, Hogan Lovells | Comments

FDA’s premarket data requirements continue to increase, with a broader range of devices subject to clinical data requirements and expectations for pre-clinical data continuing to increase. The result has been a significant increase in the regulatory...

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