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Increase Efficiency by Combining Bioburden and Tests of Sterility

October 6, 2014 8:30 am | by Sean Shepherd, Sr. Study Director, Nelson Laboratories | Comments

When it comes to radiation sterilization validation, there is a perception that the bioburden and sterility testing need to be conducted under separate submissions, with results from both then used to compile a statement report by the medical device...

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Solution for 'Spin-Out' Success

October 3, 2014 8:30 am | by Dr. Daniel Burnett, CEO, TheraNova | Comments

If I were to ask you to give me one word to define healthcare in the U.S, what would you say? I’m guessing “expensive” would be a leading response for many Americans, and they wouldn’t be wrong. Modern healthcare is costly due in part to the...

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New Data Dashboard Tool Shares FDA’s Inspection, Compliance, and Recall Data

October 2, 2014 2:02 pm | by Douglas Stearn, Director of the Office of Enforcement and Import Operations, FDA | Comments

As part of our commitment to transparency FDA is pleased to announce that we have released a new online tool to provide insight into our compliance, inspection, and recall activities. This new dynamic tool represents a departure from the...

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5 Benefits of Best-Sourcing Medical Device Teams

October 2, 2014 8:30 am | by Martine Janicki PhD, PEng and a PMP, Project Manager for IHealth | Comments

“Talent management is more than an operational practice, it is skilled art form. Human resources acquisition is the single most important area that will determine the design success or failure.” Best-Sourcing was coined by Tom Peters and...

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FDA’s New Roadmap for Progress: Strategic Priorities 2014-2018

October 1, 2014 10:18 am | by Margaret A. Hamburg, M.D., Commissioner, FDA | Comments

The U.S. Food and Drug Administration regulates products that represent about 20 cents of every dollar American consumers spend on products. This includes the safety and effectiveness of drugs, medical devices, and vaccines, the safety of blood...

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Tighter Focus and Lower Costs

October 1, 2014 8:30 am | by Chetan N. Patel, President and Founder, SMC Ltd. | SMC, Ltd. | Comments

Obviously supply chain management is very important to contract manufacturing of any kind. With the amount of regulations and sub-tier supplier management needed, the OEM needs to be confident that the product being bought by the Contract...

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Thrilling Potential in 'Hitchcock Therapy'

September 30, 2014 9:16 am | by Sam Brusco, Editorial Intern | Comments

A shrouded man holding a gun stands in a dark room, breathing heavily, just behind the door. Your heart races and your whole body tenses as you silently (or often, vocally) beg the character about to enter the room, “Don’t go in there!” It's as if...

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Communicate Early and Often

September 30, 2014 8:30 am | by Trisha Mowry, CEO, Metal Craft | Comments

Engaging contract manufacturers as a partner allows each company to focus on core capabilities and best use of dollars and talent. Bringing on strategic partners to round out your supply chain with experts who are focused their specific...

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Examining the Physician Office Lab Market: CLIA and Technology

September 29, 2014 9:21 am | by Richard Park, Contributing Editor | Comments

Kalorama Information recently released a report entitled, “Physician Office Laboratory Markets, 3rd Edition,” which provides a complete review of this important segment of the IVD industry. The following presents some of the report’s analyses...

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Intellectual Property for Competitive Advantage

September 29, 2014 8:30 am | by John Whynott, Technical Product Manager, Mikrotech | Mikrotech | Comments

It is important and will always remain important. Most medical devices manufacturers have difficulty sustaining leadership in all areas of manufacturing (vertical integration). A more cost-effective approach is to outsource areas they have...

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Important to Establish Trust

September 26, 2014 8:30 am | by Steve Heckman, Sr. R&D Engineer, Plastics One | Plastics One, Inc. | Comments

To a degree it has always been important. The OEM expects the part their subcontractor builds meets the specifications they require. As a contract manufacturer, we generally take responsibility for sourcing all of the components required...

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'Aging in Place' and Staying Active

September 25, 2014 8:30 am | by Carly Dumas, Software Engineering Manager, Breck Petrillo, Director of Engineering, Andrew Leoncyzk, Sr. Electrical Engineer; Ximedica | Ximedica | Comments

Ximedica is helping our customers leverage consumer electronics as adjuncts, or alternatives, to dedicated user interfaces and device controls. This is common in home based wellness devices, with connectivity to near field cell phones and...

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Biosensors in Smartphones and Tablets

September 24, 2014 8:30 am | by Karthik Soundar, Segment Manager, Texas Instruments | Comments

Assembly technologies that were developed to enable miniaturization of smart phones and to support high-volume production over the last 5-10 years are finding their way into health/fitness and medical devices. Examples include wafer chip scale...

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From the Hospital to the Home

September 23, 2014 8:30 am | by John DiCristina, Medical Equipment Director, Strategic Marketing Group | Comments

The main efficiency driver is the elimination of the package and moving to wafer level packages (WLP). This allows for better cost efficiencies and for dense pin outs reducing the PCB board area. We also have the ability to package multiple...

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The Clutter of Wires, a Thing of the Past

September 22, 2014 8:30 am | by Tony Zarola, Vital Signs Monitoring Marketing Manager, ADI | Analog Devices, Inc. | Comments

No, not at all, apps alone cannot replace medical devices. Sensors/connectivity interfaces to the patient along with signal processing elements are still required to measure the patient’s vital signs accurately. The apps can complement the...

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