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

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2026-07-20
- Length: 39m
- Episode: 465
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-07-20-465-why-good-medical-devices-fail-reimbursement-strategy-with-ali-samiian
- Listen: https://podcast.greenlight.guru/episode/why-good-medical-devices-fail-the-reimbursement-strategy-with-ali-samiian

## Summary

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.

## Chapters

- [0:31](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-07-20-465-why-good-medical-devices-fail-reimbursement-strategy-with-ali-samiian#t=31) Introduction: Ali Samiian and the Reimbursement Challenge
- [2:56](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-07-20-465-why-good-medical-devices-fail-reimbursement-strategy-with-ali-samiian#t=176) Product Design and Site of Care Implications
- [5:56](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-07-20-465-why-good-medical-devices-fail-reimbursement-strategy-with-ali-samiian#t=356) Case Study: DME Criteria and Product Redesign
- [12:06](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-07-20-465-why-good-medical-devices-fail-reimbursement-strategy-with-ali-samiian#t=726) Mistake 1: Ignoring Reimbursement Until After FDA Clearance
- [14:03](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-07-20-465-why-good-medical-devices-fail-reimbursement-strategy-with-ali-samiian#t=843) Mistake 2: FDA-Centric Clinical Study Design
- [18:50](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-07-20-465-why-good-medical-devices-fail-reimbursement-strategy-with-ali-samiian#t=1130) New Regulatory Programs: TAP and RAPID
- [21:17](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-07-20-465-why-good-medical-devices-fail-reimbursement-strategy-with-ali-samiian#t=1277) Mistake 3: Rushing Regulatory Pathways Without Commercial Analysis
- [26:21](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-07-20-465-why-good-medical-devices-fail-reimbursement-strategy-with-ali-samiian#t=1581) Building New Codes and Pricing Strategy
- [35:16](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-07-20-465-why-good-medical-devices-fail-reimbursement-strategy-with-ali-samiian#t=2116) Advice for Series A Founders on Market Access

## Topics

- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)
- [Pricing, margins & unit economics](https://hardwarepodcasts.com/topic/pricing-and-unit-economics)
- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Design for manufacturing & NPI](https://hardwarepodcasts.com/topic/design-for-manufacturing)
- [Policy, trade & tariffs](https://hardwarepodcasts.com/topic/policy-trade-and-tariffs)

## Most relevant to

early-stage companies

## Mentioned

- Popular Access Advisors (company)
- Abbott (company)
- FreeStyle Libre (product)
- Cala Health (company)
- CMS (company)
- FDA (company)
- TAP Program (other)
- RAPID Program (other)
- DMEPOS (other)

## Related episodes from other shows

- [027 - "Become a Historian of the Problem" with Duane Mancini](https://hardwarepodcasts.com/podcast/lets-combinate/2022-04-06-027-become-a-historian-of-the-problem-with-duane-mancini) (Let's Combinate)
- [S2 E2: Demystifying Medical Device and System Development with Alan Cohen](https://hardwarepodcasts.com/podcast/the-builder-circle/2023-12-12-s2-e2-demystifying-medical-device-and-system-development-with-alan-cohen) (The Builder Circle)
- [190 - Harmony, Not Sameness: What Drug-Device Teams Keep Getting Wrong](https://hardwarepodcasts.com/podcast/lets-combinate/2025-05-28-190-harmony-not-sameness-what-drug-device-teams-keep-getting-wrong) (Let's Combinate)
- [104: Medical Device Certification vs Wellness Device](https://hardwarepodcasts.com/podcast/product-startup/2021-12-01-104-medical-device-certification-vs-wellness-device) (Product Startup)
- [074: Medical Device Product Development Best Practices](https://hardwarepodcasts.com/podcast/product-startup/2021-05-05-074-medical-device-product-development-best-practices) (Product Startup)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-07-20-465-why-good-medical-devices-fail-reimbursement-strategy-with-ali-samiian. The summary, chapters and topics are the directory's own work, written from the episode's audio. The episode itself, its title and its audio belong to Global Medical Device Podcast.