Analytical Framework for Examining the Value of Antibacterial Products. 5.1.6 Phase Success Probabilities


While unable to provide quantitative estimates of success probabilities, industry experts interviewed for the study indicated that by the time a device reaches the clinical stage, it has a very high chance of success in making it to market.  Experts also noted that most failures tend to occur at the early research and development phase.  Based on this input, we assume success probabilities of 33 percent, 80 percent, and 96 percent for the R&D, clinical, and FDA application stages, respectively, in the analysis.  We further assume that each of these parameters follows a triangular distribution with the following bounds:

  • R&D phase success probability: Lower bound of 25 percent, upper bound of 50 percent, likely point estimate of 33 percent,
  • Clinical phase success probability: Lower bound of 70 percent, upper bound of 90 percent, likely point estimate of 80 percent, and
  • FDA 510(k) application approval success: Lower bound of 90 percent, upper bound of 99 percent, likely point estimate of 96 percent.

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