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How Will Proposed ISO 10993-1 Change Impact Your Biocompatibility Plans?

October 15, 2013 3:42 pm | by Mark Drlik, Mechanical Engineer and Project Manager, StarFish Medical | Comments

Document UCM348890 (FDA’s April 2013 proposal to change the guidance document for ISO 10993-1) seems pretty straight forward—with things like testing details associated with genotoxicity and how to go about labeling your device as “BPA-free”...

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Suggestion: Incentives for Medical Device Manufacturers Using Indiana-Based Subcontractors

October 11, 2013 4:55 pm | by Tom Ryder, CEO, Genesis Plastics Welding | Comments

It wasn’t just another day in the office at Genesis Plastics Welding. Today I was honored to participate in the Medical Technology Industry Roundtable with Indiana Governor Mike Pence held at the Greatbatch manufacturing facility in Indianapolis...

It’s a Man’s World

October 10, 2013 2:28 pm | by Melissa Barnes, Associate Editor, MDT | Comments

The lack of women in engineering has been an ongoing issue for some time. In terms of progress, we have seen some marvelous improvements and change for the better. But according to the National Science Foundation’s most recent statistics, an astonishing gender disparity remains...

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The Truth about Reshoring, Productivity & Today’s Manufacturer

October 10, 2013 11:01 am | by Jim Shepherd , Vice President of Strategy, Plex Systems | Comments

There’s been a lot of buzz about the reshoring of American manufacturing business that had previously been lost to other regions. The talk seems to center on three areas: Is reshoring actually happening? Are we really going to make up...  

Compliance Conscious Suppliers Enhance Patient Safety

October 9, 2013 5:10 pm | by Seth Stewart, PASE System Designer, Watlow | Watlow Electric Manufacturing Company | Comments

As a strategic supplier to medical OEMs, it is vital that Watlow remains knowledgeable of changes in market needs and regulations. This allows us to design and develop products in a rapid fashion that meet the unique requirements of the medical equipment market.

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The FDA’s UDI Rule is Final! What Now?

October 8, 2013 12:02 pm | by Ken Koldan, Business Development Manager, FLEXcon | Flexcon | Comments

The FDA published the final rule for the unique device identification system (UDI) during the UDI Conference in Baltimore, MD and released it on September 24, 2013. This much anticipated rule will provide a consistent way to identify medical devices and ensure that proper safety regulations are being followed.

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Don’t Need a Cleaning and Disinfection Validation? Check Again!

October 7, 2013 3:59 pm | by Mike Neilson, Section Leader, Healthcare Reprocessing, BS, RM (NRCM) CQPA (ASQ) | Nelson Laboratories, Inc. | Comments

When you hear the term “reusable medical devices,” you may think of surgical instruments like forceps or scissors. Reusable devices often have intimate patient contact, become grossly soiled during use, and need to be reprocessed before their next use.

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Evaluating FDA Guidance for RF Wireless Technology in Medical Devices

October 7, 2013 8:55 am | by Kenneth MacCallum, PEng, Principal Engineering Physicist, Starfish Medical | Comments

Last month, the FDA issued a guidance document for RF wireless technology in medical devices. Not surprisingly, the FDA is recommending a risk-based approach to design, testing, deployment, and maintenance of medical device development. This follows the risk-based approach to safety that was introduced in the 3rd edition of 60601-1.

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Obamacare vs. The ACA: A Lesson in Branding

October 3, 2013 3:21 pm | by Sean Fenske, Editor-in-Chief, MDT | Comments

You might produce the most groundbreaking piece of medical technology available tomorrow, but if the name makes it sound like the same ol’ tired thing that’s already available, sales will most certainly reflect that. No amount of sales and marketing teams hitting the pavement will change that.

Tool Reconditioning Fits Nicely with Lean Manufacturing

October 2, 2013 3:09 pm | by Jim Norton, President, Custom Products & Services Inc. | Comments

Although many manufacturing processes have become automated over the past 20 years, there is still a fair amount of manual or hand assembly and rework required. Gone are the days when electronic and industrial assembly required row upon row of technicians carefully assembling circuit boards, electronic modules, or entire assemblies without the assistance of automated or semi-automated equipment.

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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