# 093 - Combination Products Handbook Part 2: Supplier Management, Drug/Device Analytical Testing, Biologics, Digital/Connected Health and Changing Regulatory Landscape with Susan Neadle

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2023-07-12
- Length: 25m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2023-07-12-093-combination-products-handbook-part-2-supplier-management-drug-device-analyti
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/093---Combination-Products-Handbook-Part-2-Supplier-Management--DrugDevice-Analytical-Testing--Biologics--DigitalConnected-Health-and-Changing-Regulatory-Landscape-with-Susan-Neadle-e26pv29

## Summary

Susan Neadle, Principal Consultant at Combination Products Consulting Services LLC and author of 'The Combination Products Handbook', discusses advanced topics in combination product development with host Subi Saadeh. They cover supplier management nuances, specifically the risks of relying on 'medical grade' claims and the critical need for prior approval of supplier changes. The conversation also addresses analytical testing for biologics, highlighting compatibility issues between drug formulations and device constituents, and the evolving regulatory landscape for digital health and global combination products.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2023-07-12-093-combination-products-handbook-part-2-supplier-management-drug-device-analyti#t=0) Introduction and Supplier Management Overview
- [3:37](https://hardwarepodcasts.com/podcast/lets-combinate/2023-07-12-093-combination-products-handbook-part-2-supplier-management-drug-device-analyti#t=217) Supplier Quality and Raw Material Risks
- [11:41](https://hardwarepodcasts.com/podcast/lets-combinate/2023-07-12-093-combination-products-handbook-part-2-supplier-management-drug-device-analyti#t=701) Managing Supplier Changes and Quality Agreements
- [16:09](https://hardwarepodcasts.com/podcast/lets-combinate/2023-07-12-093-combination-products-handbook-part-2-supplier-management-drug-device-analyti#t=969) Analytical Testing and Container Closure Interactions
- [20:08](https://hardwarepodcasts.com/podcast/lets-combinate/2023-07-12-093-combination-products-handbook-part-2-supplier-management-drug-device-analyti#t=1208) Biologics and Device Compatibility
- [22:30](https://hardwarepodcasts.com/podcast/lets-combinate/2023-07-12-093-combination-products-handbook-part-2-supplier-management-drug-device-analyti#t=1350) Digital Health, Real World Evidence, and Global Regulations

## Topics

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

## Most relevant to

established companies

## Mentioned

- Combination Products Consulting Services LLC (company)
- The Combination Products Handbook: A Practical Guide (other)
- Taylor & Francis Group (company)
- Johnson & Johnson (company)
- ISPE (company)
- ASTM International (company)
- AAMI (company)
- UMBC (company)
- DIA (company)
- RAPS (company)
- FDA (company)
- 21 CFR 820 (other)
- ISO 10993 (other)
- Fran de Grazio (other)
- Mira R. (other)
- Daniel Bance (other)
- Jennifer Ryder (other)
- Manfred Mater (other)
- Stephanie Google (other)
- Vicki Vernon (other)
- Sherry Marty (other)
- Raj Bell (other)

## Related episodes from other shows

- [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)
- [#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)
- [#323 The Combination Products Handbook](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-06-16-323-the-combination-products-handbook) (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)
- [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/2023-07-12-093-combination-products-handbook-part-2-supplier-management-drug-device-analyti. 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.