# 043 - “Half Knowledge Can Hurt” with Shadeed Salam

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2022-07-27
- Length: 1h 14m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2022-07-27-043-half-knowledge-can-hurt-with-shadeed-salam
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/043---Half-Knowledge-Can-Hurt-with-Shadeed-Salam-e1lmi8r

## Summary

Shadeed Salem, Founder and President of Synergy Bioscience, explains the critical differences between validating test methods for pharmaceutical products versus medical devices. He details how drug methods focus on specificity, linearity, and detecting toxic degradation products (LOD/LOQ), while device methods prioritize physical, mechanical, and visual inspections using Gage R&R. Salem shares a war story about remediating 4,600 OOS investigations by separating R&D and QC labs and validating 136 unverified methods to close an FDA warning letter. He emphasizes that 'half knowledge can hurt' when engineers assume drug and device validation protocols are interchangeable without understanding the underlying regulatory and scientific distinctions.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2022-07-27-043-half-knowledge-can-hurt-with-shadeed-salam#t=0) Introduction: Shadeed Salem and Synergy Bioscience
- [5:13](https://hardwarepodcasts.com/podcast/lets-combinate/2022-07-27-043-half-knowledge-can-hurt-with-shadeed-salam#t=313) Career Transition from Lab Chemist to Quality SME
- [11:54](https://hardwarepodcasts.com/podcast/lets-combinate/2022-07-27-043-half-knowledge-can-hurt-with-shadeed-salam#t=714) War Story: Remediating 4,600 OOS and 136 Unvalidated Methods
- [18:13](https://hardwarepodcasts.com/podcast/lets-combinate/2022-07-27-043-half-knowledge-can-hurt-with-shadeed-salam#t=1093) Compendia Methods: USP (Mandatory) vs. ISO (Guideline)
- [26:53](https://hardwarepodcasts.com/podcast/lets-combinate/2022-07-27-043-half-knowledge-can-hurt-with-shadeed-salam#t=1613) Drug vs. Device Validation: Specificity, Linearity, and Gage R&R
- [30:34](https://hardwarepodcasts.com/podcast/lets-combinate/2022-07-27-043-half-knowledge-can-hurt-with-shadeed-salam#t=1834) Visual Inspection: Attribute Agreement and Automated Systems
- [41:25](https://hardwarepodcasts.com/podcast/lets-combinate/2022-07-27-043-half-knowledge-can-hurt-with-shadeed-salam#t=2485) Physical and Mechanical Testing: Gauge Sensitivity and Bias
- [50:43](https://hardwarepodcasts.com/podcast/lets-combinate/2022-07-27-043-half-knowledge-can-hurt-with-shadeed-salam#t=3043) LOD and LOQ: Detecting Toxicity in Pharmaceutical Products
- [1:06:59](https://hardwarepodcasts.com/podcast/lets-combinate/2022-07-27-043-half-knowledge-can-hurt-with-shadeed-salam#t=4019) Conclusion: 'Half Knowledge Can Hurt' and Industry Future

## Topics

- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Mechanical engineering](https://hardwarepodcasts.com/topic/mechanical-engineering)
- [Analog & power electronics](https://hardwarepodcasts.com/topic/analog-and-power-electronics)

## Most relevant to

early-stage companies

## Mentioned

- Synergy Bioscience (company)
- Bristol Myers Squibb (company)
- FDA (other)
- USP (other)
- ISO (other)
- HPLC (tool)
- FTIR (tool)
- Mass Spectrometry (tool)

## Related episodes from other shows

- [How Jon Speer Met His Most Frequent Guest: Mike Drues](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-08-26-how-jon-speer-met-his-most-frequent-guest-mike-drues) (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)
- [Setting the Record Straight on Usability & Human Factors](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-11-03-setting-the-record-straight-on-usability-human-factors) (Global Medical Device Podcast)
- [What are the Opportunities for Improvement (OFI) for Quality?](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-02-23-what-are-the-opportunities-for-improvement-ofi-for-quality) (Global Medical Device Podcast)
- [#392: Verification and Validation in MedTech: A Practical Guide with Devon Campbell](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-11-22-392-verification-and-validation-in-medtech-a-practical-guide-with-devon-campbell) (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/2022-07-27-043-half-knowledge-can-hurt-with-shadeed-salam. 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.