Medical Device Link.

Originally Published MX September/October 2004

SPECIAL REPORT: IT IN HEALTHCARE

The cost and time required to validate new or upgraded software can be a major hindrance to the adoption of IT-based systems for medtech manufacturers. But IT vendors are working hard to simplify the process.

According to Marcus Yoder, vice president of industry marketing at Agile Software Corp. (San Jose), many medtech companies are paying up to twice the price of their software packages for validation services alone. Agile's solution is to offer a set of validation templates that cover each of the company's out-of-the-box functions. And when a function can be configured to suit a company's individual needs, so can the validation template. According to Yoder, Agile's tool kit helps companies validate their systems 80% faster, and also saves companies a tremendous amount in consulting fees.

Merit Solutions (Wheaton, IL) has taken a similar strategy, having written about 60% of the validation scripts that any medtech company would need to work with its Microsoft Great Plains and Merit Life Sciences software. According to Bill Burke, Merit's president and CEO, consultants are still needed to validate parts of the systems that are unique to each business, but the prebuilt templates can save $50,000 during the implementation phase.

ASI DataMyte Inc. (Plymouth, MN) also helps customers create test scripts and data packages for validation, focused on their component of the system, says director of software engineering Peter Belsito. The company has also worked with consulting firms, and offers some templates that cover general functions of the software.

Suppliers are also helping to streamline incremental validation by creating software that can be adapted to new manufacturing lines or applications without the need to change code and revalidate the entire system. The InSite application by Camstar Systems (Campbell, CA) is an example of one such system. "We've built our platform out completely so that companies don't really have to touch it," says Milan Bhalala, life sciences director at Camstar. The company then builds tools on top of its platform so that clients can extend the system to additional production lines without needing to revalidate the entire application. They only need to revalidate the configurable portion.

In the Syspro Enterprise Software system by Syspro (Costa Mesa, CA) "every discrete business function is accessible through a component or COM object," says Harold Katz, technology enabling manager. "This means that developments don't affect the security or integrity of the core system. If a company wants to create a business-specific process that needs to be handled in a manner different from the functionality of the core Syspro system, that new process can be programmed using relevant COM objects." Again, using this approach enables companies to add to, upgrade, or customize their systems without having to revalidate the core system.

Another approach to minimizing customer validation woes involves the use of Internet-based systems. Browser-based technologies such as Camstar's InSite system limit the required amount of client-side validation, says Bhalala. Companies only need to validate the system on different browser configurations, and then once on the server side within their plant.

An even more dramatic approach to avoiding validation issues can be seen in the Internet-based CATSWeb system by AssurX (Morgan Hill, CA). According to Eric June, the company's chief software architect, the CATSWeb system is fundamentally different from other Web-based products. The system uses only pure HTML, with no client-side code such as JavaScript, ActiveX components, or plug-ins. It is impossible for client-side code to malfunction or cause errors, because there is no client-side code. "That seemingly small architectural difference has saved our customers months and months of validation effort, eliminated substantial deployment risks, and provided them with a much lower total cost of ownership," says June.

Copyright ©2004 MX