March 07, 2005
PTC Introduces Product Configuration And Data Management Template For The Medical Device Industry
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Jeff Rowe - Managing Editor

by Jeff Rowe - Contributing Editor
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PTC Introduces Product Configuration And Data Management Template For The Medical Device Industry

PTC announced the general availability of the PTC Medical Device Template, combining leading, industry specific capability and consulting expertise. Built on top of Windchill PDMLink, this packaged services offering, meets the unique needs of the medical device and equipment industry for improving time-to-market while satisfying complex FDA regulations, lowering regulatory compliance costs and reducing the time needed to obtain regulatory approval.

Innovative medical device and equipment manufacturers are faced with shortening product lifecycles that require faster product development. In addition, these medical device and equipment manufacturers are challenged by the increase in regulations requiring electronic data management, electronic signatures, secure user authentication and traceability. Because of these challenges, there is an emerging industry-wide requirement to fully automate the control of all product data and development processes, within robust and compliant quality systems. PTC now provides an easy-to-adopt solution that enables medical device and equipment manufacturers to drive product innovation, manage key product
development processes, and comply with regulatory codes relating to data integrity requirements and Quality System Regulation (QSR) governing manufacturing process controls.

With the PTC Medical Device Template, PTC now offers:
  • Data control of all electronic records with complete traceability
  • Global scalability for the extended supply chain
  • User authenticated electronic signature with document and process traceability
  • Streamlined change management process
  • "Through the control and management of product and product-related information, PLM solutions can maximize the value of R&D investment, accelerate products through the stages of ideation to commercialization, mitigate cost pressure from the market and internally by streamlining processes and sharing intellectual property, and reduce the burden of regulatory compliance and reporting," said Bruce Hudson, Meta Group.

    With the PTC Medical Device Template, customers are able to take advantage of the following benefits:
    • Reporting functionality meeting the demands of audit requests
    • Data collection support critical to design and delivery: Design History File (DHF), Device Master Record (DMR), Device History Record (DHR)
    • Process control with workflow for Corrective and Preventative Action (CAPA)
    • "With this offering, PTC is providing a focused service offering for medical device manufacturers to enable them to take advantage of Windchill as a world-class Product Development System while at the same time meeting US FDA requirements. We believe that customers will achieve significant business returns with this solution," said Andrew Rhoades, senior vice president for PTC's Services Portfolio.

      PTC solutions for medical products are designed to meet the product lifecycle management requirements of medical device, pharmaceutical, and medical equipment manufacturers. These solutions include product development process and data management, electronic verification and collaboration, authenticated electronic signatures and 3D mechanical design. PTC has over 500 medical products customers, including the top manufacturers across the globe.

      This announcement concerning medical product development comes on the heels and just a few weeks after a similar initiative was announced by PTC for the aerospace and defense industry. The template concept that PTC is putting forth would probably work well in any industry that is heavily regulated and where compliance and traceability are key business issues.

      This PDMLink template/module concept could work at just about any company, regardless of particular industry, that has to deal with information that is disconnected and spread across many organizations, making configuration management of their products a laborious, error-prone and time-intensive process.

      PDMLink is a Web-based product that sits on top of PTC's Windchill. It's main functions are capturing and controlling data associated with a product at any time in its lifecycle. PDMLink has always incorporated product templates for organizing product-related data to corporate standard, so the medical device template is just a natural extension of capabilities that have been around since the beginning. It can be integrated with virtually any MCAD product, including Pro/ENGINEER, SolidWorks, UGS NX, CATIA, AutoCAD, and Inventor. PDMLink is used primarily in the following four processes:
      • Product data management
      • Change management
      • Configuration management
      • Release to manufacturing
      • In the future, expect to see more prepackaged PDMLink templates and modules for other specific industries that could benefit from them.

        Jeffrey Rowe is the editor and publisher of MCADCafé and MCAD Weekly Review. He can be reached here or 408.850.9230.

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              -- Jeff Rowe, Contributing Editor.


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