Wireless sensors are intended to operate via short range wireless communications. That’s why they’re called “body area” networks. Due to power consumption constraints, wireless sensor radios typically don’t operate as 802.11 a/b/g/n radios used in enterprise networks. The reference designs from the manufacturers of radios intended for wireless sensors often indicate a range of a few meters and show wireless sensors communicating with a gateway device that aggregates sensor data and then communicates with the enterprise network where the sensor software applications reside.
When asked if they’d prefer their wireless sensors with a patient worn gateway (typically about the size of a deck of cards or smaller) or just the wireless sensors by themselves, most users – patients and caregivers – overwhelmingly chose the sensors-only option. They just got rid of those nasty sensor cables, why would they want some extra box they have to keep track of?
Asking requirements gathering questions on feature trade-offs that aren’t supported by the technology is often times a frustrating experience. It is, however, important to identify all market requirements, even the ones you may not be able to meet with current technology. Let’s look at how we might solve this conundrum.Read More
On August 14, 2013, AAMI reports that the FDA has, “issued a new guidance document on integrating RF technology into medical devices.” You can read the FDA blog post on this guidance here. The draft version of this guidance on RF wireless medical devices was published more than 6 years ago in 2007 (blog post here). At the time, I thought the draft guidance was not earth shattering but a solid example of the application of the Quality System regulation to wireless medical devices.
In order to effectively use this guidance, or the earlier draft guidance, one must have a working understanding of wireless technologies and the FDA’s Quality System regulations. Only then is there sufficient context to be able to properly apply the guidance to the design, manufacture, installation and support of wireless medical devices. Like many initial connectivity efforts, dealing with these wireless issues can be a case of not knowing what you don’t know.Read More
The FDA has issued a draft guidance document on the expected content of premarket submissions with respect to medical device cybersecurity. This guidance targets individual medical devices rather than the network they may be resident on, and it also includes non-networked devices. The FDA notes that both networking capability and portable media increase vulnerability. The latter issue might be called intermittent or remote connectivity.
Guidance documents tell interested people what the FDA’s current thinking is relevant to its regulatory authority, in this case the review of 510(k), PMA and related submissions. A draft guidance is in effect what the FDA is thinking about thinking. Drafts go through a comment period (90 days in this case) after which the FDA contemplates the comments and, after an unspecified time, either issues a guidance document, issues a revised draft, withdraws the draft, or just lets it sit there. Since guidance documents are not requirements, there is standard language that you can use an alternate approach if you can justify it. An open question for me is whether even a draft sufficiently establishes an FDA expectation that should be followed in the interest of a smooth submission review.There are many draft guidances currently under comment or post-comment review, including the long awaited guidance on medical apps discussed here.Read More
A recent NY Times article reported that hotel Wi-Fi capacity was again being challenged, this time by iPads and other tablets, or more specifically, tablet users. The Times notes that these users may have a smart phone and laptop going at the same time they are sucking up streaming video. The high bandwidth demand of these devices, or more specifically, their uses, is said to be reducing download speeds back to the good old days of dial-up connections. A likely solution will be a tiered charge structure, similar to the newest cellular data plans, with the result that you can waste bandwidth if you don’t care what it costs. A more general report on current and future wireless demand versus capacity has been produced by the Global Information Industry Center at the University of California San Diego. A less foreboding report on medical uses of Wi-Fi has been produced by the Wi-Fi alliance.
Smart phones have a prior history of overwhelming cell phone networks, such that in dense environments someone can’t make a phone call because too many other people are watching reality show reruns and bad movies. Now some cellular devices have been looking at switching to Wi-Fi when it is available, as explained here. This leads to the conflict ridden situation of cellular wanting to use Wi-Fi to solve its capacity problems at the same time that Wi-Fi is being over loaded by other devices. Cellular resistant building structures, which are increasing, also can create a desire to shift to Wi-Fi.Read More
From time to time, patients or family members leave comments about problems they’ve had. This is not a consumer oriented site, and most patient’s are not in a position to avail themselves of assistance from me or another industry consultants. But I do welcome and respond to consumer oriented inquiries. Unfortunately, these situations rarely result in simple straight forward replies that solve the problems.
Here’s a query I received this week:
I have been reading about connectivity of medical devices, of which I know nothing, because I am a teacher and am having signal issues, while at work, with my wireless Omnipod Insulin Pump. The alarm sounds and it stops delivering insulin. The support team at Insulet Corp. says that there is some sort of “fluck” going on. This answer does not satisfy me. My classroom has been known to have what our tech people call, “dead zones.” If you don’t mind, can you, or others, offer some insight into this situation? Thanks. My doctor is at Tufts in Boston. He’s just great.
Here’s my reply:
Uncertainty abounds regarding the potential regulation of smartphone apps by FDA and other international regulatory bodies. For this discussion we’ll divide uncertainty into two categories, uncertainty due to a lack of knowledge about the potential regulations on the part of manufacturers and uncertainty about just what various regulatory agencies are doing – or going to do – about new and innovative products that meet the definition of a medical device.
What is a Medical Device?
Let’s start with the first category; there is an astounding amount of misinformation and just plain wrong-headedness on the part of many vendors (and providers) who are outside the ranks of traditional medical device manufacturers. The first issue we need to address is the question, “What is a medical device?” Here’s the legal definition of a medical device, courtesy of FDA:Read More