How to Survive Medtech 's 'Death Valley '

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

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Source: Quality Management in Healthcare - Category: Health Management Tags: Original Articles Source Type: research
Conclusion: This article outlines the evaluation of a new program demonstrating that medical oncology practices can make improvements in the care of their underserved populations if provided with the proper tools, methods, and coaching. The use of formative evaluation methodology also identified opportunities for improvement and ultimately resulted in additional funding for more practices to participate in the program.
Source: Quality Management in Healthcare - Category: Health Management Tags: Methods and Instruments Source Type: research
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Source: The Nurse Practitioner - Category: Nursing Tags: Department: Preventing, Treating, and Surviving Cancer Source Type: research
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Source: Risk Analysis - Category: International Medicine & Public Health Authors: Tags: Original Research Article Source Type: research
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