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3 Tips for Managing Your Medical Device Design History File

March 31, 2015 8:30 am | by Jon Speer, Co-Founder & VP of QA/RA, greenlight.guru | Comments

Developing a cutting edge medical device can be really fun and exciting. There’s always something to test and do and learn from. You have that great feeling you’re changing the world. Documenting the development of a medical device isn't fun...

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Continuity of Platforms: The Next Era of Engagement in Wearable Technology

March 30, 2015 4:33 pm | by Roeen Roashan, Analyst for Medical Technology, IHS Inc. | Comments

Within six months of purchase, one-third of consumers put their wearable activity monitors in the sock drawer to never pick them up again. While this has been the general consensus of several user surveys, IHS does not believe this tells...

3 Ways 3D Printing Is Saving Our Four-Legged Friends

March 30, 2015 2:10 pm | by Sam Brusco, Associate Editor, @SamISureAm | Comments

It’s rather sad when a beloved pet meets with an unfortunate accident that drastically hinders its quality of life. Even more heart-wrenching, there are scarce few options that would allow for a pet’s full recovery – and those options are typically too expensive...

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Prototyping Processes are Becoming More Acceptable for Use in the Final Product

March 29, 2015 8:30 am | by Sean Fenske, Editor-in-Chief, @SeanFenske | Farm Design, Inc. | Comments

Using simulation and design software complements the building of physical prototypes. Both are critical to the development process. The typical cycles of designing, building, and testing are facilitated by having more rigorous engineering...

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As 3D Printing Technology Grows, Its Applications Will Explode

March 28, 2015 8:30 am | by Sean Fenske, Editor-in-Chief, @SeanFenske | Proto Labs, Inc. | Comments

Sophisticated design software is a powerful tool most often used in conjunction with physical prototypes, and not as a replacement. Simulation software can provide engineering insight, but a physical part allows for real-world testing and may...

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Laws That Kill Innovation Will Ultimately Kill People

March 27, 2015 2:02 pm | by Emily Cross, Ph.D., Director of Media and Communication, TecMed Inc. | Comments

February 2014 can be defined by updated DFA proposals supporting updated standards specific to blood glucose monitor accuracy standards for devices used in both home consumer and healthcare facilities. Twelve months later, February 2015 is...

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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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Enhancing Your Perception Through a Vest

March 26, 2015 3:19 pm | by Sean Fenske, Editor-in-Chief, @SeanFenske | Comments

Employing motors similar to those used in cell phones, this vest offers sensations to a person’s back based on the inputs provided. As illustrated through the video, that input can be generated by sound, news feeds, stock market data, or...

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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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A Wristband that Destroys Cancer Cells

March 25, 2015 3:54 pm | 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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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...

A 23andMe Approach to Your Gut Bacteria

March 24, 2015 2:41 pm | by Sam Brusco, Associate Editor, @SamISureAm | Comments

You might be surprised to learn that you’re more bacteria than human! In the body, bacterial cells outnumber human cells about ten to one. Don’t think of them as intruders, though - these microscopic soldiers are constantly working to make sure...

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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...

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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