Wi-Fi Capacity and New Devices
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.
Consumer Connectivity Issues
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:
Navigating Regulatory Uncertainty for Smartphones
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:
Why Medical Device Makers Love/Hate Wi-Fi
In this post we’re going to lift the window shade a bit on why many manufactuers love Wi-Fi, and why they also hate it with equal passion.
You see, I’m often asked by manufacturers about alternatives to Wi-Fi for wireless medical devices. And I’ve done a number of wireless technology surveys for manufacturers, looking for attractive alternatives. There are no attractive alternatives, at least for most medical device applications at this point in time.
Before we dive into this sordid tale of passion and betrayal, let’s frame the discussion. The wireless application I’m referring to is the connection between a portable or mobile medical device and the enterprise wired network. While the examples in this post come from hospitals, there is much here that is applicable to ambulatory settings. Applications that are not considered are cable replacement applications (Bluetooth or wireless USB) or wireless sensors in body area networks (BANs) that are, by their nature, low power and short range, are a different animal.
FCC Seeks Comment (Again) on MBANs
Some semi recent news on Medical Body Area Networks (MBANs) from GE Research and the FCC. It starts with GE’s September 1, 2009 press release (pdf), where they announced:
…an intiative aimed to develop wireless medical monitoring systems, or body sensor networks (BSN), which would replace the traditional tangle of bedside caables used to capture a patient’s vital signs. GE’s vision for the systems would enable wireless monitoring from anywhere in the hospital — or even remotely at home.
For the past couple years, GE’s been pushing for the allocation of spectrum for MBANs. The press release notes that, “The FCC recently issued a notice of proposed rulemaking (NPRM), acting upon GE Healthcare’s petition to establish a new, vendor-neutral dedicated radio frequency band for low-power, short-range, wireless patient monitoring devices. This petition requested creation of a new Medical Body Area Network Service (MBANS), to support wireless sensors that monitor a patient’s health state, linked together in body sensor networks.”
Here’s David Davenport talking about their wireless sensor initiative:
Apparently, GE’s going after the cable replacement business for traditional multi parameter patient monitors. LifeSync has had a product replacing ECG cables (by far the most predominate type of cables in clinical use) for several years. LifeSync also controls the Besson patent (licensed to them exclusively by Motorola) that applies to wireless sensor based physiological monitoring.The FCC Notice of Proposed Rulemaking referenced is from June 29, 2009. Another “article” written by a law firm apparently engaged by GE was published March 20, 2009 and outlines:
Proposed Frequency Band: ”identified the 2360-2400 MHz band as the preferred frequency band based on engineering studies showing that MBANS devices can successfully coexist with incumbent operators and users.” I would love to see that coexistence data. In a conversation with David Davenport of GE Global Research that, he told me that spectrum just outside 2.4 GHz was desired because it would enable the use of off the shelf 2.4 GHz components, with only minimal modifications.
Medical Device System Network Install Issues
Last week there was an interesting discussion on the Biomed Listserv about network installation for patient monitoring systems. Emphasis highlighting key issues and best practices are mine. The discussion started with a question from Scott Skinner:
I’m curious if anyone has been successful using their own vendors to pull cables for monitoring installations. With the monitoring OEM we work with, they simply get a local subcontractor to do the cable pulls.
So this would involve breaking future monitoring packages up into two quotes: one for the actual technology itself (and associated installation and implementation), and then one for just the cable pull work. The latter would get bid out, and the OEM could compete against other vendors.
Of course, the OEM can just take the profit they would have made on the cable pull and add that to the cost of the equipment bid. One would need to find a way to watch that carefully.
Which lead to a critical observation from Craig Muehling:
We have started pulling our own cable for monitoring installations. I have one happening now and I’m not exactly pleased how it’s working out. I won’t mention and names, [vendor name removed] but they make their equipment charges per drop whether you have any drops or not.
I would still like our [networking] vendor to do the networking, ie: install and configure switches and physically plug patch cables into the switches. Seems easy, but the way they [the patient monitoring vendor] charge it’s really not much less than if they did the whole job. I think from now on, we will have to take on the entire networking job.
I have learned a lesson from this last installation and will scrutinize the quotes closer from now on, but with their charging structure
(supposedly) there’s not a lot of options. Either we do the entire job, or they make lots and lots of money for relatively little work.
Here’s how they do it at the Mayo Clinic, from Steve May:
We have our own low voltage and high voltage contractors for all in-house cable pulling, to include data pulls and all project related work, so cable pulling and wiring costs are never part of an installation package, but an infrastructure cost which we earmark as Capital expenditures and plan/budget annually. Bids & labor costs are renewed by Purchasing every 2 years and our preferred contractors are all able to bid on both project services & time & material services.
