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Originally Published MX November/December 2001

INFORMATION TECHNOLOGIES

Network-Enabled Products

Medical device manufacturers can stay one step ahead of the competition by addressing today’s most pressing need in healthcare: efficiency.

Fred Thiel

Hospitals are continually on the lookout for solutions that will allow them to manage and care for patients more efficiently. In these modern times, it quickly becomes evident that a technological boost would make hospitals and other healthcare organizations run more smoothly. This opens the door for medical device manufacturers to begin searching for solutions that will enhance their product lines and meet the needs of their customers.

In pursuing new technologies to streamline hospital operations, many medical device manufacturers are considering developing products that can leverage the power of a network. Before investing in such technologies, however, medtech executives need to know exactly how they will increase efficiency, save money, and improve the bottom line.

Among medical device manufacturers, networked devices have been viewed as merely novelty items, in part because of the overwhelming media hype about how consumer devices will lead the charge toward global interconnectivity. It’s not uncommon to encounter stories about refrigerators that can automatically order food, or MP3 audio players that can seek out new material based on the owner’s musical tastes. Even a lowly gardening implement such as a hand trowel could be equipped to send soil pH data to a wireless station, which could communicate with a landscaping supply business for topsoil replenishment.

Still, medical device manufacturers may have the biggest opportunity to use networked technologies for the most profound effects on the bottom line. Harbor Research (San Francisco), a strategic consulting and research firm, predicts that in 5 years, the number of embedded chips sold to support intelligent devices could reach more than 9 billion units per year.1 Harbor Research also determined that, in the $40 billion U.S. medical device industry in 1999, $7.1 billion was spent on capital medical equipment. And as the U.S. medical device industry grows to $57 billion by 2004, so will the market opportunity for medical device manufacturers. In the near future, digital intelligence and connectivity will be designed into almost every type of electronic device. Medical device manufacturers are well positioned to take advantage of this trend toward connectivity.

To grasp the full impact of a network-enabled medical device, however, product developers need to look at what’s been there all along. The information associated with a product is at least as valuable as the device itself. Current generations of medical devices produce a range of information that includes real-time patient diagnostics, current status of operation, location, part number, purchase history, when it was installed, by whom, critical specifications, availability of replacements and alternative devices, repair instructions, and so on. Medical devices already contain all the necessary information embedded inside of them, and this data will always be accessible throughout its life cycle.

But information is worthless unless it is also put into context or utilized for a purpose. Therefore, the smart device must be connected to a network and utilized to support value-added services, including remote diagnostics and repair. These key components make up an innovative concept called device networking.

Advances in networking technologies and the Internet have opened the door for this emerging concept, and medical device manufacturers should consider jumping onboard. Considering that most medical offices and hospitals are already wired for Ethernet—one of the most popular networking technologies—the infrastructure is in place for manufacturers to add device networking capabilities to their products.

Device networking gives medtech manufacturers an opportunity to provide hospitals with products that will allow them to have real-time access to information in order to improve efficiency, make intelligent decisions, enhance customer service, and save time and money. It gives devices such as handheld blood analyzers, IVD point-of-care devices, multiparameter patient monitors, ventilators, and many other types of devices the power to share information over the network or the Internet without the need for bulky, expensive personal computers.

Increased Efficiency

One of the key advantages of network-enabling devices is the efficiency that hospitals gain from having real-time access to information. Hospitals are starting to make strides in electronic medical records and the ability to manage hospital administrative procedures electronically. However, there are still a number of paper-based systems in healthcare environments, leaving a lot of room for human error.

The UDS-10 external device server by Lantronix (Irvine, CA) allows device manufacturers to network-enable their products.

By automating the process of recording patient tests through device networking, members of the medical staff can access electronic records of a test or other vital information that was collected manually. With an electronic archive, healthcare professionals have the ability to verify information before making critical patient-care decisions.

In addition to recording information electronically and minimizing mistakes that can occur when healthcare professionals manually transcribe information, device networking can speed the exchange of information between medical devices and a healthcare provider’s laboratory or hospital information system. This means that information from alternate sites or remote facilities and central labs can be shared in real-time with the patient’s designated healthcare professionals. This allows healthcare professionals to make decisions more quickly because they have real-time access to accurate information.

The good news for medical device manufacturers is that the more they increase efficiency for hospitals and improve their process for tracking and exchanging information, the more opportunities they are going to have to sell products. For example, the more that hospitals use an IVD point-of-care (POC) device, the more they will need consumables such as test strips and test cartridges. Developers of infusion pumps will be in the same boat; the more that their devices are used, the more fluids, syringes, tubing, bags, and catheters will be needed by the healthcare provider. The same opportunities exist for a number of medical device manufacturers, including developers of multiparameter patient monitors and ventilators.

In addition to opening up new opportunities for consumables—already a $33 billion market in 1999, according to Frost & Sullivan (Mountain View, CA)—device networking will allow medical device manufacturers to put a price on something that is very difficult to measure: efficiency.2 And, considering that a manufacturer can typically add device networking capabilities to a product for about $30, the return on investment outweighs the added cost for network-enabling a device.

Improved Patient-Relationship Management

There are many examples of how network-enabled medical devices can increase the overall quality of patient care. Over the past few years, POC testing has been a prominent beneficiary of this technological adoption. Devices such as glucose, hemoglobin, and coagulation meters have enhanced their performance features by being networked.

For example, POC blood analysis systems with only serial connections were bound to individual workstations, which took up valuable bench space that could be used for other diagnostic devices. By placing such analyzers on the network, multiple workstations were eliminated, thus freeing up space. Multiple analyzers throughout the facility, and their testing results, can be remotely monitored, managed, and integrated into the laboratory and hospital information systems.

This scenario can be repeated with countless types of medical devices such as infusion pumps, multiparameter patient monitors, ventilators, cardiac output monitors, and ultrasound equipment. The overall benefit to patients and providers is that test results and other monitored health information are electronically captured, networked, and made available to the appropriate healthcare providers for assessment in real time.

Employee Utilization

For the most part, medical devices are somewhat self-contained and can perform varying levels of performance and maintenance diagnostics upon themselves. Because devices are getting smarter, however, basic field-service repairs are far less common than they used to be.

During a product’s life cycle a number of technological advances may take place. In some cases, an otherwise outdated device could be revitalized simply by making a minor software change. The challenge is to figure out how to upgrade thousands of devices already installed and in various stages of use and age. It is not an easy task, but it has been performed, or at least attempted, many times in the past.

Network-enabled devices offer an advantage in this area too. Using the healthcare provider’s network, software and embedded board-level upgrades can be installed electronically together with service and training documents. The upgrade requires minimal time, and the installations are electronically verified.

A similar example occurs when a single device has difficulties beyond the scope of its self-diagnostics. The advanced intelligence within a networked device could contact the manufacturer for assistance, enabling a technician to assess the difficulty and administer appropriate corrective measures. An automated e-mail would then be sent to notify the healthcare facility’s coordinator of the action taken.

Such scenarios are real and demand frequent attention. Network enablement can free field-support personnel to focus on improving customer service in other ways.

An Asset Life-Cycle Approach

Medical device firms understand the importance of gathering and analyzing device performance data and other related product information. Field device performance and operation data are both critical to understanding a product’s strongest and weakest attributes. Product revisions and other ancillary offerings rely heavily on a thorough analysis of a manufacturer’s installed base.

Lantronix also offers an embedded device server for network-enabling purposes.

Healthcare providers are very cautious about adopting new technologies. There is a level of comfort associated with device usage that reflects brand loyalty, ease of use, accuracy, and how the device assists in improving the overall quality of care. When product enhancements are being researched and developed, manufacturers are especially sensitive to the markets they serve.

Even so, data pertaining to warranty information, usage habits, service records, feature sets, and so on, can be difficult to attain. When they are captured, they don’t always provide the validity needed.

When devices are networked, a complete and accurate service history can be compiled. Such documentation is invaluable to product managers in assessing the overall performance and functionality of the device. Strategic product road maps and other marketing initiatives can be more readily adapted to customer needs and uses when they are based upon a reliable and accurate source of operational data.

This is not to suggest that device manufacturers can retrieve performance data by accessing their products via any healthcare provider’s network. Regulations related to the Health Insurance Portability and Accountability Act of 1996 (HIPAA) have accentuated the need for healthcare providers to safeguard patient health information. Secure systems that comply with HIPAA regulations are thus an integral part of any device networking system.

Ready to Use

The proposition of device networking may seem a vision of the future, a technology in search of a problem, or a technology that is an all-or-nothing proposition with limited impact on today’s business. However, a number of medical device and equipment manufacturers have already begun to adopt such information technologies in their products in order to create new business opportunities and add new value for their end-users.

The technology is available today, allowing device networking to be incorporated into both devices and systems. Commercially available products, including the necessary hardware and software, are available in a variety of configurations to meet the unique needs of manufacturers.

In the case of manufacturers looking to enhance existing products or an installed base of products, modular solutions are available to quickly and cost-effectively add networking capabilities. Such solutions generally attach to medical devices through an existing interface, like an RS-232 serial connection, making the information within the device accessible over a network, using technologies like Ethernet.

In one example, a manufacturer of patient-monitoring devices adopted a networking approach to simplify the installation and maintenance of its centralized monitoring systems. Previous-generation systems relied on dedicated wiring, which limited the distances between the patient-monitoring devices and the central monitoring station. By attaching the patient-monitoring devices to the hospital’s local-area network the distance limitation was overcome, enabling staff to access patient data not only from the local monitoring station but from any point on the hospital’s network.

The chip-level device server by Lantronix offers the latest-generation network-enabling
technology.

In this case, the manufacturer also found the direct network interface useful for maintenance and service purposes. With appropriate security measures in place, Internet connections can provide an alternative means of product support. By diagnosing systems remotely in advance, service personnel can be prepared with the right parts to finish the job in just one visit. Manufacturers can offer such services as part of an annual service contract, or as part of a value-added package for select customers.

Another manufacturer had similar device-networking requirements for its handheld automated blood analyzer. The company required a means of electronically transferring patient test data stored in the analyzer to information systems within the hospital, either for archival purposes or for additional laboratory testing. Because the device was portable, the company put a premium on obtaining a compact and inexpensive device-networking solution.

In this case, the use of infrared links was rejected because of the cost of dedicated cabling for the required receivers. A more efficient solution was to piggyback onto the hospital’s existing Ethernet network using a commercial off-the-shelf docking station. Within the docking station, the manufacturer’s engineers used a small circuit board to bridge the device’s serial port to the Ethernet network. With this technology, nurses and other medical personnel can submit important patient test records from their station, without having to print out or transcribe the information, thus maintaining the quality and timeliness of the information.

Conclusion

A growing number of networked devices are being developed by manufacturers and adopted by hospitals. The proven ability of such products to increase efficiency and enhance patient care should be more than enough reason for device manufacturers to stop considering them as mere novelties.

For medical device manufacturers, device networking offers a true competitive advantage that enables them to provide value-added services for their customers, increase sales of new products, enhance the use of existing products, and create more consumption of disposables. By adopting device-networking approaches sooner rather than later, medtech executives can help to ensure that their companies will remain in the black for a long time to come.


REFERENCES

1. "Introducing a Strategic Study: Capitalizing on the Pervasive Internet, Phase 1: A Comprehensive Analysis of the Device Demographics and Business Models Driving Internet Device Networking," in Harbor Research Home Page [on-line] (San Francisco: Harbor Research, 2001 [cited 26 October 2001]); available via Internet: http://harborresearch.com/frameset.html.

2. U.S. Medical Product Market [equity research report] (Mountain View, CA: Frost & Sullivan, 1999).

Fred Thiel is president and CEO of Lantronix (Irvine, CA), a provider of device-networking products that connect medical devices to networks.

Copyright ©2001 MX