Web-based Products Link Manufacturers to Remote Devices 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 the device needs service on the other side of the world? What if it 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?’” says Debbie Sexton, vice president of marketing communications at emWare Inc. (Salt Lake City, UT). 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 far-flung devices. These products are supposed to improve remote device tracking, service, support, and sales, while reducing device-related costs and customer complaints. On the Track of a Device For information about products in transit, customers of Technical Transportation Inc. (Southlake, TX) can log on to the company’s Web-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 an item’s shipping date, estimated time of arrival, delivery date, and other types of transportation information. The information is available at Technical Transportation’s Web site (http://www.techtrans.com). Once customers access TechTrans using a password, they can 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 helpful to salespeople who demonstrate devices in the field. Using TechTrans, for example, a salesperson can find the demo unit closest 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. Recently, Technical Transportation worked with Datex-Ohmeda Inc. (Madison, WI) to create a custom planning and tracking tool to manage logistics for Datex-Ohmeda’s demonstration anesthesia equipment. The software tool, available at the TechTrans Web site, tracks each anesthesia unit using a number of criteria, allowing salespeople to order specific instrument types and the required 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 at the request of 80 different 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 location it’s needed, reducing delivery time and shipping costs. Remote Monitoring Tracking systems like TechTrans let you pinpoint a product’s location, but they can’t get access to the valuable operational data locked inside a microprocessor-controlled device. To tap that information, manufacturers need some kind of remote monitoring system that lets them into devices in the field. More than a decade ago, a small medical device company installed a remote diagnostic system in its first piece of equipment. “We realized that we’d have to respond to customer needs very quickly, even though our products would be 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 home-made system that monitors, configures, and manages remote products. Called ViewCheck, the system relies on widely used 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 health-care 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 percent 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 onsite.” Before deciding on a custom-made remote-monitoring system, Merge considered several off-the-shelf options. One such option is RMS, a Web-based software suite for remote device monitoring and management made by Intrinsyc Software Inc. (Vancouver, British Columbia). Among other things, RMS allows 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. RMS also lets manufacturers load new profiles or new operating systems into remote devices. In addition, the software can be used to fix faulty devices. For example, a technician can send a remote device new software that writes over corrupt data in one of the device’s registries. 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 says. “It’s rare that a customer can tell you what’s really going on with the instrument.” So Axeda’s Device Relationship Management 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 it 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 Web browser. The software acts as a device data center, storing and managing information 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. 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 discover and fix a malfunctioning component before the device fails — and before the customer even notices a problem. Fullerton, CA-based Beckman Coulter Inc. uses Axeda DRM to keep tabs on its chemistry analyzers in hospitals. The software gathers system performance data from the analyzers and transmits it to servers at Beckman Coulter's customer service center. There, technicians can view real-time operational data using standard Web browsers. The software also notifies the technicians about operational trends that could eventually cause equipment downtime. This lets Beckman Coulter troubleshoot potential problems before they become real problems. Other manufacturers use DRM software to calibrate remote devices and view usage patterns that let them anticipate customer needs. The software also lets users see how a device is performing in comparison to other devices of the same type. “Today, it takes weeks — if not longer — to get that kind of information,” Bennett says. “Imagine being able to get it with the click of a mouse.” Right now, more than 20 medical device manufacturers use Axeda DRM to gather and transmit all 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, Rochester, NY-based Questra Corp. 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 it back to the manufacturer. The Web-based software works with a wide range of microprocessors, including the 8-bit processors 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 Diagnostic Products Corp. (Los Angeles), which makes test kits and related instruments. Questra’s software will allow DPC to monitor, test, and control remote devices. By doing so, DPC will be able to remotely diagnose problems in advance of service calls, ensuring that technicians are dispatched with the right skills, equipment, and parts to fix devices in the field. Like Axeda DRM, Questra’s software lets manufacturers gather and manage data from large numbers of remote devices. For example, a company can receive information at regular intervals from a big group of similar devices in the field. By comparing data from one device to that 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. Besides improving service, Questra’s software can be used to automate the process of replenishing consumables. “In the medical device industry, the consumables business is a major revenue stream,” Swartz notes. By monitoring remote equipment usage, Questra’s software will know when the supply of consumables runs low. At that point, it can trigger an automatic order that the manufacturer fills. The software also lets manufacturers employ usage-based billing arrangements. In these arrangements, customers would pay manufacturers based on equipment usage monitored by Questra’s software. “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 products like those made by NetSilicon Inc. (Waltham, MA), which offers a family of system-on- silicon chips for attaching devices to a network. The 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 system comes 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. The NetSilicon system is installed on a device’s PC board. With its microprocessor, the system can add both processing and networking capability to the device, notes Bill Pisel, NetSilicon’s chief technology officer. Users of the NetSilicon system can view device data with any standard Web browser. In addition, users can set up processes that alert them if something goes wrong in a device. 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 the parts before they cause a failure, manufacturers 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. “If you want to add Internet access to devices in the field, you would buy Digi’s product,” Pisel explains. “If you have a new design that needs a processor and Ethernet connectivity, you would buy NetSilicon’s product.” End-to-End System 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/software gateway, the DeviceGate allows both constant and message-based wide-area 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 cellphone. When a user types in a request for device data, the EMG sends a page to the DeviceGate attached to that unit. Then the DeviceGate signals the medical device to provide 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 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 the Internet and a variety of Web-based products and services, manufacturers can gather all kinds of data about 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." This article was published in Medical Device & Diagnostic Industry magazine.