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Recharging Medical Devices Faster…MUCH Faster

October 17, 2014 | by Sean Fenske, Editor-in-Chief | Comments

When it comes to portable electronics, the power source can often be the biggest challenge for a designer attempting to reduce the size of a device. Batteries are typically the largest component in the device design. When it comes to medical devices...

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Leverage a Quality Function Deployment Tool

October 20, 2014 8:30 am | by Brian Handerhan, Business Development Manager, Parker Hannifin | Comments

I personally subscribe to the concept that 80% of the cost optimization opportunity of any product is frozen at the point of the design freeze, leaving only 20% of the opportunity to be addressed through conventional cost reduction efforts...

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An ERP Software Solution for Managing Costs

October 17, 2014 8:30 am | by Joey Benadretti, President, SYSPRO USA | Comments

Employ Enterprise Resource Planning (ERP) software to facilitate timely and accurate decision-making via access to real-time, integrated data. Predict demand to optimize inventory levels. Streamline supply chains to maximize efficiencies...

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Congress Needs to Give Green Light to Health IT Innovation

October 16, 2014 10:02 am | by David LeDuc, Sr. Director of Public Policy, Software & Information Industry Association | Comments

Healthcare systems around the world are being challenged by aging populations, chronic illness and revolutionary—but expensive—treatments. Appropriate solutions are often not available to patients in need, while medical providers, academics...

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A Healthy Dose of Facebook

October 16, 2014 9:47 am | by Sam Brusco, Editorial Intern | Comments

Facebook allows its users to map the footprints of their various walks of life. It functions as a digital reflection of the human condition, abound with pictures, status updates, links, and private (or, for emphasis, public) conversations...

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Simplify to Cut Costs

October 16, 2014 8:30 am | by Mark Shal, Ph. D., Founder, Insight Technology | Comments

The key word characterizing today's medical device development environment is confusion. In addition to doing their jobs, people are being asked to implement confusing, complex, and at times misleading procedures. Pushed by the FDA to move...

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New York State: A Beacon for Bio/Med Growth

October 15, 2014 8:30 am | by Jessica Crawford, President, MedTech Association | Comments

The Bio/Med Breakthroughs: Advancing New York’s Innovation Economy industry report by MedTech, the trade association for bioscience and medical technology (Bio/Med) companies in New York, which was launched at MEDTECH 2014, reveals a number...

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FDA Seeks to Address Cybersecurity Challenges in Medical Devices

October 14, 2014 2:39 pm | by Suzanne B. Schwartz, M.D., M.B.A., Director of Emergency Preparedness/Operations & Medical Countermeasures, CDRH | Comments

Cyber vulnerabilities – bugs or loopholes in software codes or other unintentional access points – are a real and constant threat to our networked laptops, mobile phones, or tablets. The Heartbleed virus and security breaches at major retailers...

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For Medical Device Industry, Fewer Recalls but Further Complexity

October 14, 2014 8:30 am | by Mike Rozembajgier, Stericycle | Comments

Product recalls happen daily across industries and geographies. While each recall event presents its own challenges, when a medical device is recalled the process involved in alerting consumers and retrieving product is quite complex. Recalls...

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Examining the Physician Office Lab Market: Growth and Reimbursement

October 13, 2014 2:49 pm | by Richard Park, Contributing Editor | Comments

According to the report, the global market for physician office laboratory (POL) diagnostics was estimated at $2.4 billion in 2014. The U.S., Europe, and Japan represent 58%, 32%, and 5% of the market, respectively. The rest of the world accounts...

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Gaming Through Clinical Trials

October 13, 2014 2:41 pm | by Sean Fenske, Editor-in-Chief | Comments

Recently, I saw a news piece out of Carnegie Mellon University where researchers supported the use of “video game” style trials of life science hypotheses to prevent the instance of error and fraud. Massive online laboratories would be established...

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5 Key Lessons to Successfully Prepare and Publish Data to the FDA’s GUDID

October 13, 2014 8:30 am | by Denise Odenkirk, Senior Director, Industry Solutions, GHX | Comments

While the deadline for medical device companies to submit Class III product data to the FDA's Production Global UDI Database (GUDID) passed on September 24, 2014, the remaining 90 percent of all medical device implantables, as well as products...

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5 Things Engineers Regret About Their Careers

October 10, 2014 8:30 am | by Kasey Panetta, Managing Editor, ECN | Comments

If only they knew then what they know now, who knows what would have happened? It’s a lamentable thought, but, short of the invention of some sort of time machine, the best engineers can do is offer their advice to the younger generation. It...

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IEEE Technology Time Machine Takes on the Future of Health

October 9, 2014 4:06 pm | by Bruce Wheeler, IEEE | Comments

Innovation is driving a seemingly exponential growth of health-monitoring devices, many aimed at consumers with accuracy and reliability that falls far short of what is needed in the highly regulated healthcare market. Innovators need to be...

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FDA’s Program Alignment Addresses New Regulatory Challenges

October 9, 2014 11:04 am | by Margaret A. Hamburg, Commissioner, U.S. Food and Drug Administration | Comments

Over the last year, a group of senior FDA leaders, under my direction, were tasked to develop plans to modify FDA’s functions and processes in order to address new regulatory challenges. Among these challenges are: the increasing breadth and...

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FDA Clearance: Are Your Mobile Applications Being Used for Diagnosis Without It?

October 9, 2014 8:30 am | by Pierre Lemire, President and CTO, Calgary Scientific | Comments

On August 1st, the FDA released new rules that exempts many medical applications created for mobile devices from its regulatory scope. In general, the new rules are targeted at consumer applications and devices that the guidelines say are...

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