Medical Device Link.

Originally Published MX September/October 2001

MARKET ANALYSIS

Flora Nguyen

Few would deny that healthcare-oriented wireless devices provide impressive capabilities. Wireless monitoring devices allow nurses to track patients' vital signs from a distance. Personal digital assistants (PDAs) provide doctors with patient records and reference materials, and can transmit legible prescriptions to pharmacies.

These wireless wonders may be on the cutting edge of healthcare information technology (IT), but in a number of hospitals they're already performing. Wireless technology is quickly becoming a brave new world of full-color handheld organizers, smart phones, and personal area networks that use the human body to conduct data signals.

For more than five years, aggressive IT departments, network vendors, consultants, and systems providers have been working to solve the problems of transmitting patient records, interoffice e-mail, medical literature, and lab results to untethered computers. The result is that many wireless systems and devices have already been integrated into the daily routines of doctors and nurses. A recent report by J. P. Morgan H & Q (San Francisco) indicates that wireless technologies currently have the following healthcare applications.

• Bedside charting and access to patient records.
• Nurses' shift reports.
• Admission assessment.
• Emergency room operations.
• Supply inventory.
• Remote monitoring of vital signs.
• Pharmaceutical monitoring and ordering.
• Compliance.¹

What most of these applications have in common are potential inefficiencies caused by gaps in time or space between the point of care and the relevant data. If a caregiver must walk down the hall to enter new information about a patient—or, even worse, wait until the end of the day to do so—the odds increase that the information will become untimely and won't be available when it's most needed, both of which can have life-threatening consequences. Wireless networks put the data-entry and data-retrieval mechanisms directly at the point of care, closing the gap and tightening the slack in a hospital's workflow.

It makes sense, then, that wireless integration is being promoted as the most promising technological development in healthcare since penicillin. But given the current healthcare environment, with its distinct technological shortcomings, can wireless technology live up to its hype? Does wireless integration evoke excitement or frustration for hospital administrators? In many industries, such as financial services, wireless capabilities have created immediate improvements not only in communications, but in daily operations. In healthcare, however, the challenges of maximizing wireless technology are greater and more intense because patients' lives are at stake.

Hospitals typically have highly specialized and segmented work-forces. Job functions may require customized equipment and tools. In addition, the interactive processes and communications requirements vary widely based on the employees' roles. Such disparity has resulted in the implementation of fragmented wireless systems that may meet the needs of one department, but cannot interface effectively with other key areas of the hospital.

While the growth of wireless implementation is making the jobs of healthcare providers easier by saving time and improving accuracy, it also opens the door to a security threat that must be countered with user-authentication protocols. The administrative simplification section of the Health Insurance Portability and Accountability Act (HIPAA) will set standards for the security, privacy, transmission, coding, and identification of health information that will affect the use of wireless technology in the healthcare setting.

This article looks at the present landscape of wireless technologies in the healthcare arena, outlining current usage as well as future applications that will alter the way that business is done in healthcare. It will also discuss barriers to implementation and explain what medical device manufacturers have to do to be prepared for the wireless future.

The Wireless Landscape

According to David E. Patterson, president of the Patterson Group (Chicago), a strategic consulting firm serving the healthcare industry, healthcare was one of the first markets to embrace wireless technology. Early innovations began with beepers; paging technology advanced through voice, numeric, and alphanumeric devices, and the numbers and types grew exponentially.

Hospitals purchased and deployed communications infrastructure. "Owning their own systems gave hospitals control, and enabled real-time notification that was not delayed by wide-area carriers' queuing," says Patterson. "These facilities opted to incur the capital expense to eliminate the monthly costs experienced when using service providers. When new devices and services became available and service providers became more cost-competitive, healthcare providers added various devices and service providers to their systems."

Patient-monitoring equipment has also become increasingly wireless based, says Patterson. Telemetry and nurse call systems often come equipped with software that enables them to conduct wireless transmissions. Next, wireless technology began to penetrate functions in facility management, he says. Fire alarms, security systems, and many types of specialized medical equipment can be wireless enabled.

"The latest wireless technology includes specialized bedside equipment that allows caregivers to document, send, and receive all patient information while they are tending patients," says Bill Wood, senior vice president for product development and technology at Colorado Medtech (Boulder, CO), an outsourcing firm serving the medical device industry. "Physicians are integrating PDAs and wireless computers into their practices. Wireless local-area networks (LANs) and creative computing options are in the purchasing window. Imaging is also being extended to reach wireless devices."

Now, with the advent of the wireless Internet, hospitals are examining the costs and benefits of an Internet-based system, which means that medical technology manufacturers had better be prepared to join their ranks. According to John Pantano, worldwide product manager for patient monitoring at Philips Medical Cardiac and Monitoring Systems (formerly Agilent Healthcare Solutions Group; Palo Alto, CA), "The blending of wireless communications requirements with IT requirements demands unification of telecommunications and IT departments. Application service providers (ASPs) have also entered the healthcare arena to offer the option of outsourced application delivery. ASPs help hospitals overcome IT personnel shortages and limitations by providing various types of software and levels of service that allow hospitals to focus on their core business—patient care. Physicians are demonstrating interest in wireless interaction with medical portals to access information on drugs, disease diagnosis factors, and new medical findings."

The Current State of Affairs

Healthcare has used in-building wireless systems for many years, says Joel Cook, product manager for wireless systems at Eclipsys Corp. (Delray Beach, FL), an IT company that develops wireless healthcare devices and networks. He explains that "such systems are based on existing technologies, and use a portion of the radio spectrum reserved for industrial, scientific, and medical purposes—the ISM band." Examples of such applications include telemetry systems and wireless telephones.

Many other wireless applications have already been integrated into the daily routines of healthcare providers. Jerry Klintz, program director for wireless connectivity at Colorado Medtech, reports that wireless technologies are being deployed on a more-frequent basis in healthcare settings because they offer the following key benefits.

Figure 1. The OnCallData system by InstantDX provides physicians with access to real-time patient data.

Real-Time Communication. The first goal of wireless capabilities is communications. Enabling baseline search, location, and communication abilities in an environment where virtually all employees are mobile is the number one driver of wireless applications in healthcare. "Real-time communication is especially enabling in rural settings, where it's a potentially lifesaving application," says Klintz. "General-practice physicians can now consult specialists from far away." More than any other vertical market, healthcare employees depend on their pagers, cell phones, PDAs, and specialized devices to receive information that is critical to job performance.

One company that offers such specialized devices is PatientKeeper (Brighton, MA), developer of the PatientKeeper Personal, which is currently the most widely used handheld patient-management system. The system allows clinicians to communicate wirelessly with their hospital's information systems and perform critical-care functions from a single handheld device. The company also offers the LabKeeper, which allows clinicians to review lab results wirelessly.

VitalCom Inc. (Tustin, CA), a Data Critical company, also offers a patient-management device that supplies instant, real-time data. The company's PatientNet wireless network is compliant with the Federal Communications Commission's wireless medical telemetry service regulations, and includes a spread-spectrum data link for patient information. The device features scalability to support thousands of patients on a single network, and seamless roaming between radio-frequency access points. The system's access-point technology also supports communication over the same Ethernet backbone with network infrastructure sharing, enabling different wireless LANs to share network wires and access points.

InstantDX (Gaithersburg, MD) manufactures the OnCallData system, which allows physicians to view real-time patient data and lab results, as well as transmit prescriptions via wireless phone or handheld computer (see Figure 1). The device can be programmed to deliver "stat," "panic," or abnormal lab-result warnings immediately.

Enhanced Patient Care. According to Klintz, wireless technology can be a key component for enhancing patient care. From convenience considerations such as improved check-in and check-out procedures to mission-critical code-blue alarms, wireless devices are nearly ubiquitous in the healthcare setting. "Wireless technology has resulted in both higher customer-satisfaction ratings and lifesaving response times," he says.

Figure 2. Eclipsys's mobile computing stations offer enhanced patient care by saving caregivers time.

Several companies currently market products to improve the quality of patient care. Among them is Eclipsys, which offers a mobile PC workstation that can be used for a variety of purposes (see Figure 2). According to Cook, the workstation is being used mostly by nurses and registration clerks in emergency rooms for admission assessment, as the unit can be pushed outside to meet patients as they are lifted from the ambulance. "Such convenience saves time for caregivers, who are able to devote their attention to more-pressing concerns. It can also save the lives of critically injured patients, for whom every second counts," says Cook.

Data Critical Corp. (Bothell, WA) is also a key player in patient-care devices. The company's StatView product alerts nurses when alarms from primary patient-monitoring systems are triggered. "The device connects to an existing patient-monitoring network, collects alarm data from these monitors, and transmits electrocardiograms (ECGs), vital signs, and other patient information, all of which is transmitted wirelessly to a StatView receiver unit worn by the caregiver," says Brad Harlow, senior vice president of Data Critical. "It operates on a wireless LAN and integrates with most patient-monitoring and telemetry systems."

The company also offers a system designed to create a virtual monitoring network through connections to stand-alone devices. The AlarmView attaches to the backs of nonnetworked primary patient monitors, infusion pumps, and other intelligent devices, and delivers near-immediate alarms and other information to wireless receivers. The information from AlarmView transmitters can be sent to StatView receivers worn by caregivers. "AlarmView is designed to automatically communicate with devices manufactured by other companies immediately upon connection," says Harlow. "Accordingly, AlarmView can be easily transferred between a number of devices without costly and time-consuming setup."

Figure 3. The ActiveECG device by Active Corp. provides real-time display and recording of electrocardiogram data.

Active Corp. (Castine, ME) has developed the ActiveECG device, a pocket-sized, handheld, computer-based cardiac monitor for use with Palm OS handheld devices (see Figure 3). It is designed for both on-site and remote monitoring, and provides real-time display and recording of ECG data. ECG strips can be viewed, printed, or archived on any compatible PC, and can also be transmitted to other computers. The device has applications in many settings, but the most important in terms of improving patient care is in the home. In fact, the home-healthcare market for wireless devices has an outlook that's too promising to ignore. Cardiac giant Medtronic (Minneapolis) also offers a wireless implantable defibrillator.

Increased Productivity and Work Efficiency. Although wireless technology was originally deployed almost exclusively for caregivers in the healthcare environment, says Klintz, new efficiencies and economies of scale are being realized by integrating wireless software with back-office operations. "Software applications developed specifically for medical records, patient accounting, inventory management, and similar behind-the-scenes functions can now be extended to the appropriate mobile employees."

"Wireless technologies are taking the weight of administrative duties off the shoulders of healthcare professionals," says Brian Vink, vice president of marketing for iAnywhere Solutions (Emeryville, CA), a subsidiary of Sybase Inc. The company's m-Business platform provides an integrated end-to-end software platform for extending the reach of e-business applications and enterprise data and content to wireless devices, making it less time-consuming to manage back-office operations.

Another company seeking to increase the work efficiency of healthcare professionals is iScribe (Redwood City, CA). It offers handheld computing products and related services that place decision-making tools into the physician's hands at the point of care to automate key day-to-day activities such as prescribing drugs and capturing charges. The most significant benefits include the elimination of prescription rework, and protection against medication errors, saving time and lowering costs.

MediNotes Corp. (West Des Moines, IA) provides the Charting Plus electronic medical-records device to maximize the efficiency of medical staff through automation. The Charting Plus device creates and stores physician's notes and medical records. The unit comes with a user-friendly point-and-click interface through which information is available via wireless networking.

Medscape Inc. (Hillsboro, OR) has developed the Logician system, a digital health-record system that allows physicians to share data with practice-management software, laboratories, transcription services, and hospital information systems. The Logician is the most widely used digital health record in the exam room. The company also offers Medscape Charts, which includes a wireless Web-enabled application that eliminates the hassle of creating chart notes that are compliant with requirements of the Centers for Medicare and Medicaid Services (Baltimore).

MDeverywhere (Durham, NC) makes use of wireless technology to help physicians access, input, and control information. The company's flagship product, the EveryCharge device, is a handheld wireless electronic charge-capture tool that comes equipped with a rules engine to help ensure accuracy, consistency, and timely payment.

Barriers to Wireless Implementation

"In addition to in-building wireless systems, healthcare has also taken advantage of fixed point-to-point and multipoint wireless technology for connecting buildings on campuses," says Dave Hoglund, senior systems analyst for the healthcare group at Symbol Technologies (Holtsville, NY), a provider of wireless infrastructure. "But for each successfully deployed wireless application, there are a number of issues that have become apparent." Top-line concerns that recur in industry include the following.

Data Privacy and Security. "Security is already important in healthcare communications," says David Patterson of the Patterson Group, "but when hospitals make a commitment to using the wireless Internet as their communications platform, it becomes industry's top concern." When it comes to the need for patient authorization, the HIPAA privacy standard is an expansion, under most state laws, of a hospital's ability to disclose patient information without prior approval. According to Patterson, HIPAA's proposed privacy standard states that patient data can be shared without authorization if it is neccessary for treatment, payment, or healthcare operations.

"Vendors in the wireless arena are adopting required security measures by embedding user-authentication protocols and encryption technology in their products," says Harlow of Data Critical. "That's not where the difficulty lies. A major part of addressing HIPAA requirements will come in the form of education. Wireless vendors, device manufacturers, and hospital administrators will have to work together to define policies and procedures, and then train healthcare providers on the requirements."

Total Cost of Ownership. Wireless technology is revolutionizing the healthcare workplace, but at what cost? "Infrastructure, including expensive routers, modem banks, servers, systems software, security software, and devices, compose the back end," says Patterson. "Increased infrastructure requirements to facilitate the conversion of data to fit the narrower displays of wireless handheld devices is affecting total cost. In addition—and perhaps the most expensive of all—the cost of personnel to deploy, manage, upgrade, repair, and maintain the mountain of systems must be considered. And these are only the costs we know about; industry hasn't even begun to address the cost of integration."

According to Kenneth A. Kleinberg, vice president and research director for healthcare industry research and advisory services at Gartner Group (Stamford, CT), hospitals must be clear about how to approach ownership of wireless devices because they have important data on them. "Buy them and control them, or don't bother," he says. "The optimal goal would be to hit predefined targets in a total cost of ownership. The challenge remains that hard costs are easy to figure out; it's the soft costs that are a different story."

In addition, says Kleinberg, neither a real nor a perceived return on investment has yet been advanced by the vendor community or existing clients to serve as a meaningful benchmark for value. "By partnering with medical device manufacturers, a few vendors have succeeded in packaging wireless technology with specific clinical software applications that demonstrate significant return and added value to the clinician," he notes. "But that's only been done on a per-device basis. In order to recognize benefits, hospitals need to make a very large investment for the deployment of wireless technology on a wide scale, and they need to have an underlying network infrastructure. Industry's simply not there yet."

Lack of Connectivity and System Life. Hospitals use a variety of applications, databases, and systems to generate, manage, and maintain financial, clinical, and administrative information. Unfortunately, says John Pantano of Philips, current applications and databases are often not interconnected or even compatible with one another. "In many cases, in order for healthcare providers to obtain all the pertinent information on a patient, they need to access one application for medical history, another for x-rays or lab results, and a third for billing information," he explains. "The process is not only tedious and time-consuming, but also requires hospital personnel to be trained for a variety of systems that may not be applicable to their day-to-day responsibilities." Pantano continues, "Determining what wireless standards and devices will have an appropriate longevity to justify investment has become increasingly difficult for hospital administrators and medical device manufacturers alike."

Hoglund agrees: "The market confusion relative to protocols, service providers, and devices leaves many hospital decision makers wary to select systems that are expected to support operations for an extended period of time. It also leaves many medical device manufacturers at a loss when deciding which wireless-enabling vendors to partner with to augment their products."

According to Bill Wood of Colorado Medtech, the most important barrier to wireless implementation is the lack of an industrywide standard. "Having no accepted standard has permitted the growth of proprietary wireless technology and inconsistent technology deployment on the part of vendors, which has in turn created instability and confusion among medical device manufacturers," he says.

Interference and Nonperformance. Medical device manufacturers must also consider the radio-frequency issues in wireless deployment. Some of what appear to be excellent technologies for healthcare are eliminated from consideration because they either interfere or do not work in a hospital setting. According to Joel Cook of Eclipsys, device manufacturers should pay particular attention to possible interference problems and the number of access points required in a full implementation before selecting a wireless vendor to partner with.

The Future Is in Sight

The impediments discussed above have prevented a more widespread use of wireless technology in healthcare. According to Symbol's Hoglund, "These obstacles must be overcome before next-generation wireless solutions can be developed to tackle the bigger-picture problems of healthcare." He categorizes such problems under the following rubrics.

Integrated Communication. Implementing and maintaining effective wireless communications systems has become more demanding as healthcare organizations have expanded and merged. "Multicampus environments are the norm," says Hoglund. "In many cases, a strategic deployment vision was not in place for early adopters of wireless technology, and as a result, different standards- and nonstandards-based systems were maintained for separate facilities or departments. This can become a management nightmare," he explains (see sidebar, page 26). "In the future, there will be solutions that allow multiple systems to be merged into a seamless system."

Complete Automation. The vision of an all-digital, completely automated healthcare system has spurred some in industry to action. According to Klintz of Colorado Medtech, however, such capability is still in the distant future. "Medical device manufacturers aren't being bold enough in this respect, and for good reason," he says. "Wireless vendors have not yet adequately defined which business processes will be completely digitized with which technologies. There are still too many issues to be resolved before the complete automation of healthcare can arise."

Figure 4. Colorado Medtech's vision for the wireless future in healthcare is rooted in bedside connectivity.

Nevertheless, Colorado Medtech believes strongly in wireless capability. The company has even propounded its own vision for the wireless future called "Exploring the Future of Medical Device Connectivity" (see Figure 4). Says Bill Wood: "It's our version of a concept car. But the difficulty of bedside connectivity lies in making sure that all the separate devices—in most cases manufactured by different device companies—are equipped with the appropriate interfaces to allow the transferring of data among them."

Figure 5. The chip-level device server by Lantronix allows medical device manufacturers to quickly network-enable their products.

But perhaps the automation of the healthcare system is closer than industry thinks. There are already several companies that offer device connectivity solutions. One such company is Lantronix (Irvine, CA), a provider of device-networking products that connect medical devices to a wireless network (see Figure 5). The company also offers systems to manage network equipment. "We offer a series of different connectivity solutions that can be customized to meet the specific requirements of device manufacturers," says Tom Armbrust, medical segment manager of Lantronix. "The most basic level is the device networking space," he continues. "Most medical devices already have an existing serial interface that enables them to be attached to a network in minutes, which works fine as a short-term solution."

But as Paul Wacker, technical marketing manager of Lantronix, explains, "That's not the toughest part. We are of course currently working with manufacturers and their design teams to get our technology inside the new products they are developing. The problem remains addressing the installed base—the devices already in use—and enabling them to work with future applications."

Lantronix has already partnered with several large medical device manufacturers, including Abbott Laboratories (Abbott Park, IL), LifeScan Inc. (Milpitas, CA), Bayer Corp. (Tarrytown, NY), and Roche (Basel, Switzerland).

Instrument Interactivity. Take Colorado Medtech's vision one step further, and what industry faces is the possibility of not just instrument interconnectivity, but instrument interactivity. As Wood explains, "The time will come when medical devices of all types, from ventilators to infusion pumps to vital-signs monitors, are able to communicate with each other and collaborate without physician intervention, but right now the idea is preposterous to industry. It will take medical device manufacturers a few years to realize that wireless technology has the capability to facilitate this kind of interactivity, but when that happens, we'll really see the growth of wireless implementation in healthcare."

Conclusion

All consumers—healthcare providers included—want easy access from a central location. They want to be able to receive and query a single location to gain access to everything they need, whether it's an application or a data file.

Such a demand ensures that wireless technologies will not disappear from the healthcare arena. But what is now being promoted as a revolution may well take a different shape and make its way into industry gradually. The wireless revolution, that is, could become the wireless evolution.

In many respects, the technology needed to start the revolution is already available. In healthcare, however, the challenges for wireless integration are not only the speed of change and the alliances shaping up between wireless vendors and medical device manufacturers that daily alter the space, but also the lagging commitment of budget to implement currently available technologies. In short, wireless technology will be practical in healthcare when industry understands the difference between the hype and the reality, and moves forward with implementing technology that improves patient care and enables caregivers to work more efficiently.

The telecom industry is already planning the implementation process for next-generation wireless technology in healthcare. Companies expect to offer solutions to device interoperability, interconnectivity, and (eventually) interactivity, and they are actively investing in development and exploring opportunity areas.

Such advanced thinking may be a normal course of events for many developing technologies, but it's unusual to see next-generation solutions in the works when so many issues remain unclear.

For medical device manufacturers, anticipating where next-generation wireless technology is going is essential to avoiding costly mistakes. The best way for device manufacturers to prepare for the wireless future, then, is to understand the current landscape, keeping in mind that the next generation of wireless technology cannot be totally divorced from today's selection of offerings.

REFERENCE

1. "Industry Report: The Cure Is in Hand" [on-line] (San Francisco: W. R. Hambrecht & Co., 2000 [cited 19 October 2000]); available from Internet: http://www.wrhambrecht.com/research/coverage/ehealth/ir.html.

Flora Nguyen is assistant editor of MX.

Copyright ©2001 MX