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Computer Modeling & Simulation in
MedTech Product Development & Submissions
A virtual conference
January 27-28, 2021
11:00 AM - 4:00 PM ET Computer modeling and simulation (CM&S) are widespread in many industries, but are only recently being adopted in med tech, which still largely relies on a “build and test” approach. Prototyping, testing, and design optimization are costly and time-consuming. Clinical studies consume even more time and money, and there are practical and ethical limitations on the populations, parameters, and treatment contexts that can be explored.
The use of CM&S in both the product development and clinical evidence development phases can expand the realm of designs, tests, manufacturing strategies, and patient characteristics, and enable companies to focus on those critical issues that might still need to be examined through traditional means. In some cases CM&S can do important studies that are impossible through physical testing.
CM&S is no longer only for very large companies with specially skilled internal staffs, but can benefit smaller device manufacturers as well.
This two-day virtual conference provides a comprehensive overview of what CM&S can and cannot do, the potential advantages throughout the product life cycle, the business case for simulation, FDA’s views on in silico data in regulatory submissions, and demonstrations and case studies of its use in diverse applications.
Who should attend:
· Senior management
· Product development strategy
· Regulatory and quality
What you will learn:
· The uses and limitation of CM&S in med tech product development
· Simulation to support, enhance, or replace clinical studies
· Relevant examples from other industries
· The business case for CM&S
· FDA’s perspective of CM&S
· Standards and validation of modeling data
· The processes of CM&S
· Case studies of successful med tech CM&S
· The promise of digital twins, personalized modeling, and 3D printing
· The future of CM&S
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