Biomedical innovation: a risky business at risk.

Journal Article (Journal Article)

Regulatory and financial challenges conspire to stall the development and market approval of breakthrough medical products. Inconsistent parameters are used to assess the safety and efficacy of drugs, biologics, and devices; this glitch in the system introduces uncertainty, slows or blocks product approvals, and increases the costs of product development. Here, we consider how to balance the benefits and risks to the public in the assessment of innovative medical products. We also discuss the Institute of Medicine's recent report on the medical device approval process.

Full Text

Duke Authors

Cited Authors

  • Stack, RS; Harrington, RA

Published Date

  • August 17, 2011

Published In

Volume / Issue

  • 3 / 96

Start / End Page

  • 96cm23 -

PubMed ID

  • 21849662

Electronic International Standard Serial Number (EISSN)

  • 1946-6242

Digital Object Identifier (DOI)

  • 10.1126/scitranslmed.3002459


  • eng

Conference Location

  • United States