Products: Medical Product Labeling

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Medical Device Product Labeling Application

The Product Information Explosion

The medical device industry creates a significant amount of product information that is consumed by many audiences, including global health authorities, customers, internal personnel and partners. This information is constantly created and duplicated across the enterprise, showing up in product labeling, packaging, instructions for use, product catalogs, product web sites, sales and marketing materials, and many other outputs. This proliferation of redundant content wreaks havoc on organizations.

• Increased cost of content production and delivery
• Slower time to market due to inefficient processes
• Increased compliance risks due to inconsistent usage of product information
• Increased translation costs
• Inability to scale content production to support globalization

Taking Control of Your Information

Although a vast amount of product information is created during the research and development process, the content of the labeling submission to health authorities provides a significant opportunity for content reuse and additional benefits to the enterprise. Using a component-based approach for creating product labeling content, medical device firms can expedite and automate the production of downstream labeling content including package inserts, product web sites, IFUs, and other packaging artwork. In addition, translation costs can be dramatically reduced by only translating those components that change rather than entire documents.

Medical Device Labeling Application

The Medical Device Labeling Application is an out-of-the-box solution for creating and publishing medical device package inserts. The application combines the integrated suite of PTC Arbortext products for content authoring, management and delivery with configuration files and extensions that incorporate industry best practices for product labeling. Knowing each customer is different, the application is easily configured to meet your specific business processes and output formats. It can also be configured to support other document types, in case you don’t want to start with package inserts.

With seamlessly integrated Arbortext products, you can reduce custom integration costs, leverage enhanced features unique to Arbortext products, and minimize the impact of software upgrades. In addition, the application significantly reduces implementation time and cost, and provides the platform to easily extend the use of product information across the enterprise.

Key capabilities of the Medical Device Labeling Application include:

• Component-based authoring – collaborative authoring, review and approval of information components rather than entire documents enables quicker update cycles, lower translation costs and content reuse
• Centralized Content Repository – centralized management of information components provides secure version control to components throughout the content lifecycle and allows for integration to other enterprise systems such as databases and translation management
• Dynamic Publishing – automated assembly and publishing of information components from the content repository and enterprise databases ensures the right information is produced in the right format at the right time