Notwithstanding an occasional blip, the environment for medical device companies has never been stronger, with robust technology development, company creation rewarded with high levels of private and venture investment, and strong M&A activity all supporting a business model that was born out of the doldrums that device companies found themselves in a decade ago. Still, there are pressures that are straining the current model and raising legitimate concerns, including physician conflict-of-interest charges; regulatory pathways that are trickier and a climate of evidence-based medicine that leads to longer, more expensive trials; and a robust M&A environment that is sustainable only if a next-generation of acquiring companies steps up. Part one of a two-part series.