After seemingly endless rounds of rhetoric and debate, the 2012 Presidential Campaign has finally reached its conclusion. We know what each of the candidates had said they would do, but now that the President has been re-elected, the focus has moved from politics to policy. So what can pharmaceutical and medical device manufacturers expect to happen next?

PPACA emerged from the frustration of increasing healthcare costs, inadequate quality, and coverage issues… clearly, inadequate value for each dollar spent. But the idea of demonstrating value is far from revolutionary for the medical products industry. The recent ‘big’ news (and threat) has been comparative effectiveness research (CER) and increasing global pressure to demonstrate economic and clinical value. Whether or not healthcare policy exists in its current form, manufacturers will need to demonstrate value for their products. As CER makes its way to the delivery sector, and new requirements for predictive care paths emerge alongside downward reimbursement pressure, having branded products “baked in” to these care paths will be essential to future success.