QPack is an end-to-end solution for Application Lifecycle Management, containing all development lifecycle modules, such as market requirements, system specs, development, testing, and delivery. QPack ALM supports the marketing team, system architects, developers and testers by providing each team with professional tools suited to its specific needs and methodologies. QPack...
I meet a lot of Silicon Valley companies but rarely do I come across a story as inspiring as this one. Robert Goldman is the founder of Vascular Designs, a company that just won FDA approval to sell a breakthrough medical device that could save the lives of countless terminally...
Red tape keeps Conficker on medical devicesAnd of course we [i]want[/i] the governmentto run healthcare? If they are interfereng with routine patching due to their regulations, then having those regulations interfere with fixing the issues the regulations caused, maybe it is time they stepped aside and let the staff maintaine...
FDA orders new approvals on old medical devicesYet another agency failing at its job. I am glad they are fixing it.but waiting 30-40 years? Thats just plain failure to do your job. Yet again a manufacturer says "trust me" and the goverment says goofy voice "ok".Where I...
So what we're left with is risky devices that were never tested but lie beyond the reach of civil law because courts claim the untested approval is binding. The new round of tests will close the loophole. by Dana Blankenhorn
The number and variety of wireless medical devices is growing rapidly, driven by the expansion of wireless communication technology and the medical needs of the aging US population. In 2008, two independent groups demonstrated how a defibrillator may be wirelessly attacked. An electromagnetic field enabled a wireless connection with the...
Trinity Biotech wanted to launch a new haemostasis analyser. This required standardised hardware from a solution provider who understood the challenges of regulatory compliance. Dell OEM Industry Solutions Group ISG provided a desktop to support Trinity's custom-built software. As a Trinity approved supplier, Dell simplified the compliance process. Custom Factory...
Medical device depreciation friend or foe?Imaging is just one industrySingapore Airlines enjoys a far better depreciation environment than other airlines and they also have continuously had the newest fleet of planes for years.Pushing that accelerated depreciation to medical imaging will only allow for newer and better imaging for patients. ...
Today's MRIs are so much better than yesterday's the old stuff is worthless, even though it may work well, even though it may have cost a fortune. by Dana Blankenhorn
Conceptus lacked visibility into its performance data, and salespeople found it difficult to check order status. Key metrics were hard to obtain, and reports took days to write. Conceptus deployed Microsoft® PerformancePoint® Server 2007 business intelligence BI software in a solution that integrates with Microsoft Dynamics® CRM and the company's...
One solution for health IT is the use of electronic medical devices that utilize the enhanced management capabilities offered by Intel Active Management Technology Intel AMT. Intel AMT is a set of hardware-based capabilities that expand and enhance the ability of health IT to remotely monitor, maintain, and repair medical...
HemoCleanse, located in West Lafayette, Indiana, designs, develops, manufactures and distributes sorbent-based blood treatment systems. Consisting of a portable core machine and a disposable treatment kit, the machine moves fluids by alternating positive and negative pressure applied to a sorbent suspension in the dialyzer. A customized VersaLogic STD 32 Bus...
With a rapidly approaching March 2010 deadline to comply with the European Union's revised Medical Device Directive, Nerac advises that manufacturers, now faced with an enormous amount of work to complete in a short period of time, take immediate steps to deal with the coming changes. At stake is maintaining...
How medical device makers can improve U.S. health careIt could be that 289,241,887 less people areeasier to take care of?Population of the US: 305,682,000Population of the Netherlands: 16,440,113A minor difference to be sure.Additionally, how many people imigrate, or are illegal to the Netherlands vs the United States? Are these poeple...
Up to date equipment is key to productivity in any business and it's clear that the device industry's policies are holding down that productivity here. by Dana Blankenhorn
Increasing healthcare costs, the prevalence of chronic diseases, an aging "Baby boomer" community, and large emerging markets in countries such as China, India, and Brazil, are creating tremendous demand for affordable, robust, and reliable medical devices to improve the treatment and care of millions of patients worldwide, and to cure...
Will vendors now boycott Massachusetts?Medical device development in MassachusettsSpeaking as a member of the orthopedic medical device industry, it is our hope that the regulatory process will allow input from industry to develop reasonable disclosure guidelines without stifling activities that are beneficial to Massachusetts healthcare consumers. Below is an abbreviated...
ElectroMagnetic Interference EMI from commercially available RFID reader/writers on implantable cardiac pacemakers and cardioverter-defibrillator ICD were investigated. The author has carried out detailed in-vitro experiments to assess the EMI due to RFID reader/writers for implantable medical devices (RFID/IMD-EMI). In this paper, an assessment methodology for the RFID/IMD-EMI based on three-dimensional...
Are hospitals really safe?More on the Medical Device Interoperability Program MD PnPDear Mr. Piquepaille, Thank you for referencing our work.The Technology Review story may have left the impression that I'm not very optimistic about the adoption of medical device interoperability. However, the story didn't have enough room to convey that...
Now that we have access to more information about health care and what goes on inside a hospital, what should we be most worried about? How do human errors prevent us from getting the best possible health care when we do have access to fabulous diagnostic tools and intelligent health...
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