Originally Published MDDI July 2002

INFORMATION TECHNOLOGY

Software, hardware, and service offerings provide valuable data about far-flung equipment.

William Leventon

When a finished medical device leaves the factory, the manufacturer's worries are far from over. What if there's a shipping mishap? What if a device on the other side of the world needs service? What if a critical component fails in a hospital at a life-or-death moment?

"People who run medical companies are saying, 'I've taken care of my core business process. But what about the edge? I have all these devices out there in the field. How do I improve that part of my business?'" explains Debbie Sexton, vice president of marketing communications at emWare Inc. (Salt Lake City).

To help companies answer that question, emWare and other firms offer a host of new products that tap the Internet to keep manufacturers in touch with devices in distant locations. These products are intended to improve remote device tracking, service, support, and sales, while reducing device-related costs and customer complaints.

KEEPING DEVICE SHIPPING ON TRACK

For information about products in transit, customers of Technical Transportation Inc. (Southlake, TX) can log on to the company's Internet-based logistics and tracking system. The system, called TechTrans, stores data gathered by shippers at several points along a product's route. Controlled by a server at Technical Transportation's headquarters, TechTrans contains product shipping dates, estimated arrival times, delivery dates, and other types of transportation information.

Using a password, customers access the TechTrans Web site (www.techtrans.com) and view shipping data for a specific item number, item type, project number, or location. They can also check undelivered products, delivered shipments, or shipping activity in a certain date range. "They can cut, slice, and dice their information however they want," says Len Batcha, president of Technical Transportation, whose 1500 agents provide transportation, logistics, and tracking services.

According to Batcha, TechTrans is used primarily by sales, marketing, and inventory-control personnel. The service can be especially useful to salespeople who demonstrate devices in the field. Using TechTrans, for example, a salesperson can find a demo unit close to the site of a potential customer, reserve the unit for the required time period, and make shipping arrangements that will get the unit to the site at the right time.

Technical Transportation recently worked with Datex-Ohmeda Inc. (Madison, WI) to create a custom planning and tracking tool to manage logistics for that company's demonstration anesthesia equipment. The software tool, which is also available at the TechTrans Web site, tracks each anesthesia unit using a number of criteria. This allows salespeople to order specific instrument types and arrange the necessary transportation services.

Before the software tracking system was developed, Datex-Ohmeda personnel tried to manage the process of moving hundreds of demo units around the country to meet the needs of 80 salespeople. Not surprisingly, this process was often time-consuming and inefficient.

By contrast, the new software lets users instantly track and trace any machine. At the TechTrans Web site, users can sort demo unit data by a variety of criteria. With distance tracking, for example, the user can select the available demo unit that's closest to the location where it is needed—reducing delivery time and shipping costs.

REMOTE MONITORING

Tracking systems like TechTrans allow a product's location to be pinpointed, but can't provide access to the valuable operational data locked inside a microprocessor-controlled device. To make use of that information, manufacturers need some kind of remote monitoring system that lets them tap into devices in the field.

More than a decade ago, a small medical device company installed a remote diagnostic system in its first product line. "We realized that we'd have to respond to customer needs very quickly, even though our products would be located all over the world," recalls Bill Mortimore, chairman of Merge Technologies Inc. (Milwaukee), which makes radiology equipment.

To maintain that equipment today, Merge uses a proprietary system to monitor, configure, and manage remote products. Called ViewCheck, the system relies on common Internet technologies such as secure Simple Network Management Protocol (SNMP), which lets Merge access its devices in a way that meets the security requirements of healthcare institutions.

The ViewCheck system features software "agents" that are loaded into Merge's devices. These agents continuously gather operational data and send it to the ViewCheck server. When the server detects a problem, it pages or e-mails a service engineer, who logs into the system to look at the device data. Once the problem is identified, the engineer can use ViewCheck to make the necessary adjustments—often before customers even notice the problem.

"In about 99% of the cases, we can do the fix remotely," reports Anton van Kimmenade, Merge's vice president of service. "So we rarely have to send anyone on-site."

Before deciding on a custom-made remote monitoring system, Merge considered several off-the-shelf options. One such option is RMS, an Internet-based software suite for remote device monitoring and management made by Intrinsyc Software Inc. (Vancouver). Among other things, RMS enables manufacturers to transmit identity data to new devices installed in the field. "When a device is connected to the Internet, it can download information that tells it what it is and what it's supposed to be doing," explains Neil McDonnell, Intrinsyc's CEO.

Manufacturers can also use RMS to load new profiles or operating systems into remote devices. In addition, the software provides tools to fix faulty devices. For example, a technician can send new software to overwrite corrupt data in one of the registries of a remote device.

DEVICE RELATIONSHIP MANAGEMENT

First and foremost, many remote monitoring products aim to improve device service. In a conventional service scenario, a device user spots something abnormal and calls the manufacturer. "But by that time, there's already a problem," notes Dave Bennett, director of medical devices for Axeda Systems Inc. (Mansfield, MA), which makes so-called device relationship management (DRM) software. "In many cases, the instrument's not able to function, so the customer is down."

To make matters worse, the manufacturer must depend on the customer for information about the problem. "And usually, that information isn't very good," Bennett adds. "It's rare that a customer can tell you what's really going on with the instrument."

So Axeda's DRM system uses the Internet to connect remote devices directly to the manufacturer. "The idea is to monitor conditions" inside a device, Bennett explains. "And when something looks like it's going to fail—but hasn't failed yet—[the device] automatically sends a message to a technician saying, 'Soon I might not be well. Someone needs to come look at me.' If the technician goes to the site and fixes the device while it's still working, you eliminate downtime."

Axeda DRM has a device component and an enterprise component. At the device end, a software agent gathers data and sends that information to a location designated by the manufacturer. The agent can be installed in the device itself or in an attached unit that serves as a "gateway" into the device.

At the data-receiving end, Axeda's enterprise software lets users view device information using a standard Internet browser. The software acts as a device data center, where information can be stored and managed in a secure environment. The software also allows remote device administration, diagnostics, and adjustment. The software can handle data from hundreds, thousands, or even millions of devices, according to the company.

Throughout the life of a device, Axeda DRM provides manufacturers with a continuous flow of information that can be used to improve service. By monitoring data trends, for instance, a manufacturer can identify and fix a malfunctioning component before the device fails.

Beckman Coulter Inc. (Fullerton, CA) uses Axeda DRM to keep tabs on its chemistry analyzers installed in hospitals. The software gathers system performance data from the analyzers and transmits the data via the Internet to servers at Beckman Coulter's customer service center. There, technicians can view operational data in real time and detect operational trends that could be indicative of potential equipment malfunctions. These capabilities enable Beckman Coulter technicians to troubleshoot impending failures before they occur.

Other manufacturers use DRM software to calibrate remote devices and view usage patterns that let them anticipate customer needs. The software also enables users to see how a device is performing in comparison with other devices of the same type. "Previously, it took weeks—if not longer—to get that kind of information," Bennett says. "Imagine being able to get it with the click of a mouse."

More than 20 medical device manufacturers currently use Axeda DRM to gather and transmit various kinds of device information. "Our solution is like plumbing," Bennett says. "It provides a new way of getting data from point A to point B."

MORE DRM

Like Axeda, Questra Corp. (Rochester, NY) sells DRM software to medical device manufacturers. Questra's product, known as Questra Smart Service Solution, works much like the Axeda offering, using software agents to collect remote-device data and send the infomation to the manufacturer. The Internet-based software works with a wide range of microprocessors, including the eight-bit processors used in some small devices.

As the name implies, the main purpose of Questra Smart Service Solution "is to help manufacturers provide superior customer service," says Vesna Swartz, Questra's vice president of marketing and business development. "Manufacturers can dramatically improve the services they deliver to customers at a much lower cost than they pay for traditional methods."

Recently, Questra formed a technology partnership with Los Angeles–based Diagnostic Products Corp. (DPC), which makes test kits and related instruments. Questra's software will allow DPC to monitor, test, and control remote devices. DPC will use the system to diagnose problems in advance of service calls, ensuring that technicians are dispatched with the right skills, equipment, and parts to repair devices in the field.

Questra's software gives manufacturers the ability to compile and manage data from large numbers of remote devices. For example, a company can receive information at regular intervals from a group of similar devices in the field. Then, by comparing data from one device to those of its peers, the manufacturer can see if the device is trending away from normal operation, notes Eric Baller, chief architect of Questra's software.

Aside from improving service, the software can be used to automate the process of replenishing consumables. "In the medical device industry, the consumables business is a major revenue stream," Questra's Swartz notes. By monitoring remote-equipment usage, the software can determine when the supply of consumables runs low. At that point, the system can trigger an automatic order that the manufacturer fills.

The DRM software also lets manufacturers employ usage-based billing arrangements in which customers would pay manufacturers based on the actual equipment usage monitored. "As opposed to paying for equipment upfront, this would be a pay-as-you-go approach," Swartz explains.

HARDWARE AND SOFTWARE

DRM software runs on equipment like that made by NetSilicon Inc. (Waltham, MA), which offers a family of silicon chip–based systems for attaching devices to a network. Each system includes a 32-bit microprocessor core, a 10/100 Ethernet media interface controller, serial and parallel ports, and several other hardware components. In addition, the systems come with software such as a commercial operating system, a complete TCP/IP stack, and a set of Internet applications that includes a Web server, e-mail protocols, SNMP, and an FTP client server.

When a NetSilicon system is installed on a new device's PC board, its microprocessor can add both processing and networking capability to the device, says Bill Pisel, NetSilicon's chief technology officer.

Users of NetSilicon system can view device data with any conventional Internet browser. In addition, users can set up processes that trigger an alert if something in a device malfunctions. For example, a user interested in temperature variations in a device could enter minimum and maximum temperatures on a special Web page. If the device temperature should move outside that range, the system could alert the user by sending an e-mail or setting off a beeper.

According to Pisel, manufacturers are starting to use products like NetSilicon's for preventive diagnostics. "If a device has moving parts that wear out over time, you can monitor the usage patterns to determine when the device will fail," Pisel says. By replacing malfunctioning components before they cause a failure, the manufacturer can reduce a customer's downtime.

NetSilicon was recently purchased by Digi International Inc. (Minnetonka, MN), which makes network-connection boxes that attach to devices but are located outside them. Digi's systems can be used to add Internet access to devices already in the field. NetSilicon's product, on the other hand, can be used if a new design needs a processor and Ethernet connectivity.

END-TO-END SYSTEM CONNECTIVITY

Like Digi, emWare makes a networking module that attaches to remote devices. The module is part of the company's end-to-end system for connecting devices over the Internet. The emWare system includes hardware, software, and services that can be used to network both new and existing devices.

To use the system, a device is attached to one of emWare's DeviceGate modules. A hardware and software gateway, the DeviceGate allows both constant and message-based wide-area network communications. Message-based communication suffices for devices that require only brief, intermittent connections to control systems. In message-based systems, the DeviceGate connects to emWare's Enterprise Messaging Gateway, or EMG. EMG software runs on servers at emWare's corporate data center.

Manufacturers and service contractors can access equipment data using a standard browser running on a desktop PC, laptop, PDA, or cell phone. When a user types in a request for device data, the EMG pages the DeviceGate attached to that unit. The DeviceGate then signals the medical device to generate the requested information. "We call it a little shoulder tap," says emWare's Debbie Sexton. In response to the signal, the device sends the data, which flows through the DeviceGate and the EMG before reaching the user.

According to Sexton, the emWare system is more secure than remote monitoring systems in which Internet lines attach directly to devices. The reason: a direct Internet attachment makes devices vulnerable to hackers, she claims. "But you can't hack into our system," she says. "To get information out of a device, a person has to send a signal that goes through the DeviceGate."

Offering a variety of subscription-based services, the emWare system provides users with an instant networking infrastructure. "Our data center is a big room with expensive servers," Sexton says. "If customers use our services, they don't have to make the investment in a huge setup like ours. They just pay $3 a month per device to connect to our EMG."

Nevertheless, some emWare customers purchase their own EMG, preferring direct communication with their devices to communication that passes through the emWare facility. "Some companies want to control [the EMG] themselves," Sexton says. "Others would rather work through us and let us manage it. So we offer both options."

CONCLUSION

Thanks to a variety of Internet-based products and services, manufacturers can gather all kinds of data from their devices in the field. But remote monitoring provides more than just raw data. Questra's Vesna Swartz points out: "This is all about turning data into actionable business intelligence that helps people make good decisions and run their companies more profitably."

William Leventon is a freelance writer and a frequent contributor to MD&DI.

Copyright ©2002 Medical Device & Diagnostic Industry