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Tool Kit Simplifies Web Site Design While Satisfying Regulatory Requirements

Originally Published MPMN April 2002

INDUSTRY NEWS

Tool Kit Simplifies Web Site Design While Satisfying Regulatory Requirements

Norbert Sparrow

Establishing and maintaining a presence on the Internet traditionally has required an investment in in-house information technologies or reliance on the services of a Web agency. In addition to funding an activity that can suck up resources, device manufacturers must take into consideration thorny regulatory issues that may arise. A new software tool kit developed by m2e2.net (New York City), Ticto gives nontechnical staff without programming experience the tools to build and maintain Web sites or intranet content. Because it also addresses security and documentation needs, Ticto has gained a growing number of converts among device OEMs.

"Ticto is designed for companies or departments that do not have internal IT expertise, or for situations where IT resources are being deployed elsewhere," says m2e2.net CEO Lauren Andersen. "Because it is provided as a service, there is no software installation or integration required—it works through an ordinary browser window. In fact, Ticto is no more complicated to use than a word processor, and anyone with a basic understanding of computers can learn to produce Web pages within minutes," she adds.

The service can be accessed from anywhere in the world via the Internet, making it suitable for distributed organizations. There is no need for a broadband connection; in fact, a Web site can even be edited over a mobile phone. An additional feature is that sites can be built in most foreign languages without additional software or plug-ins. Ticto accommodates a wide variety of character sets including Japanese and Chinese.

Archiving Feature Allays Regulatory Concerns

These user-friendly features were not developed at the expense of appropriate safeguards, however. Ticto has version control, which means that it keeps an archive of historical versions of a Web site that is accurate to the second. The archive enables a previous Web site to be restored instantly with no technical intervention or special training. It also supports workflow management: Web pages can be signed off by marketing, then queued for approval by a regulatory affairs manager.

The importance of archiving should not be underestimated. Nancy Singer, special counsel at AdvaMed and executive director of the association's Medical Technology Learning Institute, says that medical device companies "are often placed in difficult situations, because FDA has not issued specific detailed guidance on advertising and promotion practices." In particular, she notes, "it is unclear what companies can and can't do to promote products on their Web sites, and FDA has said that no such guidance is on the table." She adds that, until the agency provides some clarification on this issue, "a company's best defense is to ensure its regulatory department signs off all Web promotional material before it goes live, and to keep an archive of all changes to its site."

Money Matters

In the current economic climate, financial hurdles may seem more pressing than legal ones, and Ticto offers many benefits in terms of cost savings, says Andersen. "Users can significantly reduce the cost of maintaining a site by moving regular editing and updating tasks in-house (or in-department)," she says. Ticto can be purchased outright or rented on a monthly basis, thereby spreading the cost over multiple years. This approach can help to reduce risk on a project. The service is compatible with all existing Web site formats, so the cost of switching to Ticto is minimal, adds Andersen.

Guidant Europe in Diegem, Belgium, is using Ticto in its training department to maintain and build its e-learning Web site. The process of updating text and graphics through the company's Web agency had become cumbersome. Ticto allowed Guidant to bring this editorial work in-house, speeding up the process and lowering maintenance costs significantly. Mattie Baker, manager, radiation training, says, "Ticto has given my department direct editorial control over a major e-learning site. I estimate that the investment in this tool will pay for itself in less than three months."

Guidant is also using Ticto to create and maintain its various European country– specific Web sites.

In addition to editorial control, cost savings, and documentation, Ticto offers a number of other useful features. A built-in Web site traffic statistics feature enables users to find out how many visitors have viewed their Web site, which are the most popular pages, what sites visitors go to afterward, which keywords visitors use to search for the site, and more. All this information is available in real time, from anywhere in the world, without programming skills or technical assistance. This helps to alleviate the problem faced by many marketing managers: having to ask their IT department or Web agency for access to site traffic statistics.

Ticto also includes project management tools that allow users to assign individuals responsibility for specific sections or pages. Thus, a company can solicit feedback from its whole team on a draft Web site before it is launched, and that interaction will be confined to one place that is accessible to all team members. Project-related events such as conference calls and deadlines can also be scheduled on-line.

Unlike consumer HTML editing software, the program preserves functionality created by IT staff or by a Web agency. The software includes an automatic change history so that companies can see who has modified which files, and when. Ticto makes it unnecessary to give users direct access to Web servers—a step that could compromise security. All data for a company's Web pages are stored on secure servers, which are backed up continually to prevent loss. Ticto is supported by a multiple redundant server architecture with a history of 100% uptime.

Copyright ©2002 Medical Product Manufacturing News

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