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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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How Long Does Clearance on a 510(k) Submission Take?

March 17, 2015 5:13 pm | by Sean Fenske, Editor-in-Chief, @SeanFenske | Comments

Debate rages on over the FDA — Has it become less efficient? More efficient? Is it a barrier to innovation? Is it doing exactly what it needs to do? While these questions are not likely to be definitively answered anytime soon, one query that many do have regarding the FDA could be resolved...

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Top 5 Medical Devices from SXSW 2015

March 17, 2015 4:24 pm | by Sam Brusco, Associate Editor, @SamISureAm | Comments

The SX Health and MedTech Expo was presented for the first time on March 16th and 17th, the last two days of SXSW's "Interactive" portion. The stage was host to programming and panels, providing opportunities to learn from leading experts...

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Apple’s ResearchKit Must Outlast Novelty Value to Aid Medical Insight

March 16, 2015 11:30 am | by Niharika Midha, MSc, GlobalData Medical Device Analyst | Comments

GlobalData believes that Apple’s ResearchKit, which allows researchers to create apps and collect data for disease management by recruiting subjects via iPhones, has the potential to redefine the medical research dynamics, especially for...

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Devices Safeguard Patient Safety Only When They Work

March 16, 2015 10:57 am | by Ellen Turner, Market Development Manager, Specialty Plastics, Medical Devices, Eastman Chemical Company | Comments

Medical devices are under a lot of pressure — doing more for caregivers and patients with each innovation, all while having to withstand the wear and tear that comes with constant use. A heightened focus on patient safety, resulting from evolving...

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Photos of the Day: Top 5 Devices from ExCel Wearable Technology 2015

March 13, 2015 4:06 pm | by Sam Brusco, Associate Editor, @SamISureAm | Comments

I'm personally beginning to yawn and glaze over at every new announcement of the next "innovative fitness tracker/health monitor/attempt to keep up with the Apple Watch." But these wearables are far from ordinary - here are five that certainly...

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Don't Make the Same Device Design Mistakes

March 13, 2015 10:09 am | by Michael Appel, M.D., Anesthesiologist, INCOSE | Comments

We must not only anticipate any new hazards, but must also carefully consider the common underlying risks that have already been identified in previous devices. Using more than just a hypothetical risk process, we need to evaluate known problems...

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Chameleon Material Shows Your Body's True Colors

March 12, 2015 4:30 pm | by Sam Brusco, Associate Editor, @SamISureAm | Comments

Engineers from UC Berkeley have developed an artificial skin that changes color whenever the material flexes or receives any sort of pressure. A flexible material that changes color provides a whole spectrum of medical opportunities...  

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3 Patient Safety Considerations for Medical Device Development

March 12, 2015 8:30 am | by Maria Shepherd, President, Data Decision Group, Medtech Whitespace and Strategy Research | Comments

Usability is the piece of the medical puzzle that supports good engineering design. Simply designed devices with simple instructions reduce the possibility of use error, and the CDRH receives approximately 100,000 Medical Device Reports...

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