Defibrillator News
Boston Scientific got some press on their remote monitoring capability.
events between a patient's scheduled follow-up visits and then send the
clinical event data directly to the physician.
Over the course of 106,000 monitoring months, and out of a
15,000-patient population with an average follow-up of seven months,
the system detected 948 patients with at least one event of sustained
atrial arrhythmia for more than 24 hours.
This feature has been released for some time, but new data is always an excuse for a press release.
St Jude Medical has received FDA clearance for their wireless ICDs and CRTs. This capability replaces induction wands for programming and receiving data from the implanted devices. Unlike the remote monitoring capability provided by Biotronik and Boston Sci (above), the St Jude feature does not provide remote monitoring between follow ups.
And a while back, Medtronic announced FDA clearance for the first implantable cardiac devices available with Medtronic's
proprietary Conexus Wireless Telemetry, developed using the Medical
Implant Communications Service (MICS, 402-405 MHz). The Medtronic remote monitoring function is limited to transmissions between implanted device and a home based receiver. This contrasts with Biotronik's remote monitoring that uses a mobile phone like gateway devices that can communicate over a wireless carrier network or POTS (plain old telephone system).
Pictured right is the Biotronik wireless remote monitoring gateway, the CardioMessenger.
Medtronic Delays Sale of Physio-Control
Blaming “market turmoil,” Medtronic announced that the delay of their planned spin-off of Physio-Control. Here's their explanation:
emergency responders and in hospitals — has been in turmoil since
market leader Medtronic Inc. suspended shipments of its products in
January because of quality issues at its Redmond, Wash., plant.
In reality, the external defibrillator market has in fact been going great guns:
Cardiac Science Corp., of Bothell, Wash., said domestic sales of
AEDs shot up 83 percent in the second-quarter, compared with the same
quarter last year.
Over the past year, its stock rose 28 percent.
Zoll
Medical Corp., of Chelmsford, Mass., said sales in its North American
pre-hospital market, which includes defibrillators for public places,
increased 43 percent in the third fiscal quarter. But its stock has
performed erratically — up sharply after Physio-Control announced it
was suspending product shipments, but losing steam in recent months.
A more likely reason to delay the sale is that Medtronic won't get a fair value for Physio-Control until they're off ship hold.
In related news, Welch Allyn announced a recall on their AED 20.
Pictured right is the LifePak AED.
More WLAN Problems
Bruce Hubbert who writes the Freakquency blog has another good post titled, “The Myth of the Self-Monitoring WLAN.” Duke University recently suffered a WLAN outage caused by an unanticipated flood of ARP (address resolution protocol) traffic. The details of the failure are used to demonstrate the need for network and WLAN monitoring that goes beyond conventional proprietary end-to-end solutions.
Hospital IT shops can be very keen on single vendor solutions – sometimes to the point of accepting significant shortcomings in parts of the vendors comprehensive offering. This tendency applies to networking in spades. Certainly you need central management, but you assume the AP and controller vendor has all the answers at your own risk – as Duke learned.
Certain vendors are taking this to extremes, offering hospitals WLAN site surveys and recommending the replacement of any technologies that don't sport their logo. Hospitals have received “advice” to replace $300,000 wireless patient monitoring systems because they weren't validated for that vendor's APs. The justification for these recommendations is that I just bought a new 30' sailboat third party systems can't be integrated into our enterprise solution. (If a vendor offers to do a free site survey of your facility, by all means take them up on it – just be sure to have someone else review the findings and offer a less biased assessment.) “And the story sounds so great, “Implement our solution and it will fix itself when it breaks and protect itself when security policies are breached.” Who wouldn't want that?“
the truth is a little more complicated. As we have seen from previous
posts, sometimes the solution doesn't behave the way your business
practices need. Similarly, sometimes there are security problems within the infrastructure itself. So what to do?
In addition, as much as big market leaders would like to believe that single vendor
solutions are the new “best of breed,” we live in a multi vendor world.
the outset nor should one blame Mr. Miller. He was correctly reading
what the controllers were telling him. But it shows how important it is
to have a separate, 3rd party solution also available to get down to
the bits and bytes or even spectrum analysis (if the problem should be
something other than 802.11 protocol madness.)
Unlike commercial office space, or an open warehouse, the WLAN environment can be extremely challenging. Putting all your eggs in one network vendor is fine when all you're doing is supporting portable users moving from room to room charting or administering drugs. But when you start adding things like wireless VoIP, indoor positioning or wireless medical devices – with truly mobile users crossing subnets – look out.
Be sure to read Bruce's post, he's got some great recommendations.
UPDATE: Here are some previous posts on WLAN issues: Cisco Stumbles in Health Care, and Cisco Wireless LAN Technical Issues – Update.
Google Makes Splash in Health Care
Google announced the formation of a Health Advisory Council that includes an eclectic group of health care insiders. The result has been speculation on Google's plans ranging from an application for patients to store their medical information online to the acquisition of an EMR vendor.
The acquisition of an EMR vendor will render Google just another EMR vendor (admittedly with one with lots of money). What I wonder is how (or if) Google will go beyond their brand and Internet application platform to really differentiate and drive greater adoption of whatever vehicle the chose for the health care market.
A significant portion of the data that goes into an EMR (and that includes the whole alphabet soup of PHR and EHR) comes from medical devices. Device data is the most specific and exact data found in EMRs, and is the data that serves the bedrock for diagnosis and managing therapy. As a patient’s problem list or acuity increases (predominately due to chronic diseases) the amount of data generated by patient-attached medical devices increases exponentially. Manually entering medical device data into charting systems has the following problems:
- Data availability is delayed due to the lag between the reading and when the caregiver has a chance to enter it into the system (this lag is frequently measured in hours)
- Missing data results from readings that are taken, but never entered into the system
- Transposed data or typing errors – the analog to illegible entries in paper charts
- Selecting the wrong patient for correctly entered data – the analog to improper patient identification, a common patient safety problem
In hospitals the literature has reported the percent of data entered in error to range between the low teens and mid twenties. I’m not aware of studies looking at similar activities in physician practices or patient homes.
Medical device connectivity is a requirement with growing awareness. Last week Rob Kolodner gave the keynote at a conference on medical device connectivity (the Improving Patient Safety Through Medical Device Interoperability and High Confidence Software workshop in Boston). The FDA has signaled that they are looking at regulating medical device interfaces that write straight to an EMR’s database. And vendors continue to struggle with device connectivity – with vendors creating “open” interfaces that only work with their own medical device or EMR (think Welch Allyn or AllScripts). Retrospective connectivity via HL7 is easy to develop, but expensive to deploy (each installation must be configured); prospective “plug and play” connectivity is the easiest to deploy, but requires that competing vendors work together (something they are traditionally loath to do).
Google may well acquire an EMR vendor. Given their strengths they will probably stay as close to consumer as possible, launching a PHR and/or acquiring a practice based EMR (rather than a hospital EMR vendor). In any event, the patient populations who will benefit the most, and be Google’s greatest source of pressure to drive adoption, are those patients with chronic diseases. Care delivery for chronic disease is centered around medical device data – glucometers, non-invasive blood pressure monitors, weight scales, and more. Leaving patients to manually enter this data themselves will not work for most patients, and sending caregivers to the home to gather readings will be too expensive.
Google is uniquely positioned to provide plug and play connectivity for any site with an internet connection or even a mobile phone. Actually creating the connectivity is something they have no experience with, but they have plenty of resources and smart people – they can learn it the hard way, or use a connectologist to help. This is a potential differentiator and competitive barrier (because the industry’s not going to support more than one pervasive connectivity method) for whoever gets there first.
To be more than just “another EMR vendor,” Google will have to do something different. Medical device connectivity is the biggest unmet need on the patient side of the equation. (On the systems side, there is interoperability between EMRs and prescribing and between providers and payors – but there’s already a lot of work being done here.) Their ability to deploy web applications could be leveraged in important ways.
Pictured right is the Google holiday logo commemorating the 50th Anniversary of Understanding DNA – April 25, 2003.
[Hat tip: iHealthBeat]
GE Healthcare Launches Blogs
With little fanfare, GE Healthcare has launched a suite of blogs as part of a new campaign called PeerVision. Initially targeting the diagnostic imaging market, PeerVision could easily be expanded to include other health care market segments. Included in the site are a few blogs, a discussion forum, and the usual marketing materials.
Most medical device vendors are pretty old school, and consider things like blogs or discussion forums with distrust. The usual excuse is that as an FDA regulated vendor, everything on their web site is considered “labeling.” This is not really true, but it makes a good excuse. GE has overcome this objection with a pretty comprehensive disclaimer acknowledgment that users must accept before accessing the rest of the site. The disclaimer is pretty reasonable, but one part struck me:
consultant or have any other financial interests in the information you
provide to this site including, but not limited to the promotion of
“off-label” product uses or the disclosure of confidential or
proprietary information.
I'm a consultant and clients pay me, so does this mean I can't access the site? My interpretation of this is that if another vendor can't pay a consultant to leave forum posts or blog post comments that represent that vendor's interests. Of course the wording bars the consultant from doing this rather than trying to bar another vendor.
Time will tell whether GE's blogging and forum efforts are successful. There are many things GE can do to ensure adoption and it will be interesting to see if they do any of them and how well they work. The guest bloggers have only written a few posts, and the only posts in the forum are by the moderator. I don't recognize any of the bloggers from other sites, so they may be newbies.
From the Government Health IT story on blogs:
like the first wave of Web sites,” said David Ritter, chairman of the
Labor and Employment Practice Group of the Chicago-based law firm Neal
Gerber Eisenberg, which advises companies on social media practices.
“The health care industry will catch up. But it has to stop being
hesitant about dipping a toe into the social media area.”
As an aside, the folks at Windover Information have a nice blog called In Vivo. Check it out.
Tyco Spin Off Covidien Signals Acquisitions
The Tyco International spin off of their medical division was completed a couple weeks ago. The new company, Covidien has about $10 billion in sales. With a stable of mature health care technology, Covidien is looking to acquisitions to fuel growth.
It is now investing aggressively in research and development in its
core devices business and would consider acquisitions in the $60
million to $250 million range, [Richard] Meelia [president and CEO of Covidien] said, as it looks to expand its
offerings of surgical, respiratory and energy-based devices.
It expects ultimately to boost R&D spending in devices to 5
percent to 6 percent of sales from 2.7 percent today, Meelia said.
Like many mature medical device vendors, the company “which makes surgical instruments, ventilators and syringes, struggled
with sluggish revenue growth and declining profitability due to
underinvestment.”
Many medical device vendors face the challenges of mature undifferentiated core technologies (and resulting products) and changing market requirements that demand workflow automation beyond the operation of the medical device itself. For example, there has been a market need for a patient worn wireless SpO2 monitor (Covidien's Nellcor product line) for years, yet the company chose to milk the cash cow of sensors and disposables rather than investing in next generation products. Ditto for ventilators, where the transition of ventilated patients from critical care units to general wards has created new surveillance and alarm notification requirements. It is also notable that Covidien's medical devices do not provide connectivity (sorry, serial ports don't count).
Perhaps Covidien will acquire a software company to develop a common connectivity platform for all their devices. Such a strategy would not likely generate incremental revenue, but could certainly drive medium and long term organic growth in their existing product lines. Pictured right is a Nellcor SpO2 monitor made “portable” with the addition of a wireless radio wart.
