# 254 - Saying No Is the Easy Part of Quality

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2026-09-13
- Length: 12m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2026-09-13-254-saying-no-is-the-easy-part-of-quality
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/254---Saying-No-Is-the-Easy-Part-of-Quality-e3oqbsp

## Summary

Subhi Saadeh, founder of Let’s Combinate, outlines four scenarios where quality professionals must firmly say no, including real patient risk, insufficient evidence, requirement violations, and schedule pressure. He contrasts these with three weak reasons for saying no, such as personal preference, technical uncertainty, and applying excessive GMP rigor to early-stage development. Saadeh advocates for a flexible quality culture that distinguishes between rigid compliance and risk-based decision-making, using a drug delivery platform case study to illustrate evidence-based stops.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2026-09-13-254-saying-no-is-the-easy-part-of-quality#t=0) Introduction: The Role of Quality in Saying No

## Topics

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

## Most relevant to

early-stage companies

## Mentioned

- The Effective Executive (other)

## Related episodes from other shows

- [Past, Present, Future State (and World) of Quality in the Medical Device Industry](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-09-22-past-present-future-state-and-world-of-quality-in-the-medical-device-industry) (Global Medical Device Podcast)
- [Guerilla Tactics for Quality Leadership](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-07-20-guerilla-tactics-for-quality-leadership) (Global Medical Device Podcast)
- [#390: Building a Non-BS QMS: 4 Core Principles for MedTech Success with Ashkon Rasooli](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-11-07-390-building-a-non-bs-qms-4-core-principles-for-medtech-success-with-ashkon-raso) (Global Medical Device Podcast)
- [#352: Fundamentals of Quality & Regulatory](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-01-18-352-fundamentals-of-quality-regulatory) (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)

## 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/2026-09-13-254-saying-no-is-the-easy-part-of-quality. 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.