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Establish Cost Based on Time and Materials

October 21, 2014 8:30 am | by Chris Zandstra, Engineering Manager, Rose Technologies | Rose Medical | Comments

As a contract manufacturer, when we quote development projects to our customer, we prefer to use a time and materials basis instead of a flat rate. This method gives the developer the flexibility to keep the project moving when the scope...

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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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Congress Tackles LDT Regulation: Labs Acting Like IVD Manufacturers

October 17, 2014 4:38 pm | by Richard Park, Contributing Editor | Comments

A couple of weeks ago, FDA released its two draft guidances on the regulation of laboratory-developed tests (LDT): Framework for Regulatory Oversight of LDTs and FDA Notification and Medical Device Reporting for LDTs. With the release of these...

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Students Sharpen Research Skills with the FDA

October 17, 2014 3:49 pm | by Nysia George, Ph.D., Intern Program Coordinator, and Tom Powers, Communication Officer; National Center for Toxicological Research | Comments

Biology. Chemistry. Bioinformatics. Toxicology. Practical, hands-on laboratory work is important for all college students who want to become scientists — but, for many of them, such experiences are out of reach. That’s one of the reasons why every...

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Recharging Medical Devices Faster…MUCH Faster

October 17, 2014 3:00 pm | 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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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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