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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.

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.

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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.

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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.

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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?

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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.

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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.

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