Originally Published MDDI March 2002

SOFTWARE

New software systems can reduce the burdens of paperwork and make regulatory compliance easier and less costly.

William Leventon

There's no way around it: If you want to play in the medical device field, you have to pay the price of regulatory compliance. To comply with regulations and standards, companies must gather detailed information about the devices they make throughout the product life cycle. Until recently, that meant keeping product information on paper—tons of it. In fact, a company's paper records were sometimes so voluminous that they could fill a warehouse.

Several years ago, however, FDA struck a blow against paperwork proliferation by announcing new rules that allowed medical device manufacturers to submit electronic device history records. This paved the way for the use of software that automatically gathers and stores the data needed for compliance, thereby greatly reducing the cost and difficulty of the recordkeeping process.

Though some companies develop their own compliance software, others are turning to commercially available software packages. Besides lightening the compliance burden, some commercial software systems can analyze the data they collect to help companies improve their development and manufacturing processes. The idea is to turn the burden of compliance into a benefit that bolsters the bottom line.

AUTOMATED PERSONNEL MANAGEMENT

Many companies employ disparate, ad hoc methods of training their workers. But according to Saba Software Inc. (Redwood Shores, CA), companies that replace these training methods with a single automated personnel system can ease their compliance burden while also boosting productivity, cutting costs, and reducing the time it takes to get products to market.

Saba's software, called Saba Learning, provides companies with a single system for managing training and performance. Saba Learning supports instructor-led, computer-based, and on-the-job training, as well as seminars, videos, and workbooks. For certification purposes, the software monitors the training status of a company's workers. The software tracks which training programs have been completed, which are in progress, and which have yet to begin. It also notifies workers of impending certification expirations and shows them how to fulfill new requirements.

Not to be confused with training material, Saba's software is an automated system that helps workers find training information. "We don't make content," explains Kim Woodward, Saba's vice president of marketing. "We make the system that manages the learning content. If you log into our system, it would help you locate classes about whatever training or certification tracks are required for your job." In most cases, the system leads workers to training information developed by their own company. But it also allows users to search the Internet for other applicable training offerings.

To satisfy auditors, Saba Learning maintains records that contain all training information required by FDA, including times, dates, instructors, attendance records, and results. "Say an FDA auditor wants to know when someone got training on a certain good manufacturing practice," Woodward says. "Using our system, the auditor could run a report that reveals: 'The person got the training on this date, got this score, and completion was verified by the boss.' So it provides proof, in a simple electronic manner, that required training has taken place."

Providing such proof can be anything but simple for companies with far-flung training records on paper. "Maybe they've complied but they can't easily pull the records on that compliance," Woodward notes. "Say an auditor calls at your New Jersey site and asks for records for the whole company, but the New Jersey office doesn't have records for the office in Switzerland. Then you're in trouble."

When installed at all the facilities of Minneapolis-based Medtronic Inc., Saba Learning's software will consolidate multiple training systems from four different business units. "We have all of our training records spread out," says Dean Meek, the company's director of human resources systems. At present, Medtronic's training records are a hodgepodge of different paper files and spreadsheets. "Everyone's doing his own thing to keep track of training," Meek says.

According to Meek, Saba's system will ensure that all training is tracked and documented. "More and more often during audits, FDA is asking for training verification for manufacturing labor," he says. "We bought Saba's software to make sure we could prove to FDA that we've trained people."

TRAIN FOR A CHANGE

Medtronic plans to tie Saba Learning into its document management system, which houses records of all the company's manufacturing processes. "Every time there's a change in the manufacturing process, [the document management system] will interface with Saba, which will trigger a training course," Meek explains. "Then people in the manufacturing line will be notified that they have to be trained to change the process."

At Medtronic, manufacturing changes occur frequently, which means workers are constantly being retrained. To satisfy FDA, retraining is always documented.

"The manual records were mounting, and the tracking was getting more and more burdensome and administrative," Meek says. "Finally we decided to automate the process so we could produce those documents on-line." Now, instead of presenting auditors with "tons of stuff," Meek says, Medtronic will simply give them access to the Saba system.

By consolidating all of a company's training records into a single, electronically accessible system, Saba Learning helps companies avoid large fines and recalls. "That's the biggest bottom-line benefit," Woodward says. "Our customers can just push a button to get a report that proves that required training has taken place."

Streamlining the training process also makes it less cumbersome and less costly. "Most medical device companies have different training systems for manufacturing, sales, IT, and customers," Woodward says. "Our software consolidates all those systems into one, which reduces hardware and software costs and also reduces the administration and maintenance personnel required to keep all those systems up and running."

Without Saba Learning, Medtronic would soon have had 10 incompatible training systems operating throughout the company. "In Ireland, we had two people who were just keeping track of all the training records that were stacking up," Meek says. "Hopefully, we can give them something else to do."

Medtronic also believes timely training could reduce the company's scrap rate. "If there's a manufacturing process that has to be changed because it's inefficient, we can get the training done more quickly," Meek says. "So we can see our manufacturing costs going down."

TRACKING PROBLEMS

On the manufacturing line, CATSweb software from AssurX Inc. (Morgan Hill, CA) helps firms track problems from identification through disposition and corrective action. A Web-based version of an older AssurX product, CATSweb can be accessed from any computer running any operating system. The Web-based software also makes it easy for medical companies to bring computer systems into compliance, according to Tamar June, director of marketing for AssurX.

When an FDA-regulated company installs software into a client-server system, each of the client's PCs must be separately validated, June explains. "But since our system is Web-based, the only machine that has to be validated is the server that's hosting the software." On the client end, CATSweb requires only a browser.

CATSweb is made of pure hypertext markup language, with no bells and whistles such as JavaScript, which performs functions at the browser end of the computer system. Why no Java? It creates a "validation nightmare," June notes, because it may function differently on different client machines. Thus, every client machine has to be validated to ensure that the JavaScript is performing the functions properly.

CATSweb does no computing or data capture on the client end. So manufacturers with hundreds of client PCs may be able to save hundreds of hours of validation time, while also sparing themselves all the attendant problems and expenses.

Like Saba Learning, CATSweb replaces paper-based recordkeeping systems, which makes things easier for manufacturers and auditors alike. "Instead of dealing with hundreds or thousands of paper record files, you capture all the information in electronic format," June says. "This saves time, reduces redundancy, and prevents misplacement of files and all the other things that can go wrong with paper-based systems."

It also saves manufacturers money, as does the fact that CATSweb is installed and validated on just one machine. In addition, June notes, manufacturers save big when it comes time to upgrade the software. "If you're running 50 different pieces of software, it takes a heavy toll to keep upgrading the client software with new versions that come out," she says. "But with Web-based systems, you just need to upgrade the browser—a tremendous savings compared with the cost of upgrading 50 pieces of client software."

While some companies develop their own corrective action software, June claims it makes no sense to do so. For one thing, the IT department won't be able to keep up with the new features and advances offered by software makers like AssurX. Then there's cost. Manufacturers "are starting to realize that it costs a lot more to have a team of programmers develop a system than to buy one off the shelf and configure it," she says.

Not long ago, a man working on an in-house software system told June he was six months into the project and had already spent $70,000. "I told him he could have had our software installed five months ago at a cost of $37,000. He told me he could kick himself."

SOFTWARE PARTNERS

A few months ago, AssurX announced that it had agreed to link CATSweb with software from Camstar Systems Inc. (Campbell, CA), whose Collaborative Manufacturing Execution (CME) software allows users to manage geographically distributed production processes. CATSweb will be teamed up with Camstar's InSiteLive, a CME offering for managing real-time production information and processes.

To help medical device manufacturers meet compliance requirements, InSiteLive produces a record of all resources and components that go into a finished device. "Our software is for quality-sensitive manufacturers who want complete traceability of resource trails," says Robert Rudder, Camstar's vice president of business development and solutions marketing.

When they work together, InSiteLive and CATSweb are viewed in the same browser. Users model their manufacturing and business processes using InSiteLive, incorporating all applicable production standards. As the process moves forward, InSiteLive automatically tracks and records production activities.

When the software detects something that doesn't conform to production standards, it creates an "issue" in the CATSweb system. Issues trigger a predetermined response for correcting the problem. CATSweb monitors the corrective action process while InSiteLive restricts production until the corrections have been made.

The InSiteLive/CATSweb duo records all the process information companies need for compliance. At the same time, Rudder notes, the information is also being used to continuously troubleshoot the process, boosting production yields and helping manufacturers get products to market more quickly.

SWEEPING UP THE DATA

These same tasks are performed by Advantage 4.0, a multifaceted software program developed by Datasweep Inc. (San Jose). Advantage 4.0 is a Web-based system that performs a variety of manufacturing, quality assurance, repair, and analysis functions.

Advantage helps with compliance in two ways. First, it lets medical device companies employ control mechanisms to make sure their manufacturing processes adhere to standard operating procedures. For example, workers won't be able to log into a system unless they have the right qualifications to perform that operation. "So now you have a control mechanism, where before you were depend- ing on operators to remember whether their training was valid," notes Julie La, Datasweep's market development manager for life sciences.

In conformance with FDA requirements, Advantage also automates data collection for device history records and provides a secure electronic signature process. Before purchasing Advantage, one Datasweep customer would spend three days compiling, validating, and archiving a single 6-in.-thick device history record. Now, the process is completed with "the push of a button," La says.

At SonoSite Inc. (Bothell, WA), a maker of ultrasound devices, device history records have been kept using a piecemeal system made up partly of paper and partly of computer spreadsheets. "In the past, [auditors] would come and do a six-week audit, which meant there was a lot of time for us to get the data together," recalls Michael Hoffman, SonoSite's director of regulatory affairs and quality systems. "Now the auditors try to finish up in a week, so you need to be able to speed up audits."

According to Hoffman, SonoSite will be able to accomplish this feat once its Advantage system is fully installed. "I'll be able to go on-line and in one fell swoop show an investigator all the history records, from the receipt of material to customer feedback on the product," he says.

By providing a single electronic repository for all device data, Advantage can greatly reduce the administrative and reporting costs of compliance, according to La. At one company, the software slashed reporting costs by 75%, she says.

Such savings aren't surprising when you think of the unwieldy paper-based systems most companies now use to keep records. Before introducing a new product line, La says, one potential Datasweep customer rented an 8000-sq-ft warehouse just for storing paper records. In all, the company stored more than 15 million pages of product data.

CAN YOU STAY COMPETITIVE?

Despite the burdens of this kind of recordkeeping, "you can be compliant if you have an all-paper system," La says. "But can you stay competitive?"

Companies that use paper-based records or store information in disparate databases will have trouble putting their product data to use. "I was talking to a customer who in one plant alone had more than 50 systems just for manufacturing," La recalls. "And each system was invisible to everyone except the person who owned that database. How do you spot overall trends when everyone owns his own little pocket of data?"

It can be done, La says, but it's a "very painful" process. "You have to manually scrub and match up data, which is time-consuming and costly."

Unlike conventional recordkeeping systems, Advantage can automatically turn raw data into useful information that helps companies improve their manufacturing processes and reduce costs. Using the software's business intelligence tool, La says, manufacturers can "drill down" to get to the root of manufacturing problems. For example, the software can quickly zero in on the factory, shift, and operator turning out defective products. Or it can quickly point to the supplier of a defective component and tell whether that supplier has a history of shipping defective parts to the company.

As a result of ongoing cycles of data analysis and corrective action, "there's constant improvement in the design and quality of the product," La says. The payoff can be dramatic. According to La, Datasweep customers have reported 25–50% reductions of recurrent quality issues and drops in reject rates from about 20% to 1%.

SonoSite is still in the process of getting Advantage up and running, so the company has yet to gain any significant bottom-line benefits from the software. In two pilot lines, however, "we've already begun to see some reduction in workmanship errors," says Brad Garrett, SonoSite's chief customer fulfillment officer. Eventually, Garrett expects the software to reduce both scrap and throughput time.

Advantage lets you "see a problem sooner and respond to it more quickly," Garrett says. "And it gives you better, more accurate data to go after the problem."

CONCLUSION

Spurred by new FDA rules for electronic records and signatures, software firms have introduced a variety of systems that automate compliance-related tasks. These software packages are designed to be easier to use and more efficient than paper-based record systems and disparate electronic databases. What's more, they can bolster a company's bottom line by streamlining the compliance process.

With some systems, process data can even be used to improve manufacturing operations. "For a long time, people looked at compliance systems as just a cost of doing business," says Camstar's Robert Rudder. "But we said, 'We've got all this detailed process information. Let's put it to work.' It's a paradigm shift."

William Leventon contributes frequently to MD&DI.

Copyright ©2002 Medical Device & Diagnostic Industry