Virtual Patient Models in Medical Device Clinical Studies: FDA & Industry Collaboration
3:15 PM - 4:00 PMThu
Speakers
Adam Himes
Senior Engineering Manager, Technical Fellow
Medtronic
• How a predictive virtual patient models can be used to simulate clinical outcomes. · Incorporating virtual patients into clinical studies with Bayesian statistical techniques · Results show improved clinical study characteristics compared to no prior information · Mock submission process has benefits for both regulators and manufacturers