The Cure for the Common Supply Chain: Medical device OEMs con cure their supply-chain ills with suppliers who do more than supply

摘要

The changing regulatory and political actions imposed upon medical device OEMs are pressuring them to further scrutinize their businesses to remain competitive. Industry reports estimate that more than 75% of the average $31 million cost to bring a low-to-moderate 510(k) medical device to market; and 75% of the average $94 million cost to bring a high-risk device that requires premarket approval to market are related to clearing regulatory requirements. Added to that is the impact of the Affordable Care Act's 2.3% excise tax on all US sales of medical devices - a projected (by AdvaMed) $30 billion industry hit over the next decade and a 33% increase in the medtech industry's overall tax burden.