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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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From Wearables to Implantables to…What’s Next?

October 8, 2014 9:39 am | by Sean Fenske, Editor-in-Chief | Comments

Some time has passed since the Apple announcement of the company’s “iWatch” (at least as of the time I’m writing this) and all the pomp and circumstance that goes along with it. Unfortunately, from the mobile healthcare aspect, it was underwhelming...

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Glucose Control - Both a Challenge and an Opportunity in MedTech

October 8, 2014 8:30 am | by Emily L. Cross, Ph.D, Director of Media and Communication, TecMed, Inc. | Comments

In a 2009 educational presentation Dr. Alia Rizvi, a medical scholar-practitioner from the University Of South Carolina School Of Medicine reported that glucose control in the hospital, in-patient outcomes, and overall cost of patient care...

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Ramifications of UDI Requirements

October 7, 2014 8:30 am | by Craig Jones, VP Global Supports Services, PRISYM ID | Comments

The implications of product recall are well understood, and they serve as an operational driver for a change of approach. But there are regulatory maneuvers afoot too. The phased introduction of Unique Device Identification (UDI) requirements...

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FDA Invents: How Technology Transfer Gets FDA Inventions from Lab to Marketplace

October 6, 2014 2:18 pm | by Alice Welch, Ph.D, Director — Technology Transfer Program, FDA | Comments

If you think the term “government invention” is an oxymoron — well, think again. You may be surprised to learn that many of the breakthrough technologies that shape our lives today are the brainchildren of government researchers — including those...

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