# 243 - Why Kitting A Finished Medical Device with a Drug Create So Much Work

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2026-06-24
- Length: 14m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2026-06-24-243-why-kitting-a-finished-medical-device-with-a-drug-create-so-much-work
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/243---Why-Kitting-A-Finished-Medical-Device-with-a-Drug-Create-So-Much-Work-e3l6s0r

## Summary

Subhi Saadeh, Founder of Let’s Combinate, explains why selecting commercially available finished medical devices for combination product kits creates significant regulatory and quality challenges. He argues that an 'already approved' device is not automatically qualified for a new combination product context, as the buyer inherits the supplier's design, QMS, and validation decisions. Saadeh outlines three critical lifecycle moments—before, during, and after supplier selection—to mitigate risks, emphasizing the need for structured qualification using PPAP concepts like PFMEA and control plans. He warns that assuming commercial availability equals suitability often leads to late-stage failures, such as coring issues or market approval gaps.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2026-06-24-243-why-kitting-a-finished-medical-device-with-a-drug-create-so-much-work#t=0) Introduction: The Stakes of Device Selection in Combination Products

## Topics

- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Sourcing & supply chain](https://hardwarepodcasts.com/topic/sourcing-and-supply-chain)

## Most relevant to

early-stage companies

## Mentioned

- FDA (other)
- PPAP (tool)
- PFMEA (tool)

## Related episodes from other shows

- [#467: Combination Product Compliance: PMOA, 21 CFR Part 4 & QMS Alignment](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-08-03-467-combination-product-compliance-pmoa-21-cfr-part-4-qms-alignment) (Global Medical Device Podcast)
- [#380: Navigating the Complex World of Combination Products with Subhi Saadeh](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-08-30-380-navigating-the-complex-world-of-combination-products-with-subhi-saadeh) (Global Medical Device Podcast)
- [Why Supplier Quality Management Is So Important For Medical Device Companies](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-11-27-why-supplier-quality-management-is-so-important-for-medical-device-companies) (Global Medical Device Podcast)
- [Knowing vs. Doing as Medical Device Professionals](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-04-19-knowing-vs-doing-as-medical-device-professionals) (Global Medical Device Podcast)
- [How to Select a Contract Manufacturer](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-02-02-how-to-select-a-contract-manufacturer) (Global Medical Device Podcast)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/lets-combinate/2026-06-24-243-why-kitting-a-finished-medical-device-with-a-drug-create-so-much-work. 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 Let's Combinate.