I repeatedly hear two competing, contradictory themes discussed at every symposia – the need to lower healthcare costs and that costs to bring new technology to market are rapidly increasing. The U.S. leadership position as a medical technological innovator is slipping to Europe, where there is a much wider selection of devices to choose from. The requirements to gain CE mark clearance are much more lenient than U.S. Food and Drug Administration (FDA) pre-market approval. Â
