MES Extends Its Reach

For better results, manufacturing software is being integrated with other common business programs.

Medical device makers require even more software assistance than that provided by the capable manufacturing
execution system (MES), which manages and monitors factory production work. Other common 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, marketing manager for ASI DataMyte Inc. (Plymouth, MN), which develops and sells manufacturing
software. The result is 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 email or in paper form to others outside the
department. “But we know that papers get lost and 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 MES with other types of software used by the firm. 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 standalone 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

Due to the importance of quality in medical device production, manufacturers may find it helpful to integrate MES with
quality management software (QMS) like 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 the 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. Therefore, 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 MES. In this case, Lozier says, 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
dispositioned tomorrow, in time to help fill the order if it can be used as is.

Another QMS system that can be integrated with MES is TrackWise from Sparta Systems Inc. (Holmdel, NJ). Like the
EtQ system, TrackWise can get information about a production problem directly from a manufacturing program.
Without integrated systems, MES would send notification of the problem to a 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 MES, TrackWise automatically creates a record of the problem that’s easier for quality
personnel to use, according to Kopecky. “TrackWise removes some of the sophistication and machine-oriented
nature of MES data and puts it 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 lifecycle 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), which 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 other types of software to each other. Middleware consists of Web
services, software systems that 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 CD 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 is 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. When two or more programs share a centralized database, moreover, 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 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’s already been recorded by MES.”

On the other hand, he adds, make sure that your integration plan doesn’t provide 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 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 MES, those
three fields should be integrated in your new system. Then, Lozier says, “instead of emailing the information to
someone in quality, you’ll just hit a button on your MES and kick off 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 multi-step 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
they’re based on a paper-based 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 try 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 as one example of progress, he cites the widespread use of SQL and Oracle database conventions.
“People are saying, ‘If I’m going to provide fundamental data that’s going to go out in all these different directions, I
want to put it 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 like Microsoft Excel.

As Lozier sees it, the main challenge in integrating MES and QMS is understanding what 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 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, the TrackWise QMS product is configurable for MES integration using a point-and-click
process, though 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.

Another integrated product, EnterpriseIQ from IQMS, aims 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,” says Flamm.

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.

EnterpriseIQ 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.”

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

Integration Today

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.”

This article appeared in Medical Device & Diagnostic Industry magazine.