Healthcare decision-makers worldwide are increasingly sophisticated in their ability to discern the value of medical technology. While not all health systems incorporate perfect incentives for ensuring a clear correlation between product value and the innovator's financial returns, the trend toward value-based pricing and associated reimbursement is clear. Pay-for-performance, though taking a wide range of forms, now plays a central role in the payment systems of public and private insurers in the US and major international markets. The implications of these trends are profound. Medical technology firms must now consider and be prepared to address the following types of questions:

• How can we best ensure we're capturing data in our clinical trials that will be needed for pricing and reimbursement?
• What is the unmet medical need in this category and how do we measure and convey it in a compelling way to our customers?
• Will the costs associated with monitoring patients on this medication outweigh the potential clinical benefits?
• How do we measure the value of our product across vastly different healthcare systems?
• What is the potential budget impact of our product on various payers?
• How will existing or planned quality metrics and practice guidelines influence product acceptance?
• Might we be more profitable by pursuing specific subpopulations rather than all potential patients?

Biopharmaceutical firms today need to develop and articulate compelling value propositions for their products. Such health economic and outcomes research information will be requested or mandated by payers and health care decision makers in every major market. Further, the methodological standards for the collection, analysis, presentation and interpretation of these data are dynamic. Add to this complex environment that political forces and key opinion leaders influence coverage decisions and it becomes clear that having an experienced partner to help navigate your way through the commercialization process has never been more critical.