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What Do You Mean You Aren’t Outsourcing?

December 17, 2014 10:07 am | by Sean Fenske, Editor-in-Chief | Comments

When I started covering this industry more than 15 years ago, using outsourcing service providers was something that was done sparingly and much less of a common practice when compared to today. Medical device manufacturers were not ready...

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Reduce and/or Combine Components to Cut Molding Costs

December 17, 2014 7:30 am | by Kelly Peterson, New Product Development Manager, JunoPacific | JunoPacific, Inc. | Comments

Molded-in seals, hermetic seals (LIM), multiple components assembled in-mold, anti-microbial additives, RFID tags, electrical conductivity. The ability to micro-mold components is continually driving the miniaturization of implantable and...

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Integrate Vendor Into Product Development Process

December 16, 2014 7:30 am | by Lars Gerding, Technology Director, Helix Medical | Comments

One great advantage with molding is the freedom to design various shapes and functional features into a part. This freedom includes the choice of raw material with a wide range of properties that are suitable for various applications. Newly...

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Innovative Technologies for DNA Diagnostics and Health Monitoring

December 15, 2014 11:13 am | by Mina Rais-Zadeh, IEDM 2014 Focus Session Chair, Associate Professor, University of Michigan | Comments

Several papers on advanced medical electronics technology will be presented at the IEEE International Electron Devices Meeting (IEDM) in San Francisco on Dec. 15-17, including bio-MEMS, bio-sensors, and technology for DNA diagnostics and...

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Battle Lines Being Drawn Over LDT Regulation

December 15, 2014 9:54 am | by Richard Park, Contributing Editor | Comments

“The heart of Bradley Thompson’s argument rests on, ‘if a company is manufacturing an IVD test, the agency has full authority.’ Developing and performing most LDTs is not ‘manufacturing’ in a recognized sense of the word and never has been (although...

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Miniaturization in the Device Market

December 15, 2014 7:30 am | by Tim Reis, VP of Healthcare Business Development, GW Plastics | GW Plastics, Inc. | Comments

Some new/additional features that can be incorporated are soft touch molding and gasketing functionality because of two-shot molding, aesthetic features and market branding. Medical devices themselves are being downsized into smaller...

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Mobile Vital Signs Monitoring Devices Will Revolutionize Healthcare

December 12, 2014 8:00 am | by Sean Fenske, Editor-in-Chief | Analog Devices, Inc. | Comments

Over the next five years, we are likely to see vital signs monitoring as a universal facet of everyday life. The sensing will be discreet, convenient, and painless. Expert systems will sit quietly in the background and occasionally rear their head to warn...

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Using Smartphone Cameras as Test Strip Reading Devices

December 12, 2014 7:30 am | by Thomas M. Tsakeris, President, Devices and Diagnostics Consulting Group | Comments

In my experience as a regulatory consultant mainly in the IVD area, I have observed over the last year or so an increasing interest in linking traditional IVD home-use test strips such as urinalysis (protein, pH, glucose keytones, nitrite, etc...

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Might Portable Clean Air Hold the Key for Better Health?

December 11, 2014 2:39 pm | by Sean Fenske, Editor-in-Chief | @SeanFenske | Comments

There’s little argument when it comes to the value of clean air. Air pollution – bad! Clean, fresh air – good! However, is creating an environment where someone is exposed to clean air exclusively a good idea? I happened upon a device that is being...

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Collaborating With Clinicians to Set Standards

December 11, 2014 7:30 am | by Tom O’Dwyer, Director of Healthcare Technology, Analog Devices | Analog Devices, Inc. | Comments

Home healthcare can really be divided into two sub-sections, clinical-grade and non-clinical grade. Clinical grade is currently limited largely to glucose testing and blood pressure cuffs. Non-clinical grade refers to areas such as...

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Implementation of the UDI System Is Critical to Public Health

December 10, 2014 10:33 am | by Jeffrey Shuren, M.D., Director, CDRH | Comments

As the FDA works with manufacturers to launch a new system of identifying medical devices using standard bar codes and numbers, we look forward to the day when the system, called the Unique Device Identifier (UDI) system, will be fully set up — with...

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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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