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Gentlemen, We Can Rebuild Him. We [Will] Have The Technology.

October 1, 2013 3:35 pm | by Sean Fenske, Editor-in-Chief, MDT | Comments

One day, I envision that there will be medical technology that can exceed the capabilities of the human body’s natural physiology. Should someone with such a device be prevented from playing professional sports due to the competitive advantage it provides?

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Study Focuses on How Plasticizers in PVC Affect Non-PVC Plastics

September 30, 2013 2:13 pm | by Daniel J. Marshall, Technical Service Associate, Vinyl Division, Teknor Apex Company | Teknor Apex Company | Comments

Scores of medical manufacturing professionals have contacted Teknor Apex Company in the few days since we announced the results of a study we conducted on the effects of plasticizer migration on non-PVC device components that come into contact with components made of PVC.

Is Tape Encryption the Answer for Data Security?

September 27, 2013 4:22 pm | by Laura Loredo, Product Marketing Manager, Nearline Storage, Hewlett Packard; Craig Butler, Senior Program Manager, Data Protection and Retention Systems, IBM; and Yan Yan Liang, Segment Marketing Manager, Quantum Corporation | Comments

Medical professionals can agree that protecting patient information is one of their top priorities. Patients put a lot of trust into their healthcare providers to maintain that their information is never lost or stolen, and providers are subject to rigorous standards, such as the Health Insurance Portability and Accountability Act (HIPAA).

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Securing Patient Data in Motion and At Rest

September 26, 2013 3:57 pm | by Vivian Funkhouser, Principal of Healthcare Vertical Solutions, Motorola Solutions | Motorola | Comments

Data security is a hot topic in the healthcare industry. Healthcare network providers have the difficult task of identifying the correct technology to collect and store data all while maintaining a secure network to communicate and transmit the data. It is important to not only consider the type of technology healthcare networks utilize to collect data...

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Device Makers: Custodians of Patient Data

September 25, 2013 3:04 pm | by Charles Murphy, Vice President, Cloud Operations, Pilgrim Software | Pilgrim Quality Solutions | Comments

The key to protecting PHI data is education, execution, and continuous verification. The first thing is to understand your obligation as a custodian of this sensitive data. This is best done through formal HIPAA/HIPAA-HITECH training to understand the regulation.

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Determining Marginal Improvement in Innovation

September 25, 2013 10:23 am | by Keith Calvert, Director, CMNA Engineering Administration, The Tech Group | The Tech Group, Inc. | Comments

Research and development is the cornerstone of growth in the medical device industry. R&D funding is available; however, the issue isn’t availability as much as availability for marginal improvement. The question to ask is, “Will a marginal improvement reduce costs for the patient and caregiver?”

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Medical Innovation, One Brick at a Time

September 23, 2013 4:52 pm | by Sean Fenske, Editor-in-Chief, MDT | Comments

I can be a kid at heart. And when I say that, I state it with an almost literal meaning. I still enjoy toys. Now, I’m not the 40-year-old virgin character from the movie of the same name, but I can’t admit to not still tinkering with Lego bricks and finding enjoyment from it.

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Innovation Will Come via Investment

September 20, 2013 1:59 pm | by James H. Bleck, President/CEO, Bleck Design Group | Bleck Design Group | Comments

We see funding for new medical devices driven by private investment from individuals or private companies. These bold investors are capable of quick decisions as they meter the funding to match progress and discover the real market opportunity.  

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Will The Wave of New Wearable Products Change Product Development?

September 19, 2013 12:03 pm | by Kevin Prendeville, Managing Director, Accenture’s Product Lifecycle Services practice | Comments

The buzz around wearable technology has been escalating the past several months. In fact, wearable technology has moved beyond product concepts to actual products worn by consumers. These include virtual reality eyeglasses, sophisticated health monitoring devices housed within an elastic wristband, sensor-based canes for the blind, and smartwatches with many features.

Partnerships Can Keep Medical Innovation Alive

September 18, 2013 12:21 pm | by Greg Thompson, VP of Engineering, Sanmina Medical Division | Comments

The financial pressures medical device OEMs are facing are very real. They’re experiencing reduced reimbursements from the government and insurance companies, increased taxes, and global competition. As a result, new business models are evolving to ensure new product innovation is not stifled and, most importantly, patient safety is not compromised.

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Innovation Impacted for Start-Ups

September 17, 2013 4:02 pm | by Randolph J Sablich, President and CEO, Metrigraphics, LLC | Metrigraphics, LLC | Comments

While Metrigraphics LLC certainly does not speak for the medical device OEM industry, as a custom contract manufacturer of leading edge micro components, we certainly feel the impacts of various external elements on the ebb and flow of R&D and innovation activities of the OEMs.

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Addressing Financial Pressures in Device Development

September 16, 2013 3:10 pm | by James Schultz, Research and Development Engineer, Plastics One | Plastics One, Inc. | Comments

As OEM’s streamline to meet financial pressures, top level designs will be emphasized but second and third level particulars will adhere more closely to a suppliers understanding of their present capability. The particulars are under a fine balancing act and vision outside will require a thorough knowledge, down to the step-by-step production process to lean out waste.

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Existing Equipment Still has Staying Power—Part 2

September 13, 2013 3:53 pm | by George Karalias, Director of Marketing and Communications, Rochester Electronics | Rochester Electronics | Comments

In Part 1 of this blog, we discussed disruptive technology as it pertains to the medical equipment market. Due to the high cost of leading-edge medical technology, sales are lagging for the most cutting-edge systems, such as hybrid x-rays, which combine radiology/cardiology interventional x-ray systems.

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Existing Equipment Still has Staying Power—Part 1

September 11, 2013 12:13 pm | by George Karalias, Director of Marketing and Communications, Rochester Electronics | Rochester Electronics | Comments

Any time a disruptive technology comes along, prior generations of similar technologies are impacted. In the consumer market, customers generally adopt new technology rapidly if the price is right. For higher-value equipment, though, prior generations may find a new lease on life while customers wait until new technology price points come down.

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Updates from ISO 10993 Working Groups’ Italy Session

September 11, 2013 11:41 am | by Thor Rollins B.S. RM(NRCM), Biocompatibility Expert, Nelson Laboratories | Nelson Laboratories, Inc. | Comments

The European Center for the Validation of Alternative Methods performed a validation for in vitro irritation test for cosmetics and chemicals to replace the rabbit irritation test. Nelson Laboratories is participating in a round robin study to see if the validation will apply to medical devices in a three-phase process.

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