PLM software speeds FDA approval

SuperDimension has received US Food and Drug Administration (FDA) approval of its SuperDimension/Bronchus system developed using PLM technology from IBM and Dassault Systemes.

SuperDimension, a medical equipment manufacturer that specialises in minimally invasive diagnosis and treatment of lung disease via CT-guided bronchoscopy, has developed and received US Food and Drug Administration (FDA) approval of its SuperDimension/Bronchus system using PLM technology from IBM and Dassault Systemes.

IBM PLM Solutions, with Smarteam for collaborative product data and lifecycle management developed by Dassault Systemes, have enabled SuperDimension to develop and deliver a real-time minimally invasive lung navigation system an estimated 30% faster than originally planned.

The innovative medical device, the SuperDimension/Bronchus system, improves the success rate in diagnosing and treating lung cancer and other lung diseases via CT-guided bronchoscopy by enabling access to the peripheral areas of the lungs in a minimally invasive manner.

SuperDimension used Smarteam's regulatory approval template to speed SuperDimension/Bronchus through regulatory approvals, in this case, the US Government's Food and Drug Administration (FDA) certified Code of Federal Regulations (CFR) 21 Part 11.

The template feature stores thousands of pages of SuperDimension's design reviews, market data and engineering data in an easily searchable, organised, secure and audited structured platform with electronic signatures for accountability.

"Using Smarteam, the cycle time at SuperDimension for developing SuperDimension/Bronchus was reduced dramatically, and we expect even more time-savings once we start production and begin outsourcing components", said David Tolkowsky, President and CEO at SuperDimension.

"PLM technology has helped us develop a tool that was affordable and could be delivered very rapidly".

"In addition to data management, Smarteam was also used to create a complex workflow for engineering change orders and change requests in the development of the Bronchus system", said Denis Senpere, vice President PLM Europe, Dassault Systemes.

"Using Smarteam for the entire process, changes are quicker, more accurate, paperless, and can easily be updated and accessed online".

SuperDimension/Bronchus has also received CE Mark approval, which indicates that a product complies with the essential requirements of European laws, and has successfully completed clinical trials in Germany and Israel.

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