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How the Smartphone Can Revolutionize Healthcare

September 10, 2013 3:15 pm | by Chet Kolley, Business Unit Vice President, GlobalLogic | Comments

Over 200 million people have downloaded a healthcare application to their smartphone. However, only a small number of those downloaded apps are used regularly and, since most apps are free, even a smaller number of applications actually generate any revenue.


The New FDA Draft Guidance for Biocompatibility: What You Need to Know

September 9, 2013 2:27 pm | by Thor Rollins B.S. RM(NRCM), Biocompatibility Expert, Nelson Laboratories | Nelson Laboratories, Inc. | Comments

In a draft guidance document, FDA has placed its summary of ideas regarding biocompatibility and possible changes that could eventually replace FDA G-95 Blue Book Memorandum #G95-1 on biocompatibility. The draft document has been out since April and is widely available, though it has not been formally released.


Sensing a Healthcare Revolution

September 6, 2013 12:06 pm | by Mark Winter, Senior Director, Nokia Sensing XCHALLENGE and the Qualcomm Tricorder XPRIZE | Comments

In today’s interconnected world, it’s easier to set a DVR from an airplane seat or remotely watch the kids arrive home than to gather significant data about our health. Traditional office visits, laboratory tests, and hospital-based equipment are still the primary means of acquiring information about a person’s health.


Possible Replacement of the Rabbit Irritation Test with an In Vitro Model

September 5, 2013 3:45 pm | by Thor Rollins B.S. RM(NRCM), Biocompatibility Expert, Nelson Labs | Nelson Laboratories, Inc. | Comments

In order to reduce unneeded animal testing and possible cost and duration of testing, the ISO 10993 committee is looking to add an in vitro option to irritation testing. For the past 20 years, if you wanted to test for irritation, you had to do a version of the animal irritation test.

Is Surgeon Driven Innovation the Future for Medical Device Development?

September 4, 2013 2:57 pm | by Fiona Haig, Manager—Surgical Sector, Sagentia | Comments

Anyone who has ever been in an OR with a surgeon will know that pleasing them with your new device is no mean feat! So should we be looking at surgical innovation in a different way? Is industry completely misaligned to the needs of the surgeon and should we be looking to our surgeon customers to drive our approach to innovation?


Special Patent Considerations for Medical Device Manufacturers

September 3, 2013 2:04 pm | by Justin N. Mullen, KramerAmado, P.C. | Comments

Intellectual property has become an increasingly hot topic recently in the medical and biotechnology field. Recently, the Supreme Court upheld non-naturally occurring DNA as being patent eligible in Association for Molecular Pathology v. Myriad Genetics.

Packaging Provides Initial Dataset Necessary for Patient Confidentiality

August 28, 2013 3:49 pm | by Tom Egan, Vice President, Industry Services, PMMI | Comments

Making sure patient information is secure begins with coding on the package. No matter to whom the medical device is targeted—for a specific patient, hospital, or doctor—the coding placed on the package is the first part of the data set used to track the device.


Security for EHRs

August 28, 2013 3:32 pm | by Steve Spatig, General Manager, Electronic Access Solutions, Southco | Southco | Comments

While the adoption of electronic health records helps healthcare facilities streamline data collection and retention, it also presents challenges when it comes to security. Traditional paper file storage in healthcare facilities is being replaced by computers and portable electronic devices that are often more exposed to threats.


Your Data Is Only as Secure as Your Device

August 28, 2013 3:24 pm | by Alan Grau, CEO, Icon Labs | Comments

The inherent insecurity of many medical devices was highlighted in a recent FDA and Homeland Security alert. Over 300 devices have been identified that utilize a hard code password, creating a huge security loophole. With so many medical devices now collecting and storing patient data, this raises the question of how secure is the data stored on these devices?


Designing Medical Electronics

August 27, 2013 3:16 pm | by Guy Francfort, Vice President, Sales and Marketing, MEGA Electronics Inc. | Mega Electronics, Inc. | Comments

Guy Francfort, vice president of sales and marketing for MEGA Electronics Inc., was a part of the staff written article, “Portability Is the Name of the Game.” He took time to present a full array of responses that were not able to be included in the article, so they are presented here.


A Look at Today’s Medical Electronics Landscape

August 26, 2013 4:28 pm | by Mel Berman, former Product Marketing Manager, TDK-Lambda Americas | Comments

Mel Berman, former product marketing manager (now retired) for TDK-Lambda Americas, was a part of the staff written article, “Portability Is the Name of the Game.” He took time to present a full array of responses that were not able to be included in the article, so they are presented here.


Medical Device Manufacturers Put Quality Management at the Core of Their Global Business Processes

August 23, 2013 4:23 pm | by David Medina, Vice President, QAD Life Sciences | QAD | Comments

The real challenge facing life science companies is that meeting these extensive regulatory and quality procedures, codified in cGMP [current good manufacturing practices] regulations burdens companies, delays product rollouts, impedes innovation, and hinders business processes.

Giving Color to the Medical Device Designer

August 21, 2013 12:03 pm | by David Scott, Global Creative, KYDEX, LLC | KYDEX, LLC | Comments

In recent years, we have seen a notable increase in the use of thermoplastics in medical devices. All signs indicate that this growth will continue as the medical device market expands across the globe. We’ve also witnessed closer collaboration between designers and manufacturers at earlier stages of the design process.

Healthcare Workplaces Deemed Most Dangerous for Employees

August 21, 2013 11:52 am | by Dave Johnson, COO, Skyline Medical Inc. | Comments

Healthcare personnel dedicate their time and effort to saving lives; in return, they should not have to compromise their own health and safety. As anyone who has spent time in or around an operating room knows, improvements are long overdue for the hazardous conditions that lead to slips, falls, or exposure to potentially harmful hazardous materials.

Borrowing from Cell Phone Technology

August 20, 2013 4:10 pm | by Stephen Swift, Senior VP & GM, Medical Products, Microsemi Corporation | Microsemi Corp./Corporate | Comments

Stephen Swift, senior VP & GM of Medical Products at Microsemi Corporation, was a part of the staff written article, “Portability Is the Name of the Game.” He took time to present a full array of responses that were not able to be included in the article, so they are presented here.


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