Device developers tend to focus on the FDA approval process—PMAs and 510(k) clearances—while overlooking another major challenge: getting insurers to cover the device. Before approaching investors, and certainly before doing any studies, keep payers in mind, advises Maren Anderson, president of MDA Consulting, Inc., which specializes in reimbursement planning.
In the old days, doctors prescribed, and insurers paid. Under health care reform, that’s changed, says Anderson. …
In Part 1 last week, Vector took a look at digital health apps, telemedicine, genomics, phenomics and new behavioral diagnostics as transformative trends in pediatrics. This week, we complete our list. These posts will also appear as an article in the fall issue of Children’s Hospitals Today magazine.
6. New pharma research and development (R&D) models
Academic medical centers have always worked with the pharmaceutical industry but never so closely as now. In the old model, industry drove therapeutic development. A company might fund an academic project or supply reagents, but the relationship generally ended with the project (and publication of a paper).
Now, with drug pipelines drying up and R&D costs rising, Big Pharma is under pressure to change. New industry-academia collaborations are forging creative partnerships, altering how both parties do business. The new models are allowing hospital researchers to do what they’ve never done before: take the lead in R&D. …
“Value is more important than innovation,” declared Angus Russell, CEO of Shire Pharmaceuticals, in his opening keynote address at Biopharm America last week. At a drug development conference, where attendees typically focus on interesting new ways to address therapeutic problems, that sounded a bit heretical.
But it was a telling example of how cost pressures are now manifesting in pharma. Some complex treatments can be new and innovative, but not provide measurable improvement in patient outcomes. Can we conclude that they have no value? This has been one of the central questions fueling the debate over U.S. healthcare reform, and will influence development of medicines into the future.