Digital Evidence Generation:
Simulation and the Digital Twin for Better Medical Device Design

The potential for proactive use of simulation and CAE in medical devices is huge: saving lives and saving millions of dollars for the industry. This could be accomplished by optimizing designs for performance and reliability, reducing the number of required benchtop tests and clinical trials, as well as accelerating the regulatory approval process. Successfully employing simulation forms the fundamental basis for a sound product engineering practice and drives design excellence. The FDA and regulatory agencies worldwide are supporting efforts to use simulation in streamlining the regulatory process through interactions with industry, academics and consortia like the MDIC (Medical Device Innovation Consortium), or organizations like ASME or Avicenna.

Digital evidence generation is a term coined during a meeting between Siemens PLM and the FDA in October 2017. It describes the process of generating data required for regulatory reporting through digital technologies for digital evidence submission. This then ties into overall digital enterprise through the use of a digital twin and product lifecycle management over the full product lifecycle. Digital evidence generation and digital evidence submission provide the means to reduce clinical trial costs by offloading animal and human trials to their digital twins and set the stage for a revolution in medical device design.  

In this webinar, expert speakers will discuss how these technologies will enable medical device companies to improve product engineering practice, drive design excellence and reduce the time to clearance.