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Reimbursement is critical to market success for products that are administered in hospitals or clinics. BMS advises planning for reimbursement at every stage of product development. Reimbursement issues, such as whether new or existing medical codes are appropriate, affect regulatory choices in product claims and labeling and (for devices) whether to prepare 510(k) vs.PMA applications.

Clinical studies are the key to achieving acceptance of new technologies and medical treatments not only for regulatory authorities, but also for reimbursement coverage, formulary acceptance, and physician utilization. Success in clinical studies can be achieved only by excellence and attention to detail in clinical protocols and statistical plans.

Managed care has transformed the pharmaceutical and medical device marketplace. Physicians, hospital administrators, and managed care medical directors need relevant, credible information, and your marketing program needs to deliver this information effectively. Accurate competitive intelligence that is timely and segmented can be the key to maximizing market penetration while minimizing sales force costs.