Statistics in the World of Medical Devices: The Contrast with Pharmaceuticals

Abstract

Medical devices play a vital role in people's lives as these products are revolutionizing medicine with breathtaking advances in both the treatment and the detection of many diseases. While a similar, primarily therapeutic, revolution is ongoing in the pharmaceutical world; the focus here is the effect this device revolution is having on the statistical world. The similarities and differences between medical devices and pharmaceutical drugs are explored in terms of their natures, industries, and how they are regulated in the U.S. and globally. Statistical issues concerning the evaluation of devices versus those of drugs are compared and contrasted. These trends are creating new challenges for the statistical world in the development and evaluation of these new medical products.

Key Words:

• Bayesian clinical trials
• Diagnostic test evaluation
• Pharmacogenomics
• Regulatory statistics

Notes

*The views expressed in this paper are those of the author; no official endorsement of this paper by the Food and Drug Administration is intended or should be inferred.