To be successful in today’s dynamic and increasingly cost conscious healthcare environment requires companies to fundamentally change the way they think about their products. Companies need to develop an understanding of how their products contribute to improved clinical outcomes against existing therapies and what data they will need to prove it. Government agencies are increasingly resistant to providing reimbursement at premium — and sometimes even par levels — without solid data showing significantly improved outcomes. Even with solid outcomes, if the product fails to demonstrate critical economic and clinical value (ECV) against existing treatments, reimbursement decisions can be less than favorable. As national agencies try harder to contain the cost of healthcare, adaptation to the new rules of pricing and reimbursement will continue to be a major challenge for pharmaceutical and medical device companies.