Medical Device Link.

Originally Published EMDM January/February 2002

WEB WATCH

A new service that simplifies site design and content maintenance also helps to satisfy regulatory needs.

Lauren Andersen

Despite all the pronouncements of an Internet revolution, some companies may feel that they still are not using the Web to its fullest potential. Hampered by insufficient information technology (IT) resources, regulatory concerns, or financial constraints, some medical manufacturers may not be taking full advantage of the Web as a means of marketing their company and interacting with their customers.

The UK-based firm m2e2.net has responded to these concerns by offering a powerful software tool kit called Ticto. The program enables nontechnical staff to build and maintain their own live Web site or intranet content—without programming skills. As a result, the amount of technical assistance required to keep a Web site or intranet up to date can be cut drastically.

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

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. And 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.

Regulatory Needs Addressed

Such a service, which can disperse the ability to author Web pages within an organization, might sound like a regulatory affairs manager's worst nightmare. In fact, Ticto contains features that are especially well suited to the medical industry's need for security and documentation. It 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 is easy to use and is created in a storage-efficient manner. It enables a previous Web site to be restored instantaneously with no technical intervention or special training. It also supports workflow management, meaning, for instance, that 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. Many companies—even large ones—that have Web sites may not be keeping a complete archive of previous versions. In other words, if the organization were asked by regulators or a court of law to produce a copy of its Web site from a specific date and time in the past, the organization would find it difficult to do so. This poses potentially serious regulatory and liability problems.

Nancy Singer, special counsel at AdvaMed and executive director of the association's popular Medical Technology Learning Institute, confirms that Web site documentation is both critical and often neglected in the medical industry. She says that medical device companies "are often placed in difficult situations because US 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 US FDA has said that no such guidance is on the table." Until the agency provides some clarification on this issue, she adds, "a company's best defence is to ensure that 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, however, financial hurdles may seem larger than legal ones. Ticto responds to the finance department's concerns as well. By moving regular editing and updating tasks in-house (or in-department), users can significantly reduce the cost of maintaining a site. Ticto can be purchased outright or rented on a monthly basis, thereby spreading the cost over multiple years. This approach can help reduce risk on a project. Furthermore, the program software's rapid deployment allows savings to begin immediately.

Ticto is currently being used by both large and small companies in the US and Europe. One example is Guidant Europe (Diegem, Belgium), whose training department is using Ticto 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 of 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 Web sites. Some of the multilingual content is a straightforward translation of the main English-language site, but there are other sections that contain new content specific to each country's needs. Chris Haig, Guidant's European e-business director, says, "Traditionally, all Web site content has been sent to a translation agency, then the resulting foreign language text has been sent to a Web agency. The Web agency then uses the translated text to populate the pages of the Web site.

"Ticto streamlines this process," he explains. "The person who initiated the content change now edits the site on the spot. Translators or Guidant staff in the various countries can put the translated text directly into the Web pages using Ticto. Guidant staff then review the pages, which go live when the sign-off process is complete."

Feasibility for Small Firms

In addition to large companies, small firms are finding that such software solutions make sense. Many smaller companies either limit their Web content to the basics or do not update their Web sites frequently enough, and, consequently, their sites are not being used to their fullest potential. Such companies are held back by a combination of factors, including insufficient in-house IT expertise and a lack of financial resources. Ticto can address both problems.

For instance, consider the case of a small medical device company in the UK. The firm, which works in contract manufacturing and laboratory services, recently switched its corporate Web site to Ticto to make it easier to maintain. Staff members no longer have to send new pages or changes to a Web agency, and content management stays within the marketing department—where it belongs. The new system will reduce the firm's overall Web site costs by 80% and dramatically improve the quality and quantity of its on-line content.

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.

Topping off the offering are some helpful project management tools. For example, a company may want to give several people within (or outside) its business responsibility for creating and reviewing pages, but it may also wish to limit the authority of these people to publish pages to the live site. Ticto addresses this need by allowing 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.

Finally, Ticto is friendly to IT departments. Unlike consumer HTML editing software, the program preserves functionality created by IT staff or by a Web agency. Code generated by Ticto is robust, efficient, and can be viewed in all popular Web browsers. 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 se- cure servers, which are backed up continually to prevent loss. Ticto is supported by a multiple redundant server architecture with a history of 100% uptime.

Lauren Andersen is CEO of m2e2.net, which develops and markets Ticto. To find out more about the service, contact the company at Friars House, 157-168 Blackfriars Rd., London SE1 8EZ, UK; phone: +44 870 2414458; fax: +44 870 2414583; e-mail: info@m2e2.net; Internet: www.ticto.net.

Copyright ©2002 European Medical Device Manufacturer