Design Control

Dassault Systèmes (DS)' solutions for Design Control are designed to meet specific needs of product designers as well as quality analysis engineers.  It enables medical device manufacturers to integrate systems definition and validation with product design, while ensuring compliance to internal as well as external requirements.  DS' solutions enable all development efforts to be centralized on a unified product definition so that various disciplines are brought together on a common platform that fosters collaboration and innovation.  Since 80% of product cost is committed when a company establishes product requirements, optimizing the system function as early as possible in the development process provides a clear competitive advantage.  With DS solutions, all efforts related to quality engineering are no longer regarded as costly and time consuming activities in the product development cycle but as essential steps to meet customer requirements.

Another key aspect of the Design Control process is compliance with the numerous and complex material or chemical substance regulations that are emerging globally.  Although Medical Devices are currently exempt from the European Union’s Restriction of Hazardous Substances (RoHS) Directive, that exemption is expected to be removed by no later than 2012.  As environmental and health concerns continue to grow in society, governmental push on manufacturing companies to adopt “Eco-design” practices is expected to increase.  Eco-design is about integrating environmental considerations into product development, maintenance, and disposal.  This solution enables companies to implement “design for compliance” functions as an integral part of product development.  Your product development team can now check material content information from any design view early on and throughout the product development cycle.  Reports can be generated to compare the compliance of manufacturing equivalents, list recyclable content, or evaluate best and worst case manufacturing locations.  Component suppliers can also be incorporated into the material compliance evaluation process using our solution to ensure that the component library contains the most current material compositions and RoHS certifications. 

The Abaqus Unified FEA product suite from DS’s SIMULIA brand is playing an increasing important role in the medical device product development process.  It has been successfully used to simulate implanted devices (stents, artificial heart valves, dental implants), orthopedics (artificial knees, hips), brain injury due to head impact damage, mechanics of feet, and portable devices for blood monitoring, among other applications.  Abaqus results have been used in PMA and 510-K submissions required by the US FDA and have similarly been used to obtain CE mark approval in Europe.  To meet industry demand for more realistic simulation in the development of medical devices, implants, and surgical procedures, SIMULIA is focusing on developing new capabilities and enhancements within the Abaqus Unified FEA product suite.  With the recent acquisition of Engineous Software, we are also delivering a new add-on product to Abaqus to enable rapid and extensive design exploration.  Isight for Abaqus allows users to explore thousands of design variations, which can be computed simultaneously on multi-processor machines and help optimize the simulation driven design.  Visit SIMULIA for Life Sciences for more information on DS Life Sciences simulation solutions.

DS Solution for Design Control includes:

  • Requirement management
  • Simulation & validation
  • Traceability matrices
  • Design assessment
  • Material compliance

With the realistic simulation solutions from SIMULIA, we have improved device performance, reduced development times, and need fewer physical prototypes than before.

Morten Birkmose Søndergaard Senior Acoustic Engineer, GN ReSound