Software Systems Breaking Boundaries for Device Makers

NEWS TRENDS

Software for medical device operations tends to be divided into well-established, compartmentalized categories. But some firms recently have been trying to break the mold by introducing systems that stretch across two or more of these categories.

If this trend continues, medical device manufacturers eventually won't need as many software systems as they do now. They might even be able to access data across systems that currently can't communicate very well (if at all).

For example, Omnify Software (Andover, MA) has traditionally stuck to product life cycle management (PLM) systems. But now it has come out with PLM software that has modules that ensure compliance with the quality system regulation. For example, it has a quality management module that automates the capture and routing of data related to product issues and defects in a closed-loop corrective and preventive action system. That previously required a separate software system. Other modules include a training monitor and an automated project management system.

“Before, to do all these things, there was no unified system,” says Chuck Cimalor, Omnify's chief technical officer. “You had to export things from one system into another. But now, all modules are already integrated. You can see all quality issues at once, all customer issues at once, and so on.”

Because the system is on a Web-based platform, device companies can also integrate it with the systems used by their contract manufacturers, contract designers, and other partners, Cimalor says.

“Extending the capability of the system to capture manufacturing, quality, and customer information, and tie it back to the product record, improves visibility to all aspects of product data. [That helps] drive better design and streamline product development even further,” he adds.

Also cutting across software sectors, manufacturing execution system (MES) vendor Camstar Systems Inc. (Charlotte, NC) and PLM vendor PTC Corp. (Needham, PA) have teamed up. They now offer software that combines features from both types of systems. The idea, the firms say, is to synchronize product and process management.

The system can, among other things, integrate the software used for design and the software used for manufacturing, says Chris Parsons, Camstar's director of marketing. “It gives [design engineers] a full feedback loop [from manufacturing], and they can exchange data in real time,” he says. “This capability gives everyone the knowledge base needed in order to execute design for manufacturability.”

A white paper written for Camstar and PTC by Daniel Matlis, founder and president of healthcare analysis firm Axendia (Yardley, PA), sheds more light on the boundaries the system wants to break.

Complying with FDA regulations, he wrote, comes down to answering three questions: What do you make, how do you plan to make it, and can you prove it? Information to answer the first question is in the design history file (DHF). Information to answer the second question is found in the device master record (DMR). And the solution to the third question is found in the device history record (DHR).

The problem, he wrote, is that for most device manufacturers, the answers are found in separate stand-alone systems (and sometimes on paper). The DHF resides in computer-­aided design and product development systems. The DMR resides in document management, product development, and manufacturing specification systems. And the DHR resides in various MES files. These include lot and batch records, equipment maintenance and calibration records, and operator certifications.

“For medical device manufacturers, this requirement necessitates a direct link and constant feedback between the DMR, DHR, and DHF,” Matlis wrote. “To achieve this goal, device manufacturers must close the loop between the PLM and MES systems. However, the level of synergy required to meet the challenges . . . can only be achieved through the use of a fully integrated product development, manufacturing, and quality platform. This integrated platform approach can improve performance of business processes and facilitate robust design, operational excellence, regulatory compliance, quality systems management, change management, and requirements management.”

Achieving that, he concluded, should allow device manufacturers to support continuous improvement.

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