Medtronic to Expand Wireless Sensor Offering
Medrtonic announced a new clinical trial to determine the safety and efficacy of an implantable cardioverter defibrillator (ICD) combined with a sensor that continuously records pressure inside the heart, potentially alerting
physicians to potential heart-failure complications before they worsen.
(press release).
both the traditional ICD's ability to restore normal heart rhythm
following a dangerously fast heartbeat and the first-ever real-time
tracking of pressure inside the heart, body temperature, patient
activity and heart rate 24 hours a day. Patients implanted with a
Chronicle ICD will transmit that information from home, using a
standard phone line, to their physicians who view the recorded data
from a secure Web site in their office and then potentially make
changes to patients' medications or diet.
Along with their competitors, Medtronic is working to leverage implants as sensor platforms for chronic disease management. The first logical target is congestive heart failure.
rhythm and disease management technologies, both investigational and
FDA approved, which monitor patients' heart functions and allow
cardiologists to make immediate care decisions based on this
information. Some of Medtronic's pioneering devices include the
following:
— Concerto(TM) AT Cardiac Resynchronization
Therapy-Defibrillator. Medtronic's Concerto(TM) CRT-D with Atrial
Therapies (AT) is an investigational heart-failure management device
designed to automatically and wirelessly delivers information from a
patient's device to the physician's office.
— OptiVol(TM)
Fluid Status Monitoring. Available in select Medtronic CRT-D devices,
this diagnostic feature helps manage and detect worsening heart failure
by measuring the pulmonary fluid build-up in the thoracic (lungs and
heart) cavity.
— Reveal(R) Insertable Loop Recorder. The
world's only implantable cardiac monitor that captures and stores the
heart's rate and rhythm to determine if fainting, dizziness,
palpitations or unexplained seizure-like episodes are related to a
heart-rhythm problem.
— Medtronic CareLink(R) Network. An
Internet-based heart-monitoring system that enables patients with
implantable devices to transmit data from their device, while at home
or traveling, to their physician using a portable monitor that is
connected to a standard telephone line.
With a cost of $25.8 billion in 2004 and more than a million hospital admissions per year, congestive heart failure is an attractive target for medical device vendors. Any meaningful reduction in admissions could result in significant reductions in health care costs. A key to success will be the end to end connectivity – something that's simple and unobtrusive for patients, and conveys meaningful data and alarms to clinicians.
Hidden Costs in CVIS and Cardiology PACS
Mike Gray has an update on his attendance of SCAR in Austin. He touches on one of the hidden costs in PACS or CVIS systems – proprietary storage. Back in the early days of PACS many vendors used their own file management systems and stored data in proprietary formats. That's no big deal when you're just buying your PACS – but years down the road when you want to switch vendors, it becomes a very big deal. A non-standard file management system means that no one but that vendor knows where specific patients and exams are stored. Non-DICOM data means that only the vendor that wrote that non-DICOM data can read it.
A whole market has resulted from customers who need to extract their data from a proprietary system so that it can be used in a different vendor's system. Hot shot economists call this “erecting changing costs” and “lock-in.” You can read a previous post on this here. The later in the process you learn this, of course, the more shocking it is.
If you know what to look for, there are vendors out there who either allow you to avoid this problem or can be coerced convinced to make the appropriate accommodations when you first purchase their system (it's all about planning ahead). The bad news is that most storage vendors are playing the same games as some PACS/CVIS vendors.
Pictured right are some fancy RAID storage systems.
Embedded 802.11a/b/g Radios
Health care delivery is inherently mobile; patients and staff not only go from place to place for diagnosis or therapy – surveillance, alarm notification and voice communications can require wireless network connectivity while traversing significant distances. Consequently, one of the largest challenges facing medical device vendors today is wirelessly enabling their products. Not only do vendors have to manage the short life cycles (6 to 18 months) of general purpose computing components, they also need access to a whole new esoteric specialty, RF engineering.
There is a scarcity of OEM suppliers that can provide 802.11 radios suitable for embedded use – so few that some medical device vendors are building their own component radios. In the early days of 802.11FH, there were a number of suppliers used by medical device vendors, like Proxim, Symbol, Nortel and Aironet. These days the embedded radio vendor of choice (based on recent adoption by GE and Spacelabs) seems to be Symbol. Symbol is a great company with great products; but they're a manufacturer of their own products first, and an OEM supplier second.
There is a recent market entry that is taking aim at the embedded radio business as their sole focus: Summit Data Communications. According to this eWeek article:
Using 802.11b/g Wi-Fi radios from Broadcom, the Summit modules are
tweaked to optimize the radio's range and to maximize the battery life
of the device, [Summit VP Ron] Seide said.
They are designed to run in environments from 22 below zero to 167 degrees Fahrenheit.
So far Summit has two products—a Compact Flash module with antenna connectors and a PCMCIA adapter. [Both pictured right.]
Initially they support Microsoft Windows CE, but future versions
will support Windows XP, variants of Linux, and some proprietary
real-time operating systems.
The company also will ship software that lets users set radio and security parameters, Seide said.
Much of Summit's management came from the wireless radio group at Cisco. When Cisco moved away from their own radios, they saw an untapped need for vertical market embedded radio products combined with RF engineering support to make wireless enablement a less harrowing experience.
UPDATE: It occurred to me this morning that perhaps I should mention some of the wireless enablement challenges that lie beyond integrating an embedded radio. If you're a connectivity buyer, the following will show you what to look for in a vendor who can effectively deliver a robust solution.
Perhaps the biggest challenge is the fact that a wireless medical device has to talk to something, like a server. Medical device servers are not rocket science, but they entail a comprehensive set of requirements and can cost as much or more to develop than the medical device they support (the good news is you don't necessarily have to write your own server). Oh, and once you start the R&D for a server (or client software, for that matter) you will never stop. Unlike your medical device that only requires occasional sustaining R&D work after release, software products are never really finished. There's also a new set of market requirements that come into play, things like reliability, security and integrating with third party systems.
Adopting connectivity also requires an adjustment to your business delivery system. The first of these changes comes in the regulatory strategy for your connectivity system – the networked device, clients, and server. Making the same risk assumptions and taking the same regulatory approach as you do with stand alone devices, will add unnecessarily to your time to market and R&D costs throughout the system's life cycle. The way you manufacture, sell, quote, install and support networked medical devices is also different enough from standalone medical devices to impact profitability and customer satisfaction if certain changes are not made. Best practice requires business planning that extends beyond R&D to anticipate and plan for impacts across the organization.
So, look to your radio vendor for help with radio integration, antenna design, and optimizing RF performance. For the rest, call your connectologist.
Alphanumeric Paging in an Academic Hospital Setting
The American Journal of Surgery published this paper on the benefits of an alphanumeric paging system on physician's work environment (full text $30). It is not surprise that improved communications was beneficial.
intervention were high and did not differ significantly
postintervention. For nursing staff, postintervention perceptions of
the text-paging system were significantly more positive than
preintervention, especially with regard to perceived improvements in
patient care (54.1% versus 81.6%, P < .05). Residents’
paging logs reflected significantly decreased interruptions to patient
care after the intervention (28.2% versus 46.9%, P < .05), with less pages requiring a call back (100% versus 73.6%, P < .05).
It's always nice to see quantitative data demonstrating the value of improved communications. Doing a study like this with an old and obsolete technology like pagers seems, well, a waste. No one's ever studied the effectiveness of pager based communications in a hospital before?
Perhaps this is just my pager bias showing. Pagers are an open loop system – there is nothing that ensures that a page was sent and received by the pager, let alone acknowledged by the user. This is a poor technology platform for communications that is intended to improve patient safety. A study like this measuring the impact of new more capable technologies, like wireless voice-over-IP (VoIP) would seem much more relevant. Perhaps the investigators could repeat their study with Vocera badges or a VoIP phone with graphics (for waveforms) to see if there is an increase in effectiveness with the newer technologies.
IntelliDOT Raises $13 Million in Series C Round
San Diego company IntelliDOT announced today raising $13 million in a Series C round lead by Integral Capital Partners of Menlo, CA (press release). The funds raised will be used for sales and marketing of their CAREt bedside bar coding system.
error prevention solution for hospitals and other health care
providers. IntelliDOT's CAREt System incorporates a unique wireless
handheld computing device, an enterprise-class server and a
sophisticated, but flexible software application. In addition to
reading conventional bar codes, the CAREt System reads small,
information-rich codes called MedDOTs that can be used to create
customized documentation and communication applications.
IntelliDOT CEO, Thomas Klopack, notes that, “Recent studies have demonstrated that bar code point-of-care technology
can significantly reduce medication errors; however, less than 8
percent of hospitals in the country have adopted the technology.” At first glance two things separate IntelliDOT's solution, their unique bar code and the bar code reader (pictured right). Their proprietary bar code, called MedDOTs, is an aztec-like bar code that can encode a large amount of data. The bar code reader appears to hit all the important health care requirements – small, light weight, can be wiped down with disinfectant, and the battery lasts a 12 hour shift.
So let's run down the most common barriers to adoption for point of care solutions:
- Poor design – most of IntelliDOT's management worked together at Pyxis, so they've probably got the workflow down cold
- Ill suited hardware – they've done a lot of things right with their bar code reader – better than current PDA/bar code readers – the only open question is durability
- Proprietary technology – MedDOT comes to mind here, but perhaps there's a good justification for this over a standard aztec bar code
- Cost – there are so many things hospitals can invest in to improve patient safety and reduce operating costs, and everything's pretty expensive
It will be interesting to see how IntelliDOT does as a best of breed point of care solution against broader pharmacy systems from the likes of Cerner, McKesson, et. al. The fact that they've got a Novation contract (pdf) can't hurt. Myself, I can't help but root for the underdog.
