Hardware Podcasts

#465: Why Good Medical Devices Fail: Reimbursement Strategy with Ali Samiian

Global Medical Device Podcast · 20 Jul 2026 · 39m · Episode 465

What this episode covers

Ali Samiian, founder of Popular Access Advisors, explains why medical device companies fail commercially by treating reimbursement as a post-FDA paperwork exercise rather than a core product strategy. He details how product design, clinical trial endpoints, and regulatory pathways (such as 510(k) vs. De Novo) must align with payer requirements for durable medical equipment (DME) or other categories to ensure coverage. Samiian highlights the importance of demonstrating durability, standard-of-care comparisons, and value to the healthcare system to secure appropriate pricing from CMS and private payers.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Popular Access Advisors, Abbott, Cala Health, CMS, FDA
Products
FreeStyle Libre
Also
TAP Program, RAPID Program, DMEPOS

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