There is absolutely no connection between these two headline items, except that in both industries something went wrong. Naturally enough, medical device disasters provoke about as much public furore, but there the similarity ends.
This week we take a look at some snippets from the Kransky vs J&J DePuy proceedings and conclude that getting a device successfully and safely into use is not a black and white case of ticking boxes to say it works. Risk analysis is clearly much more subtle than that, and any regulatory regime that tries to paint validation activities into tick boxes will leave us with more failures in the future.
Anyway, enjoy the read here and remember it’ll be available as a podcast by Monday.