Empirical assessment of the time course of innovation in biomedical engineering: first results of a comparative approach

Abstract

The pathway from the flash of a technological invention until its use as a medical device in every day care is tedious and burdensome. But the often postulated acceleration has to balance the speed of innovation and the indispensable product safety by an improved understanding of the innovation cycle. While several studies investigated the time course of pharmaceutical innovation, a comparable empirical analysis of medical devices is lacking. Thus we evaluated the time between the patent priority date and the corresponding receipt of the CE mark as a function of a medical device risk class in 61 cases. The statistical analysis yielded a time increment (trend) from medical devices in risk category I (median = 5.8 years) compared to risk category III (median = 10.4 years), which is close to literature reported values for drug development (9–12 years). The difference between products in risk classes I and II did not reach significance. To investigate the underlying facts, a text-mining approach especially to resolve the ambiguity of, e.g. patents, CE Marks etc. is suggested for increasing the sample size.

Keywords

• information retrieval
• medical device
• pace
• technology transfer
• translational research
• time lag