How to Survive Medtech & #039;s & #039;Death Valley & #039;

Medical device companies attempting to market a new treatment in the U.S. often make the erroneous assumption that winning FDA approval is the final destination, and success is theirs. In fact, going through the regulatory process is only the halfway point. The grueling path from FDA approval to reimbursement is like a treacherous walk through Death Valley and many companies don’t make it through. In this case study, I discuss the trials and triumphs of bringing robotic high intensity focused ultrasound (HIFU), a non-invasive procedure for localized prostate cancer, to the U.S. I'll shares lessons learned as EDAP TMS began its 14-year journey, starting with the FDA pre-market approval (PMA) process, shifting to the more expedient de novo 510(k), and winning FDA clearance. Then getting through the Death Valley gauntlet to finally win the American Medical Association’s (AMA) approval of a new Category 1 CPT code for treating prostate cancer, and reimbursement from insurers.   Jumping Through Hoops: The Rigors of FDA Approval We faced a protracted process when we first applied for a PMA for EDAP’s first HIFU device. HIFU is a non-invasive option that had been in use in Europe, Asia, and South America since 2000.  It allows the surgeon to destroy only the diseased portion of the prostate, thereby preserving healthy surro...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Business Source Type: news