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Would You Operate on Yourself with a DIY Surgical Robot?

July 24, 2015 | by Sam Brusco, Associate Editor, @SamISureAm | Comments

So what’s an American to do when they can’t afford a necessary operation? Well, soon enough minor surgeries could be performed at home with a surgical robot, requiring very little doctor mediation. The robot, right now a non-functional concept...

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Improving Access to Medical Devices: FDA Uses Existing Clinical Data to Reduce Premarket Data Needs

July 28, 2015 8:30 am | by Ben Fisher, Ph.D. | Comments

At the FDA, we recognize the value of encouraging medical device innovation. We recently have acted to reduce the time and cost of clinical trials while maintaining patient protections. By doing so, FDA is helping to ensure that manufacturers will be

Don’t Let Product Development Go Off Course

July 27, 2015 8:30 am | by Tim Pelura, PhD, CEO; David Craig, Director of Operations and Interventional Services; Surpass Inc. | Comments

It is no secret that bringing medical innovation to market is a costly endeavor. By product launch, tens, or even hundreds, of millions of dollars and thousands of hours of engineering and testing have been expended. According to a 2010...

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6 Ways to Find Innovation Inspiration

July 23, 2015 4:04 pm | by Julie Wheelan, Vice President, Marketing & Strategy, Edison Nation Medical | Comments

Feeling inspired is often characterized as an “aha!” moment, but that isn’t the reality for most. Coming up with a great idea doesn’t require a particular kind of genius — inspiration can strike spontaneously with the right trigger. If you think...

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Process Development Meets Virtual Reality

July 23, 2015 10:56 am | by Josh Simon, Adjunct Professor, New Jersey Institute of Technology | Comments

Developing video games requires a lot of skill which must be developed over time, but until recently it did not really occur to me how integrally the skills for game development and biomedical engineering could be connected. The connection is obvious...

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MedTech Memoirs: 3 Disastrous Equipment Failures

July 22, 2015 2:03 pm | by Sam Brusco, Associate Editor, @SamISureAm | Comments

Most of the time, medical equipment functions exactly as intended. But sometimes even the most well-intentioned medical devices unexpectedly malfunction or cause unforeseen complications. With most consumer devices, a malfunction only...

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IEC 60601-1 3rd Edition Risk Management Requirements and Product Design

July 22, 2015 10:46 am | by Michael Brousseau, Safety Engineer and Operations Manager, Intertek | Comments

The third edition of IEC 60601-1 has been on the books for nearly a decade, and an amendment has been out for three years. Yet the standard still challenges many in the medical device industry, particularly when it comes to risk assessment...

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Does Your Medical Innovation Have Legs in the New Healthcare Reality?

July 21, 2015 10:47 am | by Tim Pelura, PhD, CEO, Surpass Inc. | Surpass, Inc. | Comments

In the present era of affordable and accountable healthcare, how that care is delivered and managed has come under tremendous pressure – and cost containment is the order of the day. Likewise, the role of technology in the care continuum has...

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Coming Soon: A Take-Home Herpes Test

July 20, 2015 4:01 pm | by Sam Brusco, Associate Editor, @SamISureAm | Comments

The FDA has recently approved a take-home HSV-1 test provided by Theranos, a company that provides diagnostic testing for hundreds of diseases with only a few drops of blood. Testers can now use Theranos’ finger-stick technology to test outside of the lab...

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A Way Forward: Enabling Effective Clinical Decision-Making Through Simulation

July 20, 2015 10:31 am | by James B. McGee, MD Scientific Advisory Board Chairman and Co-Founder, DecisionSim Inc. | Comments

Much attention is being paid to the skill of “decision-making” in healthcare. This trend is driven by a number of factors including cost, patient safety, and an increasingly complex healthcare environment. Not only are there more diagnostic and...

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6 Things to Look Forward to at MEDICA 2015

July 17, 2015 2:59 pm | by Joachim Schäfer, Managing Director, Messe Düsseldorf GmbH | Comments

To get to the top is difficult; to stay at the top is even more difficult. Every athlete knows that and this also applies to the trade show business. In this way, defending the uncontested leading position of the world’s largest and internationally...

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Star Trek-style Ultrasonic Tech Could Regenerate Skin

July 17, 2015 2:10 pm | by Sam Brusco, Associate Editor, @SamISureAm | Comments

You would think that a device that heals wounds at the touch of a button would be left a sci-fi fantasy, right? Though it’s not quite the instantaneous Star Trek fix, research has recently been published about a small, handheld ultrasonic emitter...

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Protect the Surface, Protect the Patient: A Look at Recent Antibiotic-Resistant Testing

July 17, 2015 10:39 am | by Lise Moloney, Director of Business Development, Healthcare Sciessent LLC | Comments

It’s hard not to notice all of the recent headlines: “MRSA Epidemic Fueling Antibiotic Resistance,” “Superbugs to ‘Kill More than Cancer’ by 2050,” “What You Need to Know about ‘Superbug’ CRE.” Antibiotic-resistant infections are, unfortunately...

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Get Ready for a Better Synthetic Bone Regeneration Material

July 16, 2015 4:09 pm | by Josh Simon, Adjunct Professor, New Jersey Institute of Technology | Comments

If you were in the orthopedics business from the late 1990’s through just recently, you saw the rise and fall of Bone Morphogenetic Proteins (BMP’s) on the commercial market. Their story differs somewhat depending on the specific products...

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Expanding Opportunities with Shrinking Implantable Neurostimulation

July 16, 2015 10:55 am | by Sean Fenske, Editor-in-Chief, @SeanFenske | Comments

StimGuard is a privately held medical device firm focused on the development, manufacture, and commercialization of wirelessly powered, injectable, microtechnology neurostimulators. The technology is currently going through clinical trials...

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MedTech Memoirs: Breast Implants

July 15, 2015 2:55 pm | by Sam Brusco, Associate Editor, @SamISureAm | Comments

Breast augmentation surgery is the most popular cosmetic surgery in the U.S., with about 286,000 people going under the knife in 2014. (Nose reshaping was a close second with 217,000.) With the ubiquity of celebrities and stories of women...

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