SOFTWARE

Medical device makers require even more software assistance than that provided by manufacturing execution systems (MES), which manage and monitor factory production work. Other commonly used programs help manufacturers with tasks such as quality management, business planning, and product development.

Developed to handle specific functions within a company, MES and these other software modules have traditionally been installed and used in different corporate departments, where people “are very focused on their own objectives,” says Terry Gilbert. Gilbert is marketing manager for ASI DataMyte Inc. (Plymouth, MN), which develops and sells manufacturing software. The result is the formation of separate “silos” of information within a company. When information silos are created, “data records produced in one part of the enterprise are not generally accessible to people and systems that could use them in other areas,” Gilbert notes.

When siloed information must be shared, people can send it via e-mail or in paper form to others outside the department. “But we know that papers get lost and that people make mistakes,” says Randy Flamm, president of IQMS (Paso Robles, CA), which sells enterprise resource planning (ERP) software.

According to Flamm and others, a better way to share information within a company is to pull down the silos and integrate an MES with other types of software the firm uses. By allowing different software modules to directly exchange data, integration can boost the reliability of information sharing and eliminate duplicative tasks involved in maintaining and operating stand-alone computer programs. In addition, integration can provide other benefits, including streamlined data flow, better product designs, and lower costs.

One way for a company to reap the benefits of integration is to link independently functioning software programs—a task that can pose major challenges and may require outside help. Another way is to replace separate programs with software systems that provide integrated functionality out of the box.

MES and QMS

Quality is critical in medical device production; therefore, manufacturers may find it helpful to integrate their MES with quality management software (QMS) such as that offered by EtQ Inc. (Farmingdale, NY). When a linked MES program detects a defect or problem in manufacturing, EtQ's QMS system handles nonconformance and corrective action procedures, including the determination of the proper disposition of a nonconforming item—rework, repair, scrap, etc.

The detection of a manufacturing nonconformance causes a lot to be placed on hold until the quality department determines its disposition. While the lot is on hold, manufacturing personnel “have no visibility into what the quality system is doing,” says Tim Lozier, EtQ's marketing manager. They put such lots aside and begin work on new ones in order to meet production demand.

The situation changes, however, if a QMS program is integrated with an MES. In this case, Lozier says, the QMS serves as “a window that shows you the status of the quality system in real time.” So, for example, if manufacturing personnel need 20 lots to fill a customer order, they can check the QMS system and see that Lot A is currently on hold but will be dispositioned tomorrow, in time to help fill the order.

Sparta Systems Inc. (Holmdel, NJ) also offers a QMS system that can be integrated with MES. Like the EtQ system, it can get information about a production problem directly from a manufacturing program. Without integrated systems, the MES would send notification of the problem to a designated person, who would then have to enter the data into the QMS. “Anytime you have a person doing that, it's less efficient and more prone to error,” notes Matt Kopecky, a product manager for Sparta Systems.

Using the data taken from the MES, Sparta's QMS automatically creates a record of the problem that's easier for quality personnel to use, according to Kopecky. “[It] removes some of the sophistication and machine-oriented nature of MES data and puts them in a more people-oriented form,” he says. One way the program does this is by bringing all quality-related data together in one place for the user.

Other Software Partners

In addition to QMS, many medical device firms use ERP software, which handles tasks related to sales, marketing, planning, and finance. When MES and ERP are integrated, manufacturing data “can be pushed right into the ERP system without anybody doing anything,” Flamm says. ERP can use this manufacturing data when performing tasks such as inventory control.

Thanks to integration, any kind of data captured in one program can be automatically shared with the other, eliminating the need for both programs to independently capture the same data for their own purposes, Gilbert says. At a higher level, he notes, the programs can also share results based on the processing of data. “If you're doing an analysis in an MES application and arriving at some conclusion based on that analysis, why not send that conclusion out to your ERP system? That way, you're eliminating the same kind of unnecessary repetition that was eliminated on the fundamental data-collection level.”

MES also works directly with product life cycle management (PLM) software used in corporate engineering departments. When MES software is linked to PLM, product variability data acquired during testing or on the shop floor can be quickly fed to engineering. The resulting engineering changes made in the PLM system will then be enforced by MES in the manufacturing process. “Interoperability between those systems allows information to be shared so that variability can be designed out of the product earlier in the process,” says Chris Parsons, director of marketing for Camstar Systems Inc. (Charlotte, NC). The company sells manufacturing and quality software.

Tools for Linking Programs

If a medical device firm wants to integrate two different programs, how is it done? One key to the integration process is “middleware,” software interfaces that connect different types of software to each other. Middleware consists of Web services, which allow different processes to interact over a network. Web services are used in service-oriented architecture (SOA), which differs from so-called object-oriented programming that would, for example, require every compact disc to come with its own special player. By contrast, SOA allows a CD to work with any player—that is, any device that offers a CD-playing “service.”

Effective integration also depends on how data are shared by different programs. Siloed programs make data sharing difficult because they are part of a file-based information structure in which each software module handles its own data. But integrated software systems benefit from a centralized database, which streamlines information exchange among different programs. Moreover, when two or more programs share a centralized database, updates need only be made once in order to reach all the programs that require them, Gilbert notes.

Integration Advice

Software vendors can be good sources of information on how best to integrate their programs with others. For example, Lozier advises companies to link their MES and QMS so that all relevant data can move from one system to the other. In addition to defect-related information, he says, MES should provide QMS with product data such as lot numbers and properties. “Integration is key in reducing manual double entry,” he notes. “You don't want to type the same data into your quality system that have already been recorded by the MES.”

On the other hand, he adds, make sure that your integration plan doesn't provide the QMS with too much information. “Get the data you need, but don't just integrate for integration's sake,” he says. “If you tell an IT guy to integrate your MES to your QMS, he's going to map every field, table, and database to your quality system. And then your QMS is going to be loaded with stuff that your quality guy doesn't need.”

Instead, he says, figure out exactly how you want the process to work and then map out the handoffs from the MES to QMS and vice versa. Your integration plan should be based on how and what information is exchanged in your old process. For example, if a certain person in quality now gets three different types of information from the MES, those three fields should be integrated in your new system. Then, Lozier says, “instead of e-mailing the information to someone in quality, you'll just hit a button on your MES and [initiate] a nonconformance process in quality.”

If your plan requires a complex integration process, it's best not to tackle the entire task right away, Kopecky says. Instead, he advises that a multistep integration be phased in so that lessons learned in the early integration phases can be applied in subsequent phases. “Even if our customers configure [their systems] 100% to their requirements, they always make changes based on what they've learned,” he says. For instance: “Once they get a system in place, they might realize that there are certain steps in the process or certain integration points they can eliminate because [those steps] are based on a paper system.”

A Daunting Task?

The upsides of integration are real and potentially important in medical device manufacturing. But there's also a downside that must be considered before tackling the job. Linking software systems from two different vendors “can be a daunting task,” Flamm says. “It's not easy or inexpensive to take two dissimilar systems with multiple databases and try to make them talk.”

According to Gilbert, one of the barriers to integration has been a lack of standards and common ways of exchanging data. But he cites the widespread use of SQL and Oracle database conventions as one example of progress. “People are saying, ‘If I'm going to provide fundamental data that are going to go out in all these different directions, I want to put them in a language that everybody can speak,'” he notes. Another move toward integration is the development of table structures and formatting that allow different types of software to export to common desktop applications such as Microsoft Excel.

As Lozier sees it, the main challenge in integrating an MES and QMS is to understand which data must be moved from one system to the other in order to meet the requirements of a particular company. With that information, the appropriate integration points for the two programs can be established.

Today, Lozier adds, manufacturers that want to integrate an MES and QMS will usually need the help of a software vendor. But his company is working on a technology aimed at allowing companies to perform integration with a user-friendly drag-and-drop interface that will eliminate the need for vendor involvement in the process. Along the same lines, Kopecky notes, Sparta's QMS product is configurable for MES integration using a point-and-click process, although some coding of the MES software may be necessary to complete the integration process.

Integrated Products

Given the potential hassles of integration, why don't vendors provide customers with software products that are already integrated? Good news: some products of this type are currently available to medical device manufacturers. For example, Camstar now provides manufacturing and quality software integrated into a single platform. “This allows very deep interaction” between the two programs, says Gilad Langer, the company's product manager for intelligence and interoperability. In fact, he adds, the new combination is “inherently one system.”

For a better idea of how the system works, consider a process for manufacturing a certain type of medical device. If a test data point is outside of specified limits, the nonconformance will be flagged by the manufacturing program. At the same time, a nonconformance is created in the quality module. After the device in question is dispositioned by quality, that disposition is automatically enforced in manufacturing. “Our system is seamless in how manufacturing and quality interoperate,” says Silvio Saouaf, product manager for Camstar's manufacturing suite.

The tight integration of manufacturing and quality also allows what Parsons calls “intelligent root-cause analysis.” The Camstar system “has access to all the inherent, contextual manufacturing data and trends, so it can really dig in to find the root causes of problems,” he says.

IQMS also offers an integrated product. Its goal is to handle all of a company's ERP and MES tasks without additional software or interfaces. In developing the product, “we wanted to give our customers the ability to populate the ERP system with pertinent data from the manufacturing floor,” Flamm says.

The system's core modules include manufacturing and shop-floor planning, sales and distribution, and financial management. Since all the modules are produced by the same company, they operate as a cohesive unit, according to IQMS.

The IQMS product includes an Oracle-powered database that centralizes a company's business activity and eliminates the costs and difficulties of managing multiple databases. “One of our customers replaced five or six databases that did different things,” Flamm reports. “A lot of people were needed just to administer those databases, but the company was able to eliminate those positions by switching to our system.”

Having an integrated product also simplifies training, according to Flamm. “When everything has the same look and feel, it's a lot easier to get your people up to speed,” he says.

Conclusion

Looking back over the last decade or so, Langer sees a focus on individual software systems developed to meet the needs of different parts of a business: manufacturing, engineering, accounting, etc. The result of this focus was the silo problem. “But now, as companies try to realize the value of the [software] investment they made, there's more of a focus on getting all these systems to interoperate, which solves quite a few problems in a manufacturing environment.”

Gilbert also sees a shift when it comes to integration issues. “People have been talking about a lot of these things for a long time,” he says. “What's new is that some of it is finally happening.”

Copyright ©2008 Medical Device & Diagnostic Industry