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FDA Regulation of Product Risk and Its Impact Upon Young Biomedical Firms
Author(s) -
Hauptman Oscar,
Roberts Edward B.
Publication year - 1987
Publication title -
journal of product innovation management
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.646
H-Index - 144
eISSN - 1540-5885
pISSN - 0737-6782
DOI - 10.1111/1540-5885.420138
Subject(s) - sophistication , food and drug administration , business , product (mathematics) , medical device , process (computing) , marketing , industrial organization , risk analysis (engineering) , medicine , geometry , mathematics , social science , sociology , computer science , biomedical engineering , operating system
Data gathered on 62 products from 26 biomedical firms founded in Massachusetts between 1968 and 1975 show a positive relationship between the level of technological sophistication of a firm's products and the risk associated with the use of those products. Oscar Hauptman and Edward Roberts report the results of their study of the impact of the U.S. Food and Drug Administration's approval process on these firms' resources and time. They found that young firms dealing with medical devices and pharmaceuticals were more sensitive to this regulatory process than those producing medical auxiliary products. Enactment of the 1976 FDA regulations amendment affecting medical devices apparently created a precarious environment for the marketing of new products. The amendment was found to have significant impact beyond its target product area, medical devices and supplies. It also challenged the management of firms producing drugs and Pharmaceuticals.