Uncertainty in the hybridisation of new medical devices

This case study of the intervertebral artificial disc affords the opportunity to analyse two kind of uncertainties related to new medical device designs. The uncertainties refer here not only to basic medical knowledge (as is usual in studies of innovation in medical devices, see Metcalfe et al. 2005, Mina et al. 2007, Morlacchi and Nelson 2011) but also to the performance of devices whose design is based on different fundamental understandings of disease. In this work, I argue that the hybridisation of devices is one of the strategies used to manage the latter uncertainty. Hybridisation consists of the embodiment of multiple and functionally competing operational principles ¹ within a single medical device when there is little or no clinical data on their comparative performance. Stated in conditional logic language, the justification for hybridisation is that: ‘if you do not know which operational principle is better, then choose all’.