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Easing the Burden on Healthcare Professionals

December 10, 2014 7:30 am | by Jan Wittenber, Member of IEEE and Fellow at the Center for Medical Interoperability | Comments

The following from the Background section of the ISO/IEEE 11073 Personal Health Data (PHD) Standards addresses this topic appropriately: “Demographics changes (the rapidly aging population in many industrialized countries) and an increase...

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Home (Healthcare) Is Where the Need Is

December 9, 2014 7:30 am | by Carlos Castillo, Biomedical Engineer & Research Biomedical Engineering Advisor, Loma Linda University Zhang Neuroscience Laboratory | Comments

Short answer, where the need is! Perhaps numbers will make this more clear. Sen. Rob Portman (R-Ohio) gives us the first part of this equation “Each day, 10,000 baby boomers retire and begin receiving Medicare and Social Security benefits”... 

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IVD Companies Join Ebola Fight

December 8, 2014 9:58 am | by Richard Park, Contributing Editor | Comments

While the initial hysteria and fear of an Ebola pandemic has quieted down, the fight against this disease is far from over. National Public Radio reported that there were 537 new Ebola infections in Sierra Leone in one week, which is the largest weekly...

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Bionic Bra Proves Necessity Is Apparently Not the Mother of Invention

December 8, 2014 9:34 am | by Melissa Barnes, Associate Editor | Comments

The recent story about a “Bionic Bra” from the University of Wollongong had me wondering...why?! Of all the medical devices we have a dire need for, a sensor-equipped, “smart yarn”-infused, automatic-tightening bra certainly isn’t one of them. The...

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Exploit Opportunities Offered by UDI Initiative

December 8, 2014 7:30 am | by Dave Taylor, Vice President, Global Products, PRISYM ID | Comments

Sep. 24 saw the first UDI compliance deadline which means that organizations should now be focusing on the implementation phase, following a thorough preparation phase reviewing all current processes and systems in place. The implementation...

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A Harmonic Convergence of MedTech

December 5, 2014 2:08 pm | by Sean Fenske, Editor-in-Chief | Comments

Honestly, if you attend Medica and don’t find yourself exhilarated by all the creativity and innovation that’s happening in the medtech space, you’re in the wrong job. The event is not just an educational or networking opportunity, but rather an event that truly celebrates medical technology...

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Friday 5: Connecting Healthcare with TE Connectivity's Thomas Medina

December 5, 2014 9:42 am | by Sean Fenske, Editor-in-Chief | TE Connectivity, Ltd. | Comments

I foresee a continuous transition from body-worn to body-integrated devices designed to deliver very specific, customized care. Device function will be monitored and controlled remotely, determined via gene-based diagnosis and therapies; and will be...

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Trust, But Verify In Order to Comply with UDI

December 5, 2014 7:30 am | by Steve Cochran, Chief Technology Officer, GHX | Comments

“Trust, but verify” is my advice to manufacturers seeking to comply with the UDI rule. As a third party submitter that has successfully loaded data into the Global UDI Database (GUDID), I can confidently tell manufacturers, "trust that it...

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Develop an Internal Team for UDI

December 4, 2014 7:30 am | by Deborah Kacera, Regulatory & Industry Strategist, Pilgrim Quality Solutions | Comments

Working with industry, we still see a need for more internal conversations among various stakeholders within organizations for an effective rollout of UDI. This is because the regulation has “amended” many existing regulations that will impact...

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Roll-Out UDI to the Device Manufacturer and Supply-Chain Partners

December 3, 2014 7:30 am | by Matt Kelly, Key Account Manager, Medical, Watlow | Comments

The Food and Drug Administration (FDA) has released a final rule requiring that most medical devices distributed in the United States carry a unique device identifier, or UDI. A UDI system has the potential to improve the quality of...

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Have A Solid Team in Place for UDI Compliance

December 2, 2014 7:30 am | by Linda Chatwin, Esq, RAC Manager, Medical Regulatory Advisory Services North America, Life and Health, UL LLC | Comments

Preparing for UDI requires a well-thought through project plan. Someone in the organization needs to own the project and manage it carefully, or bring in outside resources to help. The key to success lies in examining current labeling processes...

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Lab Group Hires Lawyers for LDT Fight

December 1, 2014 9:23 am | by Richard Park, Contributing Editor | Comments

The American Clinical Laboratory Association (ACLA) has retained former Solicitor General Paul D. Clement, a partner with Bancroft PLLC, and Laurence H. Tribe, the Carl M. Loeb University Professor and Professor of Constitutional Law at Harvard University...

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3D Printing to Eliminate Assembly

December 1, 2014 7:30 am | by Norm Riley, Technical Marketing Director, Applied Silicone Corporation | Applied Silicone Corporation | Comments

Advances in adhesives technology for wound care directly affect the quality of treatment.  Hydrophilic wound care adhesives provide longer wear between dressing changes, which prolongs the optimal healing environment. Bio-inert and vapor...

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A MedTech Thanksgiving Tale

November 26, 2014 8:30 am | by Sean Fenske, Editor-in-Chief | Comments

Not so long ago, the collective nations of the medtech Native Americans co-existed in relative peace in a land far from all others. Sure, there was the occasional squabble between tribes, while other times, one tribe would absorb a smaller tribe into...

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Recognizing Market Shifts and Providing Support

November 26, 2014 7:30 am | by Alexandra Kiniry, Global Marketing Manager for Medical, Henkel Corporation | Comments

Fast Cure - The majority of medical device companies Henkel supplies produce disposable assemblies. Therefore fast curing adhesives allow manufacturers to improve their yields and cycles times. ISO 10993 Certification - ISO certification is...

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