This is why medical devices are so expensive, the copious levels protection. When it comes to lives at risk, everything should be considered for testing. I'm not a big advocate of IP protection, but foreign companies are always looking to copy top-dollar products.
Alan, I'm curious how important it is to have a secure operating system for some of these medical devices. We often see operating systems decribed in terms of levels or security -- what level of security should designers aspire to?
Interesting article - the layered strategy makes good sense as well as not advertising any specifics about the security methods that are in place. A lot of what was said applies to technology in general as well. Too bad we can't direct the energy and innovation that must be used to make products secure to enhance perofrmance instead. Malicious attacks on medical devices is a sad statement of our society - but then, I have never understood why so many hackers waste so much time and energy to cause problems when they could direct their abilities towards doing good and contributing to society with their accomplishments...
The high cost of medical devices is due in part to a longer history of liability problems than of leaked data, a much more recent concern. Other factors like very high performance and the high cost of middlemen no doubt contribute yet more cost. But I think Cabe's point about leaked data is a good one--that's probably going to be a contributing factor to higher device costs in the near future.
From a patient safety standpoint, I'm not as concerned with the pirating of medical information as I am about a hacker who infiltrates the medical device with malicious intent. I think we should consider ways to mitigate hacker risk if a medical device is connected to a network and could be vulnerable to an attack on its operating system (where applicable).
From design feasibility, to development, to production, having the right information to make good decisions can ultimately keep a product from failing validation. The key is highly focused information that doesn’t come from conventional, statistics-based tests but from accelerated stress testing.
There’s a good chance that a few of the things mentioned here won't fully come to fruition in 2015 but rather much later down the line. However, as Malcolm X once said, "The future belongs to those who prepare for it today."
Pressure vessels are part of common equipment utilized in plants to store liquids and gases under high pressure. It is certain that pressurized fluids will develop stresses in the vessel, which when exceeds failure limits, will lead to hazardous incidents and fatalities.
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