ARTICLE SUMMARY:
Device firms need to proactively implement programs to ensure that patient claims data is available from clinical trials to support future strategic efforts to establish coverage, codes, and payment for a new medical technology. This means implementing well-managed patient access programs early. By Kelli Hallas and Mike Simon.
There is a misconception that patient access to new medical technologies begins with FDA approval. In fact, patient access to emerging technologies begins at the onset of an FDA-approved clinical trial.