MedTech Intelligence

Six FDA Experts to Weigh in on Computational Modeling & Simulation in MedTech Product Development

By MedTech Intelligence Staff
MedTech Intelligence

No longer just “the big company advantage,” CM&S is an accepted and viable device industry path to market for large and small medical device makers alike.

Computational modeling and simulation (CM&S) delivers significant advantages to traditional build and test prototype design and regulatory pathways using animal and clinical studies alone. Join MedTech Intelligence from January 27–28 for a complimentary virtual program consisting of comprehensive presentations and demonstrations of how CM&S can be used throughout the product lifecycle to help many useful medical devices gain approval and help patients sooner. We will be joined by industry experts in CM&S, including six speakers from FDA.

Learn More about the Value CM&S Delivers Across Your Organization

Executives: The business case for using CM&S to accelerate medical device innovation and regulatory decision-making.

Product Teams: How modeling & simulation saves time and expense in route from concept to market for device innovation.

Engineering/R&D: Ability to explore more and different product design variations and situations than can be tested solely through physical means.

RA/QA: Using modeling & simulations with real-world evidence to inform clinical trials.

Sustainability & Ethics: Using CM&S to supplement and complement data from animal, bench and human testing in regulatory submissions to significantly reduce the burden and reliance on animal models and human data, thus reducing cost and accelerating innovation of new and next-generation devices.

Learn more and register for the complimentary Computer Modeling & Simulation in MedTech Product Development Submissions Virtual Conference
When: January 27–28, 2020
Where: Anywhere!

Speakers include:

  • Dr. Mark Palmer, Distinguished Scientist & Lead, Medtronic
  • Francisco Vicenty, Program Manager, Case for Quality, CDRH, FDA
  • Pras Pathmanathan, Research Scientist & Lead, OSEL Credibility fo Computational Models Regulatory Science Program, CDRH, FDA
  • Finn Donaldson, Acting Assistant Director, Peripheral Interventional Devices Team, OPEQ, CDRH, FDA
  • Andreu Badal, Physicist, Division of Imaging, Diagnostics & Software Reliability, OSEL, CDRH, FDA
  • Andrew Baumann, Mechanical Engineer, Division of Applied Mechanics, OSEL, CDRH, FDA
  • Brent Craven, Research Scientist, Division of Applied Mechanics, OSEL, CDRH, FDA
  • Jeff Bischoff, Director, Biomedics Research, Zimmer Biomet
  • Steve Levine, Executive Director, Living Heart Project
  • Randall Schiestl, Vice President, R&D, Boston Scientific
  • Payman Afshari, Senior Principal Engineer, Depuy Synthes Spine
  • Marc Horner, Senior Principal Engineer – Healthcare, Ansys
  • Dr. Arlen Ward, Principal, System Insight Engineering
  • Lisbet Geris, Executive Director, Virtual Physiological Human Institute
  • Alex Francois-Saint-Cyr, Portfolio Development Executive, Siemens Digital Industry Software

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