Mobile Router for Emergency Response
Here's a review of the Kyocera KR1 mobile EV-DO router. Slide a carrier's high speed EV-DO CDMA card into this device, and it will broadcast a WiFi hotspot providing wireless network connectivity. Verizon has great wireless broadband coverage in the U.S. and a router like this would be applicable for ambulances, covering triage areas in parking lots or setting up wireless networks at disaster sites.
Pictured right is the Kyocera KR1 mobile EV-DO router, complete with Verizon EV-DO radio card.
ZigBee Networks and Medical Devices
Medical Design has a nice overview article on ZigBee, promoting the technology for medical devices. There are currently ZigBee based RTLS systems from a number of vendors, but to date I'm not aware of any medical devices using ZigBee radios.
ZigBee's low power consumption is attractive, but the technology is also intended for low duty cycle sensors, active less than 1% of the time. This eliminates ZigBee for many clinical applications. The examples mentioned in the article are all generalized facilities management applications that apply to the manufacturing floor as well as the nursing floor.
such as data that is periodic, intermittent, and repetitive low-latency.
- Periodic data is information usually defined by the application such as
a wireless sensor or meter. It typically is handled using a beaconing system
in which a sensor wakes at a set time, checks for the beacon, exchanges data,
and returns sleep. - Intermittent data is either application or external stimulus, such as a
wireless light switch. Data can be handled in a beaconless or disconnected
system. In disconnected operations, the device only attaches to the network
when communication is required, saving energy. - Repetitive low-latency data uses time-slot allocations as needed by security
systems. These applications may use guaranteed time slots. It is a quality-of-service
method that gives each device a specific duration as defined by the PAN coordinator
(a network organizer) in the Super-frame to do whatever it requires without
contention or latency.
Reading a meter, for instance, represents periodic traffic with data from water
or gas meters transmitted to a line-powered electric meter which passes the
data over a power line to a central location. For this operation, the RFD meter
wakes up and listens for the beacon from the PAN coordinator. When received,
the RFD requests to join the network. The coordinator accepts the request. Once
connected, the device passes its meter information and returns to sleep.
Oops, the medical mask fell right off!
Pictured right is a ZigBee radio module with antenna.
UPDATE: In the comment below, connectologist Arnaud Houette notes why his firm (Capsule Technologie) evaluated ZigBee and passed.
Are Traditional Vendors Threatened by Connectivity?
While this story does not speak directly to connectivity, it is interesting in light of alternative business strategies in a number of evolving medical device markets. Forbes profiles glucose monitoring vendor Home Diagnostics in light of recent market changes. Home Diagnostics markets their glucose monitors and consumables co-branded with drug stores, supermarkets, mass merchandisers, distributors and mail-order companies.
The company is shopping an IPO with half of the shares offered coming from existing stockholders. Vendors like Home Diagnostics are seen to be pressured on one side by less expensive Asian imports and the other by fancy new continuous glucose monitors from Medtronic, DexCom, and others. There are currently 5 continuous glucose monitoring systems with FDA approval (1 from DexCom, 1 from Cygnus, and 3 from Medtronic). With new technology on the horizon, traditional finger prick glucose testing is becoming a commodity market where manufacturing costs and efficiencies of the distribution channel are critical. Here's how Forbes sees it:
the company is likely to be squeezed by advances in the field that
eliminate the need to prick a finger to check glucose levels. This will
make the company's equipment obsolete, undercutting its price. At the
same time, the company's old style monitors will be pressured by
cheaper Asian imports. This looks like an all-but-guaranteed formula to
hammer margins.
Continuous glucose monitoring solutions have yet to receive reimbursement from payors. Vendors of these advanced solutions will have to demonstrate that their additional costs will save payors money elsewhere. My guess is that clinical studies will find a subset of diabetics who truly benefit from continuous versus period monitoring – how big this segment becomes will spell the fate for vendors like DexCom and Cygnus. In any event, the traditional approach to glucose monitoring will continue for many years to come, and market winners will have to depend on good business strategy and execution to win in the market.
co-branding strategy extends its reach, sales are up, and net income is
rising. But there is nothing to distinguish the company's technology
from the competition. The next generation of monitors will depress
prices for the equipment Home Diagnostics now makes, and the company
has no plans–and apparently lacks the means–to leapfrog the
innovators and gain market share. Over the long haul, it's difficult to
see how Home Diagnostics will produce the strong growth that makes IPOs
so enticing.
Next generation (continuous) monitors will only depress prices after they receive reimbursement, and maybe not even then. Competition will come from competitors who can out market and/or out manufacture and distribute Home Diagnostics. Choosing not to follow others with continuous monitoring solutions is a very viable business strategy.
Will wireless sensor based systems transform medical device markets? Maybe, but there are many factors to take into account, besides the existence of new wireless products.
Baxter Signs Consent Decree with FDA
Baxter Healthcare and the FDA came to an agreement regarding certain of Baxter's infusion pumps. From the FDA's press release:
provide routine service maintenance, or to replace components, parts,
or accessories for the Colleague and Syndeo Infusion Pumps that were
already in the hands of customers before October 12, 2005. Baxter is
also required to submit to FDA an acceptable detailed corrective action
plan to bring the Colleague and Syndeo Infusion Pumps currently in use
in the United States into compliance with the Federal Food, Drug, and
Cosmetic Act (the Act). The agency recently issued a Preliminary Public
Health Notification dated April 28, 2006 with recommendations for
users, titled “Important Safety Recommendations for Baxter's COLLEAGUE
Infusion Pumps” (see http://www.fda.gov/cdrh/safety/042806‑baxter.html).
The corrective action plan is due to the FDA for approval within 20 days. The plan will include the upgrades and modifications for pumps currently in use, as well as changes to bring Baxter's operations into compliance with the FDA's Current Good Manufacturing Practices (CGMP) and Quality System regulation (QSR).
Baxter claims an installed base of 200,000 pumps in the U.S., and 50,000 in the rest of the world. The scope of regulatory compliance issues and Baxter's world wide operations (the manufacturing plan in question is in Singapore), will have a major impact on Baxter's operations.
customer accommodations and to adjust reserves previously established
for remediation costs, the company expects to record a second quarter
after-tax charge of up to $70 million (or $.11 per diluted share).
Excluding this charge, the announcement does not affect the company's
financial outlook for the second quarter or full-year 2006.
Here's some history of the pump situation, also from the FDA's press release:
The most recent FDA inspection of Baxter's Round Lake Facility,
conducted on June 20-30, 2005, revealed deficiencies with the CGMP and
QS requirements for devices, including the firm's failure to implement
adequate management controls over its quality system operations and
corrective and preventive actions (CAPA) procedures. During this
inspection, design defects relating to the reliability of both the
Colleague and the Syndeo Infusion Pumps were also revealed.
During
the course of FDA's June inspection, Baxter initiated a voluntary
world-wide hold on all Syndeo Infusion Pumps due to design defects that
can cause the device to stop functioning. Also during the June
inspection, Baxter initiated a voluntary world-wide hold on all
Colleague Infusion Pumps due to a product design defect relating to a
temperature sensitive component of the device's timing circuit, known
as the Y2A crystal, which causes the timing circuit to fail.
Before
the June 2005 inspection, FDA conducted two previous inspections of
Baxter's medication delivery systems facility in Round Lake, Illinois,
in September 2000 and June 2002, all of which revealed lack of
management controls over the firm’s quality system operations and
inadequacy of its CAPA and complaint handling systems. These
deficiencies undermined Baxter's ability to assure the quality of the
devices manufactured at its Singapore plant. In September 1999, FDA
issued a Warning Letter to the firm addressing its lack of CAPA
procedures. In August 2001, another Warning Letter was issued to
Baxter addressing deficiencies in its CAPA procedures.
The
consent decree also resolves the disposition of Colleague and Syndeo
Infusion Pumps that were seized by the Department of Justice on behalf
of FDA in October 2005. The consent decree was entered today (June 29, 2006) by the
U.S. District Court for the Northern District of Illinois.
Recently I've noted comments on the Biomed Listserv eliminating Baxter from consideration for future infusion pump purchases because of an apparent lack of interest in patient safety or quality. While a vendor selection process could find reasons to choose other vendor's pumps over Baxter's, a blanket dismissal of Baxter for this type of conjecture is unfair. The folks I know at Baxter are as concerned about this situation as anyone – their family members are as likely to be connected to a Colleague or Syndeo pump as anyone.
It's not uncommon for one major vendor or another to have gotten sloppy and ended up in the FDA's dog house. Major process and product problems have suspended entire product lines in the past at a number of top companies. The obvious need for oversight is why the FDA exists; I'm sure this is not the last case where the FDA's diligence brings to light issues that require aggressive action.
UPDATE: Here's a couple of stories from the Chicago Tribune on recent Baxter/FDA news. The older story includes the following tidbits:
devices, mostly pumps, distributed from two of Baxter's suburban
facilities. Defects in the pumps may have led to eight deaths and 16
serious injuries, the company and the FDA have said. Colleague generated annual sales of about $170 million. Baxter generates about $10 billion in annual sales.
The most recent story provides some analysis on Baxter's pump problems, which started back in 1999.
step that allows FDA significant power to oversee and shape the
rebuilding of Baxter's quality systems in the coming years, as well as
tightly control its commercial activities for the affected products,”
Ben Andrew, analyst with William Blair & Co. in Chicago, said in a
report last week. “While we can argue that this particular consent
decree isn't too bad–limited to just one product area whereas often
they relate to entire business units–historically under this process
FDA is a tough, deliberate taskmaster.”
Baxter said it intends
to take a $70 million charge in the second quarter for remediation
connected with the settlement. If Baxter fails to comply with tenets of
the decree, the company could face penalties up to $10 million a year,
the government said.
To be sure, North Chicago-based Abbott
Laboratories in 1999 paid a $100 million settlement as part of a
punishing consent decree. The FDA said Abbott ignored federal
regulations and failed to comply with standards as far back as 1993.
It was not until late 2003–four years after signing its consent
decree–that Abbott won approval to reintroduce dozens of diagnostic
tests the federal government forced from the U.S. market in November
1999.
It was also hugely expensive for Abbott. It took the
company four years of costly, exhaustive efforts to comply. Analysts
estimate the ordeal cost Abbott more than $1 billion in penalties and
lost sales.
So far, Baxter is also missing out on more than $150 million in annual pump sales, analyst and company figures show.
Pictured right is Baxter's Syndeo pump.
