By Melissa Masters

Cybersecurity is a growing concern in all aspects of our lives. From our home computers, servers that store our credit card information and identities, and now our medical information and medical devices that we rely on to keep us healthy (and even alive in some cases) are all at risk. But, with new FDA guidance and growing media awareness, the bar is being raised regarding the expectations for a secure device. At the same time, the opportunities for attacks by cyber criminals are increasing. Securing devices, systems, and infrastructure is a critical issue for all of our safety and the challenges here are great.
 

...

September 24th, 2014
0

If you're heading to Minneapolis October 29 and 30 for the show, here are four happenings you'll want to catch.

Minneapolis has long been the center of the medical device universe, serving as a home to industry giants and startups alike. And on October 29 and 30, 2014, thousands of other industry professionals will converge on this important medical device industry hub for MD&M Minneapolis, the Midwest’s largest medical design and manufacturing conference and exposition. If you’re heading to Minneapolis for the show, here are five happenings you won’t want to miss.

Conference Sessions

Stay on top of industry trends and developments by attending some of the educational sessions available at the...

September 23rd, 2014
0

FDA has announced its intention to issue draft guidances on the regulation of laboratory-developed tests—a controversial decision that could increase the burden of compliance and stifle innovation.

By Allyson B. Mullen

Allyson Mullen

For decades, FDA has asserted that it has the authority to regulate laboratory-developed tests (LDTs). But on July 31, 2014, FDA took its biggest steps yet toward actively regulating such tests: FDA notified Congress of its intent to issue two draft guidance documents regarding oversight of LDTs, entitled “Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)” and “...

September 19th, 2014
0

Historically, the United States has been at the forefront of innovation in the life sciences. And yet there appears to be evidence that the dominance the country has held for decades may be fading. Upstarts in emerging regions like Asia are catching up making the U.S. somewhat of an old guard.

Data and charts from the Life Sciences Cluster Report published in June by Jones Lang LaSalle, a commercial real estate firm, capture this shift. The data was shared at a recent event organized by LifeScience Alley, a Minnesota industry association.  The analysis is based on the number of Patent Cooperation Treaty applications...

September 18th, 2014
0

By Wendy Mach and Jennifer Gygi

           
The dark areas indicate where the seal is starting to clarify.

Before package testing can begin, there are several items that need to be considered, including—but not limited to—cost, sample size, test method, and acceptance criteria. Arriving at the perfect combination of variables in a packaging test validation procedure is just the beginning.

But what if your packaging fails to perform as expected?  The answer is simple: investigate. A test failure does not automatically mean that the packaging is inadequate. It does, however, demand evaluation and adjustments. A...

September 12th, 2014
0

We routinely talk about advances in medical technology, recording excitement from physicians who believe that new technologies that can prove their clinical effectiveness will bring better outcomes for patients.

Startups developing innovative technologies are also aiming to change the status quo of conventional disease treatment. But this infographic from medexsupply.com succinctly captures how far medical technology has altered over time that has resulted in huge changes in the way everything from the common cold to mental conditions are treated.  

...

September 12th, 2014
0

Proactive medical device companies are taking a more strategic approach to the management of data by implementing fully integrated, end-to-end label life cycle management systems that capture, store, and disseminate data safely, quickly, and accurately.

By Warren Ward-Stacey

Across the global medical device sector, the way many companies approach the design, creation, and printing of labels is both variable and fragmented.

It’s typically an onerous—and often primitive—process that’s not only inefficient and costly, but also resource-intensive, a hostage to product updates and country-specific regulatory requirements, and prone to human error. Worse still, label data rarely integrates with other organizational business systems...

September 10th, 2014
0

New technologies, regulations, and corporate megamergers have made summer 2014 a busy one for medtech. The programming at MD&M Chicago is geared toward keeping you on top of the latest industry trends. 

Keynote Speakers

In the wake of their recently announced merger, MD&M Chicago will be featuring keynote presentations from representatives from both Medtronic and Covidien. On Thursday, October 16, Dr. Todd Zielinski, senior principal scientist at Medtronic, will share case studies on deep...

September 10th, 2014
0

China is one of the world's fastest-growing medical device markets, so it's no surprise that companies are racing to capture a share. But if you were expecting to simply bring products designed for Western markets to China, you better think again.

China's medical device market has its own unique dynamics, and users there have needs that differ from those of users in other parts of the world. Smart companies understand that and have learned to adapt their products for this emerging market. 

Worrell, a product design, development, and strategy firm that collaborates with medical device companies and entrepreneurs, collected a few tips for designing medical devices for the Chinese market from industry leaders who have already established a foothold in the country: 

...
September 9th, 2014
0