Biomedical innovation: A risky business at risk

Richard S. Stack, Robert A. Harrington

Research output: Contribution to journalComment/debatepeer-review

3 Scopus citations


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.

Original languageEnglish (US)
Article number96cm23
JournalScience Translational Medicine
Issue number96
StatePublished - Aug 17 2011
Externally publishedYes

ASJC Scopus subject areas

  • Medicine(all)


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