2004S-0233 - Solicitation of Comments on Stimulating Innovation in Medical Technologies
FDA Comment Number : EC1
Submitter : Dr. Stephen Small Date & Time: 06/10/2004 04:06:13
Organization : U Chicago/Developing Center Patient Safety
Academia
Category :
Issue Areas/Comments
Questions
1. What strategies and approaches could HHS implement to accelerate the development and application of new medical technologies?
Understanding and ameliorating risks is a critical process step in developing, approving, and applying new medical technologies and devices. The use of simulation techniques has potential to accelerate technology innovation by enabling a much more rapid, systematic and thorough understanding of actual user and operational issues that impact risk. Traditional methods - convenience, ad-hoc, or laboratory condition testing - are not cost or time efficient ways to provide relevant "stress tests" required to more fully understand or explore use risks. Simulation approaches can reliably and efficiently provide these operational stress tests in a shorter time frame and so have the potential to accelerate applications. An additional benefit would be the potential avoidance of possible patient injuries and near misses which would occur under operational conditions in the post approval period.