Medical Device & Diagnostic Industry Magazine
MDDI Article Index

Originally Published MDDI October 2005

Software

Device Makers Access Key Data
from a Distance

Monitoring software lets manufacturers tap off-site sources of process and product information remotely.

By William Leventon

A service technician in an office wants to know what's wrong with a device in the field. A company president in China wants to know what's happening on the floor of the company's plant back home in the United States. A molding manager wants to know what's causing so much downtime on the graveyard shift at the factory.

What do these people have in common? They're all potential users of remote monitoring software. Some of these software packages enable manufacturers to check and even fix their devices at customer sites. Others let users track plant-floor operations—from a nearby office or a foreign country.

Keeping Up with Downtime

Companies that want to monitor and control production processes may find answers in a type of software known as a manufacturing execution system (MES). One MES product provides manufacturers with up-to-date information on a key subject: whether or not their machines are running. “One of the main things our customers complain about is downtime,” reports Dave Monroe, vice president of sales and marketing for Mattec Corp. The Loveland, OH– based firm sells ProHelp EPM and ProHelp Millennium software. “The customer's process has stopped, the machine is jammed or broken, and it may be 20 minutes before anyone realizes it's not producing parts.”

The MES software also keeps track of equipment speeds, temperatures, pressures, and other variables that affect part production. In addition, it lets users track and see important trends in manufacturing operations.

The software is installed in a device that's hooked up to the machine the user wishes to monitor. The interface device sends the machine data to a Mattec file server that is connected to a corporate network.

One Mattec customer moved its manufacturing operations to Mexico, but all of the firm's manufacturing experts remained in the United States. Aided by the software, Monroe says, these experts monitor the company's Mexico facilities and troubleshoot machine problems. They also do statistical process control analysis to make sure that parts are being manufactured according to the company's standards.

ProHelp is also useful to Mike Venino, molding manager for The MedTech Group Inc. (South Plainfield, NJ), a contract manufacturing firm that works with medical device companies. Hooked up to a MedTech molding machine, Mattec's machine interface device monitors parameters such as temperature, cycle time, and injection time.

Venino can check on all the molding machines in a plant using the software's real-time monitoring screen. The screen displays a graphical representation of the plant floor, with icons marking the location of each molding machine. The color of an icon shows the status of the machine it represents. A green icon represents a machine that's up and running with all monitored parameters within specified limits. A yellow icon represents a machine that's running, but with one or more monitored parameters outside specified limits. And a red icon represents a down machine.

Even from home, Venino can stay informed about the status of his machines. “Using my home computer, I can connect to our network, pull up the [monitoring] screen, and find out exactly what's going on at the plant,” he says.

The information is also available to people in MedTech's quality control department. They use the software to chart machine conditions in relation to control limits. The software also helps the firm's materials group track data such as part production counts and the weight of consumed materials. In the future, MedTech may install Mattec monitoring systems at its Costa Rica and Puerto Rico divisions. “Then, people at multiple divisions in different plants will all be able to look at each other's processes,” Venino says.

MES for Multisite Monitoring

Another MES product is InSite, developed by Camstar Systems Inc. (Charlotte, NC). It tracks production yields, cycle times, defects, and other process and product data, according to Susan Lamb, InSite's marketing manager.

The product was designed for the management of multisite enterprises. “You can be anywhere and see what's going on throughout the world,” Lamb says.

With the software's browser-based interface, users can aggregate manufacturing information from multiple plants at different sites. They can also view the audit trails of products made in different locations.

In addition, the remote monitoring software can notify the user of a manufacturing problem at a distant plant. “Maybe that person is responsible for the resolution of the problem,” Lamb says. “If so, the person can be notified by e-mail or a message to a [personal digital assistant].”

After receiving such a message, users can take corrective action via a browser. For example, someone responsible for a product not performing as specified could assign the problem to an engineer. Before doing so, the person would enter an electronic signature showing that he or she has the authority to take that action.

At Carl Zeiss Meditec's Dublin, CA, facility, personnel use InSite to collect key data on the company's products, which are used to diagnose and treat eye diseases. The software assigns a serial number to each product and then tracks that serial number as the product moves through production, assembly, and testing processes. The collected data constitute a device history record for the product, explains Kal Nawawi, the company's director of manufacturing.

Nawawi's firm is still testing the new software. Until the testing is completed, it will be used in parallel with the company's old system, which requires plant personnel to gather product data and write the information down. These paper-based data are collected and entered into a computer spreadsheet on a monthly basis. “So if I wanted to look at yield data, that would only be available for last month,” Nawawi notes.

The system provides more up-to-date information because factory workers enter data directly into a computer. So before Nawawi leaves the office for the day, he says, “I can look at yields for yesterday, this morning, or this afternoon.”

Using a Web interface, Nawawi and his colleagues can monitor plant-floor data from their offices. The data can be used to locate production bottlenecks, workstations overcrowded with products, and units remaining in the process longer than the normal cycle time. Soon, Nawawi reports, office-based personnel will also be able to look at live defect data of flawed units as the products move through production.

Live defect data are now available from the company's affiliates in Japan and Germany. These affiliates inspect products received from the U.S. plant. If defects are found, the inspectors report them using the software. “We can see the data as soon as they enter it,” Nawawi says. “It comes up on the screen as: ‘Japan found this issue' or ‘Germany found that issue.'”

The product database isn't available only to office-bound personnel; it's also open to service people in the field. Using a Web interface, Carl Zeiss technicians can access rework information and other product data that might be helpful in fixing a unit at a customer's site.

RealTime Data

Another production-monitoring software, RealTime, is installed in an interface device that gathers and sends out machine data that end up in a server connected to the corporate network. But it is different from some other MES products, notes Terry Cline, because it's integrated into an enterprise resource planning (ERP) system. Cline is vice president of IQMS, the Paso Robles, CA–based firm that developed the software.

The software monitors manufacturing machines to keep track of cycle counts, good or scrap parts, and up- and downtime. This information “is brought back into the ERP system, so you can do real-time scheduling, production management, and inventory management,” Cline says. “You don't have to wait until the end of the day or the end of the week to learn about what happened on the plant floor.”

People with access to the corporate network can remotely track plant-floor activity on a screen that looks like a spreadsheet. For example, Cline says, managers can check plant activity from home after work. One company even uses the product to run and manage its machines at a customer's site.

Monitoring devices are hooked up to production equipment at C. Brewer Co., a custom molder based in Anaheim, CA, that works with a number of medical device companies. The monitoring devices keep track of scrap produced during manufacturing jobs, according to Larry Sanders, the company's IT manager.

In addition, the software counts manufacturing cycles, keeping plant personnel informed about the status of work orders. C. Brewer workers also use the data to time cycles, Sanders notes. This lets them know whether they're meeting company standards for cycle time, which has a major effect on corporate finances and product quality.

Another RealTime task is to help the firm's managers monitor plant technicians and their problem-solving techniques. “We don't let them slow our cycle way down to fix a problem that should have been solved some other way,” Sanders says. “And we don't let them speed up a cycle, which could cause us quality problems.”

C. Brewer's Anaheim plant includes three separate molding areas. Using one PC, the molding supervisor on duty can monitor all three areas simply by switching between them on the RealTime screen, Sanders notes.

The company also has another manufacturing facility about 20 miles from the Anaheim plant. Managers use the software to monitor production at both facilities, which are connected to the company's wide-area network.

“Our manufacturing director is concerned at all times about how his facilities are running,” Sanders says. “With RealTime, he can check the facilities by logging in to our network from wherever he is.” For example, the manager can monitor one plant while he is in the other. Or he can monitor manufacturing operations in both plants from his office. By hooking up to the corporate network via the Internet, he can even monitor both plants while on the road.

Remote Medical Device Monitoring

Besides checking up on remote processes, software products can also let manufacturing personnel keep track of devices once they leave the factory. One such product is Axeda DRM, which continuously monitors remote devices for indications of problems. If a customer calls about a problem with a device, the manufacturer can remotely check the status of the device and its data history to determine what's wrong. Remote troubleshooting takes less time than dispatching a technician to the customer's site to diagnose the problem, notes Brian Anderson, vice president of marketing for Mansfield, MA-based Axeda Systems Inc.

Axeda DRM can also help prevent device problems. If a key device reading reaches a certain threshold value, for example, the software can send a message to the manufacturer's service department. Alerted to the situation, the service department can fix the device before it fails, minimizing or preventing equipment downtime.

The system includes a central server located in the device manufacturer's support center. The system also features a software agent that's installed in the medical device being monitored or in a computer near the device.

According to Anderson, the security features that protect the system allow the monitored devices to stay safely behind the user's firewall. “We've done a lot of work on security,” he says.

Like Axeda DRM, Questra Smart Service Solution is designed to reduce field service calls (see Figure 1). The software lets manufacturers access remote machines to monitor operations and run tests, explains Walt Rossi, vice president of marketing for Questra Corp. in Redwood City, CA.

If a remote device has a software problem, the manufacturer may be able to solve it remotely by sending a new version of the software to the device via the Internet. Such remote fixes aren't uncommon. “In some cases, our customers cut the number of times field engineers are dispatched by 50–70 percent,” Rossi says. “That's a big cost savings to the manufacturer.”

Soon, Questra will release a new version of its remote monitoring software. Featuring rich Internet application (RIA) technology, it allows video, voice, and enhanced graphics to be used in the remote diagnosis of device problems. With this RIA-enhanced version of the software, Rossi says, users will be able to look at live video of components operating inside a remote device. “Or they could press a button and get a chat session going with a remote person without picking up a phone,” he adds. “They could also rotate a CAT scan machine in a 3-D view to help them determine what's wrong with it.”

Reports from Users

Medical device companies report impressive results from their use of remote device-monitoring software. Varian Medical Systems Inc. (Palo Alto, CA) uses Axeda DRM to monitor several of its products. These include Clinac, a linear accelerator that administers radiation treatments to patients, and Varis Vision, a software product that verifies the correctness of Clinac treatments. “If there's a bug in the software, [Axeda DRM] allows us to analyze the bug and work on the fix without going on-site,” says Bob Larsen, Varian's director of marketing for customer support.

Software fixes include setting new parameters and sending patches or updates. “Many times, we're able to fix the problem during the remote access session,” reports Todd Lauer, Varian's director of product support engineering.

Varian was able to do the same things with another type of software, but that product didn't include features that effectively prevented unauthorized access to remote systems. Unlike the old product, Axeda DRM includes a sophisticated algorithm for maintaining security, Lauer notes. “There's a log that shows all the activity that took place,” he says, which means that both the hospitals and the device makers can track anybody monitoring their operations.

In the past, Varian support personnel would often travel to a customer's site to fix a product only to discover that the only problem was an operator who didn't fully understand the software. Not surprisingly, the company found that these site visits were an expensive way to train operators. So now, Varian conducts many training sessions using the software. “It lets us hook up to the systems of our customers, monitor what they're doing, and help them through any [difficulties] they're having with the software—without going on-site,” Lauer says.

To service the Clinac system, Varian tried a number of remote-support techniques before implementing Axeda DRM. One was to download event logs from the machines using a phone-line modem. These event logs provided some useful information, but what Lauer and his colleagues really wanted was to view all the key machine parameters in real time rather than after a malfunction.

The Axeda system lets them do just that. Technicians use the software to connect to a Clinac unit at a customer site and take remote control of the machine's service mode. “That allows us to troubleshoot different problems as they're occurring,” Lauer says.

Varian currently uses the software to respond to customer calls. At some point, though, Lauer would like to launch a more advanced service process that involves data collection and trending aimed at catching and fixing minor problems before they become major ones that cause equipment downtime. When these fixes can't be done remotely, a service technician will be dispatched to the customer's site already understanding the problem and how to fix it, as well as with any parts that might be required to make the necessary repairs.

Lauer also believes Axeda's remote monitoring software can help the company take measures to prevent field failures. After reviewing data collected during remote monitoring sessions, for example, a design team might decide to stop using a component that is repeatedly causing problems in the field.

Another medical equipment company, Omnicell Inc., based in Mountain View, CA, uses Questra Smart Service Solution to monitor its drug-dispensing systems, which are located at nursing stations throughout a hospital. Loaded onto servers that are connected to multiple drug-dispensing systems, the software is currently installed at about 20 customer sites. But Omnicell plans to increase the number of installations roughly tenfold in the next few months, according to Michael Cline, the company's vice president of service.

Before deploying the product, Omnicell's service department waited for customers to call with a problem. If access to a remote system were required, a service engineer would try to establish a connection to log in to the customer's network. “We could easily waste two or three hours trying to get connected,” Cline recalls.

To make matters worse, problems often were noticed and reported an hour or two after they had occurred. So in all, Cline and his colleagues might have had five hours of system data to sort through to find the cause of the trouble.

The process is very different with Smart Service Solution in charge. The software monitors about 40 key system parameters—everything from server cpu utilization time to computer reboots. When a problem occurs, the software can instantly send a message to Omnicell's service department, which is able to connect quickly to the remote system to run diagnostics or query for additional data. “So you can reduce the time required to troubleshoot a problem from hours to minutes,” Cline says.

The same connection can then be used to make repairs, run cleanup routines, or send software updates. In some cases, the remote process can eliminate the need for Omnicell to dispatch service personnel to fix systems in the field. In others, it can actually avert disasters. During a remote monitoring pilot program involving eight of its customers, Omnicell found that three systems weren't following proper backup procedures. “By fixing those problems, we avoided three catastrophes,” Cline says, adding that such events could have been very costly for the customers involved as well as for Omnicell.

But along with benefits, remote monitoring software also brings challenges to a service operation. According to Cline, service departments will need to rethink and redesign their processes when they shift from fielding customer phone calls to fielding computer alerts from remote devices.

“If I were to deploy this software right now to all of my 1600 customers, I probably wouldn't be able to deal with the computer-based traffic flow coming in here,” Cline says. “So this is a change that won't happen overnight. It's a multiyear project.”

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