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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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Look Beyond Traditional Adhesives

November 25, 2014 7:30 am | by Ravi Ramjit, Ph. D, VP of R&D, EuroMed | Comments

Advances in adhesive development technology have allowed medical device manufactures to engineer new product solutions in the wound care space. Traditional, overaggressive adhesives have been plagued by patients reporting pain and trauma...

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Micro Molding Drives Innovation for MedTech

November 24, 2014 9:27 am | by Dale Gildemeister, Program Manager, Sil-Pro | Sil-Pro, LLC | Comments

As medical processes become less invasive and the expectations for rapid recoveries increase, the need for smaller devices is driving the need for micro-molded components. The tools used to manufacture micro-molded components are becoming...

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WHO: Ebola IVDs Urgently Needed

November 24, 2014 9:00 am | by Richard Park, Contributing Editor | Comments

Last week, the World Health Organization (WHO) released an assessment of the Ebola virus situation. In its assessment, WHO stressed that IVDs for Ebola are “urgently needed.” “The goal of interrupting chains of Ebola virus transmission depends...

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Friday 5: Don Labriola of QuickSilver Controls Speaks on Automated Healthcare

November 21, 2014 10:23 am | by Sean Fenske, Editor-in-Chief | Comments

According to Labriola, he “grew up” at Beckman (now under Danaher), starting with the company at age 17 and worked there for the next 20 years of his career. Most of his time was spent in the Medical Diagnostics Group. “I worked on the electronics...

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Converging Medical Device, Drug, and Biotech Companies

November 21, 2014 7:30 am | by Michael Drues, Founder & President, Vascular Sciences | Comments

Most device development is evolutionary, (i.e., come out with one device, tweak it a bit to make a new device, etc.) I understand the advantages of evolutionary device development from a technology perspective, from a business perspective...

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Top 10 Ways to Cut Manufacturer Supply Chain Costs

November 20, 2014 3:34 pm | by Denise Odenkirk, Senior Director, Industry Solutions, GHX | Comments

Although over 85% of med-surg manufacturers are transacting electronically with providers, manual, paper-based supply chain processes for other medical devices, such as implantables continues to contribute significantly to the soaring costs in healthcare...

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Working More Closely With Hospital Systems and Payers

November 20, 2014 7:30 am | by Michael Pereira, Senior Vice President of Technology & Operations, Ximedica | Ximedica | Comments

Innovations are occurring from multiple paths, all fueled from a consumerization of the medical industry. Our expectations as patients, or as clinicians, or even as payers are changing what is acceptable coming from the medical device industry...

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Preventing and Reducing Hospital Admissions

November 19, 2014 7:30 am | by Marc Dubreuil, Vice President of Business Development, Farm Design | Comments

We are beginning to see more integration of capabilities in order to provide imaging, diagnostics, and tissue manipulation within a single device and procedure. This allows the clinician, after confirming suspicious tissue, to biopsy, ablate...

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Search History for 'Lessons Learned'

November 18, 2014 7:30 am | by Deborah Kacera, Regulatory & Industry Strategist, Pilgrim Quality Solutions | Pilgrim Quality Solutions | Comments

Increased quality and regulatory oversight, increased demand from an aging population and reduced reimbursements are realities for medical device companies. The Medical Device industry will have to focus on reducing costs in the product...

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Assessing the Good and the Bad in the LDT Guidances

November 17, 2014 2:35 pm | by Richard Park, Contributing Editor | Comments

FDA recently released 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 guidances, the agency...

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