According to the organizers of the upcoming AdvaMed 2012 conference, the event is off to a strong start. For the first time since its inception in 2007, the medtech conference will be held outside of Washington, D.C. The group opted for the medical manufacturing hub of Boston, Mass. on October 1-3.
The call for company presentations will open today. Last year, more than 60 companies gave presentations. In 2012, the topics that will be covered include blood, cardiovascular, dental, diagnostics, imaging, IVD, health information technology, metabolic disease/obesity, neurology, ophthalmology, orthopedics/spine, technology transfer offices, and wound healing and tissue regeneration.
Mass Device has conducted a study that claims that the device tax would generate far more revenue than the $2 billion a year than intended. Further, the online news source says revenues will be wildly disproportionate.
For example, the editors explore the following demonstrations:
For more than 75% of the other companies on our list, the tax means lower profits by between 5% and nearly 50%. Take Integra LifeSciences which posted U.S. medical device sales of about $593 million last year, according to Integra's annual report. A 2.3% whack would have taken $14 million off the top line – exactly half of Integra's 2011 profits.
At the other end of the spectrum, there's Sirona Dental Systems and the $256 million it logged in domestic medical device...
Usability has been forcefully thrust into the medical device world by, among other things, recent developments at FDA, which, in turn, has meant that more usability experts are working in medical-device development. One thing you may have noticed about my fellow usability folks (i.e., human factors professionals) is that they are prone to whining that they “aren’t involved early and often enough” in the development of medical devices. They have a legitimate point—it’s not ideal to start worrying about usability when you’re doing summative usability testing (i.e., validation research) to prove to the FDA (and TUV and its kin) that your device is adequately safe.
Medical devices have been connected sparingly to the IT network and the requirements of such a connection varies. Today, there is a hard requirement to get the data from the device into an EMR. Even though traditional devices can be connected through various aggregators available on the market, the IT departments recognize that the added layer within their network caused by a third party aggregator adds complexity and expense to the implementation. This complexity also makes it more difficult to implement a consistent security policy that is straightforward to implement and validate. Using multicore and virtualization technology is one way to address the potential issues with security in support of medical devices.
Michael Taborn, Lead Platform Architect, Healthcare Sector, Intelligent...
It has been a little more than a year since Japan was struck by a devastating earthquake and tsunami. The damage was overwhelming in Fukushima Prefecture, recalls Miki Anzai, Editor of Japan Medical Design and Manufacturing Technology. Full reconstruction is still years away, but the local government is working hard to revitalise the area, notably, by promoting it as a centre of medtech development and manufacture, writes Anzai on the medtechinsider blog.
You already know that design traceability is a cornerstone of staying compliant with the FDA’s product development traceability requirements and other international standards for submissions and validation. In many organizations, building traceability matrices is a painful and inefficient process that typically includes manually updating a spreadsheet sometime near the end of a development cycle as the team wraps up loose ends and prepares for release.
Terumo Corp.’s recent announcement that it was forming a joint venture with a subsidiary of Shandong Weigao Group Medical Polymer Co. suggests that Japan’s largest medical device maker needs strong local support to grab a share of the fast-growing peritoneal dialysis (PD) market.
Considering that Baxter International currently has a seeming monopoly on this market and that Terumo has no PD-related sales outside Japan, the Japanese medical device giant says it hopes to take advantage of China’s largest single-use medical device supplier’s nationwide sales network to penetrate the fast-growing sector.
Approximately 1,500,000 people in China suffer from end-stage kidney disease. Currently...