Simulation for Medical Device Design and Evaluation Seminar


2:00 PM - 5:00 PM (PDT)

Wolf Creek Restaurant and Brewing Company
27746 McBean Parkway
Valencia, CA 91354

Verly Flores

Computational modeling & simulation provides a virtual platform for performing virtual testing of product performance throughout the development cycle. This allows companies to identify poor candidate designs before building a single physical prototype and to continually understand and optimize the design as it proceeds through the various phases of development. The benefits of modeling and simulation include compression of the initial design feasibility timeline and increased success rates during product development process.

Recognizing the increased utilization of modeling tools by the medical device industry, the US FDA established a formal modeling and simulation initiative in 2011. This has resulted in the development of guidance documents, standards, and other best practices. This has resulted in the development of a regulatory pathway for submitting computational modeling and simulation results (i.e. digital evidence) as part of device submissions.

This seminar will begin with an overview of how modeling is used in the healthcare industry followed by an update on the regulatory opportunity and best practices for using modeling and simulation results as part of a submission. This will be followed by an overview of the importance of systems modeling and a demo of the ANSYS systems modeling simulation platform. The seminar will conclude with a few case studies.


ANSYS Welcome and Introduction
ANSYS in the Healthcare Industry
Regulatory Update
  • Regulatory Pathway for Computational Modeling
  • Overview of the ASME V&V 40 Standard with Example
  • Systems Modeling in the Healthcare Industry
  • Insulin Pump Demo
  •  Case Studies
  • Electrosurgery
  • Needle and Skin Penetration
  • MRI Electromagnetics Human Body Models
  • Please register early to reserve your spot. Appetizers and refreshments will be provided.

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