OBJECTIVES: To conduct a study to assess value perceptions and the evidence needs for key stakeholders of medical product manufacturers, including payers and employers. This study was a structured, qualitative assessment of influential U.S. health plans and companies. METHODS: Telephone survey interviews were used to collect data from fifteen private U.S. payer representatives and payer-related experts. Phone and in-person interviews were conducted with twenty-six U.S. employer representatives. Working behavioral assumptions were constructed for the payer and employer groups, and stakeholder-specific discussion guides were used to facilitate the survey interviews. RESULTS: The top payer findings suggest that health plans are most interested in clinical safety, efficacy, and effectiveness evidence. Payers' demands are increasing for more clinical utility and clinical performance studies providing comparative information for medical products. Cost and cost-effectiveness were identified as important but secondary considerations for coverage and reimbursement decisions. The employers surveyed exhibited substantial diversity in their approach to providing health care benefits for employees. The majority of employers and payers reported that consumer-directed health care (CDHC) plans are increasing in scope and will play a larger role moving forward. Most reported that the effects of CDHC on costs and long-term health outcomes are unclear. Recent trends associated with health care costs increasing faster than inflation contribute to employers' difficulty with defining “value in health care” and to their challenges associated with evaluating return on investment for health care expenditures. CONCLUSION: U.S. employers and payers are struggling with clearly defining the concept of medical product value. Payers rely on phase III randomized controlled trials as their primary evidence source for covering medical products, yet request additional post-marketing comparative studies. Employers are largely engaged in cost-shifting to employees and are trying to select younger and healthier workforces to reduce their health care expenditures.