Wireless Heart Monitoring Speeds Up Care
Nice story in the St Louis Business Journal on Guidant's ICD and wireless connectivity:
by wireless technology that can connect patients over the Internet to
their doctors, who can then manage their care and possibly help them
avoid heart failure, in many cases without a visit to the doctor's
office or hospital.
Many
implantable cardiac defibrillators (ICDs) already on the market allow
doctors to capture real-time data on physiological conditions of the
heart, which are downloaded by the patient with a simple wave of a
computerized wand over the chest area. A radio frequency device in the
home then transmits health data through the Internet to the server when
it's time for a patient's checkup or if the patient is in distress. The
main difference in the wireless Guidant model is there is no need for
the wand.
Replacing the wand with a wireless RF link comes at a price.
Guidant's new wireless product costs about $2,500 more than previously
existing models. That difference is not yet covered by insurance, nor
is the online monitoring. Nobody has quite figured out who will monitor
the data, how often or how it will be billed, said Barnes-Jewish
Hospital's Lindsay.
“It's a practical business problem,” Lindsay said. “If we save a lot of
money by keeping people out of the hospital, that's great. But if it
takes a lot of nurses engaged in tracking, how do we bill for their
services?”
“As with any new technology, buyers will be behind the curve as far as
reimbursement,” said Steve Conway, administrative director for clinical
services at SSM St. Joseph Health Center. “Physicians will have to
really screen applicants for the right ones. At this point, the
clinical decision is more like rural outreach.”
Hogarth in Elsberry had his wireless defibrillator implanted Jan. 13.
He looks forward to making the hour-and-a-half drive to St. Charles
only once a year, rather than four times.
The bane of remote monitoring for years has been reimbursement, or lack thereof. Vendors will need to deliver more value that replacing a wand with a radio before payors pony up. The biggest benefit of early RF units is the elimination of the wand from the sterile field during implantation – while physicians love it, there is no clear clinical benefit.
There are two most obvious directions for future wireless enhancements of implantable devices. First is the integration of the device with a broader remote monitoring system and disease management system. The second application entails extending the monitoring potential of implanted devices with near real time data acquisition (transmitted to the hospital for analysis and diagnosis) and remote alarm notification (with sample waveforms and patient positioning data). Both potential roadmaps take implantable device companies beyond their core competencies, although one takes them much farther than the other.
UPDATE: Jack Mason from IBM relates his personal experience with remote monitoring and wireless ICDs here.
HIMSS 2005 National Nursing IT Innovation Award
The emergency nursing team at Christianna Care Health System received the above award for their implementation and utilization of PTCS' Amelior EDTracker emergency department information system.
In 2004, the emergency nursing team at Christiana Care, led by
Laskowski-Jones, managed the planning, implementation and execution of
the Amelior EDTracker automatic tracking system for their emergency
department. The system was implemented to improve patient flow by
automatically communicating the location and care status of patients in
real time. The implementation required training an emergency department
staff of over 200 people and integrating automatic tracking badges for
the 94,500 patient visits treated in their emergency department
annually.
Since implementing the system, the emergency
department has been able to track 100% of patients, decrease average
length of stay by 20-45 minutes and reduce patient walkouts by 24% due
to faster response times. During the first flu season using automatic
tracking, patient turnaround time decreased 5% despite an 8% increase
in patient volume.
Sweet.
The Health Wonk Review is UP
There's a new weekly compendium of blog posts dealing with health care. The Health Wonk Review focuses on health care policy and technology. Be sure to check out the inaugural review at Managed Care Matters.
FDA Targets Postmarket Safety
A broad international regulatory trend toward regulating medical devices after they are purchased and in use by the customer has been building for some time. Many other countries do not recognize the “veil of commerce” as a barrier to further regulation. So, in January the FDA announced their Medical Device Postmarket Transformation Initiative, the result of more than a year of planning and preparation. This new program will ensure effective monitoring of medical devices for continued safety after they are in use. The current approach has the following problems:
- Adverse events are widely under-reported by users
- Many reports contain inadequate information about the device used and possible causes
- Identification of the specific device (after the fact) is problematic
- Device use is typically no documented in patient records
- Devices lack unique identifiers
- Manufacturers continually produce modified versions of products
- Devices are frequently used “off-label”
The new program has three key components: postmarket problem
identification, problem assessment, and public health response. Problem
identification will use the medical device reporting system and reports
from hospitals to gather information. Problem assessment will be done by teams of FDA staffers and
consultants who will analyze those data and determine the nature and
magnitude of each problem. Reponses will range from urgent alerts and media
outreach to enforcement actions.
The actual impact of this initiative on medical device vendors, vendors of products that “extend” medical devices (like secondary alarm systems), and users remains to be seen.
Medical Device Commoditization Hits Health Care
This is a story about two guys who considered a then current automated external defibrillator (AED) and asked, “Why does this thing cost $4,000?” Founded seven years ago, Defibtech's been selling AEDs since 2003. With 30 employees and using state-of-the-art contract manufacturing and indirect distribution channels, revenues are approaching $30 million – with 3,000 units delivered in the last 6 months alone. They've been profitable for the past 3 years.
up for a challenge: Create a rugged consumer product on the outside,
equipped with a medical device that is subject to the highest level of
FDA scrutiny on the inside. And they were driven to make it for less
than $1,500, about half the price that existing AEDs were selling for,
without sacrificing on quality.
Defibtech is a model for the successful medical device companies of the
future; ruthlessly wring out product cost and undersell established
competitors. Taking this commoditization a little further, do you really need $30,000 patient monitors in your ICU? Wouldn't monitors that cost a third (or less) meet the needs of the vast majority of your patients?
the product in half without shortchanging them on any features,”
[president and co-founder Gintaras] Vaisnys said. “I would hate to have another company pop up and
`Defibtech' us. … I want to be the guy doing that to ourselves before
someone else does.”
Mature undifferentiated medical device markets (and that's most of them) combined with the availability of new
lower-cost technologies mean that some day soon you may be “Defibteched”, or you can “Defebtech” yourself before someone else does it for
you.
UPDATE: Fellow connectologist Brian writes:
I absolutely agree with you and this is exactly what I was thinking when I read this article about two years ago. I was at Siemens/Draeger at the time and it would be relatively easy to create a very low cost monitor using off-the-shelf hardware and software components. Even most of the algorithms you can license from the market leaders.
Here is an excerpt from the article. Know anyone who is entrepreneurial enough to challenge GE and Philips with a $3k ICU monitor? Talk about killing a cash-cow market for a big company …that might be kind of fun! Lots of opportunities and so little time ….
He's right of course. But does anything differentiate commodity products besides price? Certainly. Usability, serviceability and design can all be used to differentiate a product in any kiind of market, including a commoditized one. Here's the exceprt that Brain quotes:
It does make the mind reel. Any readers with thoughts on this, feel free to give me a call.
