In the past, all companies needed to do as they developed their products from the lab to the marketplace was to demonstrate to regulators that they were safe and effective. That will no longer be enough. As pressure grows for governments to rein in the cost of healthcare, there will be increasing demand that therapies also be shown to be cost-effective. Companies will not only have to show their products are better able to treat a disease than what is already available, but comparative effectiveness and pharmaco-economic efficiency will emerge as de facto regulatory standards.
In the near future, it will not be enough just to do something better. Pharma, biotech, and medical devices companies will also need to provide true economic savings and better patient outcomes. A dramatic change toward a performance based, high-value healthcare system is underway. Innovative products will not only be judged by how well they perform, but whether they represent true improvements over existing products and do so on a cost-effective basis.