Originally Published MX September/October 2005
IT IN HEALTHCARE
Going SmartUsing sophisticated software and product-embedded systems, medtech manufacturers are growing more-intelligent devices.
In the increasingly complex world of healthcare, medical devices must be smarter, faster, and stronger than those that came before them. Not only must they be able to capture and digest an expanding array of data and perform more-varied functions, they must also be able to continuously communicate with the systems that surround them to keep work flow moving at its optimal level.
The advance of information technologies (IT) has driven efficiencies in the healthcare industry that would have been inconceivable just a decade ago. Yet this rapid progress has also driven the industry into completely uncharted territory, bringing with it unprecedented concerns over the security of the information that is now being captured and transmitted at breakneck speed.
And while many herald the new "smart" machines, infused to varying degrees with software and embedded systems, for their role in reducing the incidence of human blunders, even this must be taken with a grain of salt.
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| Joseph Wallace |
"Some argue that IT will reduce errors caused by trying to read 'chicken-scratch,' but IT could potentially cause just as many errors," says Joseph Wallace, marketing manager for WIN Enterprises (North Andover, MA), a developer of customized embedded systems and controllers. "Let's say that, in order to write a prescription, a doctor just has to push a button on his computer—but he accidentally clicks the wrong one. That error could cause just as many problems."
Medtech manufacturers today are required to keep these new concerns in check while continually driving innovation in a competitive market. And in this market, when discussing IT innovations, few words are heard as frequently as connectivity.
Building Social Devices
One level of increasing connectivity among medical devices is occurring within healthcare facilities themselves, where one of the biggest trends driving medical device development is the need for "all the gizmos to 'talk' seamlessly with each other," according to Wallace.
"While I think that it will be the primary driving force in the next few years, we're currently only in the infancy stages of this process," he says. "Some apparatuses are connected, but they are typically independently operated. In the next few years, I think nearly all devices will be able to be monitored to some degree by a central unit."
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| Tim Gee |
The adoption of electronic health records is the biggest driving factor of this trend toward connectivity, according to Tim Gee, principal of Medical Connectivity Consulting (Beaverton, OR). "Hospitals want to get device data into their information systems as soon as they're acquired—not an hour later, when someone has time to type them in—and without likely data-entry errors," he says.
Software systems devoted to gathering patient data can be segmented into applications for monitoring and surveillance, diagnostics, and therapy. "Most of these applications transmit spot data, discrete readings that are taken on a noncontinuous basis," says Gee. "But some make use of continuous monitoring via telemetry or multiparameter patient monitors, where any loss of communications results in gaps in waveform data—and, potentially, missed alarms."
A second connectivity driver, Gee says, is work flow automation. "The new 'smart' IV pump is a good therapy work flow example, where the process of initiating the delivery of infusion therapy is automated to improve patient safety," he says. "Diagnostic work flow will include managing orders, establishing patient context, and the capture and validation of diagnostic data."
And yet a third driver of connectivity, says Gee, is alarm notification and management. "Caregivers must respond to a wide variety of medical device alarms, many of which are for life-threatening events," he says. "With the exception of wireless continuous monitoring systems, these alarms are generated at the device in the patient's room. Continued emphasis on patient safety will drive improved alarm notification. These types of solutions are just coming to market."
In order to meet the demands of these three driving forces, doctors must have the capabilities to establish patient context, and acquire and transmit data from their medical devices, Gee says.
Linking to the Outside
Enabling devices within a facility to talk to one another isn't enough. Nowadays, more and more devices are being built to communicate with the outside world as well.
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| Steve Crowley |
The medical world is moving toward a state of "information and data access anywhere," according to Steve Crowley, general manager of clinical software engineering with GE Healthcare (Chalfont St. Giles, UK).
"We're leaving the days of patient data being only available in one location on film," he says. "We have increasing ability to pull patient data off devices and transmit them from location to location. This means a lot to a doctor at home at 2 a.m.," Crowley says.
"Whether it's wireless or wired, it needs to capture and communicate information with a central system. That's an absolute," he says. The backbone of this capability, he says, is the ability of devices to connect to high-speed broadband.
"If you roll the clock back to 2001, there were very few high-speed connections to hospital equipment," he says. "We're moving to the point where if you're not connected, you will not get optimal performance."
This backbone has enabled GE to embed into its machines capabilities similar to those of OnStar remote service systems in automobiles, in which you press a button and are instantly connected to assistance. When a customer uses iLing (GE's equivalent of the General Motors system), the call moves to the front of GE's call-center queue, where the person on the other end can assess the equipment with data directly from the scanner at the time and point of the problem.
Internet accessibility has also enabled the inclusion of remote assisted training systems on equipment, which allow end-users to learn how to operate the device while a trainer on the other end remotely demonstrates procedures and monitors their progress.
The ability to hook devices into a larger network is also driving the growth of remote diagnostics and equipment monitoring. "GE has made an investment to embed 'smart' systems that allow us to monitor equipment and potentially predict when failure is likely to occur, and remotely diagnose and fix it," Crowley says. This must be done in a secure environment that protects patient and hospital data.
GE Healthcare started developing remote diagnostic capabilities in 1991, and is now working with Questra Corp. (Redwood City, CA), a provider of device management services and products, to extend the capabilities of its remote monitoring systems.
Already, Crowley says, remote diagnostics are driving efficiencies by reducing downtime on critical equipment. "No one has the money to go buy extra devices just so they have redundancy in their department in case systems go down," he says. "When we can reduce four hours of downtime to 30 minutes, that's pretty sweet."
Concerning Cost
Just as education in the form of a college degree can be an expensive enhancement to one's personal qualifications, building "smarter" IT-enabled devices does not come without a price.
"Medical device connectivity requires substantial investment," Gee says. "For example, the cost to develop an embedded radio can easily run from $2 million to $3 million, and client/server applications much more. And unlike an embedded device whose R&D spend ends with the handoff to manufacturing, software components require constant enhancement."
Partly due to the expense required, remote monitoring capabilities are not widespread throughout the medical device market, although more manufacturers are starting to take notice, Crowley says. One consideration in deciding what systems warrant technology enhancements is the capital intensity of the item. GE has built remote monitoring capabilities into high-end diagnostic imaging machines, as well as into equipment outside the medical sector, such as locomotives, aircraft engines, and industrial plant systems. Crowley says the healthcare industry presents a unique case, however, in that manufacturers also have to look beyond cost to consider the fact that the devices they build are life critical.
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| Brian Anderson |
Although cost is certainly a concern, connectivity is becoming more widely accessible to manufacturers, says Brian Anderson, vice president of marketing with Axeda Systems Inc. (Mansfield, MA), a provider of device relationship management software and services.
In its four years of business providing remote diagnostic capabilities, Anderson says his company's initial customer base of two has grown to more than 50, about half of which are in the medical field. While the innovators in the remote monitoring market were some of the device industry's biggest players, he says, smaller companies now are beginning to outfit their devices with these IT capabilities—and these capabilities are beginning to be implemented on less-expensive devices, such as drug-dispensing machines. Even the veterinary market is starting to get in the game, he says.
"We're past the early adopters," says Anderson. "We're selling to more mainstream customers, to more conservative customers. Companies are starting to budget for it. When we started, we had to retrofit existing devices. Now we're starting to work with existing customers and prospects on their next-generation products."
Security Issues
Despite the benefits of added functions, the increased incorporation of IT into medical devices means that manufacturers and users are facing new challenges, the foremost being the security issues raised whenever a new system connects to the outside world.
The wider use of standard operating systems such as Windows and Linux rather than proprietary embedded operating systems is both a blessing and a curse, according to Anderson. With easier interfaces and greater connectivity come dangers. "The Windows system is prone to viruses," he says. "If a device fully hooked up to the Internet gets a virus, then it's down."
In light of this relatively new conundrum, the government is still scrambling to determine how to regulate device software, upgrades, and patches.
"If anyone has to worry about providing secure data access and transmittal, we do," says Crowley, adding that if a client's software becomes corrupted, it can move through the system and affect others. "We take security extremely seriously."
Encryption and the removal of specific patient data are key requirements, says Crowley, as is continually upgraded virus-scanning software.
"If a facility remains an island, then there's no danger," he says. "But if it remains an island, users risk not getting optimal performance from their operation."
According to Anderson, medtech manufacturers are becoming more responsible for providing patches for the devices they produce; having equipment hooked into remote monitoring capabilities enables manufacturers to upload these patches. "We needed a more efficient way than sending CDs around all the time," Anderson says.
The Intelligent Future
Despite the reluctance sparked by security, cost, and other concerns, connectivity within the medical industry continues to grow. Down the line, Crowley envisions a hospital environment where an integrated system enhances the patient experience: patients will provide their information only one time upon entering a clinic, and as they move from department to department, they will be instantly recognized by the system. "It will no longer be about having the world's best technology, but rather about having these smart machines completely interconnected," he says.
Anderson likewise sees a future of not only smart machines, but portable smart machines in constant connection. "The next frontier for easy connectivity is wireless," he says, adding that hospital equipment will be rolled throughout facilities and still monitored at all times. With this, handheld devices are becoming more attractive to doctors, according to Anderson.
"The current state of the art for medical device connectivity is wireless, due to the inherently mobile nature of patients, equipment, and caregivers in hospitals," Gee says. "Wireless enablement can be found in continuous patient monitors, 'smart' IV pumps, ECG carts, and point-of-care diagnostics."
The expansion of these state-of-the-art technologies is in the hands of the medtech manufacturers, who will determine the IT capabilities of the next generation of equipment.
"The ultimate challenge is crafting a business strategy that provides a roadmap to meeting connectivity market requirements profitably, at an affordable cost, and within a reasonable time to market," Gee says. "This takes planning and coordination across the organization, with success dependent on senior management involvement and commitment."
Copyright ©2005 MX
