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A Wristband that Destroys Cancer Cells

March 25, 2015 | by Sam Brusco, Associate Editor, @SamISureAm | Comments

As it turns out, Google has now secured a patent for a potentially cancer cell-destroying wrist-worn device. For lack of better words, that’s pretty awesome. Winning the war against cancer may very well be all in the wrist. Take that, cancer!

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A Prototype Is Worth a Million Words

March 26, 2015 4:01 pm | by Sean Fenske, Editor-in-Chief, @SeanFenske | Stratos Product Development | Comments

Advances in prototyping are accelerating the initial phases of product development in multiple ways. First, prototyping technologies are more prevalent and faster than before. Development teams have better access to these tools allowing...

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Don't Forget About Patient Isolation to Ensure Safety

March 26, 2015 8:30 am | by Daniel Ruth, Medical Team Leader, TUV Rheinland | Comments

The IEC 60601-1 standard for basic safety and essential performance of medical devices deals with many functional issues. They are typically addressed by manufacturers in their risk management files to ensure the device does not harm the...

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Increasing Device Connectivity Improves Value for Everyone

March 26, 2015 8:30 am | by Joel Rydbeck, Healthcare Strategy Director, Infor | Comments

Robert Metcalf is recognized as the father of ethernet, the technology that enables your computer to talk with mine and everyone else’s. Less well known is his postulate, known as Metcalf’s Law. It states that the value of a telecommunications...

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When to Switch from Subsystem Testing to Assembling a Prototype

March 25, 2015 8:30 am | by Nigel Syrotuck, Medical Mechanical Engineer, StarFish Medical | Comments

If you had to engineer a product that works on the first try, how would you do it? An even better question might be: why would you do it? It almost never happens. When it does it is often joined by high fives (and a ‘too good to be true’ feeling...

Understanding Differences in 'Reprocessing Guidance for Industry and FDA Staff'

March 24, 2015 11:26 am | by Emily Mitzel, B.S. M.S. RM (NRCM), Healthcare Reprocessing Expert, Nelson Laboratories | Nelson Laboratories, Inc. | Comments

The FDA’s new guidance document, Reprocessing Guidance for Industry and FDA Staff issued March 17, 2015, outlines a summary of changes to the FDA’s May 11, 2011 reprocessing draft guidance. Based on the content and addition of Appendix E, this...

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Improving Cellular Response to Intervertebral Fusion Surgery Materials

March 24, 2015 8:40 am | by Peter Ullrich, CEO, Titan Spine | Comments

Intervertebral fusion surgery poses a uniquely challenging situation in the spinal medical device market. Ultimately, it is the only place in the body where physicians aim to hold apart two bones (the vertebral bodies) and then induce them to fuse...

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6 Considerations When Implementing Agile in Medical Device Development

March 23, 2015 10:18 am | by Heidi Giesbrecht, MEng, Project Manager, StarFish Medical | Comments

The benefits of Agile include improved quality, more opportunities for midcourse corrections, improved customer or business satisfaction, better alignment between business and IT and improved time to market,” according to a Forrester Research...

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3D Printing Medical Devices in Just Minutes

March 20, 2015 10:57 am | by Sean Fenske, Editor-in-Chief, @SeanFenske | Comments

Today, I was honestly flabbergasted over what crossed my path. In a TED video, I watched as Joseph DiSimone, CEO of Carbon3D, spoke about a new approach to 3D printing that didn’t involve layer after layer of 2D printing being performed to create a 3D part...

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No One Risk Applies to All Devices

March 20, 2015 8:46 am | by Steven W. Badelt, Ph.D., Director of Outreach, Healthcare Working Group, INCOSE | Comments

Medical device companies sometimes fail to follow a robust risk identification process. That process can neglect the risks that emerge when a device is integrated into the larger healthcare system. There is no one risk that applies to all...

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Ignoring Component Obsolescence Won’t Make It Go Away

March 19, 2015 2:46 pm | by Sean Fenske, Editor-in-Chief, @SeanFenske | Comments

MDT recently conducted a survey on component obsolescence in the medical device design space. While some responses were expected, I was rather surprised by several others. Considering how much of an impact a component obsolescence issue...

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Consider the Patient to Ensure Safety in Device Development

March 19, 2015 8:30 am | by Deborah Kacera, Regulatory and Industry Strategist, Pilgrim Quality Solutions | Pilgrim Quality Solutions | Comments

It will be no surprise that the most critical consideration to ensuring patient safety when developing a medical device is to consider the patient: who are they, who will be using the device, how will they interact with the device, and what’s...

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Focus On 'Why?' Instead of Just 'How' for Device Design

March 19, 2015 8:30 am | by Ed Trevis, President and CEO, Corvalent | Comments

Every facet of the process – from circuit board design and assembly to on-site implementation of fully developed medical equipment – can affect the patient experience. Because of this, design strategies that consider long lifecycle and consistent...

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Anxiously Awaiting a Device to Calm Down

March 18, 2015 4:11 pm | by Sam Brusco, Associate Editor, @SamISureAm | Comments

Sporadic bouts of anxiety aren’t really considered a medical condition – but if you’re anxious enough, it can sure feel like an illness! Your heart starts racing, breathing turns short and shallow, and the world moves a little too quickly for comfort...

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FDA Advances Medical Product Innovation

March 18, 2015 9:03 am | by Margaret A. Hamburg, M.D., Commissioner, Food and Drug Administration | Comments

On March 10, I had the pleasure of appearing with my colleague Dr. Francis Collins before the Senate Committee on Health, Education, Labor and Pensions to testify at a hearing on the subject of “Continuing America’s Leadership in Medical...

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Powering Wearable Health Devices

March 18, 2015 8:42 am | by Christian Defeo, eSupplier Manager, Newark element14 | Comments

Our competitors are hard at work in element14’s Sudden Impact design challenge - creating wearable health solutions for athletes, coaches and trainers to use on the field in real time. As we move toward the May 8 deadline to submit the final...

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