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

Medical Device, Medical Device Clinical Trials, Medical Device Safety and Regulation, Medical Device Design,
  • Friday, February 23, 2018

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.


Kristian Debus, Ph.D., Industry Specialist - Medical Devices, Siemens PLM

Kristian has a PhD in mechanical engineering, CFD from the Technical University of Munich. He has experience working with ICEM CFD, Agilent, Bechtel and PAX Scientific.

As the Director for Medical Devices CCM and an industry expert at Siemens PLM Software, he focuses on business development in the pharmaceutical and biomedical device industries. His role requires that he closely interact and collaborate with customers, as well as with the sales, marketing, development and service team at Siemens PLM Software.

Message Presenter

Tom Phillips, Ph.D., Director, Simulation Portfolio Development, Siemens PLM

Tom Phillips is currently employed at Siemens PLM in the role of Director of Simulation Portfolio Development for Growth Industries in North America. Tom received his Ph.D. in Mechanical Engineering from the University of Tennessee and has more than 25 years of experience relating to engineering simulation. In his current role, Tom helps Siemens PLM customers implement simulation into their engineering process to facilitate innovation, improve engineering efficiency and enhance product performance.

Message Presenter

Who Should Attend?

  • Engineers
  • Designers
  • R&D Technical Staff
  • Engineering Management (Manager to VP level)
  • Design Management (Manager to VP level)
  • R&D Management (Manager to VP level)
  • Clinical Trial Responsible Persons


What You Will Learn

  • Improve engineering practice
  • Drive design excellence
  • Reduce time to clearance

Xtalks Partner

Siemens PLM

Siemens PLM Software offers solutions for leading companies in the medical device and pharmaceutical industries that recognize the need for a product lifecycle management (PLM) platform to answer product development challenges. Our proven, flexible solutions help speed up innovation in pharmaceutical and medical device development, ensure quality, reduce costs and maintain adherence to ever-changing global regulations, including FDA compliance.

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