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Combating Infections with the Right Materials (A Roundtable Q&A)

June 5, 2013 3:55 pm | by Gopal Saraiya, Global Segment Leader—Medical Devices, Eastman Chemical Company | Eastman Chemical Company | Comments

Eastman’s Gopal Saraiya, global segment leader of medical devices at Eastman Chemical Company, took time to address a number of questions related to the use of materials in medical device development. He was included in the staff written article, “Materials Impact Medical Device Design Trends.” Following are all of the responses he provided.


The Rise of Mobile Health and the Importance of Human Factors

June 5, 2013 2:23 pm | by Laurie Reed, Senior Human Factors Engineer, Farm | Farm | Comments

Human factors engineering, as applied to the design of medical devices, has never been as important as it is today, especially since the release of the U.S. FDA’s draft guidance document Applying Human Factors and Usability Engineering to Optimize Medical Device Design. With the rise of mobile health apps, human factors engineering principles will become even more vital to the success of this industry and to the safety of the patients.


Will Connected Health Save the Healthcare Industry?

June 4, 2013 3:07 pm | by Ralph Hugeneck, Director of Medical Technology, and Gary Baker, Marketing Communications Manager, Jabil Healthcare & Life Sciences | Jabil | Comments

The medical device ecosystem is changing dramatically from stand-alone “device + patient + physician” in the clinical environment to include access and mobility outside the four walls of the hospital. Every medical device manufacturer should consider developing a strategy around how mobile connected health will affect their business models and how they will play in the evolution of the market.


Medical Technologies: The Ones to Watch

June 3, 2013 12:33 pm | by Kevin Bottomley, Managing Director, Results Healthcare | Comments

The growth in sales of medical technologies is set to outperform prescription medicines over the coming five years. Data from Evaluate Medtech indicates that over the period 2011 to 2018, the overall global compound annual growth rate for the sector will be 4.4%, in contrast to just 2.5% for drug products.


Distributing Healthcare

May 31, 2013 3:20 pm | by Sean Fenske, Editor-in-Chief, MDT | Comments

One of the most interesting things about my position is seeing the changes in one of the most dynamic industries around—the medical device industry (and, in a broader sense, the healthcare industry). In my 13+ years of reporting on this industry, I’ve seen many changes and technological advances. It truly is remarkable to think about how far certain sectors of the industry have come in what is really a very short period of time.


Home Healthcare and Home-Use Medical Device Design

May 30, 2013 3:14 pm | by Kristina Bosland, Sr. Human Factors Engineer, Farm Design | Farm | Comments

Home healthcare and the use of medical devices outside of the professional healthcare environment are on the rise. Modern medicine allows us to live longer and provides those with chronic diseases the ability to receive medical care at home. Examples of home-use devices are oxygen concentrators, hospital beds, sleep apnea monitors, body-worn nerve and muscle stimulators, and dialysis machines, just to name a few.


Medical Device Technology: Our Best Hope for Delivering Global Healthcare

May 29, 2013 11:36 am | by Simon Karger, Associate Director, Surgical & Interventional, Cambridge Consultants | Cambridge Consultants Inc | Comments

The technology at the heart of the next generation of medical devices is critical to our ability to offer comprehensive care in the coming decades. While our current systems of care have served us well thus far, they are crumbling under the pressures of modern expectations of care, economics, scale, and the sheer breadth of medical science.


Next Generation of Visual Inspection Systems

May 28, 2013 2:58 pm | by Jim Norton, President, Custom Products & Services | Comments

In recent years, many electronics manufacturers have been adopting the use of video inspection systems utilizing digital cameras to perform many of the visual inspection functions formerly performed with optical microscopes. Digital camera technology has improved to the point where the image quality now rivals that of optical instruments for many applications.


Benefits of Supplier Collaboration in Business Development

May 24, 2013 1:11 pm | by Elizabeth Borelli and Anita Beahm, Beahm Designs | Beahm Designs, Inc. | Comments

Industry-wide, companies of all sizes are discovering one of the most effective tools in business growth—collaboration. Gartner Research Group findings cite that collaborative capabilities have allowed top patient care organizations to make great strides in enabling high-quality care at optimal economic cost.

Improving Patient Safety with Unique Device Identification

May 23, 2013 11:35 am | by Warren Ward-Stacey, Sales Director, PRISYM ID | Comments

Medical device manufacturers should welcome the proposed ruling for Unique Device Identification (UDI); however, being compliant by the effective date (based on classification) for some organizations may be a concern. UDI aims to identify errors involving medical devices and provide more rapid resolution of device problems.


Silicon Nitride: A Next Generation Spinal Implant Material (Q&A)

May 22, 2013 2:55 pm | by Sean Fenske, Editor-in-Chief, MDT | Comments

Eric Olson is the chief executive officer and president of Amedica, the only company that produces medical grade Silicon Nitride. He took a moment to participate in the following Q&A about the unique material and its impact in medical devices, specifically in the orthopedic implant area.


Changing from Gamma to E-Beam

May 21, 2013 2:38 pm | by Larry Nichols, COO, and Bob Starrett, CTO, NUTEK Corporation | NUTEK Corporation | Comments

Ordinarily, changing from a validated gamma sterilization process to E-beam sterilization requires running a dose mapping study and doing a dose verification study similar to a routine quarterly dose audit. The standard radiation validation requirements of ISO 11137 require that data be “available to show that, using the same sterilization dose, microbial inactivation is not affected by differences...

Preparing for Medical Electronics RoHS Compliance

May 20, 2013 2:33 pm | by George Karalias, Director of Marketing & Communications, Rochester Electronics | Rochester Electronics | Comments

Next July, certain medical electronics will fall under the scope of RoHS—the European Union’s Restriction on Hazardous Substances. In terms of the electronics industry, that is now a tight deadline for manufacturers. Medical devices that have so far been exempt from RoHS fall into scope under the RoHS Recast (RoHS 2) beginning in July 2014.


Addressing Health Data Security with Today’s Devices

May 17, 2013 3:13 pm | by Kasey Panetta, Managing Editor, ECN | Comments

While the advent of electronic health data offers impressive potential when it comes to treatment and diagnosis, it brings with it a host of security issues. The issue is cumbersome and often slow-moving regulatory bodies are scrambling to keep up with the quickly changing landscape of the medical world and they’re leaving a path of semi-regulation in their wake.


Remove the ‘Frankenstein Effect’ from Medical Devices

May 16, 2013 12:19 pm | by Bob Frostholm, Director of Sales and Marketing, JVD Inc. | Comments

Nowhere is the concept of developing a system with ‘point-products’ more hazardous than in medical devices. It is here that the performance of every aspect of the system is critical to the long-term behavior of the end product. Interoperability between components takes on a whole new meaning in the context of critical care. Like Shelley’s monster, multiple devices from multiple suppliers will perform differently under identical conditions.


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