Dassault Launches Device Data Management Solution

It may not contain the same level of suspense or excitement as a James Bond film, but the “license” launched by Dassault Systèmes this past week nevertheless is equally as intriguing.

The 31-year-old French developer of 3-D and product lifecycle management (PLM) software unveiled an electronic initiative that helps medtech firms create a fully-traceable, compliant product development process that can expedite time to market and minimize regulatory overhead. Dubbed “Licensed to Cure,” the intiative enables companies to create a virtual environment for gathering customer feedback and creating requirements that can be managed in a holistic environment with full traceability—visible to all quality, regulatory and engineering staff—to ensure product safety, accelerate innovation and master regulatory compliance complexity.

“Increasing regulatory scrutiny is putting pressure on medical device manufacturers to achieve total quality and safety,” said Monica Menghini, executive vice president, Industry and Marketing, for Dassault Systèmes. “With the number of FDA warning letters issued on the rise, the time and budget that these manufacturers spend on regulatory activities is increasing. Our 3DEXPERIENCE platform, with dedicated industry solution experiences, enables companies to manage their business objectives in a complex regulatory environment while meeting consumers’ expectations for safe products.”

Launched on the second day of AdvaMed 2012 The Medtech Conference in Boston, Mass., Dassault’s Licensed to Cure” industry solution helps companies eliminate scattered processes and data, and “embed” regulations as an asset, thereby optimizing quality and compliance, and reducing both cost and time to market. It also ensures that a single source of information will provide manufacturers with relevant, up-to-date information and help them establish true collaboration with the same, accurate set of product data.

“Licensed to Cure allows you to create a document for a product, store all the data that is created for that product like a 3-D model, test results…whatever it is you want,” noted Jean Colombel, vice president of life sciences for Dassault. “When you need to put together a final document for the FDA, you can include all this information. And, if there are questions from the FDA about the design or the product itself, you can easily reference the source of the information and get the answer to the FDA much faster.”

Besides improving data flow and organization, Dassault’s “Licensed to Cure” platform also automates bureaucratic tasks and helps companies follow proper procedures, which potentially could minimize errors and time-consuming questions from the FDA. It also optimizes manufacturers’ supply chains and their extended ecosystems to reduce compliance and quality risks.

“This solution ensures that the information is the most up-to-date,” Colombel said. “Suppose you decide to change something like the size of a piece of tubing, from 3 centimeters to 2 centimeters. This solution ensures that everyone knows about that change. The supplier would be aware of it immediately rather than at the end of the development cycle.”