# 229 -Outsourcing Analytical Testing: What Sponsors Get Wrong in Combination Products

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2026-03-11
- Length: 31m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2026-03-11-229-outsourcing-analytical-testing-what-sponsors-get-wrong-in-combination-produc
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/229--Outsourcing-Analytical-Testing-What-Sponsors-Get-Wrong-in-Combination-Products-e3g8rta

## Summary

Jen Riter, an analytical testing leader with experience at West Pharmaceutical Services and Kindeva Drug Delivery, explains the critical differences between validating chemical methods under ICH Q2 and functional/mechanical methods for combination products. She details the necessity of using an engineering mindset, including Measurement System Analysis (MSA) and gage R&R, and the use of fabricated surrogate standards like metal syringes to validate performance methods. The discussion covers leveraging ISO 11040 for platform methods, the verification versus validation debate between ISO and USP standards, and strategic decisions regarding outsourcing specialized testing such as Container Closure Integrity Testing (CCIT) and extractables/leachables to contract laboratories.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2026-03-11-229-outsourcing-analytical-testing-what-sponsors-get-wrong-in-combination-produc#t=0) Introduction: Jen Riter and the ICH Q2 vs. MSA Mindset Shift
- [1:32](https://hardwarepodcasts.com/podcast/lets-combinate/2026-03-11-229-outsourcing-analytical-testing-what-sponsors-get-wrong-in-combination-produc#t=92) Surrogate Standards and Fabricated Controls for Mechanical Testing
- [9:09](https://hardwarepodcasts.com/podcast/lets-combinate/2026-03-11-229-outsourcing-analytical-testing-what-sponsors-get-wrong-in-combination-produc#t=549) Platform Methods and ISO 11040 Application
- [13:30](https://hardwarepodcasts.com/podcast/lets-combinate/2026-03-11-229-outsourcing-analytical-testing-what-sponsors-get-wrong-in-combination-produc#t=810) ISO vs. USP Verification and Component-Level Testing
- [18:10](https://hardwarepodcasts.com/podcast/lets-combinate/2026-03-11-229-outsourcing-analytical-testing-what-sponsors-get-wrong-in-combination-produc#t=1090) Outsourcing Strategy: Make vs. Buy for Specialized Testing
- [20:42](https://hardwarepodcasts.com/podcast/lets-combinate/2026-03-11-229-outsourcing-analytical-testing-what-sponsors-get-wrong-in-combination-produc#t=1242) Choosing the Right Test Lab and SME Expertise
- [26:17](https://hardwarepodcasts.com/podcast/lets-combinate/2026-03-11-229-outsourcing-analytical-testing-what-sponsors-get-wrong-in-combination-produc#t=1577) Sponsor Oversight and Risk Management with Contract Labs

## Topics

- [Mechanical engineering](https://hardwarepodcasts.com/topic/mechanical-engineering)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Manufacturing partners & offshoring](https://hardwarepodcasts.com/topic/manufacturing-partners)
- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)
- [Sourcing & supply chain](https://hardwarepodcasts.com/topic/sourcing-and-supply-chain)

## Most relevant to

early-stage companies

## Mentioned

- West Pharmaceutical Services (company)
- Kindeva Drug Delivery (company)
- ICH Q2 (other)
- ISO 11040 (other)
- USP 382 (other)
- CCIT (other)

## 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)
- [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)
- [Quality Management for IVD Devices vs Medical Devices](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-04-05-quality-management-for-ivd-devices-vs-medical-devices) (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)
- [#384: Insights from an Ex-FDA Investigator: Compliance, Quality Systems, and MedTech Trends](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-09-26-384-insights-from-an-ex-fda-investigator-compliance-quality-systems-and-medtech) (Global Medical Device Podcast)

## Citing this page

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