Podcast Episodes
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MedTech's Last Mile: Ensuring Uptime with Superior Logistics
Beyond regulatory approval, the success of high-complexity medical devices hinges on a robust support infrastructure. This episode explores the criti…
1 year, 1 month ago
Beyond the Handshake: Structuring MedTech Distributor Contracts That Perform
Granting distributor exclusivity can be a powerful market entry tool, but it carries significant risks if not managed correctly. This episode explore…
1 year, 1 month ago
Unlock the US IVD Market: Finding the Right Distributor Fit
Choosing the right U.S. distributor is a make-or-break decision for IVD manufacturers. This episode explores why customer fit and sales focus are mor…
1 year, 1 month ago
Cracking the Code: IVD Reimbursement in Europe vs. The United States
This episode breaks down the critical differences in securing reimbursement for In-Vitro Diagnostics (IVDs) between the European Union's national HTA…
1 year, 1 month ago
Unlocking U.S. Medicare Coverage for Your IVD Test
This episode breaks down the complex process of how the U.S. Centers for Medicare & Medicaid Services (CMS) decides whether to cover a new in-vitro d…
1 year, 1 month ago
IVD Pricing Power: The Post-Market Data Payers Demand
This episode delves into the critical post-market data strategies required to secure and defend reimbursement for innovative in-vitro diagnostics (IV…
1 year, 1 month ago
Securing Your Assay's CPT Code: A Guide to US Reimbursement and the CLFS
This episode details the process of obtaining a unique CPT or PLA code for a diagnostic assay in the U.S. and its direct impact on reimbursement unde…
1 year, 1 month ago
FDA Export Certificates: Navigating Apostille and Legalization Requirements
This episode demystifies the critical process of authenticating FDA export documents, such as the Certificate to Foreign Government (FSC/CFG), for in…
1 year, 1 month ago
Unlocking Exports: FSC Documentation by Device Class
This episode provides a detailed guide on the essential supporting documents required for a Free Sales Certificate (FSC) application. We break down t…
1 year, 1 month ago
Your Product's Passport: Unlocking Global Sales with an FSC
In this episode, we demystify the Free Sales Certificate (FSC), a critical document for medical device and IVD manufacturers aiming for international…
1 year, 1 month ago