Originally Published MDDI October 2003Software Device companies are faced with more—and more difficult—choices for manufacturing and quality software.

October 1, 2003

15 Min Read
Tough Decisions

Originally Published MDDI October 2003


Device companies are faced with more—and more difficult—choices for manufacturing and quality software. 

Eric Swain

The Datasweep Plant Platform has at its center three core elements: assets, people, and process (Click to enlarge).

Software for medical device manufacturing, quality control, and regulatory compliance is not only proliferating, it's mutating. 

As the device industry's manufacturing and regulatory compliance processes grow more complicated, the need for software to help manage them grows greater. In turn, the industry becomes more of a market for software manufacturers who see it as a growth sector in need of new and creative solutions.

The result is that device companies are learning more about new software companies and products, but may not be aware of where such products fit along the spectrum of manufacturing, quality, and regulatory operations. This is not an easy thing to keep track of, as new software with new features is coming out all the time.

The fact of the matter is, while some of these products and firms are competitors, others are complementary to one another. Many can be integrated with other software, and some companies have formed partnerships, allowing device firms to purchase all their offerings in one package. 

The two most prominent categories of software for medical device operations are manufacturing execution systems (MES) and quality management systems (QMS). As their names imply, the former are geared toward manufacturing issues and the latter toward quality and regulatory issues. 

Yet, the two fields are converging in several ways. Some MES products are now offering some features found on QMS products, and vice versa. Some MES vendors have contracted QMS vendors to provide quality and regulatory tracking systems as part of the MES package. And some in the industry expect mergers and acquisitions to hit in the future, which may create vendors with even broader offerings. 

“In three to five years, there will be consolidation and you will see vendors that offer software across the board,” says Mark Allen, director of regulatory affairs and quality assurance for NetRegulus (Oakbrook Terrace, IL). “But in the end you may still need different systems for ERP (enterprise resource planning) and document control. In any case, at present, all are increasingly self-aware and able to integrate with others.”

This article will examine some of the trends that are driving the medical device operations software industry, and show how some of the players in the different fields of the sector are responding to them.


Ease of use and FDA concerns have prompted several recent shifts in how medical device operations software is designed, programmed, and presented.

In terms of user-friendliness, the most important development has been the move to the use of open architectures that allow better integration with more kinds of programs. Device manufacturers, often prompted by concerns from FDA inspectors, have made it clear that they expect their different systems to be able to interact with one another, and for the most part software vendors have responded.

“As the standards become more stringent, it's up to us to become more flexible throughout the process,” says Tim Lozier, director of marketing for ETQ Inc. (Farmingdale, NY). “Staying flexible in this market is the key to success.”

Many software providers say, in fact, that the only things their products can't integrate with are legacy systems with proprietary architecture that can't communicate with anything. Regardless of whether those claims are true, it is clear that manufacturing, quality, regulatory, document control, and supply-chain management systems are much better able to interface with one another than they were just a few years ago.

“If a system is designed properly, integration should not be a major headache,” says Tamar June, director of marketing for AssurX Inc. (Morgan Hill, CA). “People are getting better and better about this.”

Pilgrim Software's Pareto analysis capability (Click to enlarge).

Another trend that has put both device manufacturers and FDA inspectors at ease is the emergence of Web-based servers. These enable records relevant to multiple sites to be stored on one central server, and are major contributors in simplifying software validation. “That is very critical because it reduces validation costs and development time,” says June. As a result, almost all players in this market have shifted to a Web-based system by this point. 

“The elimination of the client-server model is huge,” says ETQ's Lozier. “You had to validate every client, whereas with a Web client, you just have to validate the server. The Web client is much better suited for a regulated environment.”

Beyond validation, Web-based systems are in favor because they are easier to maintain and because operators and administrators have a comfort level with them.

“With Internet technology, we deploy one database that is not much different from those used in huge stock- trading operations. It can run an entire world of custom applications,” says Vladimir Preysman, president and chief executive officer of Datasweep Inc. (San Jose). “One database, one location, one set of people, one set of skills.”

Another trend in easing validation concerns is configuration instead of customization. The fewer programming changes that have to be made to customize software to a specific user's needs, the easier it is to validate.

“There is a big difference in terms of cost and aggravation between customizing and configuring,” says Lozier. “Customizing means you have to make changes to the software, often having to hire someone to do so, typically resulting in project delays and maintenance that is a nightmare. But if it's configurable, everything's already there, and administrators can set it the way they want it themselves, without programming. An enhanced level of configuration will also reduce deployment costs at start-up and in the future since the software will walk the user through the process. There are no massive amounts of knowledge required, just a couple of days' training. It's already out of the box, making it more cost-effective.”

With all the advancements in technology come concerns about costs, so many vendors have developed more-sophisticated tools for showing return on investment (ROI) to device makers. 

“These systems always just look like costs to upper management because they are not directly involved in the marketing, sale, or manufacture of the product,” says Allen. “We like to focus on how we eliminate duplication by having all these things in one large database.”

Preysman says device companies must focus on how much a software program will improve, streamline, or scale up the manufacturing and quality processes, and how much it will eliminate inefficiencies.

“Everyone is concerned about cost, no matter what the business,” he says. “But what's important to consider in the medical device industry is that once you have FDA approval, how fast can you produce? How will you scale up your operations? How will you collect as much data as possible? How will you do all these things as efficiently as possible? We have developed an ROI calculation that takes these things into account. It's a comprehensive approach that looks at the total cost of ownership. For example, it calculates how much is saved by improving yield.”

Valarie King-Bailey, chief marketing officer of Qumas (Cork, Ireland), says her company looks at cost savings in two ways. “One is comparing our system to what was in place before. We are preintegrated with Adobe, document management features, and 21 CFR Part 11 features. The other is that we are validatable off the shelf, which represents a major savings compared with other systems.”

Easier integration, easier validation, and better demonstration of ROI are just some of the things driving medical device operations software vendors as they develop new products and add new capabilities.

Manufacturing Systems

MES programs and other systems designed for manufacturing operations usually address the need to keep the electronic device history record up-dated. They also may offer real-time monitoring for process improvement, easy access to production records, and analysis and trending. 
The Web-based MES from Camstar Systems Inc. (Campbell, CA) enables customers to track product flow, view orders and quality data, and control and distribute product and process specifications. It can create device history records and integrate with corrective and preventive action (CAPA) systems. The company says it has reduced the cost of regulatory compliance by as much as 50% for some clients, and its systems often increase yields and throughput by 3–4%.

“We are one of the few with a totally integrated environment,” says Robert Rudder, vice president of business development and solutions marketing. “We are able to model everything in the manufacturing environment. That includes the product and process specifications, the limits, and the acceptable test results. That is a significant contributor to efficiency.”

As with many MES providers, Camstar is reaching into other areas of medical device systems. “In the markets we serve today, there are these huge disparate systems. CAPA is separate from ERP, which is separate from conformance, and so on. We see device history records tightly integrating with CAPA and connecting to ERP,” says Joseph Vinhais, vice president of FDA regulations. “Customer complaints come in, and those data have to interface with ERP as well.” 

Datasweep is also developing a wide reach. It offers an MES that extends from manufacturing into complaint handling, CAPA, supply management, and statistical process control. 

“What we subscribe to is having the broadest footprint possible,” says Datasweep's Preysman. “We provide the systems FDA would like to see in place. It all begins with the device history record. FDA likes to collect everything there is — the product, the process, the people, the corrective action. They like to collect an ‘ecosystem' of data around the manufacturing data.”

Particularly important, says Lou Unkeless, vice president of marketing, is being able to generate “as-built” records telling manufacturers everything they need to know about the product and process. “We can generate an as-built record including statistical process control, quality issues, and yield,” he says. 

“These data can then help in CAPA, complaint handling, and failure analysis. All of it is used to create a device history record, an audit trail, analytical information, and other things. Tying all these together into a single suite allows users to capture and analyze manufacturing data, interface more effectively with their customer base, and analyze problems and take action on them.”

Quality Systems

The size and complexity of a QMS can vary. Some are enterprise-wide, some are simpler tracking systems. What is becoming common among them, however, is their ability to coordinate CAPA management with the handling of customer complaints. Again, this is a development spurred by device manufacturers reacting to FDA inspectors' concerns.

“More firms are understanding what FDA is looking for in CAPA,” says Jaideep Rao, applications engineer for Pilgrim Software (Tampa, FL). “[FDA wants to know] if you're using it as a total tool to help manage deviation. A lot of systems record a complaint and keep it in a database. But what do you do with it?”

Tying customer complaints into corrective action procedures helps to ensure that any problems that arise with the product are fixed, and tying customer complaints into preventive action procedures helps to ensure that any problems that arise with the product won't be repeated.

“CAPA systems are a major trend because there is more of a proclivity to look at risk analysis in defined, proven methodology,” said Deborah Kacera, product development and applications engineer for Pilgrim Software. “By understanding how to take preventive actions based on past results, you can incorporate these lessons up front in the development process, which reduces risk in the long run. That is one reason why it is so important to tie customer complaints back in to CAPA.”

AssurX offers a Web-based quality- tracking system that the company says is highly integratable with anything in the manufacturing facility. It is used to manage manufacturing defects, CAPA, customer complaints, safety issues, supplier quality, audits, and other related reports. It can integrate with document control systems, supply-chain management systems, ERP systems, business intelligence systems, and MES systems. A server is set up at a customer's corporate headquarters, and its facilities all over the world can have access to the same information. 

ETQ provides web-based enterprise quality and compliance management software platforms and application suites. The processes its products cover include CAPA, audits, customer complaints, nonconforming materials, training, document control, engineering changes, and many more. It integrates with ERP systems and other previously existing databases.

“One of the strengths of our products is that they allow administrators to configure the work flow to the way they do business,” says Lozier. “They can define keywords and users, and determine which fields will be editable and which will be read-only, and to whom. There is a full search factor and a full audit trail. We can also integrate ETQ forms with Microsoft Office, allowing for seamless updates between the work flow and written procedures.” 

NetRegulus is another firm that offers enterprise systems for quality applications. Its software can cover complaint handling, CAPA, adverse-event tracking and exception reporting, clinical trial data management, and audit findings. 

“We like to think we complement ERP and management systems that are directed toward getting products built and out the door,” says NetRegulus's Allen. “We would link to batch records if there are issues or problems during the manufacturing process. We like to think we are compatible with all the major ones.”

Pilgrim Software is also a member of this category. It offers Web-based enterprise quality and compliance solutions that include fully integrated CAPA management, document management, audit management, employee training and certification management, supplier and partner management, inspection management, and calibration and maintenance management. “We are basically the ERP for quality and compliance,” says Chris Parsons, director of marketing for Pilgrim Software. “A large corporation typically runs ERP, PDM (product data management), PLM (product lifecycle management) and supply- chain management and other systems. These often have very limited or no enterprise-level quality and compliance capabilities built in. We tightly integrate with these systems to fill that gap. For instance, we have strategic OEM alliances with key MES players which provide the regulated manufacturing market with an end-to-end solution.” In fact, Pilgrim provides the quality portion to Camstar's MES solution. 

Qumas focuses on document management but also offers enterprise compliance management solutions. One suite includes tools for audit management, CAPA management, management of nonconformances and deviations, and change control.

“We have a suite of applications spread across the new-product life cycle,” says King-Bailey. “For devices, the suite is focused on the device history record. It also deals with label control, batch records, GMP/SOP records, product specifications, commodity specifications, material specifications, and any other documents required by the QSR. It is repository-neutral and sits on top of a relational database. No matter what platform they are using, they can use our application. Companies can link together all their GMP-related and SOP-related documents from different locations.” 

Hollister Inc. (Libertyville, IL) implemented a Qumas system to manage documents such as product specifications and drawings, and operating procedures. William Ferguson, director of quality management, says the system has been easy to use for all personnel at the five plants where it is in place. “Everyone can pull up any document they need because they are on the same central server, and any document they pull up is the existing document as approved, with all changes made.” He also says the system was quick to install, implement, and validate, with the latter taking just two weeks. “There have been no surprises at all,” he says. “It is very reliable and very flexible.”

Sparta Systems Inc. (Holmdel, NJ) offers a quality management software suite that incorporates customer complaints, CAPA, deviations and incidents, audit tracking, and change control. It can integrate with ERP systems, among others. 

“This is a tool that allows management to be in control of their operations, and to make sure that everything is falling within specifications of all performance SOPs,” says Ran J. Flam, president and chief executive officer. “Customers use our software to log all events and make sure they are completed in a satisfactory manner. They also use it to know what is being completed on time and what is behind schedule. If you integrate a quality management system with an ERP system, that will enable you to manage everything FDA requires from you.” 

Software for the Start-up

Scalability is a very important feature for a software vendor to offer the device industry, as so many of its members are small, Flam said. “With software that we sell to smaller companies, we always have a commitment to accommodate them to any size they want to grow,” he says. 
Expandable Software (Santa Clara, CA) has made growing with small device companies a core mission. It provides scalable ERP systems geared toward start-up device firms, especially those funded by venture capital. They can integrate with document control systems, among other programs. The company says it caters to firms looking for ease of use, functionality, and low cost of ownership.

“Our customers have a finite amount of money and must get from concept to production and beyond with a given budget,” says John Donovan, director of corporate marketing. “They cannot afford to have a day of downtime. They need for us to be almost in the background while they focus on production and getting their product to the market. They need rapid implementation, and for [software] to work without a major IT effort to support it.”

Nonetheless, Expandable's systems can work with others if needed. “There are extensive audit trails throughout the system, and if there's one the customer needs that we don't have within our platform database, we can still capture all the data within our system,” says Jerry Lass, vice president and cofounder.

Choose Wisely

Whether large or small, device firms have a wide range of manufacturing, quality, and regulatory software to choose from. While it can be staggering to assess all the choices that are available, it is important to pick wisely. If there is a snag in validation, tracking, or anything else relating to software, FDA may not be willing to listen to any excuses. 

Copyright ©2003 Medical Device & Diagnostic Industry

Sign up for the QMED & MD+DI Daily newsletter.

You May Also Like